Clinical Trial

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

Terminated Phase 2
View on ClinicalTrials.gov →
Why the trial stopped
Sponsor has concluded that patients are unlikely to derive sufficient benefit from treatment with BGB-45035 to support continuation of the clinical development program due to unfavored benefit/risk profile.
Summary
This study aims to evaluate the efficacy of BGB-45035 in adults with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or biologic disease-modifying antirheumatic drugs (bDMARDs)/targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs).
Protocol Amendment History 6 changes
critical Trial terminated 2026-05-29
critical Reason stopped changed: — → Sponsor has concluded that patients are unlikely to derive sufficient benefit from treatment with BGB-45035 to support continuation of the clinical development program due to unfavored benefit/risk profile. 2026-05-29
notable Primary completion moved earlier: 2026-10-18 -> 2026-05-12 2026-05-29
minor Completion moved earlier: 2026-10-18 -> 2026-05-12 2026-05-29
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-04-16
notable Enrollment reduced: 90 -> 49 participants 2026-04-16
Trial Details
NCT Number NCT07100938
Lead Sponsor BeiGene
Conditions Rheumatoid Arthritis
Enrollment 49 participants
Start Date 2025-08-21
Primary Completion 2026-05-12 (estimated)
Study Completion 2026-05-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-28