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

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/21/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Aaron Mangold, M.D.

Closed for enrollment

Contact information:

Nicholas Heidenfelder

(480) 301-4913

Heidenfelder.Nicholas@mayo.edu

More information

Publications

Publications are currently not available