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A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03104413
Recruitment Status : Completed
First Posted : April 7, 2017
Results First Posted : June 14, 2022
Last Update Posted : June 14, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Crohn's Disease
Interventions Drug: placebo for risankizumab IV
Drug: risankizumab SC
Drug: risankizumab IV
Enrollment 618
Recruitment Details Subjects were randomized to receive 600mg risankizumab, 1200mg risankizumab or placebo during the double-blind, placebo-controlled Period 1. At Week 12, subjects who do not achieve clinical response were randomized into Period 2 to receive 180mg risankizumab, 360mg risankizumab or 1200mg risankizumab. Subjects who received placebo received 1200mg.
Pre-assignment Details A total of 618 subjects were enrolled and 605 were included in the intent-to-treat (ITT) population; 569 of those had a baseline eligible Simple Endoscopic Score for Crohn's disease (SES-CD) of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component and were included in the ITT1A population. This population was the primary population for both the United States (US) specific as well as the Global (Outside the US) efficacy analysis' of the 12-Week Induction Period.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1) Risankizumab Dose 180mg (Induction Period 2) Risankizumab 360mg (Induction Period 2) Risankizumab 1200mg (Induction Period 2) Placebo/Risankizumab 1200mg (Induction Period 2)
Hide Arm/Group Description

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 180mg by subcutaneous(SC) injection at Weeks 12 and 20.

risankizumab SC: risankizumab administered by subcutaneous (SC) injection.

Participants randomized to receive risankizumab 360mg by subcutaneous injection at Weeks 12 and 20.

risankizumab SC: risankizumab administered by subcutaneous (SC) injection

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Weeks 12, 16 and 20.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants who received placebo in Induction Period 1 received 1200 mg risankizumab by intravenous infusion at Weeks 12, 16, and 20.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Period Title: Induction Period 1
Started 207 206 205 0 0 0 0
Completed 186 202 199 0 0 0 0
Not Completed 21 4 6 0 0 0 0
Period Title: Induction Period 2
Started 0 0 0 41 42 42 86
Completed 0 0 0 39 39 38 76
Not Completed 0 0 0 2 3 4 10
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1) Total
Hide Arm/Group Description

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Total of all reporting groups
Overall Number of Baseline Participants 207 206 205 618
Hide Baseline Analysis Population Description
The safety population (SA) consists of all subjects who received at least 1 dose of study medication.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 207 participants 206 participants 205 participants 618 participants
<=18 years
3
   1.4%
1
   0.5%
1
   0.5%
5
   0.8%
Between 18 and 65 years
193
  93.2%
191
  92.7%
198
  96.6%
582
  94.2%
>=65 years
11
   5.3%
14
   6.8%
6
   2.9%
31
   5.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 207 participants 206 participants 205 participants 618 participants
39.4  (13.28) 40.4  (13.54) 39.6  (12.85) 39.8  (13.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 207 participants 206 participants 205 participants 618 participants
Female
104
  50.2%
106
  51.5%
99
  48.3%
309
  50.0%
Male
103
  49.8%
100
  48.5%
106
  51.7%
309
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 207 participants 206 participants 205 participants 618 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
16
   7.7%
9
   4.4%
14
   6.8%
39
   6.3%
Native Hawaiian or Other Pacific Islander
2
   1.0%
0
   0.0%
0
   0.0%
2
   0.3%
Black or African American
12
   5.8%
8
   3.9%
8
   3.9%
28
   4.5%
White
176
  85.0%
189
  91.7%
182
  88.8%
547
  88.5%
More than one race
1
   0.5%
0
   0.0%
1
   0.5%
2
   0.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Hide Description The CDAI consists of 8 components; 7 are based on participant diary entries, participant interviews, physical examinations, measurement of body weight and height and 1 is based on laboratory analysis. CDAI clinical remission of Crohn's disease is defined as CDAI < 150.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 187 191 191
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
19.8
(14.1 to 25.5)
42.0
(34.9 to 49.0)
40.3
(33.4 to 47.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 22.1
Confidence Interval (2-Sided) 95%
13.1 to 31.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 20.5
Confidence Interval (2-Sided) 95%
11.6 to 29.5
Estimation Comments [Not Specified]
2.Primary Outcome
Title US Specific: Percentage of Participants With Endoscopic Response
Hide Description The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 187 191 191
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
11.2
(6.7 to 15.8)
28.8
(22.4 to 35.3)
34.2
(27.4 to 40.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 17.6
Confidence Interval (2-Sided) 95%
9.9 to 25.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 23.1
Confidence Interval (2-Sided) 95%
15.1 to 31.1
Estimation Comments [Not Specified]
3.Primary Outcome
Title Global Outside of US: Percentage of Participants With Clinical Remission
Hide Description Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 187 191 191
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
11.2
(6.7 to 15.8)
28.8
(22.4 to 35.3)
34.2
(27.4 to 40.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 17.6
Confidence Interval (2-Sided) 95%
9.9 to 25.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 23.1
Confidence Interval (2-Sided) 95%
15.1 to 31.1
Estimation Comments [Not Specified]
4.Primary Outcome
Title Global Outside of US: Percentage of Participants With Endoscopic Response
Hide Description The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 187 191 191
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
19.3
(13.6 to 24.9)
34.6
(27.8 to 41.3)
39.8
(32.8 to 46.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 15.2
Confidence Interval (2-Sided) 95%
6.4 to 24
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 20.4
Confidence Interval (2-Sided) 95%
11.5 to 29.3
Estimation Comments [Not Specified]
5.Secondary Outcome
Title US Specific: Percentage of Participants With Clinical Remission
Hide Description Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 187 191 191
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
19.3
(13.6 to 24.9)
34.6
(27.8 to 41.3)
39.8
(32.8 to 46.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 15.2
Confidence Interval (2-Sided) 95%
6.4 to 24.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 20.4
Confidence Interval (2-Sided) 95%
11.5 to 29.3
Estimation Comments [Not Specified]
6.Secondary Outcome
Title US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Hide Description Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 187 191 191
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
20.9
(15.0 to 26.7)
36.6
(29.8 to 43.5)
32.5
(25.8 to 39.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 15.7
Confidence Interval (2-Sided) 95%
6.8 to 24.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 11.8
Confidence Interval (2-Sided) 95%
3.0 to 20.5
Estimation Comments [Not Specified]
7.Secondary Outcome
Title US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Hide Description Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 187 191 191
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
30.0
(23.4 to 36.6)
59.5
(52.5 to 66.5)
60.7
(53.8 to 67.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 29.4
Confidence Interval (2-Sided) 95%
19.9 to 39.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 30.6
Confidence Interval (2-Sided) 95%
21.1 to 40.1
Estimation Comments [Not Specified]
8.Secondary Outcome
Title US Specific: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Hide Description The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 144 168 172
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
7.7  (0.87) 10.5  (0.81) 10.8  (0.81)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments [Not Specified]
Method Mixed-Effect Model Repeat Measurement
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.8
Confidence Interval (2-Sided) 95%
0.4 to 5.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Mixed-Effect Model Repeat Measurement
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.0
Confidence Interval (2-Sided) 95%
0.7 to 5.3
Estimation Comments [Not Specified]
9.Secondary Outcome
Title US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Hide Description Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical remission of Crohn's disease is defined as CDAI < 150.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 187 191 191
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
11.2
(6.7 to 15.8)
20.9
(15.2 to 26.7)
19.4
(13.8 to 25.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 9.6
Confidence Interval (2-Sided) 95%
2.3 to 16.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 8.2
Confidence Interval (2-Sided) 95%
1.1 to 15.3
Estimation Comments [Not Specified]
10.Secondary Outcome
Title US Specific: Percentage of Participants With CDAI Clinical Response and Endoscopic Response
Hide Description

Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.

Endoscopic response was a decrease in Simplified Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2 point reduction from Baseline).

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 187 191 191
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5.3
(2.1 to 8.6)
20.5
(14.7 to 26.2)
23.0
(17.1 to 29.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 15.0
Confidence Interval (2-Sided) 95%
8.5 to 21.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 17.8
Confidence Interval (2-Sided) 95%
11.1 to 24.5
Estimation Comments [Not Specified]
11.Secondary Outcome
Title US Specific: Percentage of Participants With Stool Frequency (SF) Remission
Hide Description Stool Frequency (SF) remission is defined as an average daily SF <= 2.8 and not worse than baseline.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the 12-Week Induction Period and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 187 191 191
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
28.3
(21.9 to 34.8)
46.1
(39.9 to 53.1)
48.7
(41.6 to 55.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 17.5
Confidence Interval (2-Sided) 95%
8.0 to 26.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 20.3
Confidence Interval (2-Sided) 95%
10.8 to 29.8
Estimation Comments [Not Specified]
12.Secondary Outcome
Title US Specific: Percentage of Participants With Abdominal Pain (AP) Remission
Hide Description The Abdominal Pain rating is an assessment that is graded from 0 to 3: 0= None, 1= Mild, 2= Moderate and 3= Severe. AP remission is defined as average daily AP score <= 1 and not worse than baseline.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 187 191 191
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
36.4
(29.5 to 43.3)
58.1
(51.1 to 65.1)
59.2
(52.2 to 66.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 21.8
Confidence Interval (2-Sided) 95%
12.1 to 31.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 22.7
Confidence Interval (2-Sided) 95%
13.0 to 32.5
Estimation Comments [Not Specified]
13.Secondary Outcome
Title US Specific: Percentage of Participants With Endoscopic Remission
Hide Description Endoscopic remission: SES-CD ≤ 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 187 191 191
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
4.3
(1.4 to 7.2)
19.4
(13.8 to 25.1)
20.4
(14.7 to 26.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 15.0
Confidence Interval (2-Sided) 95%
8.9 to 21.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 16.2
Confidence Interval (2-Sided) 95%
9.9 to 22.4
Estimation Comments [Not Specified]
14.Secondary Outcome
Title US Specific: Percentage of Participants With Enhanced Clinical Response
Hide Description Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 187 191 191
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
31.6
(24.9 to 38.2)
45.0
(38.0 to 52.1)
38.7
(31.8 to 45.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 13.6
Confidence Interval (2-Sided) 95%
4.0 to 23.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.142
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 7.1
Confidence Interval (2-Sided) 95%
-2.4 to 16.6
Estimation Comments [Not Specified]
15.Secondary Outcome
Title US Specific: Percentage of Participants With Ulcer-Free Endoscopy
Hide Description Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore ≥ 1 at Baseline
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the 12-Week Induction Period and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 186 190 189
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
4.3
(1.4 to 7.2)
13.8
(8.9 to 18.7)
15.4
(10.2 to 20.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 9.4
Confidence Interval (2-Sided) 95%
3.8 to 15.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 11.2
Confidence Interval (2-Sided) 95%
5.3 to 17.0
Estimation Comments [Not Specified]
16.Secondary Outcome
Title US Specific: Percentage of Participants With Enhanced Clinical Response
Hide Description Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 187 191 191
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
39.1
(32.1 to 46.1)
61.8
(54.9 to 68.7)
59.2
(52.2 to 66.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 22.8
Confidence Interval (2-Sided) 95%
13.0 to 32.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 20.0
Confidence Interval (2-Sided) 95%
10.2 to 29.9
Estimation Comments [Not Specified]
17.Secondary Outcome
Title US Specific: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline Baseline
Hide Description Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the 12-Week Induction Period and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 97 100 97
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
23.7
(15.2 to 32.2)
29.5
(20.5 to 38.5)
37.1
(27.5 to 46.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.377
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 5.6
Confidence Interval (2-Sided) 95%
-6.8 to 17.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 13.4
Confidence Interval (2-Sided) 95%
0.7 to 26.1
Estimation Comments [Not Specified]
18.Secondary Outcome
Title US Specific: Percentage of Participants With CD-Related Hospitalization
Hide Description Participants with at least one admission to the hospital due to Crohn's Disease.
Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 187 191 191
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
11.2
(6.7 to 15.8)
3.1
(0.7 to 5.6)
2.1
(0.1 to 4.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -8.1
Confidence Interval (2-Sided) 95%
-13.2 to -2.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -9.1
Confidence Interval (2-Sided) 95%
-14.1 to -4.2
Estimation Comments [Not Specified]
19.Secondary Outcome
Title US Specific: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline
Hide Description Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 15 14 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
13.3
(0.0 to 30.5)
7.1
(0.0 to 20.6)
43.8
(19.4 to 68.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -6.2
Confidence Interval (2-Sided) 95%
-28.1 to 15.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.113
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 30.4
Confidence Interval (2-Sided) 95%
0.6 to 60.2
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Hide Description The CDAI consists of 8 components; 6 are based on participant diary entries, participant interviews, and physical examinations, and 2 are based on laboratory analysis, and measurement of body weight and height. CDAI clinical remission of Crohn's disease is defined as CDAI < 150.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 187 191 191
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
19.8
(14.1 to 25.5)
42
(34.9 to 49.0)
40.3
(33.4 to 47.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 22.1
Confidence Interval (2-Sided) 95%
13.1 to 31.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 20.5
Confidence Interval (2-Sided) 95%
11.6 to 29.5
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Hide Description Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 187 191 191
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
20.9
(15.0 to 26.7)
36.6
(29.8 to 43.5)
32.5
(25.8 to 39.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 15.7
Confidence Interval (2-Sided) 95%
6.8 to 24.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 11.8
Confidence Interval (2-Sided) 95%
3 to 20.5
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Global Outside of US: Percentage of Participants With Clinical Remission
Hide Description Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 187 191 191
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8
(4.1 to 11.9)
17.3
(11.9 to 22.6)
18.3
(12.8 to 23.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 9.2
Confidence Interval (2-Sided) 95%
2.6 to 15.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 10.3
Confidence Interval (2-Sided) 95%
3.7 to 16.8
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Hide Description Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 187 191 191
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
30.0
(23.4 to 36.6)
59.5
(52.5 to 66.5)
60.7
(53.8 to 67.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 29.4
Confidence Interval (2-Sided) 95%
19.9 to 39.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 30.6
Confidence Interval (2-Sided) 95%
21.1 to 40.1
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Global Outside of US: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Hide Description The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 144 168 172
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
7.7  (0.87) 10.5  (0.81) 10.8  (0.81)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments [Not Specified]
Method Mixed-Effect Model Repeat Measurement
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.8
Confidence Interval (2-Sided) 95%
0.4 to 5.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Mixed-Effect Model Repeat Measurement
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.0
Confidence Interval (2-Sided) 95%
0.7 to 5.3
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Global Outside of US: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
Hide Description The IBDQ is a 32-item (ranges 1 - 7) self-report questionnaire for patients with IBD to evaluate the patient reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). The IBDQ total Score ranges from 32 to 224 with a higher score indicating better outcome.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 144 168 172
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
27.2
(21.8 to 32.6)
39.6
(34.5 to 44.7)
42.2
(37.1 to 47.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Mixed-Effect Model Repeat Measurement
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 12.4
Confidence Interval (2-Sided) 95%
5.0 to 19.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed-Effect Model Repeat Measurement
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 15
Confidence Interval (2-Sided) 95%
7.7 to 22.4
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Global Outside of US: Percentage of Participants With Enhanced Clinical Response and Endoscopic Response
Hide Description Enhanced clinical response was defined as ≥ 60% decrease in average daily Stool Frequency and/or ≥ 35% decrease in average daily Abdominal Pain score and both not worse than baseline, and/or clinical remission. Endoscopic Response was defined as a decrease in Simplified Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2 point reduction from Baseline).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 187 191 191
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
7
(3.3 to 10.6)
21
(15.2 to 26.8)
24.1
(18.0 to 30.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 13.9
Confidence Interval (2-Sided) 95%
7.1 to 20.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 17.3
Confidence Interval (2-Sided) 95%
10.3 to 24.2
Estimation Comments [Not Specified]
27.Secondary Outcome
Title Global Outside of US:: Percentage of Participants With Endoscopic Remission
Hide Description Endoscopic remission: SES-CD ≤ 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 187 191 191
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
4.3
(1.4 to 7.2)
19.4
(13.8 to 25.1)
20.4
(14.7 to 26.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 15.0
Confidence Interval (2-Sided) 95%
8.9 to 21.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 16.2
Confidence Interval (2-Sided) 95%
9.9 to 22.4
Estimation Comments [Not Specified]
28.Secondary Outcome
Title Global Outside of US: Percentage of Participants With Enhanced Clinical Response
Hide Description Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 187 191 191
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
31.6
(24.9 to 38.2)
45
(38.0 to 52.1)
38.7
(31.8 to 45.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 13.6
Confidence Interval (2-Sided) 95%
4 to 23.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.142
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 7.1
Confidence Interval (2-Sided) 95%
-2.4 to 16.6
Estimation Comments [Not Specified]
29.Secondary Outcome
Title Global Outside of US: Percentage of Participants With Ulcer-Free Endoscopy
Hide Description Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore ≥ 1 at Baseline
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 186 190 189
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
4.3
(1.4 to 7.2)
13.8
(8.9 to 18.7)
15.4
(10.2 to 20.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 9.4
Confidence Interval (2-Sided) 95%
3.8 to 15.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 11.2
Confidence Interval (2-Sided) 95%
5.3 to 17.0
Estimation Comments [Not Specified]
30.Secondary Outcome
Title Global Outside of US: Percentage of Participants With Enhanced Clinical Response
Hide Description Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 187 191 191
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
39.1
(32.1 to 46.1)
61.8
(54.9 to 68.7)
59.2
(52.2 to 66.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 22.8
Confidence Interval (2-Sided) 95%
13.0 to 32.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 20
Confidence Interval (2-Sided) 95%
10.2 to 29.9
Estimation Comments [Not Specified]
31.Secondary Outcome
Title Global Outside of US: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline Baseline
Hide Description Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 97 100 97
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
23.7
(15.2 to 32.2)
29.5
(20.5 to 38.5)
37.1
(27.5 to 46.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.377
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 5.6
Confidence Interval (2-Sided) 95%
-6.8 to 17.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 13.4
Confidence Interval (2-Sided) 95%
0.7 to 26.1
Estimation Comments [Not Specified]
32.Secondary Outcome
Title Global Outside of US: Percentage of Participants With CD-Related Hospitalization
Hide Description Participants with at least one admission to the hospital due to Crohn's Disease.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 187 191 191
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
11.2
(6.7 to 15.8)
3.1
(0.7 to 5.6)
2.1
(0.1 to 4.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Mixed-Effect Model Repeat Measurement
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -8.1
Confidence Interval (2-Sided) 95%
-13.2 to -2.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed-Effect Model Repeat Measurement
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -9.1
Confidence Interval (2-Sided) 95%
-14.1 to -4.2
Estimation Comments [Not Specified]
33.Secondary Outcome
Title Global Outside of US: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline
Hide Description Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 15 14 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
13.3
(0.0 to 30.5)
7.1
(0.0 to 20.6)
43.8
(19.4 to 68.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Mixed-Effect Model Repeat Measurement
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -6.2
Confidence Interval (2-Sided) 95%
-28.1 to 15.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.113
Comments [Not Specified]
Method Mixed-Effect Model Repeat Measurement
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 30.4
Confidence Interval (2-Sided) 95%
0.6 to 60.2
Estimation Comments [Not Specified]
34.Secondary Outcome
Title Global Outside of US: Change From Baseline in Work Productivity and Impairment Questionnaire - Crohn's Disease (WPAI-CD) Overall Work Impairment
Hide Description WPAI: CD is a questionnaire used to evaluate lost productivity due to CD ; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Total work productivity impairment takes into account both hours missed due to CD symptoms and the patient's assessment of the degree to which CD affected their productivity while working (overall work impairment [OWI]). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 68 73 86
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-12.253  (3.3683) -19.576  (3.2747) -21.013  (3.0074)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.113
Comments [Not Specified]
Method Mixed-Effect Model Repeat Measurement
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -7.323
Confidence Interval (2-Sided) 95%
-16.399 to 1.753
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.050
Comments [Not Specified]
Method Mixed-Effect Model Repeat Measurement
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -8.759
Confidence Interval (2-Sided) 95%
-17.518 to -0.001
Estimation Comments [Not Specified]
35.Secondary Outcome
Title Global Outside of US: Change From Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) Score
Hide Description The Short Form-36 Health Survey determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat 1A Population: all randomized subjects who received at least one dose of study drug during the Induction Period 1 and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1)
Hide Arm/Group Description:

Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8.

placebo for risankizumab IV: placebo for risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8.

risankizumab IV: risankizumab administered as intravenous (IV) infusion.

Overall Number of Participants Analyzed 142 167 172
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
5.237  (0.6166) 7.458  (0.5767) 7.951  (0.5749)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 600mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Mixed-Effect Model Repeat Measurement
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.221
Confidence Interval (2-Sided) 95%
0.577 to 3.865
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Induction Period 1), Risankizumab 1200mg (Induction Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Mixed-Effect Model Repeat Measurement
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.714
Confidence Interval (2-Sided) 95%
1.077 to 4.351
Estimation Comments [Not Specified]
Time Frame From first dose of study drug until 140 days following last dose of study drug, or the first dose of next period/study (up to 24 weeks), whichever occurs earlier
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1) Period 1 Risankizumab Total Risankizumab Dose 180mg (Induction Period 2) Risankizumab 360mg (Induction Period 2) Risankizumab 1200mg (Induction Period 2) Placebo/Risankizumab 1200mg (Induction Period 2) Period 2 Risankizumab Total
Hide Arm/Group Description Participants randomized to receive Placebo by intravenous (IV) infusion at Baseline, Weeks 4 and 8. Participants randomized to receive risankizumab 600mg by intravenous infusion at Baseline, Weeks 4 and 8. Participants randomized to receive risankizumab 1200mg by intravenous infusion at Baseline, Weeks 4 and 8. Total Period 1 participants randomized into the Risankizumab treatment arm Participants randomized to receive risankizumab 180mg by subcutaneous (SC) injection at Weeks 12 and 20. Participants randomized to receive risankizumab 360mg by subcutaneous injection at Weeks 12 and 20. Participants randomized to receive risankizumab 1200mg by intravenous infusion at Weeks 12, 16 and 20. Participants who received placebo in Induction Period 1 received 1200 mg risankizumab by intravenous infusion at Weeks 12, 16, and 20. Total Period 2 participants randomized into the Risankizumab treatment arm
All-Cause Mortality
Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1) Period 1 Risankizumab Total Risankizumab Dose 180mg (Induction Period 2) Risankizumab 360mg (Induction Period 2) Risankizumab 1200mg (Induction Period 2) Placebo/Risankizumab 1200mg (Induction Period 2) Period 2 Risankizumab Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/207 (0.00%)      0/206 (0.00%)      2/205 (0.98%)      2/411 (0.49%)      0/41 (0.00%)      0/42 (0.00%)      1/42 (2.38%)      0/86 (0.00%)      1/211 (0.47%)    
Hide Serious Adverse Events
Placebo (Induction Period 1) Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1) Period 1 Risankizumab Total Risankizumab Dose 180mg (Induction Period 2) Risankizumab 360mg (Induction Period 2) Risankizumab 1200mg (Induction Period 2) Placebo/Risankizumab 1200mg (Induction Period 2) Period 2 Risankizumab Total
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/207 (12.56%)      10/206 (4.85%)      9/205 (4.39%)      19/411 (4.62%)      2/41 (4.88%)      2/42 (4.76%)      3/42 (7.14%)      9/86 (10.47%)      16/211 (7.58%)    
Blood and lymphatic system disorders                   
ANAEMIA  1  0/207 (0.00%)  0 2/206 (0.97%)  2 2/205 (0.98%)  2 4/411 (0.97%)  4 0/41 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 1/86 (1.16%)  1 1/211 (0.47%)  1
BONE MARROW FAILURE  1  1/207 (0.48%)  1 0/206 (0.00%)  0 0/205 (0.00%)  0 0/411 (0.00%)  0 0/41 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/86 (0.00%)  0 0/211 (0.00%)  0
MYELOSUPPRESSION  1  1/207 (0.48%)  1 0/206 (0.00%)  0 0/205 (0.00%)  0 0/411 (0.00%)  0 0/41 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/86 (0.00%)  0 0/211 (0.00%)  0
Cardiac disorders                   
ATRIAL FLUTTER  1  0/207 (0.00%)  0 1/206 (0.49%)  1 0/205 (0.00%)  0 1/411 (0.24%)  1 0/41 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/86 (0.00%)  0 0/211 (0.00%)  0
Gastrointestinal disorders                   
ABDOMINAL PAIN  1  1/207 (0.48%)  1 0/206 (0.00%)  0 0/205 (0.00%)  0 0/411 (0.00%)  0 2/41 (4.88%)  2 0/42 (0.00%)  0 0/42 (0.00%)  0 0/86 (0.00%)  0 2/211 (0.95%)  2
ANAL FISTULA  1  0/207 (0.00%)  0 1/206 (0.49%)  1 0/205 (0.00%)  0 1/411 (0.24%)  1 0/41 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/86 (0.00%)  0 0/211 (0.00%)  0
ANAL SPHINCTER ATONY  1  1/207 (0.48%)  1 0/206 (0.00%)  0 0/205 (0.00%)  0 0/411 (0.00%)  0 0/41 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/86 (0.00%)  0 0/211 (0.00%)  0
ANAL STENOSIS  1  0/207 (0.00%)  0 0/206 (0.00%)  0 0/205 (0.00%)  0 0/411 (0.00%)  0 0/41 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 1/86 (1.16%)  1 1/211 (0.47%)  1
ANORECTAL DISORDER  1  1/207 (0.48%)  2 0/206 (0.00%)  0 0/205 (0.00%)  0 0/411 (0.00%)  0 0/41 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/86 (0.00%)  0 0/211 (0.00%)  0
CROHN'S DISEASE  1  20/207 (9.66%)  22 1/206 (0.49%)  1 1/205 (0.49%)  1 2/411 (0.49%)  2 0/41 (0.00%)  0 0/42 (0.00%)  0 2/42 (4.76%)  2 2/86 (2.33%)  2 4/211 (1.90%)  4
DYSBIOSIS  1  1/207 (0.48%)  1 0/206 (0.00%)  0 0/205 (0.00%)  0 0/411 (0.00%)  0 0/41 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/86 (0.00%)  0 0/211 (0.00%)  0
HAEMATOCHEZIA  1  0/207 (0.00%)  0 1/206 (0.49%)  1 0/205 (0.00%)  0 1/411 (0.24%)  1 0/41 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/86 (0.00%)  0 0/211 (0.00%)  0
ILEAL STENOSIS  1  1/207 (0.48%)  1 0/206 (0.00%)  0 0/205 (0.00%)  0 0/411 (0.00%)  0 0/41 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 1/86 (1.16%)  1 1/211 (0.47%)  1
ILEUS  1  0/207 (0.00%)  0 1/206 (0.49%)  1 0/205 (0.00%)  0 1/411 (0.24%)  1 0/41 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/86 (0.00%)  0 0/211 (0.00%)  0
ILEUS PARALYTIC  1  1/207 (0.48%)  1 0/206 (0.00%)  0 0/205 (0.00%)  0 0/411 (0.00%)  0 0/41 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/86 (0.00%)  0 0/211 (0.00%)  0
INTESTINAL OBSTRUCTION  1  0/207 (0.00%)  0 0/206 (0.00%)  0 0/205 (0.00%)  0 0/411 (0.00%)  0 0/41 (0.00%)  0 1/42 (2.38%)  1 0/42 (0.00%)  0 0/86 (0.00%)  0 1/211 (0.47%)  1
JEJUNAL STENOSIS  1  0/207 (0.00%)  0 0/206 (0.00%)  0 0/205 (0.00%)  0 0/411 (0.00%)  0 0/41 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 1/86 (1.16%)  1 1/211 (0.47%)  1
NAUSEA  1  1/207 (0.48%)  1 0/206 (0.00%)  0 0/205 (0.00%)  0 0/411 (0.00%)  0 1/41 (2.44%)  1 0/42 (0.00%)  0 0/42 (0.00%)  0 0/86 (0.00%)  0 1/211 (0.47%)  1
SMALL INTESTINAL OBSTRUCTION  1  2/207 (0.97%)  2 1/206 (0.49%)  1 0/205 (0.00%)  0 1/411 (0.24%)  1 0/41 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/86 (0.00%)  0 0/211 (0.00%)  0
UMBILICAL HERNIA  1  0/207 (0.00%)  0 0/206 (0.00%)  0 0/205 (0.00%)  0 0/411 (0.00%)  0 0/41 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 1/86 (1.16%)  1 1/211 (0.47%)  1
General disorders                   
PYREXIA  1  1/207 (0.48%)  1 0/206 (0.00%)  0 1/205 (0.49%)  1 1/411 (0.24%)  1 1/41 (2.44%)  1 0/42 (0.00%)  0 0/42 (0.00%)  0 0/86 (0.00%)  0 1/211 (0.47%)  1
Hepatobiliary disorders                   
BILE DUCT STENOSIS  1  0/207 (0.00%)  0 1/206 (0.49%)  1 0/205 (0.00%)  0 1/411 (0.24%)  1 0/41 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/86 (0.00%)  0 0/211 (0.00%)  0
Infections and infestations                   
ABDOMINAL ABSCESS  1  1/207 (0.48%)  1 0/206 (0.00%)  0 0/205 (0.00%)  0 0/411 (0.00%)  0 0/41 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 0/86 (0.00%)  0 0/211 (0.00%)  0
ANAL ABSCESS  1  0/207 (0.00%)  0 0/206 (0.00%)  0 0/205 (0.00%)  0 0/411 (0.00%)  0 0/41 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 1/86 (1.16%)  1 1/211 (0.47%)  1
BRONCHOPULMONARY ASPERGILLOSIS  1  0/207 (0.00%)  0 0/206 (0.00%)  0 0/205 (0.00%)  0 0/411 (0.00%)  0 0/41 (0.00%)  0 0/42 (0.00%)  0 0/42 (0.00%)  0 1/86 (1.16%)  1 1/211 (0.47%)  1
CELLULITIS OF MALE EXTERNAL GENITAL ORGAN  1  1/207 (0.48%)  1 0/206 (0.00%)  0 0/205 (0.00%)  0 0/411 (0.00%)  0 0/41 (0.00%)  0