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

NCT ID: NCT03920267

Last Updated: 2025-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

261 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-26

Study Completion Date

2025-03-21

Brief Summary

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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

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Conditions

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Systemic Lupus Erythematosus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BMS-986165 Dose 1

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Specified dose on specified days

BMS-986165 Dose 2

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Specified dose on specified days

BMS-986165 Dose 3

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986165

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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Deucravacitinib

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0077

Birmingham, Alabama, United States

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Local Institution - 0030

El Cajon, California, United States

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Local Institution - 0049

Torrance, California, United States

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Local Institution - 0074

New Haven, Connecticut, United States

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Local Institution - 0115

Aventura, Florida, United States

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Local Institution - 0044

Brandon, Florida, United States

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Local Institution - 0140

Gainesville, Florida, United States

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Local Institution - 0133

Orlando, Florida, United States

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Local Institution - 0032

Ormond Beach, Florida, United States

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Local Institution - 0048

Tampa, Florida, United States

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Local Institution - 0094

Atlanta, Georgia, United States

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Local Institution - 0050

Lawrenceville, Georgia, United States

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Local Institution - 0123

Brooklyn, New York, United States

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Local Institution - 0131

New York, New York, United States

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Local Institution - 0071

Chapel Hill, North Carolina, United States

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Local Institution - 0031

Charlotte, North Carolina, United States

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Local Institution - 0064

Oklahoma City, Oklahoma, United States

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Local Institution - 0035

Wyomissing, Pennsylvania, United States

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Local Institution - 0121

Charleston, South Carolina, United States

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Local Institution - 0001

Jackson, Tennessee, United States

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Local Institution - 0041

Austin, Texas, United States

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Tekton Research - Austin

Austin, Texas, United States

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Local Institution - 0114

Dallas, Texas, United States

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Local Institution - 0037

Houston, Texas, United States

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Local Institution - 0046

Mesquite, Texas, United States

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Clinica Adventista Belgrano

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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Local Institution - 0125

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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Local Institution - 0098

Rosario, Santa Fe Province, Argentina

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Local Institution - 0091

San Miguel de Tucum, Tucumán Province, Argentina

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Local Institution - 0100

CABA, , Argentina

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Local Institution - 0122

Córdoba, , Argentina

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Local Institution - 0095

Mendoza, , Argentina

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Local Institution - 0116

Salvador, Estado de Bahia, Brazil

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Local Institution - 0118

Goiߡ, Goiás, Brazil

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Local Institution - 0106

Juiz de Fora, Minas Gerais, Brazil

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Local Institution - 0120

Curitiba, Paraná, Brazil

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Local Institution - 0107

Porto Alegre, Rio Grande do Sul, Brazil

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Local Institution - 0111

São Bernardo do Campo, São Paulo, Brazil

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Local Institution - 0105

São Paulo, , Brazil

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University of Calgary

Calgary, Alberta, Canada

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Local Institution - 0136

Toronto, Ontario, Canada

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Local Institution - 0108

Barranquilla, , Colombia

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Local Institution - 0101

Bogotá, , Colombia

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Local Institution - 0103

Chía, , Colombia

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Local Institution - 0096

Zipaquirá, , Colombia

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Local Institution - 0039

Debrecen, , Hungary

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Local Institution - 0038

Gyula, , Hungary

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Local Institution - 0045

Szeged, , Hungary

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National Hospital Organization Chibahigashi National Hospital

Chiba, Chiba, Japan

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Local Institution - 0092

Kitakyushu, Fukuoka, Japan

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Local Institution - 0119

Sapporo, Hokkaido, Japan

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Hokkaido University Hospital

Sapporo, Hokkaido, Japan

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Local Institution - 0063

Sendai, Miyagi, Japan

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Local Institution - 0069

Shimotsuke, Tochigi, Japan

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Local Institution - 0065

Chuo-ku, Tokyo, Japan

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Local Institution - 0078

Tokyo, , Japan

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Local Institution - 0066

Tokyo, , Japan

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Local Institution - 0093

Tokyo, , Japan

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Local Institution - 0080

León, Guanajuato, Mexico

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Local Institution - 0086

León, Guanajuato, Mexico

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Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.

Zapopan, Jalisco, Mexico

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Local Institution - 0087

Mexico City, Mexico City, Mexico

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Local Institution - 0084

Monterrey, Nuevo León, Mexico

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Local Institution - 0082

San Luis Potosí City, , Mexico

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Local Institution - 0025

Bydgoszcz, , Poland

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Local Institution - 0015

Kościan, , Poland

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Local Institution - 0014

Krakow, , Poland

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Local Institution - 0027

Krakow, , Poland

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Local Institution - 0018

Krakow, , Poland

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Local Institution - 0016

Lublin, , Poland

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Local Institution - 0024

Poznan, , Poland

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Local Institution - 0029

Sosnowiec, , Poland

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Local Institution - 0019

Warsaw, , Poland

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Local Institution - 0022

Warsaw, , Poland

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Local Institution - 0010

Wroclaw, , Poland

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Local Institution - 0023

Wroclaw, , Poland

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Local Institution - 0033

Brasov, , Romania

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Local Institution - 0004

Galati, , Romania

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Local Institution - 0002

Râmnicu Vâlcea, , Romania

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Local Institution - 0056

Kemerovo, , Russia

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Local Institution - 0072

Novosibirsk, , Russia

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Local Institution - 0057

Orenburg, , Russia

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Local Institution - 0062

Saint Petersburg, , Russia

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Local Institution - 0058

Saint Petersburg, , Russia

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Local Institution - 0070

Smolensk, , Russia

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Local Institution - 0055

Vladimir, , Russia

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Local Institution - 0068

Yaroslavl, , Russia

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Local Institution - 0060

Yaroslavl, , Russia

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Local Institution - 0061

Yekaterinburg, , Russia

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Local Institution

Seoul, , South Korea

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Local Institution - 0053

Suwon, , South Korea

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Local Institution - 0126

Málaga, , Spain

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Local Institution - 0138

Sabadell, , Spain

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Local Institution - 0124

Seville, , Spain

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Local Institution - 0052

Taichung, , Taiwan

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Local Institution - 0051

Taipei, , Taiwan

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Taipei, , Taiwan

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Local Institution - 0137

Taipei, , Taiwan

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Countries

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United States Argentina Brazil Canada Colombia Hungary Japan Mexico Poland Romania Russia South Korea Spain Taiwan

Related Links

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Other Identifiers

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2018-003471-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IM011-074

Identifier Type: -

Identifier Source: org_study_id

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