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

Study acronym: AS
StatusRecruiting
PhasePhase 3
Started2025-08-29
View on ClinicalTrials.gov ↗
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.
Trial Details
NCT Number NCT07237568
Lead Sponsor Lynk Pharmaceuticals Co., Ltd
Conditions Ankylosing Spondylitis
Enrollment 352 participants
Start Date 2025-08-29
Primary Completion 2026-11 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2025-11-20