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

Phase 2

Active, not recruiting

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: BMS-986165

• Registration Number: NCT03920267
• Lead Sponsor: Bristol-Myers Squibb

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-03-26
• Study First Submitted: 2019-03-27
• Study First Submitted QC: 2019-04-16
• Study First Posted: 2019-04-18
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 261

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMS-986165 Dose 1	BMS-986165	-
BMS-986165 Dose 2	BMS-986165	-
BMS-986165 Dose 3	BMS-986165	-

Primary Outcome Measures

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

Trial Locations

Locations (97)

Local Institution - 0136; 🇨🇦 Toronto, Ontario, Canada

Local Institution - 0018; 🇵🇱 Krakow, Poland

Local Institution - 0106; 🇧🇷 Juiz de Fora, Minas Gerais, Brazil

Local Institution - 0096; 🇨🇴 Zipaquira, Colombia

Local Institution - 0094; 🇺🇸 Atlanta, Georgia, United States

Local Institution - 0140; 🇺🇸 Gainesville, Florida, United States

Local Institution - 0115; 🇺🇸 Aventura, Florida, United States

Local Institution - 0044; 🇺🇸 Brandon, Florida, United States

Local Institution - 0030; 🇺🇸 El Cajon, California, United States

Local Institution - 0031; 🇺🇸 Charlotte, North Carolina, United States

Local Institution - 0001; 🇺🇸 Jackson, Tennessee, United States

Local Institution - 0095; 🇦🇷 Mendoza, Argentina

Tekton Research - Austin; 🇺🇸 Austin, Texas, United States

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

Local Institution - 0118; 🇧🇷 Goiߡ, Goias, Brazil

Local Institution - 0116; 🇧🇷 Salvador, Bahia, Brazil

Local Institution - 0105; 🇧🇷 Sao Paulo, Brazil

Local Institution - 0091; 🇦🇷 San Miguel De Tucum, Tucuman, Argentina

Local Institution - 0046; 🇺🇸 Mesquite, Texas, United States

Local Institution - 0108; 🇨🇴 Barranquilla, Colombia

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

Local Institution - 0045; 🇭🇺 Szeged, Hungary

Local Institution - 0080; 🇲🇽 Leon, Guanajuato, Mexico

Local Institution - 0101; 🇨🇴 Bogot, Colombia

Local Institution - 0004; 🇷🇴 Galati, Romania

Local Institution - 0103; 🇨🇴 Chia, Colombia

Local Institution; 🇨🇳 Taipei City, Taiwan

Local Institution - 0084; 🇲🇽 Monterrey, Nuevo LEON, Mexico

Local Institution - 0082; 🇲🇽 San Luis Potosi, Mexico

Local Institution - 0025; 🇵🇱 Bydgoszcz, Poland

Local Institution - 0069; 🇯🇵 Shimotsuke-city, Tochigi, Japan

Local Institution - 0086; 🇲🇽 Leon, Guanajuato, Mexico

Local Institution - 0053; 🇰🇷 Suwon, Korea, Republic of

Local Institution - 0065; 🇯🇵 Chuo-ku, Tokyo, Japan

Local Institution - 0087; 🇲🇽 Mexico City, Distrito Federal, Mexico

Local Institution - 0027; 🇵🇱 Krakow, Poland

Local Institution - 0022; 🇵🇱 Warszawa, Poland

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

Local Institution - 0029; 🇵🇱 Sosnowiec, Poland

Local Institution - 0052; 🇨🇳 Taichung, Taiwan

Local Institution - 0061; 🇷🇺 Ekaterinburg, Russian Federation

Local Institution - 0056; 🇷🇺 Kemerovo, Russian Federation

Local Institution - 0051; 🇨🇳 Taipei, Taiwan

Local Institution - 0138; 🇪🇸 Sabadell, Spain

Local Institution - 0124; 🇪🇸 Sevilla, Spain

Local Institution - 0137; 🇨🇳 Taipei, Taiwan

National Hospital Organization Chibahigashi National Hospital; 🇯🇵 Chiba-shi, Chiba, Japan

Local Institution - 0092; 🇯🇵 Kitakyushu, Fukuoka, Japan

Local Institution - 0078; 🇯🇵 Tokyo, Japan

Local Institution - 0066; 🇯🇵 Tokyo, Japan

Local Institution - 0093; 🇯🇵 Tokyo, Japan

Local Institution - 0119; 🇯🇵 Sapporo-Shi, Hokkaido, Japan

Local Institution - 0063; 🇯🇵 Sendai, Miyagi, Japan

Local Institution - 0072; 🇷🇺 Novosibirsk, Russian Federation

Local Institution - 0057; 🇷🇺 Orenburg, Russian Federation

Local Institution - 0058; 🇷🇺 St. Petersburg, Russian Federation

Local Institution - 0070; 🇷🇺 Smolensk, Russian Federation

Local Institution - 0055; 🇷🇺 Vladimir, Russian Federation

Local Institution - 0060; 🇷🇺 Yaroslavl, Russian Federation

Local Institution - 0068; 🇷🇺 Yaroslavl, Russian Federation

Clinica Adventista Belgrano; 🇦🇷 Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0125; 🇦🇷 Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0100; 🇦🇷 Caba, Argentina

Local Institution - 0032; 🇺🇸 Ormond Beach, Florida, United States

Local Institution - 0120; 🇧🇷 Curitiba, Parana, Brazil

Local Institution - 0049; 🇺🇸 Torrance, California, United States

Local Institution - 0050; 🇺🇸 Lawrenceville, Georgia, United States

Local Institution - 0037; 🇺🇸 Houston, Texas, United States

Local Institution - 0123; 🇺🇸 Brooklyn, New York, United States

Local Institution - 0035; 🇺🇸 Wyomissing, Pennsylvania, United States

Local Institution - 0131; 🇺🇸 New York, New York, United States

Local Institution - 0114; 🇺🇸 Dallas, Texas, United States

Local Institution - 0098; 🇦🇷 Rosario, Santa FE, Argentina

Local Institution - 0122; 🇦🇷 Cordoba, Argentina

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

Hokkaido University Hospital; 🇯🇵 Sapporo, Hokkaido, Japan

Local Institution - 0039; 🇭🇺 Debrecen, Hungary

Local Institution - 0038; 🇭🇺 Gyula, Hungary

Local Institution - 0024; 🇵🇱 Poznan, Poland

Local Institution - 0062; 🇷🇺 Saint - Petersburg, Russian Federation

Local Institution - 0010; 🇵🇱 Wroclaw, Poland

Local Institution - 0033; 🇷🇴 Brasov, Romania

Local Institution - 0002; 🇷🇴 Ramnicu Valcea, Romania

Local Institution - 0126; 🇪🇸 Malaga, Spain

Local Institution - 0015; 🇵🇱 Koscian, Poland

Local Institution - 0014; 🇵🇱 Krakow, Poland

Local Institution - 0019; 🇵🇱 Warsaw, Poland

Local Institution - 0016; 🇵🇱 Lublin, Poland

Local Institution - 0023; 🇵🇱 Wroclaw, Poland

Local Institution - 0064; 🇺🇸 Oklahoma City, Oklahoma, United States

Local Institution - 0121; 🇺🇸 Charleston, South Carolina, United States

Local Institution - 0077; 🇺🇸 Birmingham, Alabama, United States

Local Institution - 0048; 🇺🇸 Tampa, Florida, United States

Local Institution - 0074; 🇺🇸 New Haven, Connecticut, United States

Local Institution - 0133; 🇺🇸 Orlando, Florida, United States

Local Institution - 0071; 🇺🇸 Chapel Hill, North Carolina, United States

Local Institution - 0041; 🇺🇸 Austin, Texas, United States