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

  • End date
    Jul 11, 2023
  • participants needed
  • sponsor
    Bristol-Myers Squibb
Updated on 4 October 2022
sjogren's syndrome
progressive systemic sclerosis


The purpose of this study is to evaluate the safety and effectiveness of treatment with branebrutinib treatment in participants with active systemic Lupus Erythematosus (SLE) or Primary Sjögren's Syndrome (pSS), or branebrutinib treatment followed by open-label abatacept treatment in study participants with active Rheumatoid Arthritis (RA).

Condition Autoimmune Disorder, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Primary Sjögren's Syndrome
Treatment Abatacept, branebrutinib, branebrutinib placebo
Clinical Study IdentifierNCT04186871
SponsorBristol-Myers Squibb
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

Sub-study for Systemic Lupus Erythematosus (SLE)
Active SLE as defined by the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) classification
Diagnosed with SLE more than 24 weeks before screening visit
Sub-study for primary Sjögren's Syndrome (pSS)
Moderate to severe pSS, meeting ACR-EULAR classification criteria
Sub-study for active Rheumatoid Arthritis (RA)
Moderate to severe adult-onset RA
ACR global functional status class I to III
Women and men must agree to follow instructions for methods of contraception

Exclusion Criteria

Sub-study for SLE
Certain other autoimmune diseases and overlap syndromes
Sub-study for pSS
Certain other immune-mediated diseases, active fibromyalgia, or other medical conditions
Sub-study for RA
Diagnosis with juvenile arthritis or idiopathic arthritis before age 16
For all sub-studies
History of any significant drug allergy
Active infection, significant concurrent medical condition, or clinically significant abnormalities
Other protocol defined inclusion/exclusion criteria could apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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