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BI 655066 (Risankizumab) Proof of Concept Dose Finding Study in Ankylosing Spondylitis (AS)

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ClinicalTrials.gov Identifier: NCT02047110
Recruitment Status : Completed
First Posted : January 28, 2014
Results First Posted : May 31, 2019
Last Update Posted : May 31, 2019
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Ankylosing Spondylitis (AS)
Interventions Drug: placebo for risankizumab
Drug: risankizumab
Enrollment 159
Recruitment Details  
Pre-assignment Details The trial had a double blind (DB) treatment period up to Week 24, an Escape treatment period up to Week 40, and an open-label-extension (OLE) treatment period that lasted 26 weeks after OLE entry. Each of the treatment periods was followed by a 24- week post-treatment follow-up period.
Arm/Group Title Placebo Risankizumab 18 mg Risankizumab 90 mg Risankizumab 180 mg
Hide Arm/Group Description Subcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period. Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks Subcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period Subcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
Period Title: DB Treatment Period up to Week 24
Started 40 [1] 40 [1] 39 [1] 40 [1]
Completed 35 38 36 38
Not Completed 5 2 3 2
Reason Not Completed
Adverse Event             1             0             0             0
Lost to Follow-up             1             0             0             0
Protocol Violation             1             0             0             0
Withdrawal by Subject             1             0             0             1
Other than specified             1             2             3             1
[1]
Started are the treated patients
Period Title: DB (Week 12 up to Week 24)
Started 9 [1] 17 [1] 13 [1] 12 [1]
Completed 9 15 12 12
Not Completed 0 2 1 0
Reason Not Completed
Withdrawal by Subject             0             1             0             0
Other than specified             0             1             1             0
[1]
Patients who continued treatment in the DB treatment period up to Week 24
Period Title: Escape Treatment Period
Started 26 [1] 21 [2] 23 [2] 26 [2]
Completed 23 15 20 24
Not Completed 3 6 3 2
Reason Not Completed
Withdrawal by Subject             1             2             1             1
Adverse Event             1             2             2             0
Other than specified             1             2             0             1
[1]
Assessment in SpondyloArthritis international Society (ASAS) 20 nonresponders
[2]
ASAS 20 nonresponders
Period Title: OLE Treatment Period
Started 4 [1] 8 [1] 5 [1] 9 [1]
Completed 4 8 4 9
Not Completed 0 0 1 0
Reason Not Completed
Other than specified             0             0             1             0
[1]
Patients with loss of ASAS 20 response compared with baseline
Arm/Group Title Placebo Risankizumab 18 mg Risankizumab 90 mg Risankizumab 180 mg Total
Hide Arm/Group Description Subcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period. Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks Subcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period Subcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period Total of all reporting groups
Overall Number of Baseline Participants 40 40 39 40 159
Hide Baseline Analysis Population Description
Treated set (TS): All patients who received at least 1 dose of trial medication
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 39 participants 40 participants 159 participants
37.6  (11.0) 38.0  (11.1) 39.5  (10.8) 40.6  (11.9) 38.9  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 39 participants 40 participants 159 participants
Female
15
  37.5%
12
  30.0%
9
  23.1%
10
  25.0%
46
  28.9%
Male
25
  62.5%
28
  70.0%
30
  76.9%
30
  75.0%
113
  71.1%
1.Primary Outcome
Title Percentage of Patients Who Achieved Assessment of Spondyloarthritis International Society (ASAS) 40 Improvement Criteria at Week 12.
Hide Description

ASAS 40 evaluations are based on the following 4 components (also called domains) that include patient' self-assessments on a numerical rating scale (NRS) from 0 to 10 with higher numbers representing a worse disease status:

  • Global AS disease activity
  • Inflammation based on the mean of Bath AS Disease Activity Index (BASDAI) questions addressing the level of morning stiffness and duration
  • Spinal pain based on the mean of 2 questions
  • Physical function based on the Bath AS Functional Index (BASFI) The ASAS 40 response is defined as an improvement in 3 of 4 components and no worsening in the remaining component; an improvement is defined as a reduction from baseline of ≥40% and an absolute reduction of ≥2 units in each of the 3 components.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set (FAS): FAS comprised of all randomised patients who received at least 1 dose of trial medication
Arm/Group Title Placebo Risankizumab 18 mg Risankizumab 90 mg Risankizumab 180 mg
Hide Arm/Group Description:
Subcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period.
Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks
Subcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
Subcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
Overall Number of Participants Analyzed 40 40 39 40
Measure Type: Number
Unit of Measure: Percentage of participants
17.5 25.0 20.5 15.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab 18 mg
Comments To control the type I error rate, the primary endpoint was tested in a hierarchical fixed sequence approach. The proportion of patients achieving ASAS 40 response at Week 12 was pairwise compared in the following sequence: risankizumab 180 mg vs. placebo (1.) and risankizumab 90 mg vs. placebo (2.). The significance level was 5% (1-sided). The comparison risankizumab 18 mg vs. placebo was not included in the formal testing sequence; an exploratory p-value was provided.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2652
Comments The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the primary endpoint, ASAS 40 response at Week 12, between treatment groups.
Method Suissa-Shuster unconditional exact test
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 7.5
Confidence Interval (2-Sided) 90%
-12.1 to 26.6
Estimation Comments The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as "risankizumab 18 mg minus Placebo".
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab 90 mg
Comments To control the type I error rate, the primary endpoint was tested in a hierarchical fixed sequence approach. The proportion of patients achieving ASAS 40 response at Week 12 was pairwise compared in the following sequence: risankizumab 180 mg vs. placebo (1.) and risankizumab 90 mg vs. placebo (2.). The significance level was 5% (1-sided). The comparison risankizumab 18 mg vs. placebo was not included in the formal testing sequence; an exploratory p-value was provided.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4129
Comments The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the primary endpoint, ASAS 40 response at Week 12, between treatment groups.
Method Suissa-Shuster unconditional exact test
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 3.0
Confidence Interval (2-Sided) 90%
-15.9 to 20.8
Estimation Comments The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as "risankizumab 90 mg minus Placebo".
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab 180 mg
Comments To control the type I error rate, the primary endpoint was tested in a hierarchical fixed sequence approach. The proportion of patients achieving ASAS 40 response at Week 12 was pairwise compared in the following sequence: risankizumab 180 mg vs. placebo (1.) and risankizumab 90 mg vs. placebo (2.). The significance level was 5% (1-sided). The comparison risankizumab 18 mg vs. placebo was not included in the formal testing sequence; an exploratory p-value was provided.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4243
Comments The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the primary endpoint, ASAS 40 response at Week 12, between treatment groups
Method Suissa-Shuster unconditional exact test
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -2.5
Confidence Interval (2-Sided) 90%
-21.8 to 17.0
Estimation Comments The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as "risankizumab 180 mg minus Placebo".
2.Secondary Outcome
Title Change From Baseline to Week 12 in Disease Activity Assessed by the Ankylosing Spondylitis Disease Activity Score (ASDAS).
Hide Description This is the key secondary endpoint. ASDAS is a linear function of Back Pain (Question 2 from Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI): range 0-10), Duration of Morning Stiffness (Question 6 from BASDAI: range 0-10), Patient’s global assessment of the disease on Numerical rating Scale (NRS) (range 0-10), peripheral joint pain/swelling (Question 3 from BASDAI: range 0-10) and the C-reactive protein (CRP) lab value at the visit. ASDAS-CRP: 0.121*Back pain +0.058*Duration of Morning Stiffness +0.11*Patient Global + 0.073*Peripheral pain/ Swelling + 0.579*Ln (CRP +1). For all of the scales that make up the ASDAS, higher indicates worse disease.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo Risankizumab 18 mg Risankizumab 90 mg Risankizumab 180 mg
Hide Arm/Group Description:
Subcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period.
Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks
Subcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
Subcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
Overall Number of Participants Analyzed 40 40 39 40
Median (Inter-Quartile Range)
Unit of Measure: Unit on scale
-0.2
(-0.9 to 0.2)
-0.7
(-1.3 to -0.2)
-0.6
(-1.0 to 0.1)
-0.7
(-1.1 to -0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab 18 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0229
Comments One sided p-value from Wilcoxon rank−sum test
Method Wilcoxon rank−sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median estimate by Hodges−Lehmann method
Estimated Value -0.4
Confidence Interval (2-Sided) 90%
-0.7 to -0.1
Estimation Comments The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as "risankizumab 18 mg minus Placebo".
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab 90 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1038
Comments One sided p-value from Wilcoxon rank−sum test
Method Wilcoxon rank−sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median estimate by Hodges−Lehmann method
Estimated Value -0.3
Confidence Interval (2-Sided) 90%
-0.6 to 0.1
Estimation Comments The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as "risankizumab 90 mg minus Placebo".
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab 180 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0101
Comments One sided p-value from Wilcoxon rank−sum test
Method Wilcoxon rank−sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median estimate by Hodges−Lehmann method
Estimated Value -0.5
Confidence Interval (2-Sided) 90%
-0.7 to -0.1
Estimation Comments The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as "risankizumab 180 mg minus Placebo".
3.Secondary Outcome
Title Percentage of Patients Who Achieved ASAS 5/6 Improvement Criteria at Week 12
Hide Description

The ASAS 5/6 evaluation is based on 6 components:

  • Global AS disease activity
  • Inflammation based on the mean of BASDAI questions addressing the level-of morning stiffness and duration
  • Spinal pain
  • Physical function based on the Bath AS Functional Index (BASFI)
  • Spinal mobility assessment (lateral lumbar flexion), corresponding to one out of 5 measurements of Bath Ankylosing Spondylitis Metrology Index (BASMI)
  • Serum CRP levels The ASAS 5/6 response is defined as an improvement in any 5 of the 6 components and no worsening in the remaining component. A reduction from baseline of ≥20% is defined as an improvement according to the ASAS criteria.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set (FAS): FAS comprised of all randomised patients who received at least 1 dose of trial medication
Arm/Group Title Placebo Risankizumab 18 mg Risankizumab 90 mg Risankizumab 180 mg
Hide Arm/Group Description:
Subcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period.
Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks
Subcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
Subcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
Overall Number of Participants Analyzed 40 40 39 40
Measure Type: Number
Unit of Measure: Percentage of participants
5.0 20.0 23.1 17.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab 18 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0238
Comments The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.
Method Suissa-Shuster unconditional exact test
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 15.0
Confidence Interval (2-Sided) 90%
-4.6 to 33.8
Estimation Comments The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as "risankizumab 18 mg minus Placebo".
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab 90 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0120
Comments The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.
Method Suissa-Shuster unconditional exact test
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 18.1
Confidence Interval (2-Sided) 90%
-0.8 to 35.3
Estimation Comments The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as "risankizumab 90 mg minus Placebo".
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab 180 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0465
Comments The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups
Method Suissa-Shuster unconditional exact test
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 12.5
Confidence Interval (2-Sided) 90%
-7.1 to 31.4
Estimation Comments The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as "risankizumab 180 mg minus Placebo".
4.Secondary Outcome
Title Percentage of Patients Who Achieved Partial Remission According to the ASAS Criteria at Week 12
Hide Description Percentage of patients who achieved partial remission according to the ASAS criteria at Week 12 is presented
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set (FAS): FAS comprised of all randomised patients who received at least 1 dose of trial medication
Arm/Group Title Placebo Risankizumab 18 mg Risankizumab 90 mg Risankizumab 180 mg
Hide Arm/Group Description:
Subcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period.
Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks
Subcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
Subcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
Overall Number of Participants Analyzed 40 40 39 40
Measure Type: Number
Unit of Measure: Percentage of participants
2.5 2.5 2.6 10.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab 18 mg
Comments p-values are not presented as they were not meaningful; 3 treatment groups had only a single patient with partial remission.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0
Confidence Interval (2-Sided) 90%
-19.4 to 19.4
Estimation Comments The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as "risankizumab 18 mg minus Placebo".
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab 90 mg
Comments p-values are not presented as they were not meaningful; 3 treatment groups had only a single patient with partial remission.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.1
Confidence Interval (2-Sided) 90%
-18.3 to 18.3
Estimation Comments The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as "risankizumab 90 mg minus Placebo".
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab 180 mg
Comments p-values are not presented as they were not meaningful; 3 treatment groups had only a single patient with partial remission.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 7.5
Confidence Interval (2-Sided) 90%
-12.1 to 26.6
Estimation Comments The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as "risankizumab 180 mg minus Placebo".
5.Secondary Outcome
Title Percentage of Patients Who Achieved ASAS 20 Improvement Criteria at Week 12
Hide Description

ASAS 20 evaluations are based on the following 4 components (also called domains) that include patient' self-assessments on a numerical rating scale (NRS) from 0 to 10 with higher numbers representing a worse disease status:

  • Global AS disease activity
  • Inflammation based on the mean of Bath AS Disease Activity Index (BASDAI) questions addressing the level of morning stiffness and duration
  • Spinal pain based on the mean of 2 questions
  • Physical function based on the Bath AS Functional Index (BASFI) The ASAS 20 response is defined as an improvement in 3 of 4 components and no worsening in the remaining component; an improvement is defined as a reduction from baseline of ≥20% and an absolute reduction of ≥1 units in each of the 3 components.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set (FAS): FAS comprised of all randomised patients who received at least 1 dose of trial medication
Arm/Group Title Placebo Risankizumab 18 mg Risankizumab 90 mg Risankizumab 180 mg
Hide Arm/Group Description:
Subcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period.
Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks
Subcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
Subcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
Overall Number of Participants Analyzed 40 40 39 40
Measure Type: Number
Unit of Measure: Percentage of participants
20.0 45.0 33.3 32.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab 18 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0092
Comments The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.
Method Suissa-Shuster unconditional exact test
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 25.0
Confidence Interval (2-Sided) 90%
5.5 to 43.1
Estimation Comments The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as "risankizumab 18 mg minus Placebo".
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab 90 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1243
Comments The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.
Method Suissa-Shuster unconditional exact test
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 13.3
Confidence Interval (2-Sided) 90%
-5.9 to 30.5
Estimation Comments The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as "risankizumab 90 mg minus Placebo".
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab 180 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1198
Comments The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups
Method Suissa-Shuster unconditional exact test
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 12.5
Confidence Interval (2-Sided) 90%
-7.1 to 31.4
Estimation Comments The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as "risankizumab 180 mg minus Placebo".
6.Secondary Outcome
Title Change From Baseline to Week 12 in Disease Activity Assessed by BASDAI
Hide Description

BASDAI assesses the AS disease activity of a patient within the last week based on 6 questions on a NRS (1 to 10) How would you describe the overall level of

  1. fatigue/tiredness you have experienced?
  2. AS neck, back or hip pain you have had?
  3. pain/swelling in joints other than neck, back or hips you have had?
  4. discomfort you have had from any areas tender to touch or pressure?
  5. morning stiffness you have had from the time you wake up? How long does your
  6. morning stiffness last from the time you wake up?

A score of 10 means very severe disease activity for each of the BASDAI questions 1, 2, 3, 4 and 5. BASDAI question 6 addresses the stiffness duration. A NRS of 0 means 0 h; a NRS of 10 mean ≥2 h.

The BASDAI was computed in the following way: the sum of the values of question 1 to 4 was calculated and the mean of questions 5 and 6 was added. This value was divided by 5.

Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo Risankizumab 18 mg Risankizumab 90 mg Risankizumab 180 mg
Hide Arm/Group Description:
Subcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period.
Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks
Subcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
Subcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
Overall Number of Participants Analyzed 40 40 39 40
Median (Inter-Quartile Range)
Unit of Measure: Unit on scale
-0.6
(-2.8 to -0.1)
-1.2
(-2.8 to -0.4)
-0.8
(-2.1 to 1.0)
-1.0
(-2.0 to -0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab 18 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1241
Comments One sided p-value from Wilcoxon rank−sum test
Method Wilcoxon rank−sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median estimate by Hodges−Lehmann method
Estimated Value -0.4
Confidence Interval (2-Sided) 90%
-1.0 to 0.2
Estimation Comments The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as "risankizumab 18 mg minus Placebo".
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab 90 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3033
Comments One sided p-value from Wilcoxon rank−sum test
Method Wilcoxon rank−sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median estimate by Hodges−Lehmann method
Estimated Value 0.3
Confidence Interval (2-Sided) 90%
-0.5 to 1.0
Estimation Comments The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as "risankizumab 90 mg minus Placebo".
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab 180 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3203
Comments One sided p-value from Wilcoxon rank−sum test
Method Wilcoxon rank−sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median estimate by Hodges−Lehmann method
Estimated Value -0.2
Confidence Interval (2-Sided) 90%
-0.8 to 0.4
Estimation Comments The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as "risankizumab 180 mg minus Placebo".
7.Secondary Outcome
Title Percentage of Patients Who Achieved ASAS 40 Improvement Criteria at Week 24
Hide Description Percentage of patients who achieved ASAS 40 improvement criteria at Week 24 is presented
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set (FAS): FAS comprised of all randomised patients who received at least 1 dose of trial medication
Arm/Group Title Placebo Risankizumab 18 mg Risankizumab 90 mg Risankizumab 180 mg
Hide Arm/Group Description:
Subcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period.
Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks
Subcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
Subcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
Overall Number of Participants Analyzed 40 40 39 40
Measure Type: Number
Unit of Measure: Percentage of participants
15.0 22.5 23.1 12.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab 18 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2639
Comments The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 24, between treatment groups.
Method Suissa-Shuster unconditional exact test
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 7.5
Confidence Interval (2-Sided) 90%
-12.1 to 26.6
Estimation Comments The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as "risankizumab 18 mg minus Placebo".
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab 90 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2691
Comments The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 24, between treatment groups.
Method Suissa-Shuster unconditional exact test
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 8.1
Confidence Interval (2-Sided) 90%
-10.9 to 25.7
Estimation Comments The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as "risankizumab 90 mg minus Placebo".
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Risankizumab 180 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4174
Comments The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 24, between treatment groups
Method Suissa-Shuster unconditional exact test
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -2.5
Confidence Interval (2-Sided) 90%
-21.8 to 17.0
Estimation Comments The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as "risankizumab 180 mg minus Placebo".
Time Frame All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Risankizumab 18 mg Risankizumab 90 mg Risankizumab 180 mg Escape Low Escape High Escape Open Label Extension (OLE) Risankizumab High Risankizumab Total Total_all
Hide Arm/Group Description Subcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period. Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks Subcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period Subcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period Patients who received risankizumab 180 mg in the Escape treatment period and who were randomized to either Placebo or risankizumab 18 mg at Day 1 of the DB treatment period Patients who received risankizumab 180 mg in the Escape treatment period and who were randomized to either risankizumab 90 mg or risankizumab 180 mg at Day 1 of the DB treatment period Patients who received escape treatments of risankizumab 180 mg regardless of the initial randomization group Patients who received 180 mg risankizumab (administered subcutaneously) every 8 weeks in OLE treatment period Patients who received at least one risankizumab 90 mg or 180 mg treatment during the entire trial Patients who received at least one risankizumab treatment at any dose level All randomised patients
All-Cause Mortality
Placebo Risankizumab 18 mg Risankizumab 90 mg Risankizumab 180 mg Escape Low Escape High Escape Open Label Extension (OLE) Risankizumab High Risankizumab Total Total_all
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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Risankizumab 18 mg Risankizumab 90 mg Risankizumab 180 mg Escape Low Escape High Escape Open Label Extension (OLE) Risankizumab High Risankizumab Total Total_all
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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/40 (5.00%)   0/40 (0.00%)   2/39 (5.13%)   2/40 (5.00%)   1/47 (2.13%)   2/48 (4.17%)   3/95 (3.16%)   1/26 (3.85%)   9/138 (6.52%)   9/149 (6.04%)   10/159 (6.29%) 
Gastrointestinal disorders                       
Inguinal hernia  1  0/40 (0.00%)  0/40 (0.00%)  1/39 (2.56%)  0/40 (0.00%)  0/47 (0.00%)  0/48 (0.00%)  0/95 (0.00%)  0/26 (0.00%)  1/138 (0.72%)  1/149 (0.67%)  1/159 (0.63%) 
Infections and infestations                       
Cellulitis  1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/47 (0.00%)  0/48 (0.00%)  0/95 (0.00%)  1/26 (3.85%)  1/138 (0.72%)  1/149 (0.67%)  1/159 (0.63%) 
Gastroenteritis  1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/47 (0.00%)  1/48 (2.08%)  1/95 (1.05%)  0/26 (0.00%)  1/138 (0.72%)  1/149 (0.67%)  1/159 (0.63%) 
Incision site cellulitis  1  0/40 (0.00%)  0/40 (0.00%)  1/39 (2.56%)  0/40 (0.00%)  0/47 (0.00%)  0/48 (0.00%)  0/95 (0.00%)  0/26 (0.00%)  1/138 (0.72%)  1/149 (0.67%)  1/159 (0.63%) 
Musculoskeletal and connective tissue disorders                       
Ankylosing spondylitis  1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/47 (0.00%)  1/48 (2.08%)  1/95 (1.05%)  0/26 (0.00%)  1/138 (0.72%)  1/149 (0.67%)  1/159 (0.63%) 
Arthralgia  1  1/40 (2.50%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/47 (0.00%)  0/48 (0.00%)  0/95 (0.00%)  0/26 (0.00%)  0/138 (0.00%)  0/149 (0.00%)  1/159 (0.63%) 
Spondylitis  1  1/40 (2.50%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/47 (0.00%)  0/48 (0.00%)  0/95 (0.00%)  0/26 (0.00%)  1/138 (0.72%)  1/149 (0.67%)  1/159 (0.63%) 
Nervous system disorders                       
Sciatica  1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  1/40 (2.50%)  0/47 (0.00%)  0/48 (0.00%)  0/95 (0.00%)  0/26 (0.00%)  1/138 (0.72%)  1/149 (0.67%)  1/159 (0.63%) 
Syncope  1  0/40 (0.00%)  0/40 (0.00%)  1/39 (2.56%)  0/40 (0.00%)  0/47 (0.00%)  0/48 (0.00%)  0/95 (0.00%)  0/26 (0.00%)  1/138 (0.72%)  1/149 (0.67%)  1/159 (0.63%) 
Transient ischaemic attack  1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  1/40 (2.50%)  0/47 (0.00%)  0/48 (0.00%)  0/95 (0.00%)  0/26 (0.00%)  1/138 (0.72%)  1/149 (0.67%)  1/159 (0.63%) 
Psychiatric disorders                       
Confusional state  1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  1/47 (2.13%)  0/48 (0.00%)  1/95 (1.05%)  0/26 (0.00%)  1/138 (0.72%)  1/149 (0.67%)  1/159 (0.63%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Risankizumab 18 mg Risankizumab 90 mg Risankizumab 180 mg Escape Low Escape High Escape Open Label Extension (OLE) Risankizumab High Risankizumab Total Total_all
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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   21/40 (52.50%)   21/40 (52.50%)   22/39 (56.41%)   22/40 (55.00%)   10/47 (21.28%)   17/48 (35.42%)   27/95 (28.42%)   11/26 (42.31%)   85/138 (61.59%)   91/149 (61.07%)   99/159 (62.26%) 
Gastrointestinal disorders                       
Abdominal pain upper  1  0/40 (0.00%)  0/40 (0.00%)  2/39 (5.13%)  0/40 (0.00%)  0/47 (0.00%)  1/48 (2.08%)  1/95 (1.05%)  0/26 (0.00%)  3/138 (2.17%)  3/149 (2.01%)  3/159 (1.89%) 
Diarrhoea  1  0/40 (0.00%)  2/40 (5.00%)  1/39 (2.56%)  3/40 (7.50%)  1/47 (2.13%)  1/48 (2.08%)  2/95 (2.11%)  0/26 (0.00%)  8/138 (5.80%)  8/149 (5.37%)  8/159 (5.03%) 
General disorders                       
Fatigue  1  2/40 (5.00%)  2/40 (5.00%)  1/39 (2.56%)  4/40 (10.00%)  1/47 (2.13%)  1/48 (2.08%)  2/95 (2.11%)  0/26 (0.00%)  9/138 (6.52%)  11/149 (7.38%)  11/159 (6.92%) 
Infections and infestations                       
Bronchitis  1  1/40 (2.50%)  1/40 (2.50%)  1/39 (2.56%)  3/40 (7.50%)  1/47 (2.13%)  1/48 (2.08%)  2/95 (2.11%)  0/26 (0.00%)  8/138 (5.80%)  8/149 (5.37%)  8/159 (5.03%) 
Gastroenteritis  1  1/40 (2.50%)  1/40 (2.50%)  1/39 (2.56%)  0/40 (0.00%)  0/47 (0.00%)  1/48 (2.08%)  1/95 (1.05%)  2/26 (7.69%)  4/138 (2.90%)  5/149 (3.36%)  6/159 (3.77%) 
Influenza  1  1/40 (2.50%)  2/40 (5.00%)  2/39 (5.13%)  2/40 (5.00%)  0/47 (0.00%)  0/48 (0.00%)  0/95 (0.00%)  2/26 (7.69%)  6/138 (4.35%)  7/149 (4.70%)  8/159 (5.03%) 
Nasopharyngitis  1  4/40 (10.00%)  7/40 (17.50%)  7/39 (17.95%)  5/40 (12.50%)  5/47 (10.64%)  5/48 (10.42%)  10/95 (10.53%)  2/26 (7.69%)  30/138 (21.74%)  32/149 (21.48%)  33/159 (20.75%) 
Sinusitis  1  1/40 (2.50%)  0/40 (0.00%)  3/39 (7.69%)  1/40 (2.50%)  0/47 (0.00%)  0/48 (0.00%)  0/95 (0.00%)  0/26 (0.00%)  5/138 (3.62%)  5/149 (3.36%)  5/159 (3.14%) 
Upper respiratory tract infection  1  0/40 (0.00%)  2/40 (5.00%)  1/39 (2.56%)  2/40 (5.00%)  1/47 (2.13%)  1/48 (2.08%)  2/95 (2.11%)  2/26 (7.69%)  8/138 (5.80%)  8/149 (5.37%)  8/159 (5.03%) 
Injury, poisoning and procedural complications                       
Wound  1  0/40 (0.00%)  2/40 (5.00%)  0/39 (0.00%)  1/40 (2.50%)  0/47 (0.00%)  3/48 (6.25%)  3/95 (3.16%)  0/26 (0.00%)  5/138 (3.62%)  6/149 (4.03%)  6/159 (3.77%) 
Investigations                       
Alanine aminotransferase increased  1  0/40 (0.00%)  0/40 (0.00%)  2/39 (5.13%)  0/40 (0.00%)  0/47 (0.00%)  1/48 (2.08%)  1/95 (1.05%)  0/26 (0.00%)  3/138 (2.17%)  3/149 (2.01%)  3/159 (1.89%) 
Blood creatine phosphokinase increased  1  3/40 (7.50%)  1/40 (2.50%)  2/39 (5.13%)  1/40 (2.50%)  0/47 (0.00%)  0/48 (0.00%)  0/95 (0.00%)  0/26 (0.00%)  5/138 (3.62%)  5/149 (3.36%)  7/159 (4.40%) 
Metabolism and nutrition disorders                       
Hypercholesterolaemia  1  0/40 (0.00%)  0/40 (0.00%)  2/39 (5.13%)  1/40 (2.50%)  0/47 (0.00%)  0/48 (0.00%)  0/95 (0.00%)  1/26 (3.85%)  3/138 (2.17%)  3/149 (2.01%)  3/159 (1.89%) 
Musculoskeletal and connective tissue disorders                       
Ankylosing spondylitis  1  2/40 (5.00%)  1/40 (2.50%)  1/39 (2.56%)  1/40 (2.50%)  1/47 (2.13%)  5/48 (10.42%)  6/95 (6.32%)  1/26 (3.85%)  8/138 (5.80%)  9/149 (6.04%)  11/159 (6.92%) 
Arthralgia  1  4/40 (10.00%)  0/40 (0.00%)  2/39 (5.13%)  1/40 (2.50%)  0/47 (0.00%)  1/48 (2.08%)  1/95 (1.05%)  0/26 (0.00%)  6/138 (4.35%)  6/149 (4.03%)  8/159 (5.03%) 
Back pain  1  3/40 (7.50%)  3/40 (7.50%)  2/39 (5.13%)  2/40 (5.00%)  2/47 (4.26%)  1/48 (2.08%)  3/95 (3.16%)  0/26 (0.00%)  10/138 (7.25%)  12/149 (8.05%)  12/159 (7.55%) 
Plantar fasciitis  1  0/40 (0.00%)  1/40 (2.50%)  0/39 (0.00%)  0/40 (0.00%)  1/47 (2.13%)  0/48 (0.00%)  1/95 (1.05%)  2/26 (7.69%)  3/138 (2.17%)  3/149 (2.01%)  3/159 (1.89%) 
Nervous system disorders                       
Dizziness  1  0/40 (0.00%)  0/40 (0.00%)  2/39 (5.13%)  1/40 (2.50%)  0/47 (0.00%)  1/48 (2.08%)  1/95 (1.05%)  0/26 (0.00%)  4/138 (2.90%)  4/149 (2.68%)  4/159 (2.52%) 
Headache  1  3/40 (7.50%)  5/40 (12.50%)  3/39 (7.69%)  4/40 (10.00%)  2/47 (4.26%)  1/48 (2.08%)  3/95 (3.16%)  0/26 (0.00%)  14/138 (10.14%)  15/149 (10.07%)  17/159 (10.69%) 
Renal and urinary disorders                       
Renal colic  1  0/40 (0.00%)  0/40 (0.00%)  2/39 (5.13%)  0/40 (0.00%)  0/47 (0.00%)  1/48 (2.08%)  1/95 (1.05%)  0/26 (0.00%)  3/138 (2.17%)  3/149 (2.01%)  3/159 (1.89%) 
Skin and subcutaneous tissue disorders                       
Eczema  1  1/40 (2.50%)  0/40 (0.00%)  2/39 (5.13%)  1/40 (2.50%)  0/47 (0.00%)  2/48 (4.17%)  2/95 (2.11%)  2/26 (7.69%)  7/138 (5.07%)  7/149 (4.70%)  7/159 (4.40%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
The hierarchical testing p-values are exploratory in nature, due to the study design, as the primary endpoint of study failed to meet the desired objective.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
EMail: abbvieclinicaltrials@abbvie.com
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02047110     History of Changes
Other Study ID Numbers: 1311.8
2013-003666-13 ( EudraCT Number )
First Submitted: January 24, 2014
First Posted: January 28, 2014
Results First Submitted: May 3, 2019
Results First Posted: May 31, 2019
Last Update Posted: May 31, 2019