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Lupus Erythematosus, DiscoidPhase 2NCT04857034

A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)

A Phase 2 study testing Deucravacitinib in people with Lupus Erythematosus, Discoid and Lupus Erythematosus, Subacute Cutaneous, run by Bristol-Myers Squibb at 41 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to assess the safety, efficacy, and tolerability of deucravacitinib (BMS-986165) compared with placebo in participants with active discoid and/or subacute cutaneous lupus erythematosus (DLE/SCLE). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Deucravacitinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
74 participants
Where
41 sitesin 8 countries
Study dates
12 Jul 2021to 28 Feb 2028
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Diagnosis of discoid/subacute cutaneous lupus erythematosus (DLE/SCLE) for at least 3 months prior to screening visit
  • Meets both clinical and histopathological diagnostic cutaneous lupus erythematosus (CLE) criteria per protocol
  • Currently receiving treatment for DLE/SCLE with a stable regimen of at least one of the following medications: oral corticosteroid, and/or antimalarial, and/or immunosuppressant
  • Participant could be with or without concurrent systemic lupus erythematosus (SLE)
  • If participant receives nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics treatment then the participant must be on a stable dose 2 weeks prior to screening

Who cannot join

  • Women who are pregnant, lactating, breastfeeding or planning pregnancy during the study period
  • Any of the following specific CLE subtypes in isolation: acute cutaneous lupus erythematosus (ACLE), lupus tumidus, lupus (profundus) panniculitis, chilblains
  • Drug-induced CLE and/or drug-induced systemic lupus erythematosus (SLE)
  • Antiphospholipid antibody syndrome, serious thrombotic event or unexplained pregnancy loss within 1 year before the screening visit
  • History of 3 or more unexplained consecutive pregnancy losses
  • Active severe or unstable neuropsychiatric SLE
  • Other autoimmune diseases or non-SLE driven inflammatory joint or skin disease or overlap syndromes as primary disease that in the opinion of the investigator will significantly impact the assessment of CLE/SLE disease manifestations and activity
  • Other protocol-defined inclusion/exclusion criteria apply

Trial locations and contacts

41 sites in 8 countries.

41 sites in 8 countries

United States12 sites

  • Local Institution - 0060

    Ann Arbor, Michigan, 48109

  • Local Institution - 0054

    Charleston, South Carolina, 29407

  • Local Institution - 0067

    Columbus, Ohio, 43215

  • Local Institution - 0065

    Durham, North Carolina, 27713

  • Local Institution - 0073

    Farmington, Connecticut, 06030

  • Local Institution - 0076

    Irvine, California, 92697

  • Local Institution - 0046

    Los Angeles, California, 90045

  • Local Institution - 0037

    New York, New York, 10029

  • Local Institution - 0026

    Oklahoma City, Oklahoma, 73104

  • Local Institution - 0082

    Orlando, Florida, 32827

  • Local Institution - 0077

    Scottsdale, Arizona, 85259

  • Local Institution - 0059

    St Louis, Missouri, 63108

Other trials in United States

Australia6 sites

  • Local Institution - 0003

    Botany, New South Wales, 2019

  • Local Institution - 0002

    Camberwell, Victoria, 3124

  • Local Institution - 0007

    Clayton, Victoria, 0

  • Local Institution - 0001

    Kogarah, New South Wales, 2217

  • Local Institution - 0078

    Melbourne, Victoria, 3004

  • Local Institution - 0087

    Victoria Park, Western Australia, 6100

Other trials in Australia

Mexico6 sites

  • Local Institution - 0029

    Aguascalientes, 20130

  • Local Institution

    Guadalajara, Jalisco, 45030

  • Local Institution - 0028

    Guadalajara, 0

  • Local Institution - 0071

    Mexico City, 14080

  • Local Institution - 0036

    Monterrey, Nuevo León, 64718

  • Local Institution - 0058

    Zapopan, Jalisco, 45070

Other trials in Mexico

Germany4 sites

  • Local Institution - 0035

    Berlin, 10117

  • Local Institution - 0072

    Dresden, Saxony, 01307

  • Local Institution - 0014

    Erlangen, 91054

  • Local Institution - 0006

    Hamburg, 22391

Other trials in Germany

Taiwan4 sites

  • Local Institution - 0031

    Kaohsiung City, 833

  • Local Institution - 0023

    Taichung, 402

  • Local Institution - 0021

    Taichung, 404

  • Local Institution - 0022

    Taipei, 10051

Other trials in Taiwan

Argentina3 sites

  • Local Institution - 0019

    Buenos Aires, 1431

  • Local Institution - 0018

    Capital Federal, Buenos Aires, 1023

  • Local Institution - 0013

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

France3 sites

  • Local Institution - 0038

    Bordeaux, 33075

  • Local Institution - 0027

    Créteil, 94000

  • Local Institution - 0010

    Paris, 75970

Other trials in France

Poland3 sites

  • Local Institution - 0008

    Lodz, Łódź Voivodeship, 94-046

  • Local Institution - 0005

    Rzeszów, 35-055

  • Local Institution - 0009

    Wroclaw, 50-566

Other trials in Poland

About this study

Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Deucravacitinib (BMS-986165) in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)

The purpose of this study is to assess the safety, efficacy, and tolerability of deucravacitinib (BMS-986165) compared with placebo in participants with active discoid and/or subacute cutaneous lupus erythematosus (DLE/SCLE). This study will also assess if deucravacitinib is biologically active and potentially effective in the treatment of participants with moderate to severe DLE/SCLE with or without systemic lupus erythematosus (SLE) that is not well controlled with standard of care therapy.

Being tested
Deucravacitinib, Placebo
Keywords
BMS-986165, Deucravacitinib, DLE, Discoid Lupus Erythematosus, SCLE, Subacute Cutaneous Lupus Erythematosus
Medical subject headings
Lupus Erythematosus, Discoid, Lupus Erythematosus, Cutaneous

What participants receive

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

  • DeucravacitinibDrug

    Specified dose on specified days

  • PlaceboDrug

    Specified dose on specified days

Study groups in NCT04857034
Study groupRoleWhat they receive
Active Treatment: Deucravacitinib Dose 1ExperimentalNot described
Receives: Drug: Deucravacitinib
Active Treatment: Deucravacitinib Dose 2ExperimentalNot described
Receives: Drug: Deucravacitinib
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Percentage Change From Baseline in CLASI Activity Score at Week 16

    The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE).

    It separately scores:

    • Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia)
    • Damage (e.g., dyspigmentation, scarring)

    CLASI enables classification of disease severity:

    Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70

    Measured: From first dose to Week 16 (approximately 16 weeks)

Secondary outcomes (12)

  1. Percentage of Participants With an Improvement of ≥ 50% From Baseline in the CLASI-A Score (CLASI-50).

    The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE).

    It separately scores:

    • Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia)
    • Damage (e.g., dyspigmentation, scarring)

    CLASI enables classification of disease severity:

    Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70

    Measured: From first dose to Week 16 (approximately 16 weeks)

  2. Percentage of Participants Who Have Disease Improvement as Defined by a Reduction in CLASI-A of ≥ 4 Points From Baseline.

    The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE).

    It separately scores:

    • Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia)
    • Damage (e.g., dyspigmentation, scarring)

    CLASI enables classification of disease severity:

    Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70

    Measured: From first dose to Week 16 (approximately 16 weeks)

  3. Mean Change From Baseline in CLASI-A Score.

    The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE).

    It separately scores:

    • Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia)
    • Damage (e.g., dyspigmentation, scarring)

    CLASI enables classification of disease severity:

    Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70

    Measured: From first dose to Week 16 (approximately 16 weeks)

  4. Percentage of Participants Who Have a Complete Response (CR) on CLASI-A Defined as a Score of "0".

    The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE).

    It separately scores:

    • Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia)
    • Damage (e.g., dyspigmentation, scarring)

    CLASI enables classification of disease severity:

    Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70

    Complete Response (CR) on CLASI-A defined as a score of "0".

    Measured: From first dose to Week 16 (approximately 16 weeks)

  5. Number of Participants With Safety Related Events in the Placebo Controlled Period

    Number of participants with safety related events in the placebo controlled period

    Measured: From signing informed consent to end of safety follow up period (Approximately 60 weeks)

  6. Number of Participants With Safety Related Events in the Active Treatment Period

    Number of participants with safety related events in the active treatment period

    Measured: From signing informed consent to end of safety follow up period (Approximately 60 weeks)

  7. Number of Participants With Clinically Significant Laboratory Abnormalities in the Placebo Controlled Period

    Number of participants with clinically significant laboratory abnormalities in the placebo controlled period

    Measured: From signing informed consent to end of safety follow up period (Approximately 60 weeks)

  8. Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period

    Number of participants with clinically significant laboratory abnormalities in the active treatment period

    Measured: From signing informed consent to end of safety follow up period (Approximately 60 weeks)

  9. Number of Participants With Clinically Significant Vital Sign Abnormalities in the Placebo Controlled Period

    Number of participants with clinically significant vital sign abnormalities in the placebo controlled period

    Measured: From signing informed consent to end of safety follow up period (Approximately 60 weeks)

  10. Number of Participants With Clinically Significant Vital Sign Abnormalities in the Active Treatment Period

    Number of participants with clinically significant vital sign abnormalities in the active treatment period

    Measured: From signing informed consent to end of safety follow up period (Approximately 60 weeks)

  11. Number of Participants With Clinically Significant ECG Abnormalities in the Placebo Controlled Period

    Number of participants with clinically significant ECG abnormalities in the placebo controlled period

    Measured: From signing informed consent to end of active treatment period (Approximately 56 weeks)

  12. Number of Participants With Clinically Significant ECG Abnormalities in the Active Treatment Period

    Number of participants with clinically significant ECG abnormalities in the active treatment period

    Measured: From signing informed consent to end of active treatment period (Approximately 56 weeks)

Timeline

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

  1. First posted23 Apr 2021
  2. Study start12 Jul 2021
  3. Primary completion22 Aug 2024
  4. Study completion28 Feb 2028 (estimated)

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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04857034
Sponsor's protocol ID
IM011-132
Other IDs
2020-000071-21, U1111-1246-1726
Status last verified
Aug 2025
First submitted
20 Apr 2021
Last updated
10 Sep 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Deucravacitinib in people with Lupus Erythematosus, Discoid and Lupus Erythematosus, Subacute Cutaneous, run by Bristol-Myers Squibb at 41 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, Australia, Mexico, Germany, Taiwan and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change From Baseline in CLASI Activity Score at Week 16 (time frame: From first dose to Week 16 (approximately 16 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04857034.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.

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