Trial Outcomes & Findings for BI 655066 (Risankizumab) Proof of Concept Dose Finding Study in Ankylosing Spondylitis (AS) (NCT NCT02047110)
NCT ID: NCT02047110
Last Updated: 2019-05-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
159 participants
Primary outcome timeframe
Week 12
Results posted on
2019-05-31
Participant Flow
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.
Participant milestones
| Measure |
Placebo
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.
|
Risankizumab 18 mg
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
|
Risankizumab 90 mg
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
|
Risankizumab 180 mg
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
|
|---|---|---|---|---|
|
DB Treatment Period up to Week 24
STARTED
|
40
|
40
|
39
|
40
|
|
DB Treatment Period up to Week 24
COMPLETED
|
35
|
38
|
36
|
38
|
|
DB Treatment Period up to Week 24
NOT COMPLETED
|
5
|
2
|
3
|
2
|
|
DB (Week 12 up to Week 24)
STARTED
|
9
|
17
|
13
|
12
|
|
DB (Week 12 up to Week 24)
COMPLETED
|
9
|
15
|
12
|
12
|
|
DB (Week 12 up to Week 24)
NOT COMPLETED
|
0
|
2
|
1
|
0
|
|
Escape Treatment Period
STARTED
|
26
|
21
|
23
|
26
|
|
Escape Treatment Period
COMPLETED
|
23
|
15
|
20
|
24
|
|
Escape Treatment Period
NOT COMPLETED
|
3
|
6
|
3
|
2
|
|
OLE Treatment Period
STARTED
|
4
|
8
|
5
|
9
|
|
OLE Treatment Period
COMPLETED
|
4
|
8
|
4
|
9
|
|
OLE Treatment Period
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
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.
|
Risankizumab 18 mg
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
|
Risankizumab 90 mg
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
|
Risankizumab 180 mg
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
|
|---|---|---|---|---|
|
DB Treatment Period up to Week 24
Adverse Event
|
1
|
0
|
0
|
0
|
|
DB Treatment Period up to Week 24
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
DB Treatment Period up to Week 24
Protocol Violation
|
1
|
0
|
0
|
0
|
|
DB Treatment Period up to Week 24
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
|
DB Treatment Period up to Week 24
Other than specified
|
1
|
2
|
3
|
1
|
|
DB (Week 12 up to Week 24)
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
DB (Week 12 up to Week 24)
Other than specified
|
0
|
1
|
1
|
0
|
|
Escape Treatment Period
Withdrawal by Subject
|
1
|
2
|
1
|
1
|
|
Escape Treatment Period
Adverse Event
|
1
|
2
|
2
|
0
|
|
Escape Treatment Period
Other than specified
|
1
|
2
|
0
|
1
|
|
OLE Treatment Period
Other than specified
|
0
|
0
|
1
|
0
|
Baseline Characteristics
BI 655066 (Risankizumab) Proof of Concept Dose Finding Study in Ankylosing Spondylitis (AS)
Baseline characteristics by cohort
| Measure |
Placebo
n=40 Participants
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.
|
Risankizumab 18 mg
n=40 Participants
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
|
Risankizumab 90 mg
n=39 Participants
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
|
Risankizumab 180 mg
n=40 Participants
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
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37.6 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
38.0 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
39.5 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
40.6 years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
38.9 years
STANDARD_DEVIATION 11.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
113 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Full Analysis set (FAS): FAS comprised of all randomised patients who received at least 1 dose of trial medication
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.
Outcome measures
| Measure |
Placebo
n=40 Participants
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.
|
Risankizumab 18 mg
n=40 Participants
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
|
Risankizumab 90 mg
n=39 Participants
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
|
Risankizumab 180 mg
n=40 Participants
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
|
|---|---|---|---|---|
|
Percentage of Patients Who Achieved Assessment of Spondyloarthritis International Society (ASAS) 40 Improvement Criteria at Week 12.
|
17.5 Percentage of participants
|
25.0 Percentage of participants
|
20.5 Percentage of participants
|
15.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: FAS
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.
Outcome measures
| Measure |
Placebo
n=40 Participants
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.
|
Risankizumab 18 mg
n=40 Participants
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
|
Risankizumab 90 mg
n=39 Participants
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
|
Risankizumab 180 mg
n=40 Participants
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
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in Disease Activity Assessed by the Ankylosing Spondylitis Disease Activity Score (ASDAS).
|
-0.2 Unit on scale
Interval -0.9 to 0.2
|
-0.7 Unit on scale
Interval -1.3 to -0.2
|
-0.6 Unit on scale
Interval -1.0 to 0.1
|
-0.7 Unit on scale
Interval -1.1 to -0.3
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis set (FAS): FAS comprised of all randomised patients who received at least 1 dose of trial medication
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.
Outcome measures
| Measure |
Placebo
n=40 Participants
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.
|
Risankizumab 18 mg
n=40 Participants
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
|
Risankizumab 90 mg
n=39 Participants
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
|
Risankizumab 180 mg
n=40 Participants
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
|
|---|---|---|---|---|
|
Percentage of Patients Who Achieved ASAS 5/6 Improvement Criteria at Week 12
|
5.0 Percentage of participants
|
20.0 Percentage of participants
|
23.1 Percentage of participants
|
17.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis set (FAS): FAS comprised of all randomised patients who received at least 1 dose of trial medication
Percentage of patients who achieved partial remission according to the ASAS criteria at Week 12 is presented
Outcome measures
| Measure |
Placebo
n=40 Participants
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.
|
Risankizumab 18 mg
n=40 Participants
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
|
Risankizumab 90 mg
n=39 Participants
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
|
Risankizumab 180 mg
n=40 Participants
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
|
|---|---|---|---|---|
|
Percentage of Patients Who Achieved Partial Remission According to the ASAS Criteria at Week 12
|
2.5 Percentage of participants
|
2.5 Percentage of participants
|
2.6 Percentage of participants
|
10.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis set (FAS): FAS comprised of all randomised patients who received at least 1 dose of trial medication
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.
Outcome measures
| Measure |
Placebo
n=40 Participants
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.
|
Risankizumab 18 mg
n=40 Participants
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
|
Risankizumab 90 mg
n=39 Participants
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
|
Risankizumab 180 mg
n=40 Participants
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
|
|---|---|---|---|---|
|
Percentage of Patients Who Achieved ASAS 20 Improvement Criteria at Week 12
|
20.0 Percentage of participants
|
45.0 Percentage of participants
|
33.3 Percentage of participants
|
32.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: FAS
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.
Outcome measures
| Measure |
Placebo
n=40 Participants
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.
|
Risankizumab 18 mg
n=40 Participants
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
|
Risankizumab 90 mg
n=39 Participants
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
|
Risankizumab 180 mg
n=40 Participants
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
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in Disease Activity Assessed by BASDAI
|
-0.6 Unit on scale
Interval -2.8 to -0.1
|
-1.2 Unit on scale
Interval -2.8 to -0.4
|
-0.8 Unit on scale
Interval -2.1 to 1.0
|
-1.0 Unit on scale
Interval -2.0 to -0.2
|
SECONDARY outcome
Timeframe: Week 24Population: Full Analysis set (FAS): FAS comprised of all randomised patients who received at least 1 dose of trial medication
Percentage of patients who achieved ASAS 40 improvement criteria at Week 24 is presented
Outcome measures
| Measure |
Placebo
n=40 Participants
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.
|
Risankizumab 18 mg
n=40 Participants
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
|
Risankizumab 90 mg
n=39 Participants
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
|
Risankizumab 180 mg
n=40 Participants
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
|
|---|---|---|---|---|
|
Percentage of Patients Who Achieved ASAS 40 Improvement Criteria at Week 24
|
15.0 Percentage of participants
|
22.5 Percentage of participants
|
23.1 Percentage of participants
|
12.5 Percentage of participants
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Risankizumab 18 mg
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Risankizumab 90 mg
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Risankizumab 180 mg
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Escape Low
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Escape High
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Escape
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
Open Label Extension (OLE)
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Risankizumab High
Serious events: 9 serious events
Other events: 85 other events
Deaths: 0 deaths
Risankizumab Total
Serious events: 9 serious events
Other events: 91 other events
Deaths: 0 deaths
Total_all
Serious events: 10 serious events
Other events: 99 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=40 participants at risk
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.
|
Risankizumab 18 mg
n=40 participants at risk
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
|
Risankizumab 90 mg
n=39 participants at risk
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
|
Risankizumab 180 mg
n=40 participants at risk
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
|
Escape Low
n=47 participants at risk
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
|
Escape High
n=48 participants at risk
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
|
Escape
n=95 participants at risk
Patients who received escape treatments of risankizumab 180 mg regardless of the initial randomization group
|
Open Label Extension (OLE)
n=26 participants at risk
Patients who received 180 mg risankizumab (administered subcutaneously) every 8 weeks in OLE treatment period
|
Risankizumab High
n=138 participants at risk
Patients who received at least one risankizumab 90 mg or 180 mg treatment during the entire trial
|
Risankizumab Total
n=149 participants at risk
Patients who received at least one risankizumab treatment at any dose level
|
Total_all
n=159 participants at risk
All randomised patients
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.6%
1/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.72%
1/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.67%
1/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.63%
1/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
Infections and infestations
Cellulitis
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
3.8%
1/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.72%
1/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.67%
1/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.63%
1/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.1%
1/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
1.1%
1/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.72%
1/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.67%
1/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.63%
1/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
Infections and infestations
Incision site cellulitis
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.6%
1/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.72%
1/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.67%
1/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.63%
1/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.1%
1/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
1.1%
1/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.72%
1/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.67%
1/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.63%
1/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.5%
1/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.63%
1/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
2.5%
1/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.72%
1/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.67%
1/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.63%
1/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
Nervous system disorders
Sciatica
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.5%
1/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.72%
1/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.67%
1/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.63%
1/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.6%
1/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.72%
1/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.67%
1/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.63%
1/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.5%
1/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.72%
1/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.67%
1/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.63%
1/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.1%
1/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
1.1%
1/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.72%
1/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.67%
1/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.63%
1/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
Other adverse events
| Measure |
Placebo
n=40 participants at risk
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.
|
Risankizumab 18 mg
n=40 participants at risk
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
|
Risankizumab 90 mg
n=39 participants at risk
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
|
Risankizumab 180 mg
n=40 participants at risk
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
|
Escape Low
n=47 participants at risk
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
|
Escape High
n=48 participants at risk
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
|
Escape
n=95 participants at risk
Patients who received escape treatments of risankizumab 180 mg regardless of the initial randomization group
|
Open Label Extension (OLE)
n=26 participants at risk
Patients who received 180 mg risankizumab (administered subcutaneously) every 8 weeks in OLE treatment period
|
Risankizumab High
n=138 participants at risk
Patients who received at least one risankizumab 90 mg or 180 mg treatment during the entire trial
|
Risankizumab Total
n=149 participants at risk
Patients who received at least one risankizumab treatment at any dose level
|
Total_all
n=159 participants at risk
All randomised patients
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Sinusitis
|
2.5%
1/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
7.7%
3/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.5%
1/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
3.6%
5/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
3.4%
5/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
3.1%
5/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.1%
2/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.1%
1/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
1.1%
1/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.2%
3/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.0%
3/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
1.9%
3/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.0%
2/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.6%
1/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
7.5%
3/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.1%
1/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.1%
1/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.1%
2/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.8%
8/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.4%
8/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.0%
8/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
General disorders
Fatigue
|
5.0%
2/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.0%
2/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.6%
1/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
10.0%
4/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.1%
1/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.1%
1/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.1%
2/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
6.5%
9/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
7.4%
11/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
6.9%
11/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
Infections and infestations
Bronchitis
|
2.5%
1/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.5%
1/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.6%
1/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
7.5%
3/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.1%
1/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.1%
1/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.1%
2/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.8%
8/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.4%
8/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.0%
8/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
Infections and infestations
Gastroenteritis
|
2.5%
1/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.5%
1/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.6%
1/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.1%
1/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
1.1%
1/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
7.7%
2/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.9%
4/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
3.4%
5/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
3.8%
6/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
Infections and infestations
Influenza
|
2.5%
1/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.0%
2/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.1%
2/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.0%
2/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
7.7%
2/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
4.3%
6/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
4.7%
7/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.0%
8/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
4/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
17.5%
7/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
17.9%
7/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
12.5%
5/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
10.6%
5/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
10.4%
5/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
10.5%
10/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
7.7%
2/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
21.7%
30/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
21.5%
32/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
20.8%
33/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.0%
2/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.6%
1/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.0%
2/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.1%
1/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.1%
1/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.1%
2/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
7.7%
2/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.8%
8/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.4%
8/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.0%
8/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.0%
2/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.5%
1/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
6.2%
3/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
3.2%
3/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
3.6%
5/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
4.0%
6/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
3.8%
6/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.1%
2/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.1%
1/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
1.1%
1/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.2%
3/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.0%
3/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
1.9%
3/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
7.5%
3/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.5%
1/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.1%
2/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.5%
1/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
3.6%
5/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
3.4%
5/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
4.4%
7/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.1%
2/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.5%
1/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
3.8%
1/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.2%
3/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.0%
3/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
1.9%
3/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
5.0%
2/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.5%
1/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.6%
1/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.5%
1/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.1%
1/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
10.4%
5/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
6.3%
6/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
3.8%
1/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.8%
8/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
6.0%
9/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
6.9%
11/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
4/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.1%
2/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.5%
1/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.1%
1/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
1.1%
1/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
4.3%
6/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
4.0%
6/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.0%
8/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.5%
3/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
7.5%
3/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.1%
2/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.0%
2/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
4.3%
2/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.1%
1/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
3.2%
3/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
7.2%
10/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
8.1%
12/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
7.5%
12/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.5%
1/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.1%
1/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
1.1%
1/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
7.7%
2/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.2%
3/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.0%
3/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
1.9%
3/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.1%
2/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.5%
1/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.1%
1/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
1.1%
1/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.9%
4/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.7%
4/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.5%
4/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
Nervous system disorders
Headache
|
7.5%
3/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
12.5%
5/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
7.7%
3/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
10.0%
4/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
4.3%
2/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.1%
1/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
3.2%
3/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
10.1%
14/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
10.1%
15/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
10.7%
17/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.1%
2/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.1%
1/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
1.1%
1/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.2%
3/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.0%
3/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
1.9%
3/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.5%
1/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.1%
2/39 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.5%
1/40 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
0.00%
0/47 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
4.2%
2/48 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
2.1%
2/95 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
7.7%
2/26 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
5.1%
7/138 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
4.7%
7/149 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
4.4%
7/159 • All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER