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A Study to Evaluate Efficacy and Safety of LNK01001 in Adults With Ankylosing Spondylitis
Sponsor: Lynk Pharmaceuticals Co., Ltd
Summary
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
352
Start Date
2025-08-29
Completion Date
2027-09
Last Updated
2025-11-20
Healthy Volunteers
No
Conditions
Interventions
LNK01001
Capsule; Oral
Placebo
Capsule; Oral
Locations (1)
Peking Union Medical College Hospital
Beijing, China