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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04186871
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Bristol-Myers Squibb
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Bristol-Myers Squibb
Principal Investigator Affiliation	Bristol-Myers Squibb
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Belgium, France, Germany, Mexico, Netherlands, Poland, Spain, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Autoimmune Disorder, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Primary Sjögren's Syndrome
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Systemic Lupus Erythematosus (SLE): branebrutinib

Placebo Comparator: SLE: placebo

Experimental: Primary Sjögren's Syndrome (pSS): branebrutinib

Placebo Comparator: pSS: placebo

Experimental: Rheumatoid Arthritis (RA): branebrutinib followed by abatacept

Placebo Comparator: RA: placebo followed by abatacept

Interventions

Drug: - branebrutinib

Specified dose on specified days

Drug: - abatacept

Specified dose on specified days

Drug: - branebrutinib placebo

Specified dose on specified days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Phoenix, Arizona

Status

Recruiting

Address

Arizona Arthritis and Rheumatology Research

Phoenix, Arizona, 85032

Site Contact

Saima Chohan, Site 0019

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