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.
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
- Conditions the study is for
- Lupus Erythematosus, Discoid, Lupus Erythematosus, Subacute Cutaneous
- 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
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
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
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
Germany4 sites
Local Institution - 0035
Berlin, 10117
Local Institution - 0072
Dresden, Saxony, 01307
Local Institution - 0014
Erlangen, 91054
Local Institution - 0006
Hamburg, 22391
Taiwan4 sites
Local Institution - 0031
Kaohsiung City, 833
Local Institution - 0023
Taichung, 402
Local Institution - 0021
Taichung, 404
Local Institution - 0022
Taipei, 10051
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
France3 sites
Local Institution - 0038
Bordeaux, 33075
Local Institution - 0027
Créteil, 94000
Local Institution - 0010
Paris, 75970
Poland3 sites
Local Institution - 0008
Lodz, Łódź Voivodeship, 94-046
Local Institution - 0005
Rzeszów, 35-055
Local Institution - 0009
Wroclaw, 50-566
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 group | Role | What they receive |
|---|---|---|
| Active Treatment: Deucravacitinib Dose 1 | Experimental | Not described Receives: Drug: Deucravacitinib |
| Active Treatment: Deucravacitinib Dose 2 | Experimental | Not described Receives: Drug: Deucravacitinib |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.
- First posted23 Apr 2021
- Study start12 Jul 2021
- Primary completion22 Aug 2024
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lupus Erythematosus, DiscoidStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No