NCT04732117CompletedPhase 3
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
Source: ClinicalTrials.gov · Last updated 9 Apr 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 137 (actual)
- First submitted
- 28 Jan 2021
- Start date
- 21 Jul 2021
- Primary completion date
- 3 Apr 2024
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT04732117
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 137
- From 21 Jul 2021 to the primary completion date, 3 Apr 2024
- 23 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous exposure to secukinumab or any other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor
Other illness
- Chest X-ray or MRI with evidence of ongoing infectious or malignant process
Other
- Patients with radiographic evidence for sacroiliitis, grade ≥ 2 bilaterally or grade ≥ 3 unilaterally
- Inability or unwillingness to undergo MRI
- Patients taking high potency opioid analgesics
- Pregnant or nursing (lactating) women
- Other protocol-defined inclusion/exclusion criteria may apply.
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.