A Study to Evaluate Efficacy and Safety of LNK01001 in Adults With Ankylosing Spondylitis
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Ankylosing Spondylitis
In brief
The aim of this study is to evaluate the efficacy and safety of LNK01001 in subjects with active ankylosing spondylitis. The study is comprised of a 16-week randomized, double-blind, parallel-group, placebo-controlled period (the Double-Blind Period); a 36-week open-label, long-term extension period (the Open-Label Extension Period). In the Double-Blind Period, participants will be randomized in a 1:1 ratio to receive either LNK01001 or placebo twice daily (BID). Participants in the placebo group will be switched to LNK01001 BID at Week 16 in the Open-Label Extension Period.
Key facts
- Study ID
- NCT07237568
- Run by
- Lynk Pharmaceuticals Co., Ltd
- People needed
- 352
- Starts
- 2025-08-29
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2025-11-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Peking Union Medical College Hospital — Beijing, China (enrolling)
Full record on ClinicalTrials.gov
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