LNK01001 compared with placebo in adults with active ankylosing spondylitis
Tests LNK01001 against placebo in adults with active ankylosing spondylitis.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate Efficacy and Safety of LNK01001 in Adults With Ankylosing Spondylitis
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 3
Where in China
- Peking Union Medical College HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Lynk Pharmaceuticals Co., Ltd
- Trial code
- NCT07237568
- Record updated
- 20 November 2025
- Original description
The aim of this study is to evaluate the efficacy and safety of LNK01001 in subjects with active ankylosing spondylitis.Read full original descriptionShow less
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of LNK01001 in Adult Subjects With Active Ankylosing Spondylitis
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.
Inclusion: 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: Requirement of prohibited medications during the study; Participants with known allergies to components or excipients of the study drug; Total spinal ankylosis; Participants who are pregnant, nursing, or planning a pregnancy during the study period.