Trial results for secukinumab in Chinese participants with non-radiographic axial spondyloarthritis (nr-axSpA) were posted on ClinicalTrials.gov on 2026-01-30. The Phase 3 study showed that secukinumab achieved an ASAS40 response rate of 60.10% in all participants at Week 16, compared to 24.78% for placebo.
Background
The study investigated secukinumab for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA). This condition is a form of axial spondyloarthritis where inflammation of the spine and sacroiliac joints is present, but without definitive structural damage visible on conventional X-rays.
Trial design
The study (NCT04732117) was a Phase 3, randomized, placebo-controlled trial designed to evaluate the efficacy, safety, and tolerability of secukinumab in Chinese participants with active non-radiographic axial spondyloarthritis. A total of 137 participants were enrolled. Participants were assigned to receive either secukinumab or placebo.
Key results
The trial results demonstrated differences between the secukinumab and placebo groups across several efficacy endpoints at Week 16:
- Assessment of SpondyloArthritis International Society 40 (ASAS40) Response Rate in TNF-alpha-inhibitor-naive Participants: Secukinumab group showed a response rate of 58.72%, compared to 26.03% for the placebo group.
- ASAS40 Response Rate in All Participants: Secukinumab group achieved a response rate of 60.10%, compared to 24.78% for the placebo group.
- ASAS 5/6 Response Rate: Secukinumab group showed a response rate of 61.97%, compared to 25.89% for the placebo group.
- Change From Baseline in Total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score: The secukinumab group had a least squares mean change of -3.70 (Standard Error: 0.240), while the placebo group had a least squares mean change of -2.15 (Standard Error: 0.237).
- BASDAI 50 Rate: Secukinumab group showed a rate of 64.04%, compared to 25.77% for the placebo group.
- Change From Baseline of High Sensitivity C-Reactive Protein (hsCRP): The secukinumab group had a least squares mean change of 0.38 (Standard Error: 1.137), while the placebo group had a least squares mean change of 0.74 (Standard Error: 1.136).
What this means
The results from this Phase 3 trial indicate that secukinumab demonstrated a notable improvement in key efficacy measures, such as ASAS40 and BASDAI 50 response rates, compared to placebo in Chinese participants with active non-radiographic axial spondyloarthritis. The consistent directional findings across multiple endpoints suggest a positive impact of secukinumab on disease activity in this population. These findings provide important data for the potential use of secukinumab in managing nr-axSpA.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04732117, titled "Efficacy and Safety Study of Secukinumab in Chinese Participants With Non-radiographic Axial Spondyloarthritis," were posted on 2026-01-30 on clinicaltrials.gov.