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

Last updated: January 12, 2024
Sponsor: Bristol-Myers Squibb
Overall Status: Completed

Phase

2

Condition

Collagen Vascular Diseases

Dermatomyositis (Connective Tissue Disease)

Lupus

Treatment

abatacept

branebrutinib

branebrutinib placebo

Clinical Study ID

NCT04186871
IM014-029
2019-002205-22
  • Ages 18-75
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria: Sub-study for Systemic Lupus Erythematosus (SLE)

  • Active SLE as defined by the Systemic Lupus Erythematosus International CollaboratingClinics (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

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 medicalconditions 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 significantabnormalities Other protocol defined inclusion/exclusion criteria could apply

Study Design

Total Participants: 119
Treatment Group(s): 3
Primary Treatment: abatacept
Phase: 2
Study Start date:
January 07, 2020
Estimated Completion Date:
December 05, 2022

Connect with a study center

  • Local Institution

    Ciudad Aut? De Buenos Aires, Buenos Aires C1431FWO
    Argentina

    Site Not Available

  • Local Institution - 0065

    Ciudad Autonoma de Buenos Aires, Buenos Aires C1431FWO
    Argentina

    Site Not Available

  • Local Institution

    Lanus, Buenos Aires 1824
    Argentina

    Site Not Available

  • Local Institution - 0047

    San Miguel De Tucum, Tucuman T4000AXL
    Argentina

    Site Not Available

  • Local Institution

    San Miguel de Tucuman, Tucuman T4000AXL
    Argentina

    Site Not Available

  • Local Institution - 0066

    San Juan, J5402DIL
    Argentina

    Site Not Available

  • Local Institution

    Woodville, South Australia 5011
    Australia

    Site Not Available

  • Local Institution - 0064

    Gent, 9000
    Belgium

    Site Not Available

  • Local Institution - 0069

    Leuven, 3000
    Belgium

    Site Not Available

  • Local Institution

    Liege, 4000
    Belgium

    Site Not Available

  • Local Institution - 0075

    Brest, 29609
    France

    Site Not Available

  • Local Institution

    Le Kremlin-Bic?, 94275
    France

    Site Not Available

  • Local Institution

    Le Kremlin-Bicetre, 94275
    France

    Site Not Available

  • Hopital Europeen Marseille

    Marseille, 13003
    France

    Site Not Available

  • Local Institution - 0070

    Marseille, 13003
    France

    Site Not Available

  • Hopital Lapeyronie

    Montpellier Cedex 5, 34295
    France

    Site Not Available

  • Local Institution - 0067

    Montpellier Cedex 5, 34295
    France

    Site Not Available

  • Local Institution

    Strasbourg Cedex, 67098
    France

    Site Not Available

  • Local Institution - 0038

    Berlin, 10117
    Germany

    Site Not Available

  • Local Institution - 0049

    Freiburg, 79106
    Germany

    Site Not Available

  • Local Institution - 0074

    Herne, 44649
    Germany

    Site Not Available

  • Rheumazentrum Ruhrgebiet

    Herne, 44649
    Germany

    Site Not Available

  • Local Institution

    K?n, 50937
    Germany

    Site Not Available

  • Local Institution - 0037

    Koln, 50937
    Germany

    Site Not Available

  • Uniklinik Koln

    Koln, 50937
    Germany

    Site Not Available

  • Local Institution

    M?chen, 80336
    Germany

    Site Not Available

  • Local Institution - 0051

    Munchen, 80336
    Germany

    Site Not Available

  • Local Institution - 0057

    Saltillo, Coahuila 25000
    Mexico

    Site Not Available

  • Local Institution

    Mexico, Distrito Federal 11850
    Mexico

    Site Not Available

  • Local Institution - 0100

    Mexico City, Distrito Federal 06700
    Mexico

    Site Not Available

  • Centro Integral de Reumatologia

    Guadalajara, Jalisco 44160
    Mexico

    Site Not Available

  • Clinica de Investigacion en Reumatologia y Obesidad

    Guadalajara, Jalisco 44650
    Mexico

    Site Not Available

  • Local Institution - 0042

    Guadalajara, Jalisco 44650
    Mexico

    Site Not Available

  • Local Institution - 0060

    Guadalajara, Jalisco 44160
    Mexico

    Site Not Available

  • Local Institution - 0113

    Zapopan, Jalisco 45070
    Mexico

    Site Not Available

  • Local Institution - 0102

    Cuernavaca, Morelos 62290
    Mexico

    Site Not Available

  • Local Institution - 0104

    Merida, Yucatan 97000
    Mexico

    Site Not Available

  • Local Institution - 0050

    San Luis Potosi, 78213
    Mexico

    Site Not Available

  • Local Institution - 0059

    San Luis Potosi, 78240
    Mexico

    Site Not Available

  • Local Institution - 0114

    San Luis Potosi, 78200
    Mexico

    Site Not Available

  • Local Institution

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Local Institution - 0004

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • Local Institution - 0094

    Bialystok, 15-879
    Poland

    Site Not Available

  • Local Institution - 0072

    Bydgoszcz, 85-168
    Poland

    Site Not Available

  • Local Institution - 0089

    Bydgoszcz, 85-065
    Poland

    Site Not Available

  • Local Institution

    Elbl?g, 82-300
    Poland

    Site Not Available

  • Local Institution - 0012

    Elblag, 82-300
    Poland

    Site Not Available

  • Local Institution - 0073

    Elblag, 82-300
    Poland

    Site Not Available

  • Local Institution

    Krakow, 30-510
    Poland

    Site Not Available

  • Local Institution

    Pozna?, 60-693
    Poland

    Site Not Available

  • Local Institution - 0011

    Poznan, 60-773
    Poland

    Site Not Available

  • Local Institution - 0091

    Torun, 87-100
    Poland

    Site Not Available

  • Local Institution - 0017

    Warszawa, 00-660
    Poland

    Site Not Available

  • Local Institution - 0026

    Warszawa, 03-291
    Poland

    Site Not Available

  • Local Institution - 0033

    Warszawa, 02-691
    Poland

    Site Not Available

  • Local Institution - 0101

    Warszawa, 02-793
    Poland

    Site Not Available

  • Local Institution - 0028

    A Coru, 15006
    Spain

    Site Not Available

  • Local Institution

    A Coruna, 15006
    Spain

    Site Not Available

  • Local Institution - 0036

    Barcelona, 08035
    Spain

    Site Not Available

  • Local Institution - 0025

    Malaga, 29010
    Spain

    Site Not Available

  • Local Institution - 0018

    Sevilla, 41010
    Spain

    Site Not Available

  • Local Institution - 0061

    Valencia, 46010
    Spain

    Site Not Available

  • Local Institution

    Harlow, CM20 1QX
    United Kingdom

    Site Not Available

  • Local Institution

    Hull, HU3 2JZ
    United Kingdom

    Site Not Available

  • Local Institution - 0076

    Leeds, LS7 4SA
    United Kingdom

    Site Not Available

  • The Leeds Teaching Hospitals NHS Trust

    Leeds, LS7 4SA
    United Kingdom

    Site Not Available

  • Guys and Saint Thomas NHS Foundation Trust

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • Local Institution - 0058

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • Local Institution - 0052

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Arizona Arthritis and Rheumatology Research

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Local Institution - 0019

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Local Institution - 0002

    Covina, California 91723
    United States

    Site Not Available

  • Medvin Clinical Research - Covina Office

    Covina, California 91723
    United States

    Site Not Available

  • TriWest Research Associates

    El Cajon, California 92020
    United States

    Site Not Available

  • Local Institution - 0024

    Encino, California 91436
    United States

    Site Not Available

  • Local Institution

    Los Angeles, California 90033
    United States

    Site Not Available

  • Local Institution - 0034

    San Diego, California 92108
    United States

    Site Not Available

  • TriWest Research Associates

    San Diego, California 92108
    United States

    Site Not Available

  • Inland Rheumatology and Osteoporosis Medical Group

    Upland, California 91786
    United States

    Site Not Available

  • Local Institution - 0032

    Upland, California 91786
    United States

    Site Not Available

  • Local Institution

    Brandon, Florida 33511
    United States

    Site Not Available

  • Clinical Research of West Florida - Clearwater

    Clearwater, Florida 33765
    United States

    Site Not Available

  • Local Institution - 0062

    DeBary, Florida 32713
    United States

    Site Not Available

  • Omega Research Consultants - DeBary

    DeBary, Florida 32713
    United States

    Site Not Available

  • Local Institution

    Fort Lauderdale, Florida 33509
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32603
    United States

    Site Not Available

  • Local Institution - 0035

    Hialeah, Florida 33016
    United States

    Site Not Available

  • Local Institution

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • Local Institution

    Miami, Florida 33147
    United States

    Site Not Available

  • Local Institution

    Orlando, Florida 32806-1133
    United States

    Site Not Available

  • Integral Rheumatology & Immunology Specialists

    Plantation, Florida 33324
    United States

    Site Not Available

  • Local Institution - 0029

    Plantation, Florida 33324
    United States

    Site Not Available

  • Local Institution

    Tampa, Florida 33603
    United States

    Site Not Available

  • Local Institution

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Local Institution - 0009

    Lawrenceville, Georgia 30046
    United States

    Site Not Available

  • North Georgia Rheumatology Group-Lawrenceville

    Lawrenceville, Georgia 30046
    United States

    Site Not Available

  • Clinical Investigation Specialists - Gurnee

    Skokie, Illinois 60076
    United States

    Site Not Available

  • Local Institution - 0014

    Skokie, Illinois 60076
    United States

    Site Not Available

  • Local Institution

    Evansville, Indiana 47715
    United States

    Site Not Available

  • Local Institution

    Lexington, Kentucky 40504
    United States

    Site Not Available

  • Local Institution

    Lake Charles, Louisiana 70605
    United States

    Site Not Available

  • Arthritis and Diabetes Clinic

    Monroe, Louisiana 71203
    United States

    Site Not Available

  • Local Institution - 0005

    Monroe, Louisiana 71203
    United States

    Site Not Available

  • Local Institution - 0041

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Michigan Medical Center

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Henry Ford Medical Center - New Center One

    Detroit, Michigan 48202
    United States

    Site Not Available

  • AA Medical Research Center-Grand Blanc

    Grand Blanc, Michigan 48439
    United States

    Site Not Available

  • Local Institution - 0082

    Grand Blanc, Michigan 48439
    United States

    Site Not Available

  • Arthritis Consultants

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Local Institution - 0040

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Local Institution - 0096

    Saint Louis, Missouri 63131
    United States

    Site Not Available

  • West County Rheumatology

    Saint Louis, Missouri 63131
    United States

    Site Not Available

  • Local Institution

    Kalispell, Montana 59901
    United States

    Site Not Available

  • Arthritis Center of Nebraska

    Lincoln, Nebraska 68516
    United States

    Site Not Available

  • Local Institution - 0056

    Lincoln, Nebraska 68516
    United States

    Site Not Available

  • Innovative Health Research

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • Local Institution - 0007

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • NYU Langone Ambulatory Care Brooklyn Heights

    Brooklyn, New York 11201
    United States

    Site Not Available

  • Local Institution

    Manhasset, New York 11030
    United States

    Site Not Available

  • Local Institution

    New York, New York 10016
    United States

    Site Not Available

  • Local Institution - 0008

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Local Institution - 0006

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • Pmg Research Of Salisbury

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • Local Institution

    Minot, North Dakota 58701
    United States

    Site Not Available

  • Health Research of Oklahoma

    Oklahoma City, Oklahoma 73103-2433
    United States

    Site Not Available

  • Local Institution - 0022

    Oklahoma City, Oklahoma 79112
    United States

    Site Not Available

  • Local Institution - 0023

    Oklahoma City, Oklahoma 73103-2433
    United States

    Site Not Available

  • Local Institution

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Local Institution - 0010

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Arthritis and Osteoporosis Center - Orangeburg

    Orangeburg, South Carolina 29118
    United States

    Site Not Available

  • Local Institution - 0045

    Orangeburg, South Carolina 29118
    United States

    Site Not Available

  • Local Institution - 0021

    Summerville, South Carolina 29486
    United States

    Site Not Available

  • Low Country Rheumatology

    Summerville, South Carolina 29486
    United States

    Site Not Available

  • Local Institution - 0079

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • West Tennessee Research Institute

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • Local Institution - 0001

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Office of Ramesh C. Gupta, MD

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Local Institution

    Austin, Texas 78745
    United States

    Site Not Available

  • Trinity Universal Research

    Carrollton, Texas 75007-1601
    United States

    Site Not Available

  • Local Institution - 0092

    Colleyville, Texas 76034
    United States

    Site Not Available

  • Local Institution

    Dallas, Texas 75231
    United States

    Site Not Available

  • Local Institution - 0063

    Houston, Texas 77084
    United States

    Site Not Available

  • Local Institution

    League City, Texas 77573
    United States

    Site Not Available

  • Local Institution - 0016

    Mesquite, Texas 75150
    United States

    Site Not Available

  • Southwest Rheumatology Research

    Mesquite, Texas 75150
    United States

    Site Not Available

  • Local Institution - 0030

    Plano, Texas 75024
    United States

    Site Not Available

  • Trinity Universal Research

    Plano, Texas 75024
    United States

    Site Not Available

  • Local Institution - 0031

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Sun Research Institute

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Local Institution

    Waco, Texas 76710
    United States

    Site Not Available

  • Arthritis Northwest

    Spokane, Washington 99204
    United States

    Site Not Available

  • Local Institution - 0083

    Spokane, Washington 99204
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.