A Study Investigating the Efficacy and Safety of BGB-45035 Versus Placebo in Adults With Moderate to Severe Active Rheumatoid Arthritis
NCT ID: NCT07100938
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2025-08-21
2026-10-18
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BGB-45035
Participants will receive BGB-45035 orally for up to 12 weeks
BGB-45035
Administered orally
Placebo
Participants will receive placebo orally for up to 12 weeks
Placebo
Administered orally
Interventions
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BGB-45035
Administered orally
Placebo
Administered orally
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital, Sun Yat Sen University
Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Nanyang Central Hospital
Nanyang, Henan, China
Zhengzhou Central Hospital
Zhengzhou, Henan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Chenzhou No Peoples Hospital
Chenzhou, Hunan, China
The First Peoples Hospital of Changzhou
Changzhou, Jiangsu, China
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Northern Jiangsu Peoples Hospital
Yangzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, China
Pingxiang Peoples Hospital
Pingxiang, Jiangxi, China
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, China
Affiliated Hospital of North Sichuan Medical Colleg
Nanchong, Sichuan, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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BGB-45035-201
Identifier Type: -
Identifier Source: org_study_id