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A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

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: NCT03105128
Recruitment Status : Completed
First Posted : April 7, 2017
Results First Posted : July 6, 2022
Last Update Posted : July 6, 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
Drug: risankizumab IV
Drug: risankizumab SC
Enrollment 931
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 931 subjects were enrolled and included in the intent-to-treat (ITT) population; 850 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 Risankizumab 600mg (Induction Period 1) Risankizumab 1200mg (Induction Period 1) Placebo (Induction Period 1) Risankizumab 180mg (Induction Period 2) Risankizumab 360mg (Induction Period 2) Risankizumab 1200mg (Induction Period 2) Placebo/Risankizumab IV (Induction Period 2)
Hide Arm/Group Description

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab 180mg administered by subcutaneous (SC) injection in Period 2

Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab 360mg administered by subcutaneous (SC) injection in Period 2.

risankizumab SC: Risankizumab administered by subcutaneous (SC) injection

Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab 1200mg administered by intravenous infusion (IV) in Period 2.

risankizumab IV: Risankizumab administered by intravenous infusion (IV)

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

risankizumab IV: Risankizumab administered by intravenous infusion (IV)

Period Title: Period 1
Started [1] 373 372 186 0 0 0 0
Completed [2] 365 366 163 0 0 0 0
Not Completed 8 6 23 0 0 0 0
[1]
Randomized
[2]
Completed Period 1
Period Title: Period 2
Started 0 0 0 67 68 67 76
Completed [1] 0 0 0 62 65 64 74
Not Completed 0 0 0 5 3 3 2
[1]
Completed study
Arm/Group Title Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1) Placebo (Period 1) Total
Hide Arm/Group Description

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Total of all reporting groups
Overall Number of Baseline Participants 373 372 186 931
Hide Baseline Analysis Population Description
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 373 participants 372 participants 186 participants 931 participants
<=18 years
3
   0.8%
4
   1.1%
2
   1.1%
9
   1.0%
Between 18 and 65 years
355
  95.2%
350
  94.1%
175
  94.1%
880
  94.5%
>=65 years
15
   4.0%
18
   4.8%
9
   4.8%
42
   4.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 373 participants 372 participants 186 participants 931 participants
38.5  (13.22) 37.6  (13.55) 37.5  (13.51) 37.9  (13.40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 373 participants 372 participants 186 participants 931 participants
Female
168
  45.0%
173
  46.5%
93
  50.0%
434
  46.6%
Male
205
  55.0%
199
  53.5%
93
  50.0%
497
  53.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 373 participants 372 participants 186 participants 931 participants
Hispanic or Latino
13
   3.5%
18
   4.8%
10
   5.4%
41
   4.4%
Not Hispanic or Latino
360
  96.5%
354
  95.2%
176
  94.6%
890
  95.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 373 participants 372 participants 186 participants 931 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
68
  18.2%
75
  20.2%
32
  17.2%
175
  18.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.3%
1
   0.5%
2
   0.2%
Black or African American
10
   2.7%
13
   3.5%
9
   4.8%
32
   3.4%
White
291
  78.0%
279
  75.0%
144
  77.4%
714
  76.7%
More than one race
4
   1.1%
4
   1.1%
0
   0.0%
8
   0.9%
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 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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 175 336 339
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
24.6
(18.2 to 31.0)
45.2
(39.9 to 50.5)
41.6
(36.3 to 46.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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 20.7
Confidence Interval (2-Sided) 95%
12.4 to 29.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (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 16.7
Confidence Interval (2-Sided) 95%
8.5 to 24.9
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 175 336 339
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12.0
(7.2 to 16.8)
40.3
(35.0 to 45.6)
32.1
(27.1 to 37.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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 28.3
Confidence Interval (2-Sided) 95%
21.2 to 35.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (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%
13.6 to 27.1
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 175 336 339
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
21.7
(15.6 to 27.8)
43.5
(38.2 to 48.8)
41.0
(35.8 to 46.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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 21.9
Confidence Interval (2-Sided) 95%
13.8 to 29.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (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 18.8
Confidence Interval (2-Sided) 95%
10.8 to 26.8
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 175 336 339
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12.0
(7.2 to 16.8)
40.3
(35.0 to 45.6)
32.1
(27.1 to 37.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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 28.3
Confidence Interval (2-Sided) 95%
21.2 to 35.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (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%
13.6 to 27.1
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 175 336 339
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
21.7
(15.6 to 27.8)
43.5
(38.2 to 48.8)
41.0
(35.8 to 46.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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 Risk Difference (RD)
Estimated Value 21.9
Confidence Interval (2-Sided) 95%
13.8 to 29.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (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 18.8
Confidence Interval (2-Sided) 95%
10.8 to 26.8
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 175 336 339
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25.2
(18.7 to 31.6)
40.8
(35.5 to 46.0)
37.2
(32.0 to 42.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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 15.4
Confidence Interval (2-Sided) 95%
7.2 to 23.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
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%
3.1 to 19.2
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 175 336 339
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
36.7
(29.6 to 43.9)
59.7
(54.5 to 65.0)
64.9
(59.8 to 70.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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%
14.2 to 31.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (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 27.7
Confidence Interval (2-Sided) 95%
19.0 to 36.4
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 134 302 310
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percentage of participants
6.0
(4.4 to 7.7)
11.2
(10.1 to 12.4)
10.1
(9.0 to 11.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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 5.2
Confidence Interval (2-Sided) 95%
3.2 to 7.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (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 4.1
Confidence Interval (2-Sided) 95%
2.1 to 6.1
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 175 336 339
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
10.3
(5.8 to 14.8)
18.4
(14.3 to 22.6)
18.9
(14.7 to 23.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 7.6
Confidence Interval (2-Sided) 95%
1.5 to 13.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 8.4
Confidence Interval (2-Sided) 95%
2.3 to 14.6
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 175 336 339
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5.7
(2.3 to 9.2)
30.0
(25.1 to 34.9)
23.0
(18.5 to 27.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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 24.5
Confidence Interval (2-Sided) 95%
18.5 to 30.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (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%
11.8 to 22.9
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 Induction Period 1, and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 175 336 339
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
29.8
(23.1 to 36.6)
54.2
(48.8 to 59.5)
54.0
(48.7 to 59.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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 24.2
Confidence Interval (2-Sided) 95%
15.7 to 32.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (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 23.6
Confidence Interval (2-Sided) 95%
15.1 to 32.1
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 175 336 339
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
38.5
(31.2 to 45.7)
59.6
(54.3 to 64.8)
58.1
(52.9 to 63.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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 21.2
Confidence Interval (2-Sided) 95%
12.4 to 30.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (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 19.0
Confidence Interval (2-Sided) 95%
10.1 to 27.8
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 175 336 339
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
9.1
(4.9 to 13.4)
24.2
(19.6 to 28.7)
23.9
(19.4 to 28.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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 15.1
Confidence Interval (2-Sided) 95%
9.0 to 21.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (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 15.4
Confidence Interval (2-Sided) 95%
9.4 to 21.4
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 175 336 339
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
31.0
(24.1 to 37.9)
46.0
(40.7 to 51.3)
43.4
(38.1 to 48.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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 14.9
Confidence Interval (2-Sided) 95%
6.2 to 23.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
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%
3.2 to 20.3
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 Induction Period 1, and had baseline eligible SES-CD of ≥ 6 (≥ 4 for isolated ileal disease) excluding the narrowing component.
Arm/Group Title Placebo (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 173 336 339
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
7.6
(3.6 to 11.5)
21.0
(16.6 to 25.4)
16.4
(12.4 to 20.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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 13.7
Confidence Interval (2-Sided) 95%
7.9 to 19.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (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 9.1
Confidence Interval (2-Sided) 95%
3.7 to 14.5
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 175 336 339
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
41.9
(34.6 to 49.3)
62.8
(57.6 to 68.0)
64.3
(59.2 to 69.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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 21.0
Confidence Interval (2-Sided) 95%
12.2 to 29.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (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 21.6
Confidence Interval (2-Sided) 95%
12.8 to 30.4
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
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 64 140 158
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
20.5
(10.5 to 30.4)
38.1
(30.0 to 46.1)
43.7
(35.9 to 51.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 14.6
Confidence Interval (2-Sided) 95%
2.1 to 27.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (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 23.7
Confidence Interval (2-Sided) 95%
11.1 to 36.3
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 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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 175 339 339
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12.0
(7.2 to 16.8)
3.3
(1.4 to 5.2)
1.8
(0.4 to 3.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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 -8.7
Confidence Interval (2-Sided) 95%
-13.9 to -3.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (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 -10.2
Confidence Interval (2-Sided) 95%
-15.2 to -5.2
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 9 18 24
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
22.2
(0.0 to 49.4)
27.8
(7.1 to 48.5)
29.2
(11.0 to 47.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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 Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 5.6
Confidence Interval (2-Sided) 95%
-28.6 to 39.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 6.9
Confidence Interval (2-Sided) 25%
-25.7 to 39.6
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 175 336 339
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
24.6
(18.2 to 31.0)
45.2
(39.9 to 50.5)
41.6
(36.3 to 46.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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 20.7
Confidence Interval (2-Sided) 95%
12.4 to 29.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (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 16.7
Confidence Interval (2-Sided) 95%
8.5 to 24.9
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 175 336 339
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25.2
(18.7 to 31.6)
40.8
(35.5 to 46.0)
37.2
(32.0 to 42.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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 15.4
Confidence Interval (2-Sided) 95%
7.2 to 23.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
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%
3.1 to 19.2
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 175 336 339
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
9.1
(4.9 to 13.4)
21.0
(16.6 to 25.3)
21.2
(16.9 to 25.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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 11.5
Confidence Interval (2-Sided) 95%
5.4 to 17.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (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 11.7
Confidence Interval (2-Sided) 95%
5.7 to 17.8
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 175 336 339
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
36.7
(29.6 to 43.9)
59.7
(54.5 to 65.0)
64.9
(59.8 to 70.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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%
14.2 to 31.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (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 27.7
Confidence Interval (2-Sided) 95%
19.0 to 36.4
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 134 302 310
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
6.0
(4.4 to 7.7)
11.2
(10.1 to 12.4)
10.1
(9.0 to 11.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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 5.2
Confidence Interval (2-Sided) 95%
3.2 to 7.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (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 4.1
Confidence Interval (2-Sided) 95%
2.1 to 6.1
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 134 302 310
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
23.6
(18.2 to 28.9)
44.3
(40.6 to 48.0)
43.0
(39.4 to 46.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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 20.7
Confidence Interval (2-Sided) 95%
14.3 to 27.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (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 19.4
Confidence Interval (2-Sided) 95%
13.1 to 25.8
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 175 336 339
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.0
(4.0 to 12.0)
30.9
(25.9 to 35.8)
23.2
(18.7 to 27.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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 23.2
Confidence Interval (2-Sided) 95%
16.8 to 29.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (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%
9.3 to 21.2
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 175 336 339
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
9.1
(4.9 to 13.4)
24.2
(19.6 to 28.7)
23.9
(19.4 to 28.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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 15.1
Confidence Interval (2-Sided) 95%
9.0 to 21.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (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 15.4
Confidence Interval (2-Sided) 95%
9.4 to 21.4
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 175 336 339
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
31.0
(24.1 to 37.9)
46.0
(40.7 to 51.3)
43.4
(38.1 to 48.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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 14.9
Confidence Interval (2-Sided) 95%
6.2 to 23.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
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%
3.2 to 20.3
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 173 336 338
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
7.6
(3.6 to 11.5)
21.0
(16.6 to 25.4)
16.4
(12.4 to 20.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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 13.7
Confidence Interval (2-Sided) 95%
7.9 to 19.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (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 9.1
Confidence Interval (2-Sided) 95%
3.7 to 14.5
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 175 336 339
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
41.9
(34.6 to 49.3)
62.8
(57.6 to 68.0)
64.3
(59.2 to 69.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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 21.0
Confidence Interval (2-Sided) 95%
12.2 to 29.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (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 21.6
Confidence Interval (2-Sided) 95%
12.8 to 30.4
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
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 64 140 158
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
20.5
(10.5 to 30.4)
38.1
(30.0 to 46.1)
43.7
(35.9 to 51.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Risk Difference
Estimated Value 14.6
Confidence Interval (2-Sided) 95%
2.1 to 27.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (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 23.7
Confidence Interval (2-Sided) 95%
11.1 to 36.3
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 175 336 339
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12.0
(7.2 to 16.8)
3.3
(1.4 to 5.2)
1.8
(0.4 to 3.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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 -8.7
Confidence Interval (2-Sided) 95%
-13.9 to -3.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (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 -10.2
Confidence Interval (2-Sided) 95%
-15.2 to -5.2
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 9 18 24
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
22.2
(0.0 to 49.4)
27.8
(7.1 to 48.5)
29.2
(11.0 to 47.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Mixed-Effect Model Repeat Measurement
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 5.6
Confidence Interval (2-Sided) 95%
-28.6 to 39.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Mixed-Effect Model Repeat Measurement
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 6.9
Confidence Interval (2-Sided) 95%
-25.7 to 39.6
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 65 156 162
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-8.344  (3.5640) -17.930  (2.3446) -20.485  (2.3112)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments [Not Specified]
Method Mixed-Effect Model Repeat Measurement
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -9.586
Confidence Interval (2-Sided) 95%
-17.890 to -1.282
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Mixed-Effect Model Repeat Measurement
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -12.141
Confidence Interval (2-Sided) 95%
-20.390 to -3.892
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 (Period 1) Risankizumab 600mg (Period 1) Risankizumab 1200mg (Period 1)
Hide Arm/Group Description:

Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.

placebo for risankizumab: Placebo for risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 600mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Participants randomized to receive risankizumab 1200mg administered by intravenous (IV) infusion.

risankizumab IV: Risankizumab administered by intravenous infusion

Overall Number of Participants Analyzed 134 302 309
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
5.482  (0.5985) 8.394  (0.4107) 8.756  (0.4071)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 600mg (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 2.913
Confidence Interval (2-Sided) 95%
1.512 to 4.313
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Period 1), Risankizumab 1200mg (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 3.275
Confidence Interval (2-Sided) 95%
1.877 to 4.672
Estimation Comments [Not Specified]
Time Frame Treatment-emergent AEs (TEAEs) are from first dose of study drug until 140 days following last dose of study drug. The median duration of treatment for Period 1 with study drug for placebo and Risankizumab was 91.5 and 91 days respectively. For Period 2, the median duration of treatment with study drug for Risankizumab was 141 days.
Adverse Event Reporting Description AEs/SAEs: As treated population: All randomized participants who took at least one does of study drug (Risankizumab/placebo), analyzed by the actual treatment the participant received.
 
Arm/Group Title Period 1 Placebo IV Period 1 Risankizumab 600mg IV Period 1 Risankizumab 1200mg IV Period 1 Risankizumab Total Period 2 Risankizumab 180mg SC Period 2 Risankizumab 360mg SC Period 2 Risankizumab 1200mg IV Period 2 Placebo/Risankizumab 1200mg IV Period 2 Risankizumab Total
Hide Arm/Group Description Participants randomized to receive Placebo intravenous (IV) at Baseline, Weeks 4 and 8. Participants randomized to receive risankizumab 600mg intravenous (IV) at Baseline, Weeks 4 and 8. Participants randomized to receive risankizumab 1200mg intravenous (IV) at Baseline, Weeks 4 and 8. Total Period 1 participants randomized into the Risankizumab treatment arm Participants randomized to receive risankizumab 180mg subcutaneously (SC) at Weeks 12 and 20. Participants randomized to receive risankizumab 360mg subcutaneously (SC) at Weeks 12 and 20. Participants received risankizumab 1200mg intravenously at Weeks 12, 16, and 20. Participants who received placebo in Period 1 received 1200 mg risankizumab intravenously at Weeks 12, 16, and 20. Total Period 2 participants randomized into the Risankizumab treatment arm
All-Cause Mortality
Period 1 Placebo IV Period 1 Risankizumab 600mg IV Period 1 Risankizumab 1200mg IV Period 1 Risankizumab Total Period 2 Risankizumab 180mg SC Period 2 Risankizumab 360mg SC Period 2 Risankizumab 1200mg IV Period 2 Placebo/Risankizumab 1200mg IV 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   2/186 (1.08%)      0/373 (0.00%)      0/372 (0.00%)      0/745 (0.00%)      0/67 (0.00%)      0/68 (0.00%)      0/67 (0.00%)      0/76 (0.00%)      0/278 (0.00%)    
Hide Serious Adverse Events
Period 1 Placebo IV Period 1 Risankizumab 600mg IV Period 1 Risankizumab 1200mg IV Period 1 Risankizumab Total Period 2 Risankizumab 180mg SC Period 2 Risankizumab 360mg SC Period 2 Risankizumab 1200mg IV Period 2 Placebo/Risankizumab 1200mg IV 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   28/186 (15.05%)      27/373 (7.24%)      14/372 (3.76%)      41/745 (5.50%)      3/67 (4.48%)      3/68 (4.41%)      4/67 (5.97%)      4/76 (5.26%)      14/278 (5.04%)    
Blood and lymphatic system disorders                   
ANAEMIA  1  1/186 (0.54%)  1 0/373 (0.00%)  0 1/372 (0.27%)  2 1/745 (0.13%)  2 0/67 (0.00%)  0 0/68 (0.00%)  0 0/67 (0.00%)  0 0/76 (0.00%)  0 0/278 (0.00%)  0
Cardiac disorders                   
VENTRICULAR TACHYCARDIA  1  0/186 (0.00%)  0 1/373 (0.27%)  1 0/372 (0.00%)  0 1/745 (0.13%)  1 0/67 (0.00%)  0 0/68 (0.00%)  0 0/67 (0.00%)  0 0/76 (0.00%)  0 0/278 (0.00%)  0
Eye disorders                   
RETINAL DISORDER  1  0/186 (0.00%)  0 0/373 (0.00%)  0 0/372 (0.00%)  0 0/745 (0.00%)  0 0/67 (0.00%)  0 0/68 (0.00%)  0 0/67 (0.00%)  0 1/76 (1.32%)  1 1/278 (0.36%)  1
Gastrointestinal disorders                   
ABDOMINAL HERNIA  1  0/186 (0.00%)  0 0/373 (0.00%)  0 0/372 (0.00%)  0 0/745 (0.00%)  0 0/67 (0.00%)  0 0/68 (0.00%)  0 1/67 (1.49%)  1 0/76 (0.00%)  0 1/278 (0.36%)  1
ABDOMINAL PAIN  1  2/186 (1.08%)  3 0/373 (0.00%)  0 0/372 (0.00%)  0 0/745 (0.00%)  0 0/67 (0.00%)  0 0/68 (0.00%)  0 0/67 (0.00%)  0 0/76 (0.00%)  0 0/278 (0.00%)  0
COLITIS  1  1/186 (0.54%)  1 0/373 (0.00%)  0 0/372 (0.00%)  0 0/745 (0.00%)  0 0/67 (0.00%)  0 0/68 (0.00%)  0 0/67 (0.00%)  0 0/76 (0.00%)  0 0/278 (0.00%)  0
CROHN'S DISEASE  1  15/186 (8.06%)  16 5/373 (1.34%)  7 2/372 (0.54%)  2 7/745 (0.94%)  9 1/67 (1.49%)  1 0/68 (0.00%)  0 0/67 (0.00%)  0 0/76 (0.00%)  0 1/278 (0.36%)  1
DIARRHOEA  1  0/186 (0.00%)  0 1/373 (0.27%)  1 0/372 (0.00%)  0 1/745 (0.13%)  1 0/67 (0.00%)  0 0/68 (0.00%)  0 0/67 (0.00%)  0 0/76 (0.00%)  0 0/278 (0.00%)  0
GASTROINTESTINAL HAEMORRHAGE  1  0/186 (0.00%)  0 1/373 (0.27%)  1 0/372 (0.00%)  0 1/745 (0.13%)  1 0/67 (0.00%)  0 0/68 (0.00%)  0 0/67 (0.00%)  0 0/76 (0.00%)  0 0/278 (0.00%)  0
GASTROINTESTINAL INFLAMMATION  1  1/186 (0.54%)  1 0/373 (0.00%)  0 0/372 (0.00%)  0 0/745 (0.00%)  0 0/67 (0.00%)  0 0/68 (0.00%)  0 0/67 (0.00%)  0 0/76 (0.00%)  0 0/278 (0.00%)  0
GASTROINTESTINAL NECROSIS  1  1/186 (0.54%)  1 0/373 (0.00%)  0 0/372 (0.00%)  0 0/745 (0.00%)  0 0/67 (0.00%)  0 0/68 (0.00%)  0 1/67 (1.49%)  1 0/76 (0.00%)  0 1/278 (0.36%)  1
ILEAL PERFORATION  1  1/186 (0.54%)  1 0/373 (0.00%)  0 0/372 (0.00%)  0 0/745 (0.00%)  0 0/67 (0.00%)  0 0/68 (0.00%)  0 0/67 (0.00%)  0 0/76 (0.00%)  0 0/278 (0.00%)  0
ILEAL STENOSIS  1  0/186 (0.00%)  0 0/373 (0.00%)  0 1/372 (0.27%)  1 1/745 (0.13%)  1 0/67 (0.00%)  0 0/68 (0.00%)  0 0/67 (0.00%)  0 0/76 (0.00%)  0 0/278 (0.00%)  0
ILEUS  1  0/186 (0.00%)  0 2/373 (0.54%)  2 0/372 (0.00%)  0 2/745 (0.27%)  2 0/67 (0.00%)  0 0/68 (0.00%)  0 0/67 (0.00%)  0 0/76 (0.00%)  0 0/278 (0.00%)  0
INTESTINAL ISCHAEMIA  1  0/186 (0.00%)  0 0/373 (0.00%)  0 0/372 (0.00%)  0 0/745 (0.00%)  0 0/67 (0.00%)  0 0/68 (0.00%)  0 1/67 (1.49%)  1 0/76 (0.00%)  0 1/278 (0.36%)  1
INTESTINAL OBSTRUCTION  1  2/186 (1.08%)  2 1/373 (0.27%)  1 0/372 (0.00%)  0 1/745 (0.13%)  1 1/67 (1.49%)  1 1/68 (1.47%)  1 0/67 (0.00%)  0 1/76 (1.32%)  1 3/278 (1.08%)  3
INTESTINAL STENOSIS  1  2/186 (1.08%)  2 0/373 (0.00%)  0 0/372 (0.00%)  0 0/745 (0.00%)  0 0/67 (0.00%)  0 0/68 (0.00%)  0 0/67 (0.00%)  0 0/76 (0.00%)  0 0/278 (0.00%)  0
LARGE INTESTINE PERFORATION  1  0/186 (0.00%)  0 1/373 (0.27%)  1 1/372 (0.27%)  1 2/745 (0.27%)  2 0/67 (0.00%)  0 1/68 (1.47%)  1 0/67 (0.00%)  0 0/76 (0.00%)  0 1/278 (0.36%)  1
NAUSEA  1  0/186 (0.00%)  0 1/373 (0.27%)  1 0/372 (0.00%)  0 1/745 (0.13%)  1 0/67 (0.00%)  0 0/68 (0.00%)  0 0/67 (0.00%)  0 0/76 (0.00%)  0 0/278 (0.00%)  0
PANCREATITIS ACUTE  1  0/186 (0.00%)  0 1/373 (0.27%)  1 0/372 (0.00%)  0 1/745 (0.13%)  1 0/67 (0.00%)  0 0/68 (0.00%)  0 0/67 (0.00%)  0 0/76 (0.00%)  0 0/278 (0.00%)  0
SMALL INTESTINAL OBSTRUCTION  1  1/186 (0.54%)  1 1/373 (0.27%)  1 1/372 (0.27%)  1 2/745 (0.27%)  2 0/67 (0.00%)  0 0/68 (0.00%)  0 1/67 (1.49%)  1 0/76 (0.00%)  0 1/278 (0.36%)  1
SUBILEUS  1  0/186 (0.00%)  0 0/373 (0.00%)  0 0/372 (0.00%)  0 0/745 (0.00%)  0 0/67 (0.00%)  0 0/68 (0.00%)  0 0/67 (0.00%)  0 1/76 (1.32%)  1 1/278 (0.36%)  1
TERMINAL ILEITIS  1  0/186 (0.00%)  0 0/373 (0.00%)  0 1/372 (0.27%)  1 1/745 (0.13%)  1 0/67 (0.00%)  0 0/68 (0.00%)  0 0/67 (0.00%)  0 0/76 (0.00%)  0 0/278 (0.00%)  0
VOMITING  1  1/186 (0.54%)  1 1/373 (0.27%)  1 0/372 (0.00%)  0 1/745 (0.13%)  1 0/67 (0.00%)  0 0/68 (0.00%)  0 1/67 (1.49%)  1 0/76 (0.00%)  0 1/278 (0.36%)  1
General disorders