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
Autoimmune Disorder, Rheumatoid Arthritis, Systemic Lupus Erythematosus
About this trial
This is an interventional treatment trial for Autoimmune Disorder
Eligibility 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
Sites / Locations
- Arizona Arthritis and Rheumatology Research
- Medvin Clinical Research - Covina Office
- Local Institution - 0024
- TriWest Research Associates
- Inland Rheumatology and Osteoporosis Medical Group
- Local Institution
- Omega Research Consultants - DeBary
- Local Institution - 0035
- Local Institution
- Integral Rheumatology & Immunology Specialists
- North Georgia Rheumatology Group-Lawrenceville
- Clinical Investigation Specialists - Gurnee
- Local Institution
- Arthritis and Diabetes Clinic
- University of Michigan Medical Center
- AA Medical Research Center-Grand Blanc
- West County Rheumatology
- Arthritis Consultants
- Arthritis Center of Nebraska
- Innovative Health Research
- Local Institution
- Local Institution
- Local Institution - 0008
- Pmg Research Of Salisbury
- Local Institution
- Health Research of Oklahoma
- Local Institution - 0022
- Altoona Center for Clinical Research
- Arthritis and Osteoporosis Center - Orangeburg
- Low Country Rheumatology
- West Tennessee Research Institute
- Office of Ramesh C. Gupta, MD
- Local Institution - 0092
- Local Institution
- Local Institution - 0063
- Southwest Rheumatology Research
- Trinity Universal Research
- Sun Research Institute
- Local Institution
- Arthritis Northwest
- Local Institution - 0065
- Local Institution - 0047
- Local Institution - 0066
- Local Institution - 0064
- Local Institution - 0069
- Local Institution - 0075
- Hopital Europeen Marseille
- Hopital Lapeyronie
- Local Institution - 0038
- Local Institution - 0049
- Rheumazentrum Ruhrgebiet
- Uniklinik Koln
- Local Institution - 0051
- Centro Integral de Reumatologia
- Clinica de Investigacion en Reumatologia y Obesidad
- Local Institution - 0113
- Local Institution - 0102
- Local Institution - 0104
- Local Institution - 0114
- Local Institution - 0050
- Local Institution - 0059
- Universitair Medisch Centrum Groningen
- Local Institution - 0094
- Local Institution - 0089
- Local Institution - 0072
- Local Institution - 0012
- Local Institution - 0073
- Local Institution - 0011
- Local Institution - 0091
- Local Institution - 0017
- Local Institution - 0033
- Local Institution - 0101
- Local Institution - 0026
- Local Institution - 0028
- Local Institution - 0036
- Local Institution - 0025
- Local Institution - 0018
- Local Institution - 0061
- The Leeds Teaching Hospitals NHS Trust
- Guys and Saint Thomas NHS Foundation Trust
- University Hospital Southampton NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Systemic Lupus Erythematosus (SLE): branebrutinib
SLE: placebo
Primary Sjögren's Syndrome (pSS): branebrutinib
pSS: placebo
Rheumatoid Arthritis (RA): branebrutinib followed by abatacept
RA: placebo followed by abatacept