NCT06276998

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

A Randomized Double-Blind Placebo-controlled Phase Ⅲ Clinical Trial Evaluating the Efficacy and Safety of LNK01001 (Zemprocitinib) in Patient With Moderate-to-Severe Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drugs (COURAGE-RA)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 430 (estimated)
• Sponsor: Lynk Pharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study includes a 35-day screening period; a 24-week randomized, double-blind, parallel-group, placebo-controlled treatment period (Period 1); a 52-week open label long-term extension period (Period 2); and a 28 to 35-day follow-up period (FU). Participants who meet eligibility criteria will be randomized in a 1:1 ratio to two treatment groups: Group 1: LNK01001 12 mg BID (Day 1 to Week 24)， LNK01001 12 mg BID (Week 24 and thereafter) Group 2: Placebo (Day 1 to Week 24)， LNK01001 12 mg BID (Week 24 and thereafter) Participants who complete the Week 24 visit (end of Period 1) will enter the extension portion of the study, Period 2, and continue to receive LNK01001 12 mg BID treatment. Starting at Week 12, rescue therapy is allowed if there's less than 20% improvement in both swollen joint count (SJC) and tender joint count (TJC) compared to Baseline. Starting at Week 24, initiation of or change in corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, or adding or increasing doses in up to 2 csDMARDs (concomitant use of up to 2 csDMARDs except the combination of methotrexate and leflunomide) is allowed.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	LNK01001	Capsule; Oral
DRUG	Placebo	Capsule; Oral

Timeline

• Start date: 2023-12-12
• Primary completion: 2025-08-22
• Completion: 2026-11-20
• First posted: 2024-02-26
• Last updated: 2026-01-14

Locations

1 site across 1 country: China