Efficacy and Safety of IBI303 in Adult Patients With Active Ankylosing Spondylitis
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Study ID
- NCT02893254
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- IBI303 — DRUG12 cycles. IBI303: 40 mg, iH
- Adalimumab — DRUG12 cycles. Adalimumab: 40mg, iH
Study Details
Study of the efficacy and safety of IBI303 compared with adalimumab in adult patients with ankylosing spondylitis (AS) who have had an inadequate response to or who are intolerant to one or more nonsteroidal anti-inflammatory drugs (NSAIDs)
Key Dates
- Start date
- Sep 22, 2016
- Status verified
- Jun 2018
- Primary completion
- Jan 22, 2018
- Completion
- Mar 16, 2018
Study Design
- Enrollment
- 438 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: IBI303IBI303 40mg administered subcutaneously every other week, 12cycles
- Active Comparator: AdalimumabAdalimumab 40mg administered subcutaneously every other week
Primary Outcome Measure
Number of participants meeting the Assessment of Spondyloarthritis International Society(ASAS) ASAS20 Response Criteria [ Time Frame: Week 24 ]