New hope for back pain: higher dose of secukinumab tested in chinese ankylosing spondylitis patients
NCT ID NCT05303285
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether a higher dose (300 mg) of the drug secukinumab (Cosentyx) can safely and effectively reduce symptoms in Chinese adults with active ankylosing spondylitis who have not gotten relief from at least two NSAIDs. One hundred participants will receive either 300 mg or 150 mg of secukinumab as an injection. The main goal is to see if more patients achieve a 40% improvement in disease activity after 24 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Secukinumab (Cosentyx), a biologic drug given as an injection
- What this could lead to
- If successful, this could confirm that a higher dose of secukinumab (300 mg) is safe and effective for Chinese patients with ankylosing spondylitis who have not responded to standard treatments.
- What could go wrong
- This is a phase 4 study with a relatively small number of participants (100). The results may not apply to all patients, and there is always a risk of side effects such as infections or allergic reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of RheumatologyTongji Hospital
RECRUITINGWuhan, Hubei, 430030, China
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Tongji Hospital
RECRUITINGWuhan, Hubei, 430030, China
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Tongji Hospital
RECRUITINGWuhan, Hubei, 430030, China
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