RecruitingPhase 2NCT07100938

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

Sponsor

BeiGene

Enrollment

90 participants

Start Date

Aug 21, 2025

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new investigational drug called BGB-45035 versus a placebo in adults with moderate to severe rheumatoid arthritis (RA) — a chronic autoimmune disease causing joint pain and swelling — who have not had adequate relief from standard disease-modifying drugs. Participants continue taking their regular RA medication throughout the trial. **You may be eligible if...** - You have been diagnosed with rheumatoid arthritis for at least 3 months - Your RA has not responded well enough to at least one standard DMARD medication (such as methotrexate, hydroxychloroquine, leflunomide, or sulfasalazine) or a biologic/targeted medication - You are currently on a stable dose of one of the permitted RA medications **You may NOT be eligible if...** - Your RA is severely disabling (Class IV — unable to perform self-care) - You have had cancer in the past 5 years (with minor skin cancer exceptions) - You have failed more than two biologic or targeted synthetic DMARD treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBGB-45035

Administered orally

DRUGPlacebo

Administered orally

Locations(29)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China

Anhui Provincial Hospital

Hefei, Anhui, China

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

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

Guangzhou, Guangdong, 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 Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 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 No1 Peoples Hospital

Chenzhou, Hunan, China

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, 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

The First Hospital of Jilin University

Changchun, Jilin, China

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Shenyang, Liaoning, China

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 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 College

Nanchong, Sichuan, China

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT07100938

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