LNK01001 for adults with ankylosing spondylitis
Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of LNK01001 in Adult Subjects With Active Ankylosing Spondylitis
Run by Lynk Pharmaceuticals Co., Ltd · NCT07237568 · Data updated 2026-11-12
This trial will test whether taking LNK01001 twice daily helps adults with active ankylosing spondylitis reduce pain and inflammation compared with placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 352 (estimated) |
| Sponsor | Lynk Pharmaceuticals Co., Ltd Industry-sponsored |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | August 29, 2025 |
| Main results expected | November 2026 |
| Study ends | September 2027 |
| Registry record updated | November 20, 2025 |
| Trial ID | NCT07237568 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with active ankylosing spondylitis who meet the modified New York criteria, have BASDAI ≥4 and back pain ≥4, and have had inadequate response to or intolerance of at least two NSAIDs.
✕Probably not a fit
Patients with total spinal ankylosis, known allergies to the study drug, those who are pregnant or nursing, or those who respond well to NSAIDs may not receive benefit or may be ineligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3 trial randomizes adults with active ankylosing spondylitis 1:1 to receive LNK01001 or placebo twice daily for a 16-week double-blind period. Eligible participants must meet the modified New York criteria, have BASDAI and back pain scores ≥4, and have had an inadequate response to or intolerance of at least two NSAIDs. After 16 weeks, all participants enter a 36-week open-label extension during which those originally on placebo switch to LNK01001. The study tracks efficacy and safety outcomes to see if LNK01001 provides clinical benefit.
Why it matters
Potential benefit: If effective, LNK01001 could provide an oral treatment option that reduces symptoms and improves function for adults with active ankylosing spondylitis.
How similar studies have gone: Approved biologic therapies targeting TNF and IL-17 pathways have shown benefit in ankylosing spondylitis, but LNK01001 is a novel agent whose efficacy in this condition is not yet established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Must have a clinical diagnosis of ankylosing spondylitis (AS) and meet the modified New York Criteria for AS. * Participant must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 at the Screening and Baseline Visits and Must have a Total Back Pain score ≥ 4 based on a 0 - 10 numerical rating scale at the Screening and Baseline Visits. * Has had an inadequate response to at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or has an intolerance to or contraindication for NSAIDs as defined by the Investigator. Exclusion Criteria: * Total spinal ankylosis. * Participants with known allergies to components or excipients of the study drug. * Requirement of prohibited medications during the study. * Participants who are pregnant, nursing, or planning a pregnancy during the study period.
Where it's running
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Peking Union Medical College Hospital
Beijing, China Recruiting
Study contacts
- Study coordinator: Xiaofeng Zeng
- Email: xiaofeng.zeng@cstar.org.cn
- Phone: 13501069845
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.