A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BGB-45035 Versus Placebo in Patients With Moderate to Severe Active Rheumatoid Arthritis
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Beijing Friendship Hospital, Capital Medical University
RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
The Second Xiangya Hospital of Central South University
RECRUITING
Changsha
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
RECRUITING
Chengdu
Nanfang Hospital, Southern Medical University
RECRUITING
Guangzhou
The Second Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
The First Affiliated Hospital of Henan University of Science and Technology
RECRUITING
Luoyang
The First Affiliated Hospital of Nanchang University Branch Donghu
RECRUITING
Nanchang
Affiliated Hospital of North Sichuan Medical College
RECRUITING
Nanchong
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
RECRUITING
Nanjing
The First Affiliated Hospital of Guangxi Medical University
RECRUITING
Nanning
Nanyang Central Hospital
RECRUITING
Nanyang
Pingxiang Peoples Hospital
RECRUITING
Pingxiang
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
RECRUITING
Shenyang
Zhengzhou Central Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Study Director
clinicaltrials@beigene.com
1-877-828-5568
Time Frame
Start Date:2025-08-21
Estimated Completion Date:2026-10-18
Participants
Target number of participants:90
Treatments
Experimental: BGB-45035
Participants will receive BGB-45035 orally for up to 12 weeks
Placebo_comparator: Placebo
Participants will receive placebo orally for up to 12 weeks