Actively Recruiting
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of LNK01001 in Adult Subjects With Active Ankylosing Spondylitis
Led by Lynk Pharmaceuticals Co., Ltd · Updated on 2025-11-20
352
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of LNK01001 in adults with active ankylosing spondylitis, a chronic inflammatory disease affecting the spine. This Phase 3 clinical trial aims to assess how well LNK01001 works compared to a placebo in improving disease symptoms and activity. The study includes participants who have active disease despite prior treatment with nonsteroidal anti-inflammatory drugs (NSAIDs). Participants are randomly assigned to one of two groups during a 16-week double-blind period: one group receives LNK01001 12 mg orally twice daily, while the other receives a matching placebo twice daily. After 16 weeks, all participants enter a 36-week open-label extension in which those initially on placebo switch to LNK01001 at the same dose. This design allows researchers to compare initial responses and gather long-term safety and efficacy data. Throughout the study, participants will have regular assessments including evaluations of disease activity using the Assessment of SpondyloArthritis International Society (ASAS) 40 response at week 16 as the primary outcome. Other assessments include disease activity scores, pain ratings, functional indices, and quality of life questionnaires. Safety will be monitored continuously. The total participation duration is 52 weeks, with close follow-up to understand how the treatment affects symptoms and function over time.
CONDITIONS
Brief 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...
- Must have a clinical diagnosis of ankylosing spondylitis and meet the modified New York Criteria for AS.
- 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 0-10 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 allergies to components or excipients of the study drug.
- Requirement of 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks
Participants receive either LNK01001 or placebo capsules orally twice daily as part of the study treatment.
Regular visits during treatment period as per study schedule
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
Research Team
X
Xiaofeng Zeng
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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