Last updated: March 20, 2024
Sponsor: Lynk Pharmaceuticals Co., Ltd
Overall Status: Active - Recruiting
Phase
3
Condition
Joint Injuries
Musculoskeletal Diseases
Arthritis And Arthritic Pain
Treatment
LNK01001
Placebo
Clinical Study ID
NCT06276998
LK001304
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participants aged 18 and above.
- Diagnosis of rheumatoid arthritis (RA) for ≥ 3 months.
- ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 jointcounts) at Screening and baseline visit.
- Erythrocyte sedimentation rate (ESR) ≥ 28mm/h or high-sensitivity C-Reactive Protein (hsCRP) ≥ ULN at Screening.
- Participants have been receiving csDMARD therapy ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug.
- Have an inadequate response to ≥ 1 bDMARD.
Exclusion
Exclusion Criteria:
- Subjects who were prior exposure to Janus Kinase (JAK) inhibitor (including but notlimited to tofacitinib, baricitinib, and filgotinib) and have evidence showing aninadequate response or intolerance.
- Subjects who received intra-articular, intramuscular, intravenous, trigger point ortender point, intracapsular, or intra-tendon injections of glucocorticoids within 4weeks before randomization.
- Current diagnosis of systemic inflammatory disease other than RA.
- History of malignancy or current diagnosis of malignancy within 5 years beforescreening visit.
- Uncontrolled diabetes, hypertension, kidney disease, liver disease, severe heartdisease.
Study Design
Total Participants: 430
Treatment Group(s): 2
Primary Treatment: LNK01001
Phase: 3
Study Start date:
December 12, 2023
Estimated Completion Date:
November 20, 2026
Study Description
Connect with a study center
Peking Union Medical College Hospital
Beijing,
ChinaActive - Recruiting
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