Secukinumab 300 mg for active ankylosing spondylitis in Chinese adults

A Multicenter Study Evaluating the Efficacy and Safety of Secukinumab 300mg in Chinese Adults With Active Ankylosing Spondylitis.

This study tests whether secukinumab 300 mg can help Chinese adults with active ankylosing spondylitis who did not respond to at least two NSAIDs and who have not received biologic treatments.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Tongji Hospital (Academic / other)
• Drugs / interventions: tofacitinib, baricitinib, filgotinib, methotrexate, prednisone, secukinumab
• Locations: 3 sites (Wuhan, Hubei and 2 other locations)
• Trial ID: NCT05303285 on ClinicalTrials.gov

What this trial studies

This phase 4, randomized, double-blind, placebo-controlled trial enrolled Chinese adults with active ankylosing spondylitis who were naïve to biologic DMARDs and had an inadequate response to at least two NSAIDs. Participants were randomized 1:1 to secukinumab 300 mg subcutaneously or placebo for a 16-week double-blind period. Those who completed Period 1 entered an open-label extension and received secukinumab 300 mg for an additional 36 weeks, yielding 52 weeks total follow-up. Baseline requirements included BASDAI ≥4 and patient-reported total back pain ≥4, and certain conventional synthetic DMARDs were permitted if doses were stable.

Who should consider this trial

Good fit: Adults in China with a clinical diagnosis meeting the modified New York criteria for AS, BASDAI ≥4 and back pain ≥4, who failed at least two NSAIDs and are naïve to biologic DMARDs are the ideal candidates.

Not a fit: People who have already been treated with biologic DMARDs or whose symptoms are well controlled on current therapies are unlikely to gain additional benefit from joining this trial.

Why it matters

Potential benefit: If successful, this could demonstrate that secukinumab 300 mg is an effective treatment option to reduce inflammation and spinal symptoms for Chinese patients with active AS who have not benefited from NSAIDs.

How similar studies have performed: Secukinumab has shown efficacy and acceptable safety in multiple global trials and is an approved therapy for AS, so this trial is confirming those findings in a Chinese bDMARD‑naive population.

Eligibility criteria

Inclusion Criteria:

* Participant with a clinical diagnosis of ankylosing spondylitis (AS) and meeting the modified New York criteria for AS.
* Participant must have baseline disease activity as defined by having a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score \>= 4 and a Patient's Assessment of ●Total Back Pain score \>= 4 based on a 0 - 10 numeric rating scale (NRS) at the Screening and Baseline visits.
* Participant has had an inadequate response to at least two nonsteroidal anti-inflammatory drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or participant has an intolerance to or contraindication for NSAIDs as defined by the Investigator.
* If entering the study on concomitant methotrexate (MTX), leflunomide, sulfasalazine (SSZ), and/or hydroxychloroquine, participant must be on a stable dose of MTX (\<= 25 mg/week) and/or SSZ (\<= 3 g/day) and/or hydroxychloroquine (\<= 400 mg/day) or leflunomide (\<= 20 mg/day) for at least 28 days prior to the Baseline visit. A combination of up to two background conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) is allowed except the combination of MTX and leflunomide.
* If entering the study on concomitant oral corticosteroids, participant must be on a stable dose of prednisone (\<= 10 mg/day), or oral corticosteroid equivalents, for at least 14 days prior to the Baseline visit.
* If entering the study on concomitant NSAIDs, tramadol, combination of acetaminophen and codeine or hydrocodone, and/or non-opioid analgesics, participant must be on stable dose(s) for at least 14 days prior to the Baseline visit.

Exclusion Criteria:

* Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
* Prior exposure to any biologic therapy with a potential therapeutic impact on spondyloarthritis (SpA).
* Intra-articular joint injections, spinal/paraspinal injection(s), or parenteral administration of corticosteroids within 28 days prior to the Baseline visit. Inhaled or topical corticosteroids are allowed.
* Participant on any other DMARDs (other than those allowed), thalidomide or apremilast within 28 days or five half-lives (whichever is longer) of the drug prior to the Baseline visit.
* Participant on opioid analgesics (except for combination acetaminophen/codeine or acetaminophen/hydrocodone which are allowed) or use of inhaled marijuana within 14 days prior to the Baseline visit.
* Participant has a history of inflammatory arthritis of different etiology other than axial SpA (including but not limited to rheumatoid arthritis, psoriatic arthritis, mixed connective tissue disease, systemic lupus erythematosus, reactive arthritis, scleroderma, polymyositis, dermatomyositis, fibromyalgia), or any arthritis with onset prior to 17 years of age.
* Laboratory values meeting the following criteria within the Screening period prior to the first dose of study drug: serum aspartate transaminase \> 2 × upper limit of normal (ULN); serum alanine transaminase \> 2 × ULN; estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease formula \< 40 milliliter (mL)/minute/1.73m\^2; hemoglobin \< 10 gram/deciliter, total white blood cell count \< 2,500/microliter (μL); absolute neutrophil count \< 1,500/μL; absolute lymphocyte count \< 800/μL; and platelet count \< 100,000/μL.

Where this trial is running

Wuhan, Hubei and 2 other locations

• Department of RheumatologyTongji Hospital — Wuhan, Hubei, China (Recruiting)
• Tongji Hospital — Wuhan, Hubei, China (Recruiting)
• Tongji Hospital — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Yu Yikai, M.d

Conditions Ankylosing Spondylitis