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New pill for rheumatoid arthritis shows promise in early trial

NCT ID NCT07100938

Disease control Sponsor: BeiGene Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 study tested an experimental oral drug called BGB-45035 in 49 adults with moderate to severe rheumatoid arthritis who had not responded well to standard treatments. Participants received either the drug or a placebo to see if it could reduce joint pain and swelling. The trial was terminated early, so the full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BGB-45035 (an oral drug)
What this could lead to
If successful, this could point toward a new oral treatment option for people with rheumatoid arthritis who haven't responded well to standard therapies.
What could go wrong
This trial was terminated early with only 49 participants, so results are limited. The drug may not prove effective or safe in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

49 people

The number who actually took part.

Started

Aug 2025

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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)

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Conditions

The condition(s) this trial relates to.

hereditary sensory and autonomic neuropathy rheumatoid arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rheumatoid arthritis

Contacts and locations

Locations

  • Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

    Shenyang, Liaoning, 110000, China

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 201203, China

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan, 637000, China

  • Anhui Provincial Hospital

    Hefei, Anhui, 230000, China

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050, China

  • Chenzhou No1 Peoples Hospital

    Chenzhou, Hunan, 423000, China

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200040, China

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515, China

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

    Nanjing, Jiangsu, 210008, China

  • Nanyang Central Hospital

    Nanyang, Henan, 473000, China

  • Northern Jiangsu Peoples Hospital

    Yangzhou, Jiangsu, 225001, China

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034, China

  • Pingxiang Peoples Hospital

    Pingxiang, Jiangxi, 337055, China

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu, Sichuan, 610071, China

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

    Guangzhou, Guangdong, 510000, China

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 010050, China

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui, 233004, China

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021, China

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

    Luoyang, Henan, 471003, China

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, Shaanxi, 710061, China

  • The First Affiliated Hospital, Sun Yat Sen University

    Guangzhou, Guangdong, 510080, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The First Peoples Hospital of Changzhou

    Changzhou, Jiangsu, 213000, China

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400010, China

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009, China

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011, China

  • Zhengzhou Central Hospital

    Zhengzhou, Henan, 450007, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.