A Study of LNK01001 Capsule in Subjects With Active Rheumatoid Arthritis - Trial NCT06276998
Access comprehensive clinical trial information for NCT06276998 through Pure Global AI's free database. This Phase 3 trial is sponsored by Lynk Pharmaceuticals Co., Ltd and is currently Recruiting. The study focuses on Rheumatoid Arthritis. Target enrollment is 430 participants.
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Study Focus
Sponsor & Location
Lynk Pharmaceuticals Co., Ltd
Timeline & Enrollment
Phase 3
Dec 12, 2023
Nov 20, 2026
Primary Outcome
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24
Summary
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06276998
Non-Device Trial