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Condition / disease
Location
Status: Recruiting

A Study to Evaluate Efficacy and Safety of LNK01001 in Adults With Ankylosing Spondylitis

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.

Participants needed: 352
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Lynk Pharmaceuticals Co., LtdUpdated: Nov 20, 2025Locations: 1
Eligibility criteria

Must have a clinical diagnosis of ankylosing spondylitis (AS) and meet the modif... [+2]

Total spinal ankylosis. [+3]