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

• Status: Recruiting
• Trial end date: 2024-03-19
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate efficacy, safety and tolerability of secukinumab in Chinese patients with active nr-axSpA. Treatment difference of secukinumab 150mg vs. placebo in Chinese nr-axSpA patients in terms of ASAS 40 response rate as well as safety profile will be provided by the study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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.