Status:
COMPLETED
A Study of LNK01001 Capsule in Patients With Ankylosing Spondylitis
Lead Sponsor:
Lynk Pharmaceuticals Co., Ltd
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The objective of this study was to evaluate the safety and efficacy of multiple doses of LNK01001 monotherapy versus placebo in the treatment of adults with active Ankylosing Spondylitis
Detailed Description
This study includes two periods. In Period 1, Participants who meet eligibility criteria will be randomized in a 1:1:1 ratio to receive a twice daily oral LNK01001 Dose A or LNK01001 Dose B or a match...
Eligibility Criteria
Inclusion
- Participants between ≥ 18 and ≤75 years of age.
- Diagnosis of ankylosing spondylitis (AS) who meet the 1984 revised New York Criteria for AS.
- Subjects must have disease activity at Screening and baseline visit.
- Subjects have received NSAIDs treatment but still have active AS, or subjects have an intolerance to or contraindication for NSAIDs.
- Never received tumor necrosis factor alpha (TNFα) treatment or prior exposure to ≤1 before randomization.
Exclusion
- History of infection or any active infection.
- History of malignancy or current diagnosis of malignancy within 5 years before screening visit.
- Previous recipient of an organ transplant.
- Diagnosis of active uveitis within 6 months before randomization.
- Subject with any major surgery (including joint surgery) within 3 months before randomization or planned major surgery within the first 6 months during study.
- Prior exposure to Janus Kinase (JAK) inhibitor.
- Subjects who are allergy to any component of the study drug.
Key Trial Info
Start Date :
January 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2023
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT06085534
Start Date
January 6 2022
End Date
June 20 2023
Last Update
October 27 2023
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China