A Study of LNK01001 Capsule in Moderately to Severely Active Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2023-04-11
• Target enrollment: 0
• Participant gender: All

Summary

This study includes two periods. In Period 1, Participants who meet eligibility criteria will be randomized in a 1:1:1 ratio to receive a twice-daily oral LNK01001 Dose A or LNK01001 Dose B or a matching placebo for 12 weeks. Participants who receive a placebo in Period 1 will be re-randomized at Week 13 in a 1:1 ratio to receive a twice-daily oral LNK01001 Dose A or LNK01001 Dose B for 12 weeks (period 2). Participants who receive LNK01001 ( Dose A and Dose B) in Period 1 will maintain the treatment dose in Period 2.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lynk Pharmaceuticals Co., Ltd

Criteria

Inclusion Criteria:

• Participants between ≥ 18 and ≤70 years of age.

• Diagnosis of RA for ≥ 3 months at screening visit who also fulfill the 2010 American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) classification criteria for RA.

• ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at Screening and baseline visit.

• 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.

Exclusion Criteria:

• Subjects who are allergy to any component of the study drug.

• Subjects who are ACR functional class IV or long-term bedridden/long-term wheelchair.

• Prior exposure to Janus Kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).

• Subjects who received intra-articular, intramuscular, intravenous, trigger point or tender point, intracapsular, or intra-tendon injections of glucocorticoids within 8 weeks before randomization.

• Current use of oral or inhaled glucocorticoids and the daily dose is >10 mg of prednisone (or equivalent dose) or on a not stable dose within 4 weeks before randomization.

• Current use of Non-steroidal anti-inflammatory drugs and on a not stable dose within 4 weeks before randomization.

• Subjects who received iguratimod treatment within 4 weeks before randomization.

• Subjects who received interferon treatment 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.

• Subject with any major surgery within 4 weeks before randomization or planned major surgery during study; history of chronic pain that may affect study evaluation; previous recipient of an organ transplant.

• Any clinically significant laboratory or ECG abnormal value, as determined by the Investigator, may interfere with the evaluation of the study results.