drugset / Trial / NCT05206591
Study to Demonstrate the Efficacy and Safety of Secukinumab up to 224 Weeks in Subjects With Active Peripheral Spondyloarthritis (pSpA).
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2022-08-16
- Primary completion
- 2028-03-20
- Completion
- 2028-06-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Secukinumab | Monoclonal antibody | 300 mg | Subcutaneous |