Efficacy and Safety of SHR-1314 in Patients With Active Ankylosing Spondylitis
- Registration Number
- NCT04840485
- Lead Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Brief Summary
The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SHR-1314 in patients with active ankylosing spondylitis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 548
Inclusion Criteria
- Active Ankylosing Spondylitis, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response, contraindications or intolerance to NSAIDs
Exclusion Criteria
- pregnancy or lactation, serious infectious, malignancy, previous exposure to any biological agent excluding TNF antagonists
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group A SHR-1314 - Treatment group B SHR-1314 - Treatment group C Placebo -
- Primary Outcome Measures
Name Time Method Percentage of Participants Responded for Assessment of SpondyloArthritis international Society 20 Criteria (ASAS20) at 16 Weeks 16 Weeks
- Secondary Outcome Measures
Name Time Method Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 16 and 32 Weeks 16 and 32 Weeks Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at 16 and 32 Weeks 16 and 32 Weeks Percentage of Participants Responded for ASAS 20 Response at 32 Weeks 32 Weeks Percentage of Participants Responded for ASAS 40 Response at 16 and 32 Weeks 16 and 32 Weeks Percentage of Participants Responded for ASAS 5/6 Response at 16 and 32 Weeks 16 and 32 Weeks
Trial Locations
- Locations (1)
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China