drugset / Trial / NCT05622708

A Study of Secukinumab to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission

NCT05622708

Phase 4 Active not recruiting 240 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will establish whether prolonged chronic dosing with secukinumab is needed in participants with Non-radiographic axial spondyloarthritis, (nr-axSpA) who have achieved remission. Remission is defined as Ankylosing Spondylitis Disease Activity Score - C-reactive protein (ASDAS-CRP) Inactive Disease (ID) response (ASDAS-CRP \< 1.3). Maintenance of remission on continued secukinumab treatment will be evaluated compared to placebo using a randomized withdrawal design. The primary outcome measure for this study is the proportion of participants remaining flare-free at Week 120.

Timeline

Start
2023-03-28
Primary completion
2028-02-08
Completion
2028-04-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Secukinumab Monoclonal antibody 150 mg Subcutaneous

Indications