COMPLETEDResults postedPhase 2

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

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).

Sponsor

Bristol-Myers Squibb

Enrollment

119 participants

Sites

81 locations

Start Date

January 2020

Completion

December 2022

Autoimmune DisorderRheumatoid ArthritisSystemic Lupus ErythematosusPrimary Sjögren's Syndromebranebrutinib

Enrollment & Timeline

Completed

Target N

119

participants

Sites

locations

Duration

2.9 years

total trial span

Rate

pts/month needed

At 81 sites, each site needs to enroll approximately 0.0 patients/month to hit the enrollment target on schedule.

View on ClinicalTrials.gov

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Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Efficacy and safety of branebrutinib (BMS-986195), an irreversible Bruton's tyrosine kinase inhibitor, for the treatment of rheumatoid arthritis: a phase 2a, randomised, double-blind, placebo-controlled study.

Østergaard Mikkel, Haavardsholm Espen A, Nowak Miroslawa et al.The Lancet. Rheumatology2026

DOI PubMed

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Fetching protocol from ClinicalTrials.gov…

COMPLETEDResults postedPhase 2

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

Sponsor

Bristol-Myers Squibb

Enrollment

119 participants

Sites

81 locations

Start Date

January 2020

Completion

December 2022

Autoimmune DisorderRheumatoid ArthritisSystemic Lupus ErythematosusPrimary Sjögren's Syndromebranebrutinib

Enrollment & Timeline

Completed

Target N

119

participants

Sites

locations

Duration

2.9 years

total trial span

Rate

pts/month needed

At 81 sites, each site needs to enroll approximately 0.0 patients/month to hit the enrollment target on schedule.

View on ClinicalTrials.gov

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Østergaard Mikkel, Haavardsholm Espen A, Nowak Miroslawa et al.The Lancet. Rheumatology2026

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Primary Outcomes

The Percent of Participants With mCLASI Response at Week 24 and Corticosteroid (CS) < 10 mg/Day at Week 20 and Week 24 - SLE

Week 24

mCLASI response is defined as a decrease of ≥ 50% from baseline mCLASI activity score, in participants with a baseline mCLASI activity score ≥ 10, at Week 24. Baseline values are defined as the last nonmissing value prior to the first dose of study treatment. To be considered as meeting the second criterion, the CS (prednisone or equivalent) dose had to remain stable and ≤ 10 mg from Week 16 until Week 24. The modified CLASI (mCLASI) is defined as the activity portions of CLASI that describe skin erythema and scale/hypertrophy and inflammation of the scalp. The percentage of patients who entered the study with a positive mCLASI activity score (≥ 10) and who achieved a ≥ 50% decrease from baseline at Week 24 is considered to likely represent a clinically meaningful improvement. The scores are calculated by simple addition based on the extent of the symptoms. mCLASI: Modified Cutaneous Lupus Erythematosus Disease Area and Severity Index

The Percent of Participants With Composite Response at Week 24 - pSS

Week 24

Composite response is defined as the percent of participants with at least 3 of the following at Week 24: * Decrease of ≥ 1 point or 15% from baseline in the ESSPRI Total Score * Decrease of ≥ 3 points from baseline in ESSDAI score * Decrease of ≥ 25% from baseline in ocular staining score, or if normal score at baseline no change to abnormal * Increase of ≥ 25% from baseline in stimulated salivary flow * Improvement in one or more serological markers (rheumatoid factor (RF), immunoglobulin G protein (IgG), complement C3 or C4, cryoglobulin).

Percent of Participants With ACR50 Response at Week 12 Compared to Baseline - RA

Week 12

ACR50 response is defined as both improvement of 50% in the number of tender and swollen joints and a 50% improvement in 3 of the following 5 criteria: * Subject global assessment (SGA) * Physician global assessment (PGA) * Functional ability measure * Pain visual analog scale (VAS) * Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). Baseline values are defined as the last nonmissing value prior to the first dose of study treatment.

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

all

Healthy Volunteers

View full criteria

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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Local Institution - 0019

Phoenix, Arizona, United States

Local Institution - 0002

Covina, California, United States

Local Institution - 0024

Encino, California, United States

Local Institution - 0034

San Diego, California, United States

Local Institution - 0032

Upland, California, United States

Local Institution

Brandon, Florida, United States

Local Institution - 0062

DeBary, Florida, United States

Local Institution - 0035

Hialeah, Florida, United States

Local Institution

Jacksonville, Florida, United States

Local Institution - 0029

Plantation, Florida, United States

+71 more sites

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

Enrollment & Timeline

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

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

Enrollment & Timeline

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Primary Outcomes

Eligibility

Trial Sites (81)