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A Study of LNK01001 Capsule in Subjects With Active Rheumatoid Arthritis (COURAGE-RA)

StatusActive, Not Recruiting
PhasePhase 3
Started2023-12-12
View on ClinicalTrials.gov ↗

Amendment history

2026-01-13
minor
Study Identification, Study Status, Oversight, IPDSharing v4
Primary completion dateestimated 2025-08-04→confirmed 2025-08-22
Study title+13 characters
A Study of LNK01001 Capsule in Subjects With Active Rheumatoid Arthritis (COURAGE-RA)
2025-06-24
notable
Recruiting→Active, Not Recruiting Study Status, Oversight, Contacts/Locations, IPDSharing v3
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 1 of 1 site
2024-03-20
minor
Study Identification, Study Status v2
Study title-8 characters
A Phase 3 Study of LNK01001 Capsule in Subjects With Active Rheumatoid Arthritis
2024-03-19
minor
Study Identification, Study Status v1
Study title-9 characters
A Phase 3 Study of LNK01001 Capsule in ModeratelySubjects to SeverelyWith Active Rheumatoid Arthritis
2024-02-17
minor
Original filing
Brief Summary: This is a randomized, double-blind study comparing LNK01001 to placebo in Chinese participants with moderately to severely active rheumatoid arthritis who are on a stable dose of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and have an inadequate response or Intolerance to biologic DMARDs(bDMARDs). The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of LNK01001 12 mg twice daily (BID) versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD. The study objective of Period 2 (Week 24 to Week 76) is to evaluate the long-term safety, tolerability, and efficacy of LNK01001 12 mg BID in participants with RA who completed Period 1.
Trial Details
NCT Number NCT06276998
Lead Sponsor Lynk Pharmaceuticals Co., Ltd
Conditions Rheumatoid Arthritis
Enrollment 430 participants
Start Date 2023-12-12
Primary Completion 2025-08-22 (estimated)
Study Completion 2026-11-20 (estimated)
Updated on ClinicalTrials.gov 2026-01-14