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 Active, not recruiting April 18, 2019 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
Estimated Enrollment : 261 participants
Allocation : Randomized
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.
Intervention Model : Parallel Assignment
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 abnormal change from baseline in laboratory measurements over time [ Time Frame: Up to 30 days after last treatment dose (approximately 178 weeks) ]
2. Number of participants with AEs leading to discontinuation [ Time Frame: Up to 30 days after last treatment dose (approximately 178 weeks) ]
3. Number of participants with Adverse Events (AEs) [ Time Frame: Up to 30 days after last treatment dose (approximately 178 weeks) ]
4. Number of participants with Serious Adverse Events (SAEs) [ 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
Hungary Szegedi Tudomanyegyetem Szeged
Hungary Local Institution - 0039 Debrecen
Hungary Bekes Megyei Pandy Kalman Korhaz Gyula
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 Goiß¡
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
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
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 : 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