Testing LNK01001 for treating 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

This study is testing a new treatment called LNK01001 to see if it can help people in China with moderate to severe rheumatoid arthritis who haven't had enough relief from other medications.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 430 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Lynk Pharmaceuticals Co., Ltd (Industry-sponsored)
• Drugs / interventions: tofacitinib, baricitinib, filgotinib, methotrexate
• Locations: 1 site (Beijing)
• Trial ID: NCT06276998 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, double-blind study that compares the efficacy and safety of LNK01001 to a placebo in Chinese participants suffering from moderately to severely active rheumatoid arthritis. Participants must be on a stable dose of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and have shown inadequate response or intolerance to biologic DMARDs (bDMARDs). The study consists of a 24-week treatment period followed by a 52-week open-label extension, allowing for long-term evaluation of LNK01001's effects. Participants will be monitored for improvements in joint symptoms and overall health throughout the study duration.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of rheumatoid arthritis for at least three months and an inadequate response to at least one biologic DMARD.

Not a fit: Patients who have previously been treated with Janus Kinase (JAK) inhibitors or have received certain glucocorticoid injections recently may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with rheumatoid arthritis who have not responded well to existing therapies.

How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in evaluating new treatments for rheumatoid arthritis.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Beijing

• Peking Union Medical College Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Maggie Bao

Conditions Rheumatoid Arthritis