Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis

Recruiting at 180 trial locations

Overseen By BMS Study Connect Contact Center www.BMSStudyConnect.com

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bristol-Myers Squibb

Disqualifiers: Other autoimmune, Immune-mediated, Fibromyalgia, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

119 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing branebrutinib, a drug that reduces inflammation, in people with active systemic Lupus Erythematosus (SLE) or Primary Sjögren's Syndrome (pSS). For those with active Rheumatoid Arthritis (RA), the trial will also test if adding abatacept, which prevents immune attacks on the body, provides additional benefits. The goal is to find safer and more effective treatments for these autoimmune diseases.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

Inclusion Criteria

Sub-study for primary Sjögren's Syndrome (pSS)

Sub-study for Systemic Lupus Erythematosus (SLE)

Active SLE as defined by the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) classification

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive branebrutinib treatment for active systemic Lupus Erythematosus, Primary Sjögren's Syndrome, or Rheumatoid Arthritis, with an option for open-label abatacept treatment in RA

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants with Rheumatoid Arthritis may opt into continuation of treatment with abatacept long-term

Long-term

Treatment Details

Interventions

• abatacept
• branebrutinib
• branebrutinib placebo

Participant Groups

Group I: Systemic Lupus Erythematosus (SLE): branebrutinib Experimental Treatment 1 Intervention

Group II: Rheumatoid Arthritis (RA): branebrutinib followed by abatacept Experimental Treatment 2 Interventions

Group III: Primary Sjögren's Syndrome (pSS): branebrutinib Experimental Treatment 1 Intervention

Group IV: pSS: placebo Placebo Group 1 Intervention

Group V: SLE: placebo Placebo Group 1 Intervention

Group VI: RA: placebo followed by abatacept Placebo Group 2 Interventions

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania