A Study to Evaluate Efficacy and Safety of LNK01001 in Adults With Ankylosing Spondylitis
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of LNK01001 in Adult Subjects With Active Ankylosing Spondylitis
Lynk Pharmaceuticals Co., Ltd
352 participants
Aug 29, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- Must have a clinical diagnosis of ankylosing spondylitis (AS) and meet the modified New York Criteria for AS.
- Participant must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 at the Screening and Baseline Visits and Must have a Total Back Pain score ≥ 4 based on a 0 - 10 numerical rating scale at the Screening and Baseline Visits.
- Has had an inadequate response to at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or has an intolerance to or contraindication for NSAIDs as defined by the Investigator.
Exclusion Criteria4
- Total spinal ankylosis.
- Participants with known allergies to components or excipients of the study drug.
- Requirement of prohibited medications during the study.
- Participants who are pregnant, nursing, or planning a pregnancy during the study period.
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Interventions
Capsule; Oral
Capsule; Oral
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07237568