Efficacy and Safety Study of Secukinumab in Chinese Participants With Non-radiographic Axial Spondyloarthritis
CompletedPhase 3NCT04732117
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- Official title
- 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
- Conditions
- Non-radiographic Axial Spondyloarthritis
- Interventions
- Drug: Secukinumab
- Drug: Placebo
- Sponsor
- Novartis Pharmaceuticals
- Organization
- Novartis
- Start date
- 2021-07-21
- Primary completion
- 2024-04-03
- Sex
- All
- Age range
- from 18 Years to 100 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- China
- Total sites listed
- 29
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Male or non-pregnant, non-nursing female patients at least 18 years of age * Diagnosis of axial spondyloarthritis according to Ankylosing SpondyloArthritis International Society (ASAS) axial spondyloarthritis criteria * Objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal C-reactive protein) * Active axial spondyloarthritis as assessed by total Bath Ankylosing Spondylitis Disease Activity Index \>=4 cm * Spinal pain as measured by Bath Ankylosing Spondylitis Disease Activity Index question #2 ≥ 4 cm (0-10 cm) at baseline * Total back pain as measured by Visual Analogue scale ≥ 40 mm (0-100 mm) at baseline * Patients should have been on at least 2 different non-steroidal anti-inflammatory drugs with an inadequate response * Patients who have been on a TNFα inhibitor (not more than one) must have experienced an inadequate response Exclusion Criteria: * Patients with radiographic evidence for sacroiliitis, grade ≥ 2 bilaterally or grade ≥ 3 unilaterally * Inability or unwillingness to undergo MRI * Chest X-ray or MRI with evidence of ongoing infectious or malignant process * Patients taking high potency opioid analgesics * Previous exposure to secukinumab or any other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor * Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04732117