Active — Not RecruitingPhase 4

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

Belgium, Brazil240 participantsStarted 2023-03-28

Plain-language 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.

Who can participate

Age range18 Years – 100 Years

SexALL

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Inclusion criteria

✓. Inflammatory back pain for at least 6 months
✓. Onset before 45 years of age
✓. Sacroiliitis on MRI (magnetic resonance imaging) (as assessed by central reader) with ≥ 1 SpA feature OR HLA-B-27 positive with ≥2 SpA features

What they're measuring

The proportion of participants remaining flare-free during Treatment Period 2

Timeframe: Week 120

Trial details

NCT IDNCT05622708

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-04-19

View on ClinicalTrials.gov More Non-radiographic Axial Spondyloarthritis trials