Testing LNK01001 for treating active rheumatoid arthritis
Official title: 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
Run by Lynk Pharmaceuticals Co., Ltd · NCT06276998 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 430 (estimated) |
| Sponsor | Lynk Pharmaceuticals Co., Ltd Industry-sponsored |
| Drugs / interventions | tofacitinib, baricitinib, filgotinib, methotrexate |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06276998 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is being tested in this specific context, similar studies have shown promise in evaluating new treatments for rheumatoid arthritis.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Peking Union Medical College Hospital
Beijing, China Recruiting
Study contacts
- Study coordinator: Maggie Bao
- Email: hhbao1@lynkpharma.com
- Phone: 0086-0571-8777-1-9103
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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PTC844 in people with active rheumatoid arthritis
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First-in-human test of CND319 in healthy people and people with rheumatic diseases
This early study tests whether CND319 is safe and tolerable and whether it shows any signs of activity in healthy adults and in people with rheumatoid arthritis or Sjogren's syndrome.
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IV sarilumab for adults with rheumatoid arthritis
This study tests IV sarilumab to see how it works and how safe it is for adults with moderately to severely active rheumatoid arthritis, with or without certain standard arthritis medicines.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.