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

NCT03920267 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: IM011-0742018-003471-35
• Study Type: interventional
• Target: 261
• Locations: 14 countries
• Sites: 98

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).

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Treatment-Emergent Adverse Events and Treatment Emergent Serious Adverse Events

  A Treatment-Emergent Adverse Event (TEAE) is any untoward medical occurrence that begins or worsens after the first dose of study treatment, including any unfavorable sign, symptom, disease, or abnormal lab finding, whether or not related to the product, and may include worsening of pre-existing conditions. A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect, or is considered an important medical event requiring intervention to prevent these outcomes.

  From Day 1 until 30 days after last dose (up to approximately 42 months)

• Number of Participants With Abnormalities in Vital Signs

  Vital signs heart rate (HR) (beats/min), systolic blood pressure (SBP) (mmHG), and diastolic blood pressure (DBP) (mmHg).

  From Day 1 until 30 days after last dose (up to approximately 42 months)

• Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities

  Blood samples were collected to assess laboratory parameters. Grade 3 = Severe laboratory abnormality Grade 4 = Life-threatening or very severe laboratory abnormality

  From Day 1 until 30 days after last dose (up to approximately 42 months)

Study Arms (3)

BMS-986165 Dose 1

EXPERIMENTAL

Drug: BMS-986165

BMS-986165 Dose 2

EXPERIMENTAL

Drug: BMS-986165

BMS-986165 Dose 3

EXPERIMENTAL

Drug: BMS-986165

Interventions

BMS-986165 DRUG

Specified dose on specified days

Also known as: Deucravacitinib

BMS-986165 Dose 1; BMS-986165 Dose 2; BMS-986165 Dose 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (98)

Local Institution - 0077

Birmingham, Alabama, 35233-1913, United States

Location

Local Institution - 0030

El Cajon, California, 92020, United States

Location

Local Institution - 0049

Torrance, California, 90502, United States

Location

Local Institution - 0074

New Haven, Connecticut, 06520, United States

Location

Local Institution - 0115

Aventura, Florida, 33180, United States

Location

Local Institution - 0044

Brandon, Florida, 33511, United States

Location

Local Institution - 0140

Gainesville, Florida, 32603, United States

Location

Local Institution - 0133

Orlando, Florida, 32835, United States

Location

Local Institution - 0032

Ormond Beach, Florida, 32174-1139, United States

Location

Local Institution - 0048

Tampa, Florida, 33613, United States

Location

Local Institution - 0094

Atlanta, Georgia, 30303, United States

Location

Local Institution - 0050

Lawrenceville, Georgia, 30046, United States

Location

Local Institution - 0123

Brooklyn, New York, 11201, United States

Location

Local Institution - 0131

New York, New York, 10016, United States

Location

Local Institution - 0071

Chapel Hill, North Carolina, 27599-7280, United States

Location

Local Institution - 0031

Charlotte, North Carolina, 28204, United States

Location

Local Institution - 0064

Oklahoma City, Oklahoma, 73104, United States

Location

Local Institution - 0035

Wyomissing, Pennsylvania, 19610, United States

Location

Local Institution - 0121

Charleston, South Carolina, 29425, United States

Location

Local Institution - 0001

Jackson, Tennessee, 38305, United States

Location

Local Institution - 0041

Austin, Texas, 78731-3146, United States

Location

Tekton Research - Austin

Austin, Texas, 78745, United States

Location

Local Institution - 0114

Dallas, Texas, 75390, United States

Location

Local Institution - 0037

Houston, Texas, 77084, United States

Location

Local Institution - 0046

Mesquite, Texas, 75150, United States

Location

Clinica Adventista Belgrano

Ciudad Autonoma de Buenos Aires, Buenos Aires, 1430, Argentina

Location

Local Institution - 0125

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1046, Argentina

Location

Local Institution - 0098

Rosario, Santa Fe Province, 2000, Argentina

Location

Local Institution - 0091

San Miguel de Tucum, Tucumán Province, T4000AXL, Argentina

Location

Local Institution - 0100

CABA, 1111, Argentina

Location

Local Institution - 0122

Córdoba, X5004FHP, Argentina

Location

Local Institution - 0095

Mendoza, 5500, Argentina

Location

Local Institution - 0116

Salvador, Estado de Bahia, 40150-150, Brazil

Location

Local Institution - 0118

Goiߡ, Goiás, 74110-120, Brazil

Location

Local Institution - 0106

Juiz de Fora, Minas Gerais, 36010-570, Brazil

Location

Local Institution - 0120

Curitiba, Paraná, 80030-110, Brazil

Location

Local Institution - 0107

Porto Alegre, Rio Grande do Sul, 90480-000, Brazil

Location

Local Institution - 0111

São Bernardo do Campo, São Paulo, 09715-090, Brazil

Location

Local Institution - 0105

São Paulo, 01228-200, Brazil

Location

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

Local Institution - 0136

Toronto, Ontario, M5T 2S8, Canada

Location

Local Institution - 0108

Barranquilla, 0, Colombia

Location

Local Institution - 0101

Bogotá, 110221, Colombia

Location

Local Institution - 0103

Chía, 250001, Colombia

Location

Local Institution - 0096

Zipaquirá, 250252, Colombia

Location

Local Institution - 0039

Debrecen, 4032, Hungary

Location

Local Institution - 0038

Gyula, 5700, Hungary

Location

Local Institution - 0045

Szeged, 6725, Hungary

Location

National Hospital Organization Chibahigashi National Hospital

Chiba, Chiba, 260-8712, Japan

Location

Local Institution - 0092

Kitakyushu, Fukuoka, 807-8556, Japan

Location

Local Institution - 0119

Sapporo, Hokkaido, 060-8604, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

Location

Local Institution - 0063

Sendai, Miyagi, 9808574, Japan

Location

Local Institution - 0069

Shimotsuke, Tochigi, 329-0498, Japan

Location

Local Institution - 0065

Chuo-ku, Tokyo, 104-8560, Japan

Location

Local Institution - 0078

Tokyo, 113-8431, Japan

Location

Local Institution - 0066

Tokyo, 162-8655, Japan

Location

Local Institution - 0093

Tokyo, 173-8610, Japan

Location

Local Institution - 0080

León, Guanajuato, 37000, Mexico

Location

Local Institution - 0086

León, Guanajuato, 37160, Mexico

Location

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

Zapopan, Jalisco, 45070, Mexico

Location

Local Institution - 0087

Mexico City, Mexico City, 06760, Mexico

Location

Local Institution - 0084

Monterrey, Nuevo León, 64000, Mexico

Location

Local Institution - 0082

San Luis Potosí City, 78213, Mexico

Location

Local Institution - 0025

Bydgoszcz, 85-168, Poland

Location

Local Institution - 0015

Kościan, 64-000, Poland

Location

Local Institution - 0014

Krakow, 30-363, Poland

Location

Local Institution - 0027

Krakow, 31-011, Poland

Location

Local Institution - 0018

Krakow, 31-637, Poland

Location

Local Institution - 0016

Lublin, 20-607, Poland

Location

Local Institution - 0024

Poznan, 60-218, Poland

Location

Local Institution - 0029

Sosnowiec, 41-200, Poland

Location

Local Institution - 0019

Warsaw, 02-172, Poland

Location

Local Institution - 0022

Warsaw, 02-665, Poland

Location

Local Institution - 0010

Wroclaw, 50-363, Poland

Location

Local Institution - 0023

Wroclaw, 52-416, Poland

Location

Local Institution - 0033

Brasov, 500283, Romania

Location

Local Institution - 0004

Galati, 800578, Romania

Location

Local Institution - 0002

Râmnicu Vâlcea, 240277, Romania

Location

Local Institution - 0056

Kemerovo, 650066, Russia

Location

Local Institution - 0072

Novosibirsk, 630099, Russia

Location

Local Institution - 0057

Orenburg, 460018, Russia

Location

Local Institution - 0062

Saint Petersburg, 191045, Russia

Location

Local Institution - 0058

Saint Petersburg, 197341, Russia

Location

Local Institution - 0070

Smolensk, 214025, Russia

Location

Local Institution - 0055

Vladimir, 600005, Russia

Location

Local Institution - 0068

Yaroslavl, 150023, Russia

Location

Local Institution - 0060

Yaroslavl, 150030, Russia

Location

Local Institution - 0061

Yekaterinburg, 620043, Russia

Location

Local Institution

Seoul, 110-744, South Korea

Location

Local Institution - 0053

Suwon, 16499, South Korea

Location

Local Institution - 0126

Málaga, 29010, Spain

Location

Local Institution - 0138

Sabadell, 08208, Spain

Location

Local Institution - 0124

Seville, 41014, Spain

Location

Local Institution - 0052

Taichung, 40201, Taiwan

Location

Local Institution - 0051

Taipei, 10002, Taiwan

Location

Local Institution

Taipei, 10630, Taiwan

Location

Local Institution - 0137

Taipei, 110, Taiwan

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: April 18, 2019
• Study Start: March 26, 2019
• Primary Completion: March 21, 2025
• Study Completion: March 21, 2025
• Last Updated: March 20, 2026
• Results First Posted: March 20, 2026

Record last verified: 2026-02

Locations

RO (3); BR (7); KR (2); RU (10); CA (2); AR (7); PL (12); US (25); ME (6); JP (10); CO (4); ES (3); TW (4); HU (3)