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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

    September 16, 2021

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:Primary Sjögren's Syndrome
    Systemic Lupus Erythematosus
    Rheumatoid Arthritis
    Autoimmune Disorder
  • 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: A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects With Active Rheumatoid Arthritis
  • Actual Study Start Date: January 2020
  • Estimated Primary Completion Date: February 2023
  • Estimated Study Completion Date: February 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. SLE: mCLASI activity score response [ Time Frame: at 24 weeks ]
    Proportion of participants with a ≥ 50% reduction of mCLASI from baseline
  • 2. pSS: Proportion of subjects 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 ]
    Clinically significant improvements from baseline in ESSPRI, ESSDAI, ocular staining, salivary flow, and serological marker (rheumatoid factor [RF], IgG, complement C3 or C4, cryoglobulin) used in the composite measure.
  • 3. 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. SLE, pSS, RA: Safety [ Time Frame: up to 28 weeks ]
    Incidence of Serious Adverse Events, Adverse Events; number of clinically significant changes in lab assessment of blood, number of clinically significant changes in vital sign of body temperature, blood pressure, and respiratory rate; number of clinically significant changes in electrocardiogram.

Eligibility Criteria

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

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com. 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 Systemic Lupus Erythematosus - Certain other autoimmune diseases and overlap syndromes Sub-study for primary Sjögren's Syndrome - Certain other immune-mediated diseases, active fibromyalgia, or other medical conditions Sub-study for Rheumatoid Arthritis (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: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: 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
TriWest Research Associates
El Cajon

United States, California
Encino Research Center
Encino

United States, California
Local Institution
Los Angeles

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
Benidecto Fernandez MD PA
Hialeah

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, 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
Grand Blanc

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

United States, North Carolina
PMG Research of Salisbury
Salisbury

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
Trinity Universal Research
Carrollton

United States, Texas
Local Institution
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
Sun Research Institute
San Antonio

United States, Washington
Local Institution
Spokane

Argentina, Buenos Aires
Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno
Ciudad Autonoma de Buenos Aires

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

Argentina
Centro Polivalente de Asistencia e Investigacion Clinica CER San Juan
San Juan

Belgium
Universitair Ziekenhuis Gent
Gent

Belgium
Universitair Ziekenhuis Leuven Multidisciplinair Borstcentrum
Leuven

Belgium
Local Institution
Liege

France
Local Institution
Brest

France
Local Institution
Le Kremlin-Bicetre

France
Local Institution
Marseille

France
Local Institution
Montpellier Cedex 5

France
Local Institution
Strasbourg Cedex

Germany
Local Institution
Berlin

Germany
Local Institution
Freiburg

Germany
Rheumazentrum Ruhrgebiet
Herne

Germany
Uniklinik Koln
Koln

Germany
Klinikum der Ludwig Maximillians Universitat Munchen
Munchen

Mexico, Coahuila
Local Institution
Saltillo

Mexico, Distrito Federal
Local Institution
Mexico City

Mexico, Distrito Federal
Local Institution
Mexico

Mexico, Jalisco
Local Institution
Guadalajara

Mexico, Jalisco
Local Institution
Guadalajara

Mexico, Jalisco
Local Institution
Guadalajara

Mexico, Morelos
Local Institution
Cuernavaca

Mexico, Yucatan
Local Institution
Merida

Mexico, Yucatan
Local Institution
Merida

Mexico
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi
San Luis Potosi

Mexico
Local Institution
San Luis Potosi

Netherlands
Local Institution
Amsterdam

Netherlands
Local Institution
Groningen

Poland
Local Institution
Bialystok

Poland
Local Institution
Bydgoszcz

Poland
Szpital Uniwersytecki Number 2 im. dr. Jana Biziela w Bydgoszczy
Bydgoszcz

Poland
Ambulatorium Sp. z o.o.
Elblag

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

Poland
Local Institution
Krakow

Poland
Local Institution
Poznan

Poland
Centrum Badan Klinicznych S.C.
Poznan

Poland
Local Institution
Torun

Poland
Medycyna Kliniczna Marzena Waszczak - Jeka
Warszawa

Poland
Reumatika - Centrum Reumatologii
Warszawa

Poland
Local Institution
Warszawa

Poland
Centrum Medyczne AMED Warszawa Targowek
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
Hospital Quironsalud Infanta Luisa
Sevilla

Spain
Hospital Clinico Universitario de Valencia
Valencia

United Kingdom
Local Institution
Harlow

United Kingdom
Local Institution
Hull

United Kingdom
Local Institution
Leeds

United Kingdom
Local Institution
London

United Kingdom
Local Institution
London

United Kingdom
Local Institution
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: September 16, 2021
  • Last Verified: September 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Syndrome
    Autoimmune Diseases
    Lupus Erythematosus, Systemic
    Sjogren's Syndrome
    Arthritis, Rheumatoid
    Arthritis