Actively Recruiting
A Study to Evaluate Efficacy and Safety of LNK01001 in Adults With Ankylosing Spondylitis
Led by Lynk Pharmaceuticals Co., Ltd · Updated on 2025-11-20
352
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate Efficacy and Safety of LNK01001 in Adults With Ankylosing Spondylitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of ankylosing spondylitis meeting the modified New York Criteria
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of 4 or higher at screening and baseline
- Total Back Pain score of 4 or higher on a 0 to 10 scale at screening and baseline
- Inadequate response to at least 2 NSAIDs over at least 4 weeks at maximum tolerated doses, or intolerance/contraindication to NSAIDs
You will not qualify if you...
- Total spinal ankylosis
- Known allergy to components or excipients of the study drug
- Need for prohibited medications during the study
- Pregnant, nursing, or planning pregnancy during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
Research Team
X
Xiaofeng Zeng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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