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Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus

  • Clinicaltrials.gov identifier

    NCT03920267

  • Recruitment Status

    Active, not recruiting

  • First Posted

    April 18, 2019

  • Last update posted

    July 12, 2022

Study Description

Brief summary:

The main objective of the trial is to characterize the long-term safety and tolerability of BMS-986165 in subjects with Systemic Lupus Erythematosus (SLE).

  • Condition or Disease:Systemic Lupus Erythematosus
  • Intervention/Treatment: Drug: BMS-986165
  • Phase: Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Actual Enrollment: 261 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Participants who successfully complete the protocol-required treatment period of the Phase 2 SLE study (NCT03252587) will be offered the opportunity to continue this study.
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus
  • Actual Study Start Date: March 2019
  • Estimated Primary Completion Date: November 2023
  • Estimated Study Completion Date: November 2023

Arms and interventions

Arm Intervention/treatment
Experimental: BMS-986165 Dose 1
Drug: BMS-986165
Specified dose on specified days
Experimental: BMS-986165 Dose 2
Drug: BMS-986165
Specified dose on specified days
Experimental: BMS-986165 Dose 3
Drug: BMS-986165
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Number of participants with Adverse Events (AEs) [ Time Frame: Up to 30 days after last treatment dose (approximately 178 weeks) ]
  • 2. Number of participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 30 days after last treatment dose (approximately 178 weeks) ]
  • 3. Number of participants with AEs leading to discontinuation [ Time Frame: Up to 30 days after last treatment dose (approximately 178 weeks) ]
  • 4. Number of participants with abnormal change from baseline in laboratory measurements over time [ Time Frame: Up to 30 days after last treatment dose (approximately 178 weeks) ]
  • 5. Number of participants with abnormal change from baseline in vital signs over time [ Time Frame: Up to 30 days after last treatment dose (approximately 178 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: Completion of SLE Study (NCT03252587) through the protocol-required treatment period, and currently receiving blinded study drug. Note: If a subject is not receiving blinded study drug due to exceptional circumstances (eg, missed investigational product [IP] due to COVID-19 pandemic, delays in study approval, etc), the subject may be allowed to enroll with approval from the BMS Clinical Trial Physician or designee. Exclusion Criteria: Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or considered unsuitable by the investigator for any other reason Evidence of active tuberculosis (TB) Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Contacts

Locations

United States, Alabama
Local Institution - 0077
Birmingham

United States, California
Local Institution - 0030
El Cajon

United States, California
The Lundquist Institute at Harbor-UCLA Medical Center
Torrance

United States, Connecticut
Yale University
New Haven

United States, Florida
Arthritis & Rheumatic Disease Specialties
Aventura

United States, Florida
Local Institution - 0044
Brandon

United States, Florida
Local Institution - 0140
Gainesville

United States, Florida
Local Institution - 0133
Orlando

United States, Florida
Local Institution - 0032
Ormond Beach

United States, Florida
Advent Health Medical Group
Tampa

United States, Georgia
The Emory Clinic
Atlanta

United States, Georgia
Local Institution - 0050
Lawrenceville

United States, New York
New York University School of Medicine
Brooklyn

United States, New York
New York University School of Medicine
New York

United States, North Carolina
Thurston Arthritis Research Center
Chapel Hill

United States, North Carolina
Local Institution - 0031
Charlotte

United States, Oklahoma
Oklahoma Medical Research Foundation
Oklahoma City

United States, Pennsylvania
Local Institution - 0035
Wyomissing

United States, South Carolina
Medical University of South Carolina
Charleston

United States, Tennessee
Local Institution - 0001
Jackson

United States, Texas
Austin Regional Clinic
Austin

United States, Texas
Tekton Research - Austin
Austin

United States, Texas
University of Texas Southwestern Medical Center
Dallas

United States, Texas
Accurate Clinical Management - Greenhouse Road
Houston

United States, Texas
Southwest Rheumatology Research
Mesquite

Argentina, Buenos Aires
Clinica Adventista Belgrano
Ciudad Autonoma de Buenos Aires

Argentina, Buenos Aires
Aprillus Asistencia e Investigacion
Ciudad Autonoma de Buenos Aires

Argentina, Santa FE
Instituto CAICI
Rosario

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

Argentina
Consultorios Medicos Dr. Catalan Pellet
Caba

Argentina
Local Institution - 0122
Cordoba

Argentina
Local Institution - 0095
Mendoza

Brazil, Bahia
Local Institution - 0116
Salvador

Brazil, Goias
Local Institution - 0118
Goiߡ

Brazil, Minas Gerais
Local Institution - 0106
Juiz de Fora

Brazil, Parana
Local Institution - 0120
Curitiba

Brazil, RIO Grande DO SUL
Local Institution - 0107
Porto Alegre

Brazil, SAO Paulo
Local Institution - 0111
Sao Bernardo do Campo

Brazil
Local Institution - 0105
Sao Paulo

Canada, Alberta
University of Calgary
Calgary

Canada, Ontario
Toronto Western Hospital
Toronto

Colombia
Centro de Investigacion Medico Asistencial CIMEDICAL
Barranquilla

Colombia
Centro de Investigacion en Reumatologia y Especialidades Medicas
Bogot

Colombia
Local Institution - 0103
Chia

Colombia
Local Institution - 0096
Zipaquira

Hungary
Local Institution - 0039
Debrecen

Hungary
Bekes Megyei Pandy Kalman Korhaz
Gyula

Hungary
Szegedi Tudomanyegyetem
Szeged

Japan, Chiba
National Hospital Organization Chibahigashi National Hospital
Chiba-shi

Japan, Fukuoka
Hospital of the University of Occupational and Environmental Health Japan
Kitakyushu

Japan, Hokkaido
Sapporo City General Hospital
Sapporo-Shi

Japan, Hokkaido
Hokkaido University Hospital
Sapporo

Japan, Miyagi
Local Institution - 0063
Sendai City

Japan, Tochigi
Jichi Medical University Hospital
Shimotsuke-city

Japan, Tokyo
Local Institution - 0065
Chuo-ku

Japan
Juntendo University Hospital
Tokyo

Japan
Center Hospital of the National Center for Global Health and Medicine
Tokyo

Japan
Nihon University Itabashi Hospital
Tokyo

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Suwon

Mexico, Distrito Federal
Local Institution - 0087
Mexico City

Mexico, Guanajuato
Local Institution - 0080
Leon

Mexico, Guanajuato
Centro de Investigacion Farmacologica del Bajio
Leon

Mexico, Jalisco
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
Zapopan

Mexico, Nuevo LEON
Accelerium Clinical Research
Monterrey

Mexico
Local Institution - 0082
San Luis Potosi

Poland
Local Institution - 0025
Bydgoszcz

Poland
Intermedius
Koscian

Poland
Centrum Medyczne Plejady
Krakow

Poland
Centrum Nowoczesnych Terapii Dobry Lekarz Spolka z ograniczona odpowiedzialnoscia
Krakow

Poland
Centrum Medyczne ProMiMed
Krak

Poland
Zespol Poradni Specjalistycznych REUMED Filia Nr 1 Wallenroda
Lublin

Poland
Medyczne Centrum Hetmanska - Poznan
Poznan

Poland
Local Institution - 0029
Sosnowiec

Poland
Local Institution - 0019
Warszawa

Poland
Local Institution - 0022
Warszawa

Poland
Local Institution - 0010
Wroclaw

Poland
Local Institution - 0023
Wroclaw

Romania
Local Institution - 0033
Brasov

Romania
Local Institution - 0004
Galati

Romania
Local Institution - 0002
Ramnicu Valcea

Russian Federation
Local Institution - 0061
Ekaterinburg

Russian Federation
Local Institution - 0056
Kemerovo

Russian Federation
Medical Center Health Family
Novosibirsk

Russian Federation
Orenburg State Medical University
Orenburg

Russian Federation
S.M. Kirov Military Medical Academy
Saint - Petersburg

Russian Federation
Departmental Hospital at Smolensk Station of JSC RZhD
Smolensk

Russian Federation
Federal Almazov North-West Medical Research Centre
St. Petersburg

Russian Federation
Local Institution - 0055
Vladimir

Russian Federation
Clinical Hospital named after NA Semashko
Yaroslavl

Russian Federation
Local Institution - 0060
Yaroslavl

Spain
Hospital Regional Universitario de Malaga Hospital General
Malaga

Spain
Corporacio Sanitaria Parc Tauli
Sabadell

Spain
Local Institution - 0124
Sevilla

Taiwan
Local Institution
Taichung

Taiwan
Local Institution
Taipei City

Taiwan
Local Institution - 0051
Taipei

Taiwan
Local Institution
Taipei

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: NCT03920267 History of Changes
  • Other Study ID Numbers: IM011-074, 2018-003471-35
  • First Posted: April 18, 2019 Key Record Dates
  • Last Update Posted: July 12, 2022
  • Last Verified: July 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: Systemic Lupus Erythematosus
  • Additional relevant MeSH terms: Lupus Erythematosus, Systemic
    Connective Tissue Diseases
    Autoimmune Diseases
    Immune System Diseases