A Study to Evaluate Efficacy and Safety of LNK01001 in Adults With Ankylosing Spondylitis
NCT ID: NCT07237568
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
352 participants
INTERVENTIONAL
2025-08-29
2027-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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LNK01001 12mg
Participants receive LNK01001 12mg orally BID for 52 weeks.
LNK01001
Capsule; Oral
Placebo
Participants receive matching placebo for 16 weeks and then switch to receive LNK01001 12mg orally BID for 36 weeks.
LNK01001
Capsule; Oral
Placebo
Capsule; Oral
Interventions
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LNK01001
Capsule; Oral
Placebo
Capsule; Oral
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Lynk Pharmaceuticals Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Peking Union Medical College Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LK001302
Identifier Type: -
Identifier Source: org_study_id
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