NCT07237568RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 20 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 352 (estimated)
- First submitted
- 16 Nov 2025
- Start date
- 29 Aug 2025
- Primary completion date
- Nov 2026
- Lead sponsor
- Lynk Pharmaceuticals Co., Ltd
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT07237568
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 352
- From 29 Aug 2025 to the primary completion date, Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Requirement of prohibited medications during the study.
Other illness
- Participants with known allergies to components or excipients of the study drug.
Other
- Total spinal ankylosis.
- Participants who are pregnant, nursing, or planning a pregnancy during the study period.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.