Lupus
main-banner
Lupus
IM011-132 Enrolling

Research Trial for Cutaneous Lupus Erythematosus (60 Weeks)


Treatment: Oral Age: 18 Years

Adults aged 18 to 75 with a diagnosis of active discoid and/or subacute cutaneous lupus erythematosus (DLE/SCLE) for at least 3 months, may qualify to participate. Individuals must have active moderate to severe cutaneous lupus to be eligible for study entry. They must also currently be receiving treatment with a stable regimen of at least one of the following medications: an oral corticosteroid, and/or an antimalarial, and/or an immunosuppressant.

Participants will receive one of two dosages of investigational oral medication (active study drug) or placebo for 16 weeks. At Week 16, participants who previously received placebo will then receive one of two dosages of active study drug. Study medication and study-related procedures will be provided at no cost. Reimbursement for study-related expenses will also be provided.

Study participation will last about 60 weeks and involve about 12 visits to the study centre.


The following information is from ClinicalTrials.gov

Last Update Posted: November 27, 2022

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)

ClinicalTrials.gov ID

NCT04857034

Sponsor

Bristol-Myers Squibb

Study Description

  • Brief 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). 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.

  • Condition or Disease:

    Lupus Erythematosus, Discoid

  • Intervention/Treatment:

    Drug: Deucravacitinib
    Drug: Deucravacitinib
    Drug: Placebo
  • Phase:

    Phase 2

  • Ages Eligible for Study:

    18 Years and 75 Years (Adult)

  • Sexes Eligible for Study:

    All

Inclusion Criteria:

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

Exclusion Criteria:

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


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.


Participating Locations

COUNTRY
country-icon
Australia

Participating Experts

Dr. Stephen Shumack

Dermatologist

You May Also Be Interested In

Similar Trials

No Similar Trials Found
about-icon

Learn More About

Lupus

Learn More
2022 all rights reserved probity medical research inc
find a trial
filter trials