BI 655066 (Risankizumab) Proof of Concept Dose Finding Study in Ankylosing Spondylitis (AS)
- Conditions
- Ankylosing Spondylitis (AS)
- Interventions
- Registration Number
- NCT02047110
- Lead Sponsor
- AbbVie
- Brief Summary
The overall purpose of the trial is to assess the clinical efficacy of three different subcutaneous doses of BI 655066 (risankizumab) in adult patients with AS, in order to provide clinical proof of concept and to select dose (s) for confirmatory clinical trials.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 159
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo for risankizumab 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 risankizumab 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 180 mg risankizumab 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 Risankizumab 90 mg risankizumab 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
- Primary Outcome Measures
Name Time Method Percentage of Patients Who Achieved Assessment of Spondyloarthritis International Society (ASAS) 40 Improvement Criteria at Week 12. Week 12 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline to Week 12 in Disease Activity Assessed by the Ankylosing Spondylitis Disease Activity Score (ASDAS). Baseline and Week 12 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.
Percentage of Patients Who Achieved Partial Remission According to the ASAS Criteria at Week 12 Week 12 Percentage of patients who achieved partial remission according to the ASAS criteria at Week 12 is presented
Percentage of Patients Who Achieved ASAS 5/6 Improvement Criteria at Week 12 Week 12 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.Percentage of Patients Who Achieved ASAS 20 Improvement Criteria at Week 12 Week 12 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.Change From Baseline to Week 12 in Disease Activity Assessed by BASDAI Baseline and Week 12 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.Percentage of Patients Who Achieved ASAS 40 Improvement Criteria at Week 24 Week 24 Percentage of patients who achieved ASAS 40 improvement criteria at Week 24 is presented