Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis (INTEGUMENT 3)
A Phase 3, 52-Week Study of Once-Daily Roflumilast Cream 0.3% in Participants With Moderate to Severe Atopic Dermatitis, Including a 4-Week Double-Blind, Vehicle-Controlled Phase Followed by a 48-Week Open-Label Extension
This Phase 3 study is designed to evaluate the efficacy and safety of once-daily roflumilast cream 0.3% in children, adolescents, and adults with moderate to severe atopic dermatitis. Approximately 415 participants will be randomized in a 2:1 ratio to receive roflumilast cream 0.3% or matching vehicle cream during a 4-week double-blind, vehicle-controlled treatment period.
Following completion of the double-blind treatment period, all participants will enter a 48-week open-label extension and receive roflumilast cream 0.3%. The study will assess the efficacy of roflumilast cream 0.3% in improving signs and symptoms of atopic dermatitis and evaluate its long-term safety and tolerability through Week 52.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This Phase 3, multicenter, randomized, double-blind, vehicle-controlled study is designed to evaluate the efficacy, safety, and tolerability of once-daily roflumilast cream 0.3% in children, adolescents, and adults with moderate to severe atopic dermatitis.
Approximately 415 participants aged 6 years and older with moderate to severe atopic dermatitis will be randomized in a 2:1 ratio to receive either roflumilast cream 0.3% or matching vehicle cream once daily for 4 weeks during the double-blind treatment period.
The primary objective of the study is to evaluate the efficacy of roflumilast cream 0.3% compared with vehicle cream at Week 4. Secondary objectives include evaluation of additional efficacy measures related to the signs and symptoms of atopic dermatitis.
Participants who complete the double-blind treatment period will be eligible to enter a 48-week open-label extension period, during which all participants will receive once-daily roflumilast cream 0.3%. The open-label extension is designed to evaluate the long-term safety, tolerability, and efficacy of roflumilast cream 0.3% through Week 52.
Safety assessments will include adverse events, local tolerability, clinical laboratory evaluations, vital signs, physical examinations, and other protocol-specified safety assessments.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Arcutis Medical Information
- Número de teléfono: 1-844-692-6729
- Correo electrónico: medinfo@arcutis.com
Ubicaciones de estudio
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Illinois
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Chicago, Illinois, Estados Unidos, 60523
- Arcutis Site 1
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Male or female participants aged 6 years and older.
- Clinical diagnosis of moderate to severe atopic dermatitis.
- vIGA-AD score of 3 (Moderate) or 4 (Severe) at baseline.
- EASI score ≥5 at baseline.
- Atopic dermatitis involvement of ≥3% and ≤30% body surface area.
- Able and willing to comply with study procedures.
- Participant or parent/legal guardian able to provide informed consent/assent.
Exclusion Criteria:
- Uncontrolled medical conditions that could interfere with study participation.
- Skin disorders that may confound study assessments.
- Active infection requiring systemic treatment.
- Known hypersensitivity to roflumilast or formulation components.
- Use of prohibited medications within protocol-defined washout periods.
- Pregnant or breastfeeding participants.
- Participation in another interventional clinical trial within the protocol-defined timeframe.
- Any condition that, in the investigator's opinion, would make participation unsafe or interfere with study results.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador de placebos: Vehicle Cream
Participants will apply matching vehicle cream once daily during the 4-week double-blind treatment period. |
Matching vehicle cream administered topically once daily to affected areas during the 4-week double-blind treatment period. Participants will receive roflumilast cream 0.3% during the open-label extension phase. |
|
Experimental: Roflumilast Cream 0.3%
Participants will apply roflumilast cream 0.3% once daily during the 4-week double-blind treatment period. |
Roflumilast cream 0.3% administered topically once daily to affected areas during the 4-week double-blind treatment period. Participants may continue treatment with roflumilast cream 0.3% during the 48-week open-label extension. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Achievement of vIGA-AD Success at Week 4
Periodo de tiempo: Week 4
|
vIGA-AD Success is defined as achieving a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of Clear (0) or Almost Clear (1) with at least a 2-grade improvement from Baseline. |
Week 4
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Achievement of at least a 75% reduction in the Eczema Area and Severity Index (EASI-75)
Periodo de tiempo: Week 4
|
EASI-75 is defined as achieving at least a 75% reduction from Baseline in Eczema Area and Severity Index (EASI) score. |
Week 4
|
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In participants ≥12 years old with Baseline Itch-NRS ≥ 4, achievement of at least a 4-point reduction on the Itch-NRS
Periodo de tiempo: Week 4
|
In participants aged ≥12 years and older with a Baseline Itch Numeric Rating Scale (Itch-NRS) score of 4 or greater who achieve at least a 4-point reduction from Baseline in the Itch-NRS score at Week 4. The Itch-NRS is an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), with higher scores indicating greater itch severity. |
Week 4
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Genéticas Congénitas
- Enfermedades del sistema inmunológico
- Manifestaciones de la piel
- Hipersensibilidad, Inmediata
- Hipersensibilidad
- Enfermedades de la piel
- Enfermedades De La Piel Genéticas
- Enfermedades De La Piel Eccematosas
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades de la piel y del tejido conectivo
- Signos y síntomas
- Dermatitis Atópica
- Dermatitis
- Eczema
- Prurito
Otros números de identificación del estudio
- ARQ-151-323
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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