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 at180 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Bristol-Myers Squibb

Prior Safety Data

Breakthrough Therapy

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.

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

Treatment Details

Interventions

• abatacept (T-cell Co-stimulation Modulator)
• branebrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor)
• branebrutinib placebo (Drug)

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