drugset / Trial / NCT05206591

Study to Demonstrate the Efficacy and Safety of Secukinumab up to 224 Weeks in Subjects With Active Peripheral Spondyloarthritis (pSpA).

NCT05206591

Phase 3 Withdrawn Novartis Pharmaceuticals
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

EvaluationDrugModalityDoseRoute
Subject Secukinumab Monoclonal antibody 300 mg Subcutaneous

Indications