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

Novartis

Status and phase: Completed; Phase 3

Conditions: Non-radiographic Axial Spondyloarthritis

Treatments: Drug: Secukinumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04732117

CAIN457I2301

Details and patient eligibility

About

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).

Full 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.

Enrollment: 137 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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137 participants in 2 patient groups, including a placebo group

Secukinumab

Experimental group

Description:

Participants received secukinumab 150 mg in a pre-filled syringe (PFS). Treatment was double-blinded until Week 12. From Week 16, participants continued with an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.

Treatment:

Drug: Secukinumab

Placebo

Placebo Comparator group

Description:

Participants initially received a placebo in a pre-filled syringe (PFS) in a double-blinded manner until Week 12. At Week 16, they switched to an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.

Treatment:

Drug: Placebo