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

Last updated: April 13, 2026
Sponsor: BeiGene
Overall Status: Active - Not Recruiting

Phase

2

Condition

Rheumatoid Arthritis

Arthritis And Arthritic Pain

Musculoskeletal Diseases

Treatment

BGB-45035

Placebo

Clinical Study ID

NCT07100938
BGB-45035-201
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with rheumatoid arthritis (RA) based on American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria for at least 3 monthsprior to screening

  • Demonstrated an inadequate response to, or loss of response or intolerance to atleast 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD) (Hydroxychloroquine, methotrexate [MTX], leflunomide, or sulfasalazine) or 1biologic disease-modifying antirheumatic drug (bDMARD)/targeted syntheticdisease-modifying antirheumatic drug (tsDMARD) treatment

  • Must be on stable dose of one of the following permitted therapies for ≥ 4 weeksprior 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 sulfasalazinebetween 1000 mg/day to 3000 mg/day

Exclusion

Exclusion Criteria:

  • Class IV RA based on American College of Rheumatology revised criteria forclassification 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 ofthe skin

  • Have failed more than 2 b/tsDMARDs (eg, excluded if have failed 2 bDMARDs and 1tsDMARD)

Study Design

Total Participants: 49
Treatment Group(s): 2
Primary Treatment: BGB-45035
Phase: 2
Study Start date:
August 21, 2025
Estimated Completion Date:
October 18, 2026

Connect with a study center

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui 233004
    China

    Site Not Available

  • Anhui Provincial Hospital

    Hefei, Anhui 230000
    China

    Site Not Available

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu 1816440, Anhui 1818058 233004
    China

    Site Not Available

  • Anhui Provincial Hospital

    Hefei 1808722, Anhui 1818058 230000
    China

    Site Not Available

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality 100050
    China

    Site Not Available

  • Peking University First Hospital

    Beijing, Beijing Municipality 100034
    China

    Site Not Available

  • Beijing Friendship Hospital, Capital Medical University

    Beijing 1816670, Beijing Municipality 2038349 100050
    China

    Active - Recruiting

  • Peking University First Hospital

    Beijing 1816670, Beijing Municipality 2038349 100034
    China

    Site Not Available

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality 400010
    China

    Site Not Available

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing 1814906, Chongqing Municipality 1814905 400010
    China

    Site Not Available

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong 510515
    China

    Site Not Available

  • Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • The First Affiliated Hospital, Sun Yat Sen University

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • Nanfang Hospital, Southern Medical University

    Guangzhou 1809858, Guangdong 1809935 510515
    China

    Active - Recruiting

  • Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)

    Guangzhou 1809858, Guangdong 1809935 510000
    China

    Active - Recruiting

  • The First Affiliated Hospital, Sun Yat Sen University

    Guangzhou 1809858, Guangdong 1809935 510080
    China

    Site Not Available

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi 530021
    China

    Site Not Available

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning 1799869, Guangxi 1809867 530021
    China

    Site Not Available

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150001
    China

    Site Not Available

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin 2037013, Heilongjiang 2036965 150001
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan 471003
    China

    Site Not Available

  • Nanyang Central Hospital

    Nanyang, Henan 473000
    China

    Site Not Available

  • Zhengzhou Central Hospital

    Zhengzhou, Henan 450007
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang 1801792, Henan 1808520 471003
    China

    Site Not Available

  • Nanyang Central Hospital

    Nanyang 1799629, Henan 1808520 473000
    China

    Site Not Available

  • Zhengzhou Central Hospital

    Zhengzhou 1784658, Henan 1808520 450007
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan 410011
    China

    Site Not Available

  • Chenzhou No1 Peoples Hospital

    Chenzhou, Hunan 423000
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha 1815577, Hunan 1806691 410011
    China

    Site Not Available

  • Chenzhou No Peoples Hospital

    Chenzhou 1815059, Hunan 1806691 423000
    China

    Site Not Available

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia 010050
    China

    Site Not Available

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot 2036892, Inner Mongolia 2035607 010050
    China

    Site Not Available

  • The First Peoples Hospital of Changzhou

    Changzhou, Jiangsu 213000
    China

    Site Not Available

  • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu 210008
    China

    Site Not Available

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu 201203
    China

    Site Not Available

  • Northern Jiangsu Peoples Hospital

    Yangzhou, Jiangsu 225001
    China

    Site Not Available

  • The First Peoples Hospital of Changzhou

    Changzhou 1815456, Jiangsu 1806260 213000
    China

    Site Not Available

  • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School

    Nanjing 1799962, Jiangsu 1806260 210008
    China

    Site Not Available

  • Affiliated Hospital of Nantong University

    Nantong 1799722, Jiangsu 1806260 201203
    China

    Site Not Available

  • Northern Jiangsu Peoples Hospital

    Yangzhou 1787227, Jiangsu 1806260 225001
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • Pingxiang Peoples Hospital

    Pingxiang, Jiangxi 337055
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang 1800163, Jiangxi 1806222 330006
    China

    Site Not Available

  • Pingxiang Peoples Hospital

    Pingxiang 1798654, Jiangxi 1806222 337055
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun 2038180, Jilin 2036500 130021
    China

    Site Not Available

  • Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

    Shenyang, Liaoning 110000
    China

    Site Not Available

  • Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

    Shenyang 2034937, Liaoning 2036115 110000
    China

    Site Not Available

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, Shaanxi 710061
    China

    Site Not Available

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an 1790630, Shaanxi 1796480 710061
    China

    Site Not Available

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality 200040
    China

    Site Not Available

  • Huashan Hospital Fudan University

    Shanghai 1796236, Shanghai Municipality 1796231 200040
    China

    Site Not Available

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu, Sichuan 610071
    China

    Site Not Available

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan 637000
    China

    Site Not Available

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu 1815286, Sichuan 1794299 610071
    China

    Site Not Available

  • Affiliated Hospital of North Sichuan Medical Colleg

    Nanchong 1800146, Sichuan 1794299 637000
    China

    Site Not Available

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong 1800146, Sichuan 1794299 637000
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou 1808926, Zhejiang 1784764 310009
    China

    Site Not Available

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