NCT04732117

Efficacy and Safety Study of Secukinumab in Chinese Participants With Non-radiographic Axial Spondyloarthritis

A Randomized, Double-blind, Placebo Controlled, Multicenter, Phase III Study of Subcutaneous Secukinumab to Compare Efficacy at 16 Weeks With Placebo and to Assess Safety and Tolerability up to 52 Weeks in Chinese Participants With Active Non-radiographic Axial Spondyloarthritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the efficacy, safety, and tolerability of secukinumab in Chinese patients with active non-radiographic axial spondyloarthritis (nr-axSpA).

Detailed description

This was a randomized, double-blind, placebo-controlled study. Approximately 134 participants were planned to be randomized in a 1:1 ratio to receive secukinumab 150 mg subcutaneously (s.c.) or placebo. The double-blind treatment period lasted for 16 weeks. At the end of this period, all participants, including those who initially received placebo, switched to open-label treatment with secukinumab 150 mg s.c. The first dose of open-label treatment was administered at the Week 16 visit, after completing all necessary assessments for that visit. However, the participants and investigators remained blinded to the original treatment assignment. At Week 24, participants who did not respond to the treatment (defined as not achieving Ankylosing SpondyloArthritis International Society 20 \[ASAS20\] response) were given a higher dose of secukinumab (300 mg s.c.), while responders continued with the 150 mg s.c. dose. The study treatment continued until Week 48. Four weeks after the last study treatment administration, an end-of-treatment visit was conducted at Week 52. Additionally, a post-treatment safety follow-up visit was performed 12 weeks after the last study treatment administration for all participants, whether they completed the entire study as planned or exited early.

Conditions

• Non-radiographic Axial Spondyloarthritis

Interventions

Type	Name	Description
DRUG	Secukinumab	Secukinumab 150 mg s.c. using a PFS at Baseline, Weeks 1, 2, and 3, followed by administration every 4 weeks from Week 4 until Week 12. At Week 16, all participants continued or switched to receiving secukinumab 150 mg s.c. every 4 weeks, using a PFS. This treatment regimen continued from Week 16 through Week 48. For participants who did not respond to the secukinumab 150 mg dose during the open-label period, the dose was increased to 300 mg s.c., using two PFS, also administered every 4 weeks.
DRUG	Placebo	Placebo s.c. using a PFS at baseline, Weeks 1, 2 and 3, followed by administration every 4 weeks from Week 4 until Week 12.

Timeline

• Start date: 2021-07-21
• Primary completion: 2024-04-03
• Completion: 2025-02-14
• First posted: 2021-02-01
• Last updated: 2026-04-09
• Results posted: 2026-01-30

Locations

29 sites across 1 country: China