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NCT06276998

A Study of LNK01001 Capsule in Subjects With Active Rheumatoid Arthritis

A Randomized, Double-blind Study to Compare LNK01001 to Placebo in Adults With Rheumatoid Arthritis (RA) on a Stable Dose of csDMARDs Who Have an Inadequate Response or Intolerance to bDMARDs
Lynk Pharmaceuticals Co., Ltd·Phase 3·ClinicalTrials.gov·drugRecruiting
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Study focus
Disease/Condition
Rheumatoid Arthritis
Drug/Device/Intervention
LNK01001
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Lynk Pharmaceuticals Co., Ltd
Location
Beijing, China
Timeline & enrollment
Phase
Phase 3
Start date
Dec 12, 2023
End date
Nov 20, 2026
Enrollment
430 participants
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
Rheumatoid arthritis, unspecifiedOther rheumatoid arthritisOther specified rheumatoid arthritisRheumatoid arthritis with involvement of other organs and systemsSeronegative rheumatoid arthritis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06276998
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.