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

NCT04732117 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2026-04-09

Study results available
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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).

Conditions

  • Non-radiographic Axial Spondyloarthritis

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-21
Primary Completion
2024-04-03
Completion
2025-02-14

Countries

  • China

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04732117 on ClinicalTrials.gov