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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

  • Clinicaltrials.gov identifier

    NCT04186871

  • Recruitment Status

    Recruiting

  • First Posted

    December 5, 2019

  • Last update posted

    July 22, 2022

Study Description

Brief 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).

  • Condition or Disease:Autoimmune Disorder
    Rheumatoid Arthritis
    Systemic Lupus Erythematosus
    Primary Sjögren's Syndrome
  • Intervention/Treatment: Drug: branebrutinib
    Drug: abatacept
    Drug: branebrutinib placebo
  • Phase: Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 185 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: 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
  • Actual Study Start Date: October 2020
  • Estimated Primary Completion Date: July 2023
  • Estimated Study Completion Date: July 2023

Arms and interventions

Arm Intervention/treatment
Experimental: Primary Sjögren's Syndrome (pSS): branebrutinib
Drug: branebrutinib
Specified dose on specified days
Experimental: Rheumatoid Arthritis (RA): branebrutinib followed by abatacept
Drug: branebrutinib
Specified dose on specified days

Drug: abatacept
Specified dose on specified days
Experimental: Systemic Lupus Erythematosus (SLE): branebrutinib
Drug: branebrutinib
Specified dose on specified days
Placebo Comparator: RA: placebo followed by abatacept
Drug: abatacept
Specified dose on specified days

Drug: branebrutinib placebo
Specified dose on specified days
Placebo Comparator: SLE: placebo
Drug: branebrutinib placebo
Specified dose on specified days
Placebo Comparator: pSS: placebo
Drug: branebrutinib placebo
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Systemic lupus erythematosus (SLE): Modified Cutaneous Lupus Erythematosus Disease Area and Severity Index (mCLASI) activity score response [ Time Frame: at 24 weeks ]
    Proportion of participants with a ≥ 50% reduction of mCLASI from baseline
  • 2. pSS: Proportion of participants with changes in a composite score that includes ESSPRI (EULAR Sjögren's Syndrome Patient Reported Index), ESSDAI (EULAR Sjögren's Syndrome Disease Activity Index), ocular staining, salivary flow and serological marker [ Time Frame: at 24 weeks ]
  • 3. Rheumatoid arthritis (RA): ACR50 response [ Time Frame: at 12 weeks ]
    Proportion of participants achieving ACR50 response (American College of Rheumatology 50 criteria)
  • Secondary Outcome Measures: 1. SLE: SLEDAI-2K score response [ Time Frame: at 24 weeks ]
    Change from baseline in SLEDAI-2K score (Systemic Lupus Erythematosus Disease Activity Index 2000)
  • 2. SLE: BILAG-based Composite Lupus Assessment response [ Time Frame: at 24 weeks ]
    Change from baseline in BILAG-based (British Isles Lupus Assessment Group) Composite Lupus Assessment response
  • 3. RA: DAS28-CRP response [ Time Frame: at 12 weeks ]
    Change from baseline in DAS28-CRP (Disease Activity Score 28 - C reactive protein)
  • 4. RA: DAS28-ESR response [ Time Frame: at 12 weeks ]
    Change from baseline in DAS28-ESR (Disease Activity Score 28 - Erythrocyte Sedimentation Rate)
  • 5. RA: SDAI response [ Time Frame: at 12 weeks ]
    Change from baseline in SDAI (Simplified Disease Activity Index)
  • 6. RA: CDAI response [ Time Frame: at 12 weeks ]
    Change from baseline in CDAI (Clinical Disease Activity Index)
  • 7. RA: ACR20 response [ Time Frame: at 12 weeks ]
    Proportion of participants achieving ACR20 response (American College of Rheumatology 20 criteria)
  • 8. RA: ACR70 response [ Time Frame: at 12 weeks ]
    Proportion of participants achieving ACR70 response (American College of Rheumatology 70 criteria)
  • 9. Number of participants with adverse events (AEs) [ Time Frame: Up to 32 weeks ]
  • 10. Number of participants with clinical laboratory abnormalities [ Time Frame: Up to 32 weeks ]
  • 11. Number of participants with vital sign abnormalities [ Time Frame: Up to 32 weeks ]
  • 12. Number of participants with electrocardiogram (ECG) abnormalities [ Time Frame: Up to 32 weeks ]

Eligibility Criteria

  • Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, Arizona
Arizona Arthritis and Rheumatology Research
Phoenix

United States, California
Medvin Clinical Research - Covina Office
Covina

United States, California
Local Institution - 0024
Encino

United States, California
Local Institution
Los Angeles

United States, California
TriWest Research Associates
San Diego

United States, California
Inland Rheumatology and Osteoporosis Medical Group
Upland

United States, Florida
Local Institution
Brandon

United States, Florida
Local Institution
Clearwater

United States, Florida
Omega Research Consultants - DeBary
DeBary

United States, Florida
Local Institution
Fort Lauderdale

United States, Florida
Local Institution
Gainesville

United States, Florida
Benidecto Fernandez MD PA
Hialeah

United States, Florida
Local Institution
Jacksonville

United States, Florida
Local Institution
Miami

United States, Florida
Integral Rheumatology & Immunology Specialists
Plantation

United States, Florida
Local Institution
Tampa

United States, Georgia
Local Institution
Atlanta

United States, Georgia
North Georgia Rheumatology Group-Lawrenceville
Lawrenceville

United States, Illinois
Clinical Investigation Specialists - Gurnee
Skokie

United States, Indiana
Local Institution
Evansville

United States, Kentucky
Local Institution
Lexington

United States, Louisiana
Local Institution
Lake Charles

United States, Louisiana
Arthritis and Diabetes Clinic
Monroe

United States, Michigan
University of Michigan Medical Center
Ann Arbor

United States, Michigan
Local Institution
Detroit

United States, Michigan
AA Medical Research Center-Grand Blanc
Grand Blanc

United States, Missouri
West County Rheumatology
Saint Louis

United States, Missouri
Arthritis Consultants
Saint Louis

United States, Montana
Local Institution
Kalispell

United States, Nebraska
Arthritis Center of Nebraska
Lincoln

United States, Nevada
Innovative Health Research
Las Vegas

United States, New York
Local Institution
Brooklyn

United States, New York
Local Institution
Manhasset

United States, New York
Local Institution
New York

United States, North Carolina
Joint Muscle Medical Care and Research Institute - Lilington Office
Charlotte

United States, North Carolina
Pmg Research Of Salisbury
Salisbury

United States, North Dakota
Local Institution
Minot

United States, Oklahoma
Health Research of Oklahoma
Oklahoma City

United States, Oklahoma
Lynn Health Science Institute
Oklahoma City

United States, Oklahoma
Local Institution
Tulsa

United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville

United States, South Carolina
Arthritis and Osteoporosis Center - Orangeburg
Orangeburg

United States, South Carolina
Low Country Rheumatology
Summerville

United States, Tennessee
West Tennessee Research Institute
Jackson

United States, Tennessee
Office of Ramesh C. Gupta, MD
Memphis

United States, Texas
Local Institution
Austin

United States, Texas
Local Institution - 0092
Colleyville

United States, Texas
Local Institution
Dallas

United States, Texas
Local Institution
Houston

United States, Texas
Biopharma Informatic - Houston
Houston

United States, Texas
Local Institution
League City

United States, Texas
Southwest Rheumatology Research
Mesquite

United States, Texas
Trinity Universal Research
Plano

United States, Texas
Sun Research Institute
San Antonio

United States, Texas
Local Institution
Waco

United States, Washington
Arthritis Northwest
Spokane

Argentina, Buenos Aires
Local Institution - 0065
Ciudad Autonoma de Buenos Aires

Argentina, Tucuman
Centro Medico Privado de Reumatologia
San Miguel De Tucum

Argentina
Local Institution - 0066
San Juan

Belgium
Local Institution - 0064
Gent

Belgium
Universitair Ziekenhuis Leuven Multidisciplinair Borstcentrum
Leuven

Belgium
Local Institution
Liege

France
Local Institution - 0075
Brest

France
Local Institution
Le Kremlin-Bicetre

France
Hopital Europeen Marseille
Marseille

France
Hopital Lapeyronie
Montpellier Cedex 5

France
Local Institution
Strasbourg Cedex

Germany
Local Institution - 0038
Berlin

Germany
Local Institution - 0049
Freiburg

Germany
Rheumazentrum Ruhrgebiet
Herne

Germany
Uniklinik Koln
Koln

Germany
Local Institution - 0051
Munchen

Mexico, Coahuila
Local Institution
Saltillo

Mexico, Distrito Federal
Local Institution
Mexico City

Mexico, Distrito Federal
Local Institution
Mexico

Mexico, Jalisco
Centro Integral de Reumatologia
Guadalajara

Mexico, Jalisco
Clinica de Investigacion en Reumatologia y Obesidad
Guadalajara

Mexico, Jalisco
Local Institution
Guadalajara

Mexico, Jalisco
Local Institution
Zapopan

Mexico, Morelos
Local Institution
Cuernavaca

Mexico, Yucatan
Local Institution
Merida

Mexico, Yucatan
Local Institution
Merida

Mexico, Yucatan
Local Institution
Merida

Mexico
Local Institution
San Luis Potosi

Mexico
Local Institution - 0050
San Luis Potosi

Mexico
Local Institution - 0059
San Luis Potosi

Netherlands
Local Institution
Amsterdam

Netherlands
Universitair Medisch Centrum Groningen
Groningen

Poland
ClinicMed Daniluk Nowak Spolka Jawna
Bialystok

Poland
Local Institution - 0089
Bydgoszcz

Poland
Local Institution - 0072
Bydgoszcz

Poland
Ambulatorium Sp. z o.o. Elblag
Elblag

Poland
Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
Elblag

Poland
Local Institution
Krakow

Poland
Local Institution
Poznan

Poland
Local Institution - 0011
Poznan

Poland
Nasz Lekarz Osrodek Badan Klinicznych - Torun
Torun

Poland
Local Institution - 0017
Warszawa

Poland
Local Institution - 0033
Warszawa

Poland
ETG - Warszawa
Warszawa

Poland
Local Institution - 0026
Warszawa

Spain
Complejo Hospitalario Universitario A Coruna
A Coru

Spain
Hospital Universitari Vall dHebron
Barcelona

Spain
Hospital Regional Universitario de Malaga Hospital General
Malaga

Spain
Local Institution - 0018
Sevilla

Spain
Hospital Clinico Universitario de Valencia
Valencia

United Kingdom
Local Institution
Harlow

United Kingdom
Local Institution
Hull

United Kingdom
The Leeds Teaching Hospitals NHS Trust
Leeds

United Kingdom
Local Institution
London

United Kingdom
Guys and Saint Thomas NHS Foundation Trust
London

United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04186871 History of Changes
  • Other Study ID Numbers: IM014-029, 2019-002205-22
  • First Posted: December 5, 2019 Key Record Dates
  • Last Update Posted: July 22, 2022
  • Last Verified: July 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Rheumatic Diseases
    Connective Tissue Diseases
    Immune System Diseases
    Xerostomia
    Salivary Gland Diseases
    Mouth Diseases
    Stomatognathic Diseases
    Dry Eye Syndromes
    Lacrimal Apparatus Diseases
    Eye Diseases
    Arthritis
    Arthritis, Rheumatoid
    Sjogren's Syndrome
    Lupus Erythematosus, Systemic
    Autoimmune Diseases
    Syndrome
    Disease
    Pathologic Processes
    Joint Diseases
    Musculoskeletal Diseases