A Study to Assess the Safety of Subcutaneous Secukinumab for Treatment in Adult Indian Participants With Axial Spondyloarthritis (axSpA), Ankylosing Spondylitis (AS), and Non-Radiographic Axial Spondyloarthritis (nr-axSpA)

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07737730
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Study Details

The aim of this study is to assess the safety of secukinumab in Indian adult participants with axSpA, AS, and nr-axSpA over a 16-week treatment period. The present study is being undertaken to fulfill the Post Marketing Surveillance (PMS) mandate by the Health Authority (HA) to evaluate the safety of secukinumab solution for injection administered subcutaneously in a pre-filled pen in the indicated population under real-world clinical practice conditions.

Key Dates

First listed
Jul 30, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Secukinumab Cohort
    Adult participants diagnosed with axSpA, AS, and nr-axSpA for whom the treating physician prescribes treatment with secukinumab 150 mg subcutaneous as per approved label.

Primary Outcome Measure

Number and Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Baseline through Week 20 ]

Central Contacts

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