Study 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.
A Study Investigating the Efficacy and Safety of BGB-45035 Versus Placebo in Adults With Moderate to Severe Active Rheumatoid Arthritis
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
1 other identifier
interventional
49
1 country
29
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 rheumatoid-arthritis
Started Aug 2025
Shorter than P25 for phase_2 rheumatoid-arthritis
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2025
CompletedFirst Posted
Study publicly available on registry
August 3, 2025
CompletedStudy Start
First participant enrolled
August 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 12, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 12, 2026
CompletedMay 28, 2026
May 1, 2026
9 months
July 28, 2025
May 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in Disease Activity Score - C-reactive protein (DAS28-CRP) at Week 12
The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), high-sensitivity C-reactive protein (hsCRP in mg/L), and Patient's Global Assessment of Arthritis Pain (measured on a Visual Analog Scale \[VAS\] from 0 \[no pain\] to 100 \[worst possible pain\]). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. A score greater than 5.1 indicates high disease activity, a score between 3.2 and 5.1 indicates moderate disease activity, a score between 2.6 and 3.2 indicates low disease activity, and a score less than 2.6 indicates the participant is in remission.
Baseline and Week 12
Secondary Outcomes (12)
Percentage of participants with a 20% improvement in American College of Rheumatology Criteria (ACR20)
Baseline and Week 12
Percentage of participants with a 50% improvement in American College of Rheumatology Criteria (ACR50)
Baseline and Week 12
Percentage of participants with a 70% improvement in American College of Rheumatology Criteria (ACR70)
Baseline and Week 12
Change from Baseline in Tender Joint Count 68 (TJC 68)
Baseline up to Week 12
Change from baseline in Swollen Joint Count 66 (SJC 66)
Baseline up to Week 12
- +7 more secondary outcomes
Study Arms (2)
BGB-45035
EXPERIMENTALParticipants will receive BGB-45035 orally for up to 12 weeks
Placebo
PLACEBO COMPARATORParticipants will receive placebo orally for up to 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (29)
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233004, China
Anhui Provincial Hospital
Hefei, Anhui, 230000, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)
Guangzhou, Guangdong, 510000, China
The First Affiliated Hospital, Sun Yat Sen University
Guangzhou, Guangdong, 510080, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003, China
Nanyang Central Hospital
Nanyang, Henan, 473000, China
Zhengzhou Central Hospital
Zhengzhou, Henan, 450007, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
Chenzhou No1 Peoples Hospital
Chenzhou, Hunan, 423000, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010050, China
The First Peoples Hospital of Changzhou
Changzhou, Jiangsu, 213000, China
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 201203, China
Northern Jiangsu Peoples Hospital
Yangzhou, Jiangsu, 225001, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, 330006, China
Pingxiang Peoples Hospital
Pingxiang, Jiangxi, 337055, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, 110000, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, 610071, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, 637000, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
BeiGene
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2025
First Posted
August 3, 2025
Study Start
August 21, 2025
Primary Completion
May 12, 2026
Study Completion
May 12, 2026
Last Updated
May 28, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.