Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT03920267 Recruiting April 18, 2019 October 26, 2021

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
Intervention Model : Parallel Assignment
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: 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

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. 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

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
Poland Local Institution Stalowa Wola
Poland Local Institution Warszawa
Poland Szpital Uniwersytecki Number 2 im. dr. Jana Biziela w Bydgoszczy Bydgoszcz
Poland Local Institution Bytom
Poland Local Institution Elblag
Poland Local Institution Gdynia
Poland Local Institution Konskie
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 Poznan
Poland Centrum Medyczne Medens - Grupowa Praktyka Lekarska Sosnowiec
Poland Centrum Medyczne Pratia Warszawa Warszawa
Poland Ars Rheumatica - Reumatika Centrum Reumatologii Warszawa
Poland Synexus Polska - Wroclaw Wroclaw
Poland Centrum Medyczne Oporow Wroclaw
Poland Local Institution Wroclaw
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 University of Florida Health Shands Hospital Gainesville
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 New York University School of Medicine New York
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 Medical University of South Carolina 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 Management - Greenhouse Road Houston
United States, Texas Southwest Rheumatology Research Mesquite
Argentina, Buenos Aires Local Institution Ciudad Aut? De Buenos Aires
Argentina, Buenos Aires Clinica Adventista Belgrano Ciudad Autonoma de Buenos Aires
Argentina, Buenos Aires Aprillus Asistencia e Investigacion Ciudad Autonoma 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 Consultorios Medicos Dr. Catalan Pellet Caba
Argentina Consultora Integral de Salud - Centro Medico Privado Cordoba
Argentina Local Institution Cordoba
Argentina Instituto de Reumatologia Mendoza
Australia, Queensland Local Institution Maroochydore
Brazil, Bahia SER - Servicos Especializados em Reumatologia da Bahia Salvador
Brazil, Goias CIP - Centro Internacional de Pesquisa Goiߡ
Brazil, Minas Gerais Local Institution Belo Horizonte
Brazil, Minas Gerais Centro Mineiro de Pesquisa - CMiP Juiz de Fora
Brazil, Parana CETI-UFPR Centro de Estudos em Terapias Inovadoras Curitiba
Brazil, RIO Grande DO SUL LMK Servicos Medicos S/S Ltda Porto Alegre
Brazil, SAO Paulo Local Institution Porto Alegre
Brazil, SAO Paulo Centro Multidisciplinar de Estudos Clinicos Unidade Sao Bernardo Sao Bernardo do Campo
Brazil Local Institution Rio de Janeiro
Brazil CPCLIN - Centro de Pesquisas Clinicas Sao Paulo
Canada, Alberta University of Calgary Calgary
Canada, Ontario Toronto Western Hospital Toronto
Colombia Centro de Investigacion Medico Asistencial CIMEDICAL Barranquilla
Colombia Local Institution 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 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, 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 CAIMED Investigacion en Salud Mexico City
Mexico, Distrito Federal Centro de Investigacion y Tratamiento Reumatologico Mexico
Mexico, Guanajuato Consultorio Medico de Reumatologia Leon
Mexico, Guanajuato Centro de Investigacion Farmacologica del Bajio Leon
Mexico, Jalisco Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. Guadalajara
Mexico, Jalisco Centro Integral de Reumatologia Guadalajara
Mexico, Jalisco Juan Alberto Rodriguez Ruiz Zapopan
Mexico, Nuevo LEON Accelerium Clinical Research Monterrey
Mexico Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi San Luis Potosi
Mexico FAICIC Clinical Research Veracruz
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 Judeߥan de Urgenߡ Sfantul Apostol Andrei Galati
Romania Spitalul Judetean de Urgenta Valcea Ramnicu Valcea
Russian Federation Municipal Institution City Clinical Hospital #40 Ekaterinburg
Russian Federation Medical Center Maksimum Zdorovia Kemerovo
Russian Federation Local Institution Kemerovo
Russian Federation Medical Center Health Family 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 Departmental Hospital at Smolensk Station of JSC RZhD 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 Yaroslavl
Spain Local Institution A Coru
Spain Hospital Regional Universitario de Malaga Hospital General Malaga
Spain Corporacio Sanitaria Parc Tauli Sabadell
Spain Hospital Universitario Nuestra Senora de Valme Sevilla
Taiwan Local Institution Taichung
Taiwan Local Institution Taipei City
Taiwan Local Institution Taipei
Taiwan Local Institution Taipei
Sponsors and Collaborators
Bristol-Myers Squibb
Investigator
Study Director : Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Responsible Party : Bristol-Myers Squibb
ClinicalTrials.gov Identifier : NCT03920267     
Other Study ID Numbers : IM011-074, 2018-003471-35
First Posted : April 18, 2019
Last Update Posted : October 26, 2021
Last Verified : October 2021
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