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

NCT06276998 | Active Not Recruiting Phase 3

• 1 other identifier: LK001304
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24

  Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria: 1. 20% improvement in 68-tender joint count; 2. 20% improvement in 66-swollen joint count; and 3. 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).

  Baseline and Week 24

Secondary Outcomes (8)

• Change from Baseline in Disease Activity Score 28 (DAS28) (CRP) at week 24

  Baseline and Week 24

• Percentage of Participants with an American College of Rheumatology 50% (ACR50) Response at week 24

  Baseline and Week 24

• Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at all visits.

  Baseline to Week 76.

• Percentage of Participants with an American College of Rheumatology 70% (ACR70) Response at all visits.

  Baseline to Week 76.

• Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at all visits.

  Baseline to Week 76.

Study Arms (2)

LNK01001 12 mg

EXPERIMENTAL

Period 1: Participants receive LNK01001 12 mg twice daily for 24 weeks. Period 2: Participants will continue on LNK01001 12 mg twice daily from Week 24 to Week 76.

Drug: LNK01001

Placebo / LNK01001 12 mg

PLACEBO COMPARATOR

Period 1: Participants receive a placebo twice daily for 24 weeks. Period 2: Participants will switch to receive LNK01001 12 mg twice daily from Week 24 to Week 76.

Drug: Placebo

Interventions

LNK01001 DRUG

Capsule; Oral

LNK01001 12 mg

Placebo DRUG

Capsule; Oral

Placebo / LNK01001 12 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 joint counts) 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.

You may not qualify if:

• Subjects who were prior exposure to Janus Kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib) and have evidence showing an inadequate response or intolerance.
• Subjects who received intra-articular, intramuscular, intravenous, trigger point or tender point, intracapsular, or intra-tendon injections of glucocorticoids within 4 weeks before randomization.
• Current diagnosis of systemic inflammatory disease other than RA.
• History of malignancy or current diagnosis of malignancy within 5 years before screening visit.
• Uncontrolled diabetes, hypertension, kidney disease, liver disease, severe heart disease.

Sponsors & Collaborators

• Lynk Pharmaceuticals Co., Ltd: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Linda Wei

  Lynk Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 26, 2024
• Study Start: December 12, 2023
• Primary Completion: August 22, 2025
• Study Completion (Estimated): November 20, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

CN (1)