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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Aaron Mangold, M.D.

Cerrado para la inscripción

Contact information:

Nicholas Heidenfelder

(480) 301-4913

Heidenfelder.Nicholas@mayo.edu

More information

Publicaciones

Publications are currently not available
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CLS-20549896

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