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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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Long-Term Safety and Efficacy Study of BMS-986165 in Participants With Systemic Lupus Erythematosus

  • Clinicaltrials.gov identifier

    NCT03920267

  • Recruitment Status

    Recruiting

  • First Posted

    April 18, 2019

  • Last update posted

    October 8, 2020

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
  • Estimated Enrollment: 360 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 study
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: A Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Systemic Lupus Erythematosus
  • Actual Study Start Date: March 2019
  • Estimated Primary Completion Date: January 2023
  • Estimated Study Completion Date: January 2023

Arms and interventions

Arm Intervention/treatment
Experimental: BMS-986165 Dose 1
Drug: BMS-986165
Administered orally
Experimental: BMS-986165 Dose 2
Drug: BMS-986165
Administered orally
Experimental: BMS-986165 Dose 3
Drug: BMS-986165
Administered orally

Outcome Measures

  • Primary Outcome Measures: 1. Number of participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 30 days after last treatment dose (approximately 108 weeks) ]
  • 2. Number of participants with AEs leading to discontinuation [ Time Frame: Up to 30 days after last treatment dose (approximately 108 weeks) ]
  • 3. Number of participants with adverse events (AEs) [ Time Frame: Up to 30 days after last treatment dose (approximately 108 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 108 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 108 weeks) ]

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:

- Completion of SLE Study (NCT03252587) through the protocol-required treatment period,
and currently receiving blinded study drug

- Women of childbearing potential (WOCBP) must have a negative urine pregnancy test and
must agree to use correctly a highly effective method(s) of contraception for the
duration of treatment with study drug

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 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, Alabama
University of Alabama at Birmingham - School of Medicine
Birmingham

United States, California
TriWest Research Associates
El Cajon

United States, California
Local Institution
Palm Desert

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
Bay Area Arthritis and Osteoporosis
Brandon

United States, Florida
Omega Research Group - MetroWest
Orlando

United States, Florida
Millennium Research
Ormond Beach

United States, Florida
Advent Health Medical Group
Tampa

United States, Georgia
The Emory Clinic
Atlanta

United States, Georgia
North Georgia Rheumatology Group-Duluth
Lawrenceville

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

United States, New York
Local Institution
Manhasset

United States, New York
Local Institution
New York

United States, North Carolina
Thurston Arthritis Research Center
Chapel Hill

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

United States, Oklahoma
Local Institution
Oklahoma City

United States, Oklahoma
Oklahoma Medical Research Foundation
Oklahoma City

United States, Pennsylvania
Clinical Research Center of Reading
Wyomissing

United States, South Carolina
Local Institution
Charleston

United States, Tennessee
West Tennessee Research Institute
Jackson

United States, Texas
Austin Regional Clinic
Austin

United States, Texas
Tekton Research
Austin

United States, Texas
Local Institution
Dallas

United States, Texas
University of Texas Southwestern Medical Center
Dallas

United States, Texas
Accurate Clinical Research-Stafford
Houston

United States, Texas
Accurate Clinical Management - Greenhouse Road
Houston

United States, Texas
Southwest Rheumatology Research
Mesquite

Argentina, Buenos Aires
Local Institution
Ciudad Aut? De Buenos Aires

Argentina, Buenos Aires
Local Institution
Ciudad Aut? De Buenos Aires

Argentina, Buenos Aires
Local Institution
Ciudad Aut? De Buenos Aires

Argentina, Buenos Aires
Local Institution
Ciudad Aut? De Buenos Aires

Argentina, Buenos Aires
Local Institution
Ciudad Autonoma de Buenos Aires

Argentina, Santa FE
Instituto CAICI
Rosario

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

Argentina
Local Institution
Cordoba

Argentina
Local Institution
Cordoba

Argentina
Instituto de Reumatologia
Mendoza

Australia, Queensland
Local Institution
Maroochydore

Brazil, Bahia
Local Institution
Salvador

Brazil, Goias
Local Institution
Goi?

Brazil, Minas Gerais
Local Institution
Belo Horizonte

Brazil, Minas Gerais
Centro Mineiro de Pesquisa - CMiP
Juiz de Fora

Brazil, Parana
Local Institution
Curitiba

Brazil, RIO Grande DO SUL
Local Institution
Porto Alegre

Brazil, RIO Grande DO SUL
Local Institution
Porto Alegre

Brazil, SAO Paulo
Local Institution
Sao Bernardo do Campo

Brazil
Local Institution
Rio de Janeiro

Brazil
CPCLIN - Centro de Pesquisas Clinicas
Sao Paulo

Canada, Alberta
Local Institution
Calgary

Canada, Ontario
Local Institution
Toronto

Colombia
Local Institution
Barranquilla

Colombia
Centro de Investigacion Medico Asistencial CIMEDICAL
Barranquilla

Colombia
Centro de Investigacion en Reumatologia y Especialidades Medicas
Bogot

Colombia
Local Institution
Bucaramanga

Colombia
Preventive Care
Chia

Colombia
Healthy Medical Center
Zipaquira

Germany
Local Institution
Hannover

Hungary
Local Institution
Budapest

Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen

Hungary
Bekes Megyei Pandy Kalman Korhaz
Gyula

Hungary
Szegedi Tudomanyegyetem
Szeged

Israel
Local Institution
Ramat-Gan

Japan, Chiba
Local Institution
Chiba-shi

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

Japan, Hokkaido
Sapporo City General Hospital
Sapporo-Shi

Japan, Ishikawa
Local Institution
Kanazawa

Japan, Miyagi
Tohoku University Hospital
Sendai City

Japan, Tochigi
Jichi Medical University Hospital
Shimotsuke-city

Japan, Tokyo
St. Lukes International Hospital
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
Mexico City

Mexico, Distrito Federal
Local Institution
Mexico

Mexico, Guanajuato
Consultorio Medico de Reumatologia
Leon

Mexico, Guanajuato
Centro de Investigacion Farmacologica del Bajio
Leon

Mexico, Jalisco
Local Institution
Guadalajara

Mexico, Jalisco
Local Institution
Guadalajara

Mexico, Jalisco
Local Institution
Zapopan

Mexico, Nuevo LEON
Accelerium Clinical Research
Monterrey

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

Mexico
Local Institution
Veracruz

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

Poland
Local Institution
Bytom

Poland
Local Institution
Elbl?g

Poland
Local Institution
Gdynia

Poland
Intermedius
Ko?cian

Poland
Local Institution
Ko?skie

Poland
Centrum Medyczne Plejady
Krakow

Poland
Centrum Nowoczesnych Terapii Dobry Lekarz Spolka z ograniczona odpowiedzialnoscia
Krak

Poland
Centrum Medyczne ProMiMed
Krak

Poland
Zespol Poradni Specjalistycznych REUMED Filia Nr 1 Wallenroda
Lublin

Poland
Local Institution
Pozna?

Poland
Medyczne Centrum Hetmanska - Poznan
Poznan

Poland
Centrum Medyczne Medens - Grupowa Praktyka Lekarska
Sosnowiec

Poland
Local Institution
Stalowa Wola

Poland
Local Institution
Warszawa

Poland
Centrum Medyczne Pratia Warszawa
Warszawa

Poland
Ars Rheumatica - Reumatika Centrum Reumatologii
Warszawa

Poland
Local Institution
Wroc?aw

Poland
Centrum Medyczne Oporow
Wroc?aw

Poland
Synexus Polska - Wroclaw
Wroclaw

Romania
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed
Brasov

Romania
Local Institution
Bucuresti

Romania
Local Institution
Bucuresti

Romania
Local Institution
Bucuresti

Romania
Local Institution
Bucuresti

Romania
Local Institution
Cluj-Napoca

Romania
Spitalul Clinic Jude?an de Urgen? Sfantul Apostol Andrei
Galati

Romania
Spitalul Judetean de Urgenta Valcea
R?cu V?a

Russian Federation
Municipal Institution City Clinical Hospital #40
Ekaterinburg

Russian Federation
Local Institution
Kemerovo

Russian Federation
Medical Center Maksimum Zdorovia
Kemerovo

Russian Federation
Local Institution
Novosibirsk

Russian Federation
Orenburg State Medical University
Orenburg

Russian Federation
Local Institution
Petrozavodsk

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

Russian Federation
Local Institution
Saint Petersburg

Russian Federation
Local Institution
Saint-Petersburg

Russian Federation
Local Institution
Smolensk

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

Russian Federation
Local Institution
Tolyatti

Russian Federation
Biomed
Vladimir

Russian Federation
Clinical Hospital named after NA Semashko
Yaroslavl

Russian Federation
Municipal Institution of Health Protection
Yatoslavl

Spain
Local Institution
A Coru

Spain
Hospital Regional Universitario de Malaga Hospital General
Malaga

Spain
Local Institution
Sabadell

Spain
Hospital Universitario Nuestra Senora de Valme
Sevilla

Taiwan
Local Institution
Taichung

Taiwan
Local Institution
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: October 8, 2020
  • Last Verified: October 2020
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Lupus Erythematosus, Systemic