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New lupus pill shows promise in Long-Term safety trial

NCT ID NCT03920267

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 2 trial tested the long-term safety of deucravacitinib (BMS-986165), a daily pill, in 261 people with systemic lupus erythematosus (SLE). Participants had already completed an earlier study and continued taking the drug to monitor side effects and lab abnormalities. The goal was to see if the drug is safe enough for long-term use in controlling lupus.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Deucravacitinib (BMS-986165)
What this could lead to
If successful, this could point toward a new daily pill to help control lupus symptoms over the long term.
What could go wrong
This is a Phase 2 safety study, not a large final-stage trial. It may not prove the drug works better than existing treatments, and side effects like infections or lab abnormalities are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

261 people

The number who actually took part.

Started

Mar 2019

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic lupus erythematosus

Contacts and locations

Locations

  • Clinica Adventista Belgrano

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

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648, Japan

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

    Zapopan, Jalisco, 45070, Mexico

  • Local Institution

    Seoul, 110-744, South Korea

  • Local Institution

    Taipei, 10630, Taiwan

  • Local Institution - 0001

    Jackson, Tennessee, 38305, United States

  • Local Institution - 0002

    Râmnicu Vâlcea, 240277, Romania

  • Local Institution - 0004

    Galati, 800578, Romania

  • Local Institution - 0010

    Wroclaw, 50-363, Poland

  • Local Institution - 0014

    Krakow, 30-363, Poland

  • Local Institution - 0015

    Kościan, 64-000, Poland

  • Local Institution - 0016

    Lublin, 20-607, Poland

  • Local Institution - 0018

    Krakow, 31-637, Poland

  • Local Institution - 0019

    Warsaw, 02-172, Poland

  • Local Institution - 0022

    Warsaw, 02-665, Poland

  • Local Institution - 0023

    Wroclaw, 52-416, Poland

  • Local Institution - 0024

    Poznan, 60-218, Poland

  • Local Institution - 0025

    Bydgoszcz, 85-168, Poland

  • Local Institution - 0027

    Krakow, 31-011, Poland

  • Local Institution - 0029

    Sosnowiec, 41-200, Poland

  • Local Institution - 0030

    El Cajon, California, 92020, United States

  • Local Institution - 0031

    Charlotte, North Carolina, 28204, United States

  • Local Institution - 0032

    Ormond Beach, Florida, 32174-1139, United States

  • Local Institution - 0033

    Brasov, 500283, Romania

  • Local Institution - 0035

    Wyomissing, Pennsylvania, 19610, United States

  • Local Institution - 0037

    Houston, Texas, 77084, United States

  • Local Institution - 0038

    Gyula, 5700, Hungary

  • Local Institution - 0039

    Debrecen, 4032, Hungary

  • Local Institution - 0041

    Austin, Texas, 78731-3146, United States

  • Local Institution - 0044

    Brandon, Florida, 33511, United States

  • Local Institution - 0045

    Szeged, 6725, Hungary

  • Local Institution - 0046

    Mesquite, Texas, 75150, United States

  • Local Institution - 0048

    Tampa, Florida, 33613, United States

  • Local Institution - 0049

    Torrance, California, 90502, United States

  • Local Institution - 0050

    Lawrenceville, Georgia, 30046, United States

  • Local Institution - 0051

    Taipei, 10002, Taiwan

  • Local Institution - 0052

    Taichung, 40201, Taiwan

  • Local Institution - 0053

    Suwon, 16499, South Korea

  • Local Institution - 0055

    Vladimir, 600005, Russia

  • Local Institution - 0056

    Kemerovo, 650066, Russia

  • Local Institution - 0057

    Orenburg, 460018, Russia

  • Local Institution - 0058

    Saint Petersburg, 197341, Russia

  • Local Institution - 0060

    Yaroslavl, 150030, Russia

  • Local Institution - 0061

    Yekaterinburg, 620043, Russia

  • Local Institution - 0062

    Saint Petersburg, 191045, Russia

  • Local Institution - 0063

    Sendai, Miyagi, 9808574, Japan

  • Local Institution - 0064

    Oklahoma City, Oklahoma, 73104, United States

  • Local Institution - 0065

    Chuo-ku, Tokyo, 104-8560, Japan

  • Local Institution - 0066

    Tokyo, 162-8655, Japan

  • Local Institution - 0068

    Yaroslavl, 150023, Russia

  • Local Institution - 0069

    Shimotsuke, Tochigi, 329-0498, Japan

  • Local Institution - 0070

    Smolensk, 214025, Russia

  • Local Institution - 0071

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

  • Local Institution - 0072

    Novosibirsk, 630099, Russia

  • Local Institution - 0074

    New Haven, Connecticut, 06520, United States

  • Local Institution - 0077

    Birmingham, Alabama, 35233-1913, United States

  • Local Institution - 0078

    Tokyo, 113-8431, Japan

  • Local Institution - 0080

    León, Guanajuato, 37000, Mexico

  • Local Institution - 0082

    San Luis Potosí City, 78213, Mexico

  • Local Institution - 0084

    Monterrey, Nuevo León, 64000, Mexico

  • Local Institution - 0086

    León, Guanajuato, 37160, Mexico

  • Local Institution - 0087

    Mexico City, Mexico City, 06760, Mexico

  • Local Institution - 0091

    San Miguel de Tucum, Tucumán Province, T4000AXL, Argentina

  • Local Institution - 0092

    Kitakyushu, Fukuoka, 807-8556, Japan

  • Local Institution - 0093

    Tokyo, 173-8610, Japan

  • Local Institution - 0094

    Atlanta, Georgia, 30303, United States

  • Local Institution - 0095

    Mendoza, 5500, Argentina

  • Local Institution - 0096

    Zipaquirá, 250252, Colombia

  • Local Institution - 0098

    Rosario, Santa Fe Province, 2000, Argentina

  • Local Institution - 0100

    CABA, 1111, Argentina

  • Local Institution - 0101

    Bogotá, 110221, Colombia

  • Local Institution - 0103

    Chía, 250001, Colombia

  • Local Institution - 0105

    São Paulo, 01228-200, Brazil

  • Local Institution - 0106

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

  • Local Institution - 0107

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

  • Local Institution - 0108

    Barranquilla, 0, Colombia

  • Local Institution - 0111

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

  • Local Institution - 0114

    Dallas, Texas, 75390, United States

  • Local Institution - 0115

    Aventura, Florida, 33180, United States

  • Local Institution - 0116

    Salvador, Estado de Bahia, 40150-150, Brazil

  • Local Institution - 0118

    Goiߡ, Goiás, 74110-120, Brazil

  • Local Institution - 0119

    Sapporo, Hokkaido, 060-8604, Japan

  • Local Institution - 0120

    Curitiba, Paraná, 80030-110, Brazil

  • Local Institution - 0121

    Charleston, South Carolina, 29425, United States

  • Local Institution - 0122

    Córdoba, X5004FHP, Argentina

  • Local Institution - 0123

    Brooklyn, New York, 11201, United States

  • Local Institution - 0124

    Seville, 41014, Spain

  • Local Institution - 0125

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

  • Local Institution - 0126

    Málaga, 29010, Spain

  • Local Institution - 0131

    New York, New York, 10016, United States

  • Local Institution - 0133

    Orlando, Florida, 32835, United States

  • Local Institution - 0136

    Toronto, Ontario, M5T 2S8, Canada

  • Local Institution - 0137

    Taipei, 110, Taiwan

  • Local Institution - 0138

    Sabadell, 08208, Spain

  • Local Institution - 0140

    Gainesville, Florida, 32603, United States

  • National Hospital Organization Chibahigashi National Hospital

    Chiba, Chiba, 260-8712, Japan

  • Tekton Research - Austin

    Austin, Texas, 78745, United States

  • University of Calgary

    Calgary, Alberta, T2N 4Z6, Canada

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