A Study Investigating the Efficacy and Safety of BGB-45035 Versus Placebo in Adults With Moderate to Severe Active Rheumatoid Arthritis

Launched by BEIGENE · Aug 1, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called BGB-45035 to see if it helps adults with moderate to severe rheumatoid arthritis (RA), a condition that causes joint pain and swelling. The study is for people whose RA has not improved enough with standard treatments, including common medicines like methotrexate or other newer drugs. Researchers want to find out if BGB-45035 works better than a placebo (a dummy treatment) and if it is safe to use.

To join the study, adults must have been diagnosed with RA for at least three months and still have active symptoms despite treatment with certain approved RA medicines. Participants should be taking a stable dose of one of these medicines before and during the study. People with very severe RA, recent cancer, or who have tried and not responded to several advanced RA treatments may not be eligible. Those who join will be closely monitored to see how well BGB-45035 works and to check for any side effects. This study is not yet open for new participants but aims to offer another option for people struggling with RA symptoms.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosed with rheumatoid arthritis (RA) based on American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria for at least 3 months prior to screening
• • Demonstrated an inadequate response to, or loss of response or intolerance to at least 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD) (Hydroxychloroquine, methotrexate \[MTX\], leflunomide, or sulfasalazine) or 1 biologic disease-modifying antirheumatic drug (bDMARD)/targeted synthetic disease-modifying antirheumatic drug (tsDMARD) treatment
• • Must be on stable dose of one of the following permitted therapies for ≥ 4 weeks prior to screening and during the study: methotrexate between 7.5 mg to 25 mg/week, hydroxychloroquine up to 400 mg/day, leflunomide up to 20 mg/day, or sulfasalazine between 1000 mg/day to 3000 mg/day
• Exclusion Criteria:
• • Class IV RA based on American College of Rheumatology revised criteria for classification of functional status in rheumatoid arthritis
• • Patients with a history of cancer in the last 5 years before the Screening Visit, with the exception of adequately treated basal cell or squamous cell carcinoma of the skin
• • Have failed more than 2 b/tsDMARDs (eg, excluded if have failed 2 bDMARDs and 1 tsDMARD)