Study to Demonstrate the Efficacy and Safety of Secukinumab up to 224 Weeks in Subjects With Active Peripheral Spondyloarthritis (pSpA).
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT05206591
- Phase
- PHASE3
- Status
- Withdrawn
Conditions
- Active Peripheral Spondyloarthritis (pSpA)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Secukinumab — BIOLOGICALSecukinumab 300 s.c.
- Placebo — OTHERPlacebo
Study Details
The purpose of this study is to investigate the efficacy and safety of subcutaneous (s.c) secukinumab in comparison with placebo for participants with two subtypes of active pSpA i.e. undifferentiated pSpA and chronic reactive arthritis, and with an inadequate response to conventional therapy despite current or previous Non-steroidal Anti Inflammatory Drugs (NSAIDs) and/or csDMARDs. Additionally, the study aims to evaluate efficacy and safety of continuing versus withdrawing secukinumab therapy in maintaining remission in the study population.
Key Dates
- Start date
- Aug 16, 2022
- Status verified
- Jan 2023
- Primary completion
- Mar 20, 2028
- Completion
- Jun 12, 2028
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: SecukinumabSecukinumab 300 mg s.c
- Placebo Comparator: PlaceboPlacebo s.c.
Primary Outcome Measure
Modified Peripheral SpondyloArthritis Response Criteria (mPSpARC) [ Time Frame: Week 16 ]