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

Systemic Lupus Erythematosus Clinical Trial

Official title:

A Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Systemic Lupus Erythematosus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03920267
• Other study ID #: IM011-074
• Secondary ID: 2018-003471-35
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 26, 2019
• Est. completion date: March 31, 2025

Study information

• Verified date: May 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 261
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• BMS-986165
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	Local Institution - 0100	Caba
Argentina	Clinica Adventista Belgrano	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Local Institution - 0125	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Local Institution - 0122	Cordoba
Argentina	Local Institution - 0095	Mendoza
Argentina	Local Institution - 0098	Rosario	Santa FE
Argentina	Local Institution - 0091	San Miguel De Tucum	Tucuman
Brazil	Local Institution - 0120	Curitiba	Parana
Brazil	Local Institution - 0118	Goi?	Goias
Brazil	Local Institution - 0106	Juiz de Fora	Minas Gerais
Brazil	Local Institution - 0107	Porto Alegre	RIO Grande DO SUL
Brazil	Local Institution - 0116	Salvador	Bahia
Brazil	Local Institution - 0111	Sao Bernardo do Campo	SAO Paulo
Brazil	Local Institution - 0105	Sao Paulo
Canada	University of Calgary	Calgary	Alberta
Canada	Local Institution - 0136	Toronto	Ontario
Colombia	Local Institution - 0108	Barranquilla
Colombia	Local Institution - 0101	Bogot
Colombia	Local Institution - 0103	Chia
Colombia	Local Institution - 0096	Zipaquira
Hungary	Local Institution - 0039	Debrecen
Hungary	Local Institution - 0038	Gyula
Hungary	Local Institution - 0045	Szeged
Japan	National Hospital Organization Chibahigashi National Hospital	Chiba-shi	Chiba
Japan	Local Institution - 0065	Chuo-ku	Tokyo
Japan	Local Institution - 0092	Kitakyushu	Fukuoka
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	Local Institution - 0119	Sapporo-Shi	Hokkaido
Japan	Local Institution - 0063	Sendai	Miyagi
Japan	Local Institution - 0069	Shimotsuke-city	Tochigi
Japan	Local Institution - 0066	Tokyo
Japan	Local Institution - 0078	Tokyo
Japan	Local Institution - 0093	Tokyo
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution - 0053	Suwon
Mexico	Local Institution - 0080	Leon	Guanajuato
Mexico	Local Institution - 0086	Leon	Guanajuato
Mexico	Local Institution - 0087	Mexico City	Distrito Federal
Mexico	Local Institution - 0084	Monterrey	Nuevo LEON
Mexico	Local Institution - 0082	San Luis Potosi
Mexico	Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.	Zapopan	Jalisco
Poland	Local Institution - 0025	Bydgoszcz
Poland	Local Institution - 0015	Koscian
Poland	Local Institution - 0014	Krakow
Poland	Local Institution - 0018	Krakow
Poland	Local Institution - 0027	Krakow
Poland	Local Institution - 0016	Lublin
Poland	Local Institution - 0024	Poznan
Poland	Local Institution - 0029	Sosnowiec
Poland	Local Institution - 0019	Warsaw
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	Local Institution - 0072	Novosibirsk
Russian Federation	Local Institution - 0057	Orenburg
Russian Federation	Local Institution - 0062	Saint - Petersburg
Russian Federation	Local Institution - 0070	Smolensk
Russian Federation	Local Institution - 0058	St. Petersburg
Russian Federation	Local Institution - 0055	Vladimir
Russian Federation	Local Institution - 0060	Yaroslavl
Russian Federation	Local Institution - 0068	Yaroslavl
Spain	Local Institution - 0126	Malaga
Spain	Local Institution - 0138	Sabadell
Spain	Local Institution - 0124	Sevilla
Taiwan	Local Institution - 0052	Taichung
Taiwan	Local Institution - 0051	Taipei
Taiwan	Local Institution - 0137	Taipei
Taiwan	Local Institution	Taipei City
United States	Local Institution - 0094	Atlanta	Georgia
United States	Local Institution - 0041	Austin	Texas
United States	Tekton Research - Austin	Austin	Texas
United States	Local Institution - 0115	Aventura	Florida
United States	Local Institution - 0077	Birmingham	Alabama
United States	Local Institution - 0044	Brandon	Florida
United States	Local Institution - 0123	Brooklyn	New York
United States	Local Institution - 0071	Chapel Hill	North Carolina
United States	Local Institution - 0121	Charleston	South Carolina
United States	Local Institution - 0031	Charlotte	North Carolina
United States	Local Institution - 0114	Dallas	Texas
United States	Local Institution - 0030	El Cajon	California
United States	Local Institution - 0140	Gainesville	Florida
United States	Local Institution - 0037	Houston	Texas
United States	Local Institution - 0001	Jackson	Tennessee
United States	Local Institution - 0050	Lawrenceville	Georgia
United States	Local Institution - 0046	Mesquite	Texas
United States	Local Institution - 0074	New Haven	Connecticut
United States	Local Institution - 0131	New York	New York
United States	Local Institution - 0064	Oklahoma City	Oklahoma
United States	Local Institution - 0133	Orlando	Florida
United States	Local Institution - 0032	Ormond Beach	Florida
United States	Local Institution - 0048	Tampa	Florida
United States	Local Institution - 0049	Torrance	California
United States	Local Institution - 0035	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  Colombia,  Hungary,  Japan,  Korea, Republic of,  Mexico,  Poland,  Romania,  Russian Federation,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Adverse Events (AEs)		Up to 30 days after last treatment dose (approximately 178 weeks)
Primary	Number of participants with Serious Adverse Events (SAEs)		Up to 30 days after last treatment dose (approximately 178 weeks)
Primary	Number of participants with AEs leading to discontinuation		Up to 30 days after last treatment dose (approximately 178 weeks)
Primary	Number of participants with abnormal change from baseline in laboratory measurements over time		Up to 30 days after last treatment dose (approximately 178 weeks)
Primary	Number of participants with abnormal change from baseline in vital signs over time		Up to 30 days after last treatment dose (approximately 178 weeks)

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting