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Systemic Lupus ErythematosusPhase 2NCT03920267

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

A Phase 2 study testing BMS-986165 in people with Systemic Lupus Erythematosus, run by Bristol-Myers Squibb at 98 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
BMS-986165
Could I receive a placebo?
No, everyone receives an active treatment
How many people
261 participants
Where
98 sitesin 14 countries
Study dates
26 Mar 2019to 21 Mar 2025
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

98 sites in 14 countries.

98 sites in 14 countries

United States25 sites

  • Local Institution - 0094

    Atlanta, Georgia, 30303

  • Local Institution - 0041

    Austin, Texas, 78731-3146

  • Tekton Research - Austin

    Austin, Texas, 78745

  • Local Institution - 0115

    Aventura, Florida, 33180

  • Local Institution - 0077

    Birmingham, Alabama, 35233-1913

  • Local Institution - 0044

    Brandon, Florida, 33511

  • Local Institution - 0123

    Brooklyn, New York, 11201

  • Local Institution - 0071

    Chapel Hill, North Carolina, 27599-7280

  • Local Institution - 0121

    Charleston, South Carolina, 29425

  • Local Institution - 0031

    Charlotte, North Carolina, 28204

  • Local Institution - 0114

    Dallas, Texas, 75390

  • Local Institution - 0030

    El Cajon, California, 92020

  • Local Institution - 0140

    Gainesville, Florida, 32603

  • Local Institution - 0037

    Houston, Texas, 77084

  • Local Institution - 0001

    Jackson, Tennessee, 38305

  • Local Institution - 0050

    Lawrenceville, Georgia, 30046

  • Local Institution - 0046

    Mesquite, Texas, 75150

  • Local Institution - 0074

    New Haven, Connecticut, 06520

  • Local Institution - 0131

    New York, New York, 10016

  • Local Institution - 0064

    Oklahoma City, Oklahoma, 73104

  • Local Institution - 0133

    Orlando, Florida, 32835

  • Local Institution - 0032

    Ormond Beach, Florida, 32174-1139

  • Local Institution - 0048

    Tampa, Florida, 33613

  • Local Institution - 0049

    Torrance, California, 90502

  • Local Institution - 0035

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Poland12 sites

  • Local Institution - 0025

    Bydgoszcz, 85-168

  • Local Institution - 0015

    Kościan, 64-000

  • Local Institution - 0014

    Krakow, 30-363

  • Local Institution - 0027

    Krakow, 31-011

  • Local Institution - 0018

    Krakow, 31-637

  • Local Institution - 0016

    Lublin, 20-607

  • Local Institution - 0024

    Poznan, 60-218

  • Local Institution - 0029

    Sosnowiec, 41-200

  • Local Institution - 0019

    Warsaw, 02-172

  • Local Institution - 0022

    Warsaw, 02-665

  • Local Institution - 0010

    Wroclaw, 50-363

  • Local Institution - 0023

    Wroclaw, 52-416

Other trials in Poland

Japan10 sites

  • National Hospital Organization Chibahigashi National Hospital

    Chiba, Chiba, 260-8712

  • Local Institution - 0065

    Chuo-ku, Tokyo, 104-8560

  • Local Institution - 0092

    Kitakyushu, Fukuoka, 807-8556

  • Local Institution - 0119

    Sapporo, Hokkaido, 060-8604

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Local Institution - 0063

    Sendai, Miyagi, 9808574

  • Local Institution - 0069

    Shimotsuke, Tochigi, 329-0498

  • Local Institution - 0078

    Tokyo, 113-8431

  • Local Institution - 0066

    Tokyo, 162-8655

  • Local Institution - 0093

    Tokyo, 173-8610

Other trials in Japan

Russia10 sites

  • Local Institution - 0056

    Kemerovo, 650066

  • Local Institution - 0072

    Novosibirsk, 630099

  • Local Institution - 0057

    Orenburg, 460018

  • Local Institution - 0062

    Saint Petersburg, 191045

  • Local Institution - 0058

    Saint Petersburg, 197341

  • Local Institution - 0070

    Smolensk, 214025

  • Local Institution - 0055

    Vladimir, 600005

  • Local Institution - 0068

    Yaroslavl, 150023

  • Local Institution - 0060

    Yaroslavl, 150030

  • Local Institution - 0061

    Yekaterinburg, 620043

Other trials in Russia

Argentina7 sites

  • Local Institution - 0100

    CABA, 1111

  • Clinica Adventista Belgrano

    Ciudad Autonoma de Buenos Aires, Buenos Aires, 1430

  • Local Institution - 0125

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1046

  • Local Institution - 0122

    Córdoba, X5004FHP

  • Local Institution - 0095

    Mendoza, 5500

  • Local Institution - 0098

    Rosario, Santa Fe Province, 2000

  • Local Institution - 0091

    San Miguel de Tucum, Tucumán Province, T4000AXL

Other trials in Argentina

Brazil7 sites

  • Local Institution - 0120

    Curitiba, Paraná, 80030-110

  • Local Institution - 0118

    Goiߡ, Goiás, 74110-120

  • Local Institution - 0106

    Juiz de Fora, Minas Gerais, 36010-570

  • Local Institution - 0107

    Porto Alegre, Rio Grande do Sul, 90480-000

  • Local Institution - 0116

    Salvador, Estado de Bahia, 40150-150

  • Local Institution - 0111

    São Bernardo do Campo, São Paulo, 09715-090

  • Local Institution - 0105

    São Paulo, 01228-200

Other trials in Brazil

Mexico6 sites

  • Local Institution - 0080

    León, Guanajuato, 37000

  • Local Institution - 0086

    León, Guanajuato, 37160

  • Local Institution - 0087

    Mexico City, Mexico City, 06760

  • Local Institution - 0084

    Monterrey, Nuevo León, 64000

  • Local Institution - 0082

    San Luis Potosí City, 78213

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

    Zapopan, Jalisco, 45070

Other trials in Mexico

Colombia4 sites

  • Local Institution - 0108

    Barranquilla, 0

  • Local Institution - 0101

    Bogotá, 110221

  • Local Institution - 0103

    Chía, 250001

  • Local Institution - 0096

    Zipaquirá, 250252

Other trials in Colombia

Taiwan4 sites

  • Local Institution - 0052

    Taichung, 40201

  • Local Institution - 0051

    Taipei, 10002

  • Local Institution

    Taipei, 10630

  • Local Institution - 0137

    Taipei, 110

Other trials in Taiwan

Hungary3 sites

  • Local Institution - 0039

    Debrecen, 4032

  • Local Institution - 0038

    Gyula, 5700

  • Local Institution - 0045

    Szeged, 6725

Other trials in Hungary

Romania3 sites

  • Local Institution - 0033

    Brasov, 500283

  • Local Institution - 0004

    Galati, 800578

  • Local Institution - 0002

    Râmnicu Vâlcea, 240277

Other trials in Romania

Spain3 sites

  • Local Institution - 0126

    Málaga, 29010

  • Local Institution - 0138

    Sabadell, 08208

  • Local Institution - 0124

    Seville, 41014

Other trials in Spain

Canada2 sites

  • University of Calgary

    Calgary, Alberta, T2N 4Z6

  • Local Institution - 0136

    Toronto, Ontario, M5T 2S8

Other trials in Canada

South Korea2 sites

  • Local Institution

    Seoul, 110-744

  • Local Institution - 0053

    Suwon, 16499

Other trials in South Korea

About this study

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

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).

Being tested
BMS-986165
Keywords
Systemic Lupus Erythematosus
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-986165Drug

    Also called Deucravacitinib

    Specified dose on specified days

Study groups in NCT03920267
Study groupRoleWhat they receive
BMS-986165 Dose 1ExperimentalNot described
Receives: Drug: BMS-986165
BMS-986165 Dose 2ExperimentalNot described
Receives: Drug: BMS-986165
BMS-986165 Dose 3ExperimentalNot described
Receives: Drug: BMS-986165

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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).

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

  3. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2019
  2. Study start26 Mar 2019
  3. Primary completion21 Mar 2025
  4. Study completion21 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
261 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03920267
Sponsor's protocol ID
IM011-074
Other IDs
2018-003471-35, 2018
Status last verified
Feb 2026
First submitted
27 Mar 2019
Last updated
20 Mar 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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