Un estudio para observar cómo los pacientes adolescentes con dermatitis atópica grave a pesar de lesiones cutáneas menos extensas (área de eccema y puntuación del índice de gravedad <16) responden al tratamiento con dupilumab (AD-BEASCUITS)
Un estudio observacional prospectivo de pacientes adolescentes con dermatitis atópica grave a pesar de lesiones cutáneas menos extensas (área de eccema y puntuación del índice de gravedad <16) que reciben dupilumab
En adolescentes tratados con dupilumab, los ensayos clínicos mostraron una mejoría significativa de los signos y síntomas de la dermatitis atópica (EA), con un buen perfil de seguridad. En estos ensayos clínicos, solo se inscribieron pacientes con una puntuación del Índice de gravedad y área de eccema (EASI) mayor o igual a (≥) 16, y no se evaluó específicamente la eficacia en áreas sensibles/visibles. Por lo tanto, se necesitan más datos sobre la eficacia de dupilumab en participantes adolescentes con puntuación EASI de moderada a leve y picazón intensa y/o EA localizada para comprender mejor los posibles beneficios clínicos de dupilumab en estas poblaciones.
Este es un estudio observacional (no intervencionista) multicéntrico italiano de 52 semanas que recopilará datos sobre las características de los participantes adolescentes (de 12 a 17 años) que padecen EA grave con una puntuación EASI inferior a (<) 16, elegibles para Tratamiento sistémico con dupilumab según criterios de reembolso italianos. Estudiará la eficacia y seguridad de dupilumab en el mundo real en esta población, el efecto de dupilumab sobre la picazón (prurito), el sueño, la calidad de vida y los resultados relacionados, la EA localizada en áreas sensibles/visibles y sobre las condiciones atópicas coexistentes en adolescentes. participantes que reciben dupilumab para la EA. También documentará la satisfacción con el tratamiento con dupilumab y la interrupción de dupilumab en los participantes del estudio.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Trial Transparency email recommended (Toll free for US & Canada)
- Número de teléfono: option 6 800-633-1610
- Correo electrónico: contact-us@sanofi.com
Ubicaciones de estudio
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Bologna, Italia, 40138
- Reclutamiento
- Investigational Site Number: 002
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Brescia, Italia, 25123
- Reclutamiento
- Investigational Site Number: 006
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Florence, Italia, 50139
- Reclutamiento
- Investigational Site Number: 004
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Milan, Italia, 20122
- Reclutamiento
- Investigational Site Number: 001
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Naples, Italia, 80131
- Reclutamiento
- Investigational Site Number: 010
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Naples, Italia, 80138
- Reclutamiento
- Investigational Site Number: 011
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Roma, Italia, 00133
- Reclutamiento
- Investigational Site Number: 005
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Roma, Italia, 00168
- Reclutamiento
- Investigational Site Number: 009
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Verona, Italia, 37134
- Reclutamiento
- Investigational Site Number: 014
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Criterios de inclusión:
- Hombre o mujer, con edades comprendidas entre 12 y 17 años en la visita inicial.
- Pacientes con EA a los que se les haya prescrito dupilumab según los criterios de reembolso de la Agencia Italiana del Farmaco (AIFA) y que cumplan los siguientes criterios:
Pacientes con EASI<16 y
- Índice de calidad de vida en dermatología infantil (CDLQI) ≥ 10 o
- Escala de calificación numérica del prurito máximo (PP-NRS) ≥ 7 o
localización en áreas visibles o sensibles (cabeza/cuello/manos o genitales)
- Pacientes capaces de comprender y completar cuestionarios relacionados con el estudio.
- Proporcionó consentimiento informado firmado o consentimiento de los padres/representante legalmente aceptable y consentimiento del paciente cuando corresponda.
Criterio de exclusión:
- Uso previo de dupilumab dentro de los 6 meses anteriores al ingreso al estudio
- Pacientes que actualmente participan en cualquier ensayo clínico intervencionista que modifique la atención al paciente.
- Cualquier condición que, en opinión del investigador, pueda interferir con la capacidad del paciente para participar en el estudio (p. ej., abuso de sustancias)
La información anterior no pretende contener todas las consideraciones relevantes para una posible participación en un ensayo clínico.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Número de grupos/cohortes
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
Intervención / TratamientoIntervención / Tratamiento |
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Pediatric patients with AD
Pediatric participants (6 months to 17 years) who suffer from severe AD with EASI score < 16 for adolescents (age 12-17 years) and < 21 for children (6 months to 11 years), eligible for systemic dupilumab treatment according to Italian reimbursement criteria.
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Este estudio no administrará ningún tratamiento, solo observará el tratamiento según lo prescrito en la práctica clínica del mundo real.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Children and Adolescents: Percentage (%) change from baseline in Eczema Area and Severity Index (EASI) score
Periodo de tiempo: Baseline, Weeks 4, 16 and 52
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EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicating greater severity of AD. EASI-50: ≥ 50% reduction in score from baseline; EASI-75: ≥ 75% reduction in score from baseline; EASI-90: ≥ 90% reduction in score from baseline. |
Baseline, Weeks 4, 16 and 52
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Children and Adolescents: Percentage (%) of participants with EASI-50
Periodo de tiempo: Weeks 4, 16, 52
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EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicating greater severity of AD. EASI-50: ≥ 50% reduction in score from baseline; EASI-75: ≥ 75% reduction in score from baseline; EASI-90: ≥ 90% reduction in score from baseline. |
Weeks 4, 16, 52
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Children and Adolescents: Percentage (%) of participants with EASI-75
Periodo de tiempo: Weeks 4, 16, 52
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EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicating greater severity of AD. EASI-50: ≥ 50% reduction in score from baseline; EASI-75: ≥ 75% reduction in score from baseline; EASI-90: ≥ 90% reduction in score from baseline. |
Weeks 4, 16, 52
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Children and Adolescents: Percentage (%) of participants with EASI-90
Periodo de tiempo: Weeks 4, 16, 52
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EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicating greater severity of AD. EASI-50: ≥ 50% reduction in score from baseline; EASI-75: ≥ 75% reduction in score from baseline; EASI-90: ≥ 90% reduction in score from baseline. |
Weeks 4, 16, 52
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Children and Adolescents: Change from baseline in Patient Oriented Eczema Measure (POEM) score
Periodo de tiempo: Baseline, Weeks 4, 16, 52
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The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days).
The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease).
Higher scores indicate more severe disease and poor quality of life.
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Baseline, Weeks 4, 16, 52
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Children and Adolescents: Percentage (%) of children (6-11 years) and adolescents with a ≥ 6-point improvement from baseline in POEM score
Periodo de tiempo: Baseline, Weeks 4, 16, 52
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The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days).
The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease).
Higher scores indicate more severe disease and poor quality of life.
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Baseline, Weeks 4, 16, 52
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Children and Adolescents: Percentage of Infants (6 months-5 years) with a ≥ 3-point Improvement From Baseline in POEM score
Periodo de tiempo: Baseline, Weeks 4, 6 and 52
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The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days).
The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease).
Higher scores indicate more severe disease and poor quality of life.
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Baseline, Weeks 4, 6 and 52
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Children and Adolescents: Percentage (%) of participants with adverse events
Periodo de tiempo: Baseline to Week 52
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Baseline to Week 52
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Children only: Mean Absolute Change from Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score
Periodo de tiempo: Baseline, Weeks 4,6 and 52
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The SCORAD is a clinical tool used to assess the extent and severity of eczema. The SCORAD for each individual is A/5 + 7B/2 + C. Total score:0-103 A: Area: to determine extent, the sites affected by eczema are shaded on a drawing of a body. The rule of 9 is used to calculate the affected area (A) as a percentage of the whole body. The score for each area is added up. The total area is 'A', which has a possible maximum of 100 percent (%). B: Intensity: A representative area of eczema is selected. In this area, the intensity of each of the following signs is assessed as none (0), mild (1), moderate (2) or severe (3). The intensity scores are added together to give 'B' (maximum 18). C: Subjective symptoms (itch and sleeplessness) are each scored by the patient or relative using a visual analogue scale where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum 20). |
Baseline, Weeks 4,6 and 52
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Children only: Percentage Change from Baseline in SCORAD
Periodo de tiempo: Baseline, Weeks 4, 16 and 52
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The SCORAD is a clinical tool used to assess the extent and severity of eczema. The SCORAD for each individual is A/5 + 7B/2 + C. Total score:0-103 A: Area: to determine extent, the sites affected by eczema are shaded on a drawing of a body. The rule of 9 is used to calculate the affected area (A) as a percentage of the whole body. The score for each area is added up. The total area is 'A', which has a possible maximum of 100 percent (%). B: Intensity: A representative area of eczema is selected. In this area, the intensity of each of the following signs is assessed as none (0), mild (1), moderate (2) or severe (3). The intensity scores are added together to give 'B' (maximum 18). C: Subjective symptoms (itch and sleeplessness) are each scored by the patient or relative using a visual analogue scale where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum 20). |
Baseline, Weeks 4, 16 and 52
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Adolescents: Percentage (%) change from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) at 4, 16, 52 weeks
Periodo de tiempo: Baseline, Weeks 4, 16 and 52
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The PP-NRS is a single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD during the past 24 hours, with 0 = no itch and 10 = worst itch imaginable.
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Baseline, Weeks 4, 16 and 52
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Adolescents: Participant assessment: Percentage (%) of participants with a ≥4-point improvement from baseline in PP-NRS at 4, 16, 52 weeks
Periodo de tiempo: Baseline, Weeks 4, 16 and 52
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The PP-NRS is a single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD during the past 24 hours, with 0 = no itch and 10 = worst itch imaginable.
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Baseline, Weeks 4, 16 and 52
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Adolescents: Percentage (%) of participants with a PP-NRS score of 0, 1 to 3, and 4 to 6 at 4, 16, 52 weeks (only patients with baseline PP-NRS ≥ 7
Periodo de tiempo: Weeks 4, 16 and 52
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The PP-NRS is a single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD during the past 24 hours, with 0 = no itch and 10 = worst itch imaginable.
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Weeks 4, 16 and 52
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Children: Absolute Change from Baseline in SCORAD itch VAS
Periodo de tiempo: Baseline, Weeks 4, 16 and 52
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The SCORAD is a clinical tool used to assess the extent and severity of eczema. The SCORAD for each individual is A/5 + 7B/2 + C. Total score:0-103 A: Area: to determine extent, the sites affected by eczema are shaded on a drawing of a body. The rule of 9 is used to calculate the affected area (A) as a percentage of the whole body. The score for each area is added up. The total area is 'A', which has a possible maximum of 100 percent (%). B: Intensity: A representative area of eczema is selected. In this area, the intensity of each of the following signs is assessed as none (0), mild (1), moderate (2) or severe (3). The intensity scores are added together to give 'B' (maximum 18). C: Subjective symptoms (itch and sleeplessness) are each scored by the patient or relative using a visual analogue scale where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum 20). |
Baseline, Weeks 4, 16 and 52
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Children: Percentage of Patients with Mild or no Itch (SCORAD itch VAS < 4)
Periodo de tiempo: Baseline, Weeks 4, 16 and 52
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The SCORAD is a clinical tool used to assess the extent and severity of eczema. The SCORAD for each individual is A/5 + 7B/2 + C. Total score:0-103 A: Area: to determine extent, the sites affected by eczema are shaded on a drawing of a body. The rule of 9 is used to calculate the affected area (A) as a percentage of the whole body. The score for each area is added up. The total area is 'A', which has a possible maximum of 100 percent (%). B: Intensity: A representative area of eczema is selected. In this area, the intensity of each of the following signs is assessed as none (0), mild (1), moderate (2) or severe (3). The intensity scores are added together to give 'B' (maximum 18). C: Subjective symptoms (itch and sleeplessness) are each scored by the patient or relative using a visual analogue scale where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum 20). |
Baseline, Weeks 4, 16 and 52
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Adolescents: Percentage (%) change from baseline in Sleep Disturbance Numerical Rating Scale (SD-NRS) at 4, 16, 52 weeks
Periodo de tiempo: Baseline, Weeks 4, 16 and 52
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The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD, with 0 being "no sleep loss related to the symptoms of atopic dermatitis" and 10 being "I did not sleep at all, due to the symptoms of atopic dermatitis".
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Baseline, Weeks 4, 16 and 52
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Children: Mean Absolute Change from Baseline in SCORAD sleep VAS
Periodo de tiempo: Baseline, Weeks 4, 16, and 52
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The SCORAD is a clinical tool used to assess the extent and severity of eczema. The SCORAD for each individual is A/5 + 7B/2 + C. Total score:0-103 A: Area: to determine extent, the sites affected by eczema are shaded on a drawing of a body. The rule of 9 is used to calculate the affected area (A) as a percentage of the whole body. The score for each area is added up. The total area is 'A', which has a possible maximum of 100 percent (%). B: Intensity: A representative area of eczema is selected. In this area, the intensity of each of the following signs is assessed as none (0), mild (1), moderate (2) or severe (3). The intensity scores are added together to give 'B' (maximum 18). C: Subjective symptoms (itch and sleeplessness) are each scored by the patient or relative using a visual analogue scale where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum 20). |
Baseline, Weeks 4, 16, and 52
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Children: Percentage Change from Baseline in SCORAD Sleep VAS
Periodo de tiempo: Baseline, Weeks 4, 16 and 52
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The SCORAD is a clinical tool used to assess the extent and severity of eczema. The SCORAD for each individual is A/5 + 7B/2 + C. Total score:0-103 A: Area: to determine extent, the sites affected by eczema are shaded on a drawing of a body. The rule of 9 is used to calculate the affected area (A) as a percentage of the whole body. The score for each area is added up. The total area is 'A', which has a possible maximum of 100 percent (%). B: Intensity: A representative area of eczema is selected. In this area, the intensity of each of the following signs is assessed as none (0), mild (1), moderate (2) or severe (3). The intensity scores are added together to give 'B' (maximum 18). C: Subjective symptoms (itch and sleeplessness) are each scored by the patient or relative using a visual analogue scale where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum 20). |
Baseline, Weeks 4, 16 and 52
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Adolescents: Percentage (%) change from baseline in Children's Dermatology Life Quality Index (CDLQI) at 4, 16, 52 weeks
Periodo de tiempo: Baseline, Weeks 4, 16 and 52
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The CDLQI is a validated questionnaire designed to measure the impact of skin disease on the Quality of Life.
The higher the score, the greater the impact is on the quality of life.
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Baseline, Weeks 4, 16 and 52
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Adolescents: Percentage (%) of participants who achieve a ≥6-point reduction from baseline in CDLQI score at 4, 16, 52 weeks
Periodo de tiempo: Baseline, Weeks 4, 16 and 52
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The CDLQI is a validated questionnaire designed to measure the impact of skin disease on the Quality of Life.
The higher the score, the greater the impact is on the quality of life.
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Baseline, Weeks 4, 16 and 52
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Adolescents: Percentage of Participants with cDLQI Score of 0-1
Periodo de tiempo: Weeks 4, 16 and 52
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The CDLQI is a validated questionnaire designed to measure the impact of skin disease on the Quality of Life.
The higher the score, the greater the impact is on the quality of life.
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Weeks 4, 16 and 52
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Adolescents: Percentage (%) of Participants with CDLQI Score of < 6 at 4, 16, 52 weeks (only patients with CDLQI ≥ 10 at baseline)
Periodo de tiempo: Weeks 4, 16 and 52
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The CDLQI is a validated questionnaire designed to measure the impact of skin disease on the Quality of Life.
The higher the score, the greater the impact is on the quality of life.
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Weeks 4, 16 and 52
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Children: Mean Absolute Change from Baseline cDLQI / Infants' Dermatitis Quality of Life Index (iDQoL) (for patients ˂ 4 years of age)
Periodo de tiempo: Weeks 4, 16 and 52
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The iDQoL is a questionnaire completed by parents to assess the impact of atopic dermatitis on the quality of life of infants aged 0-3 years (i.e., up to 3 years 11 months.
The Index is calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
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Weeks 4, 16 and 52
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Children: Percentage of Participants who Achieve a ≥ 6-point Reduction from Baseline in cDLQI / iDQoL (for patients ˂ 4 years of age)
Periodo de tiempo: Weeks 4, 16 and 52
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The iDQoL is a questionnaire completed by parents to assess the impact of atopic dermatitis on the quality of life of infants aged 0-3 years (i.e., up to 3 years 11 months.
The Index is calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
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Weeks 4, 16 and 52
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Children: Percentage of Participants with cDLQI / iDQoL (for patients ˂ 4 years of age) Score of 0-1
Periodo de tiempo: Weeks 4, 16 and 52
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The iDQoL is a questionnaire completed by parents to assess the impact of atopic dermatitis on the quality of life of infants aged 0-3 years (i.e., up to 3 years 11 months.
The Index is calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
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Weeks 4, 16 and 52
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Children: Percentage of Participants with cDLQI / iDQoL (for patients ˂ 4 years of age) score < 6
Periodo de tiempo: Weeks 4, 16 and 52
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The iDQoL is a questionnaire completed by parents to assess the impact of atopic dermatitis on the quality of life of infants aged 0-3 years (i.e., up to 3 years 11 months.
The Index is calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
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Weeks 4, 16 and 52
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Adolescents: Percentage (%) change from baseline in Hospital Anxiety and Depression Scale (HADS) at 4, 16, 52 weeks
Periodo de tiempo: Baseline, Weeks 4, 16 and 52
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The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week.
It is comprised of 7 items assessing anxiety and depression respectively.
A Total score is out of 42 (21 per subscale).
Higher scores indicate greater levels of anxiety and/or depression.
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Baseline, Weeks 4, 16 and 52
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Children: Percentage (%) Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) score
Periodo de tiempo: Baseline, Weeks 4, 16 and 52
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PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children.
The total raw score is translated into a T-score for each participant by means of conversion table.
The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.
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Baseline, Weeks 4, 16 and 52
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Adolescents: Percentage (%) change from baseline Atopic Dermatitis Control Tool (ADCT) score at 4, 16, 52 weeks
Periodo de tiempo: Baseline, Weeks 4, 16 and 52
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ADCT is a six-item patient self-administered instrument designed and validated to assess atopic dermatitis (AD) control.
The score ranges from 0-24 with higher scores indicating worsening disease control.
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Baseline, Weeks 4, 16 and 52
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Adolescents: Participant assessment: Percentage (%) of participants with ADCT < 7 at 4, 16, 52 weeks
Periodo de tiempo: Weeks 4, 16 and 52
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ADCT is a six-item patient self-administered instrument designed and validated to assess atopic dermatitis (AD) control.
The score ranges from 0-24 with higher scores indicating worsening disease control.
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Weeks 4, 16 and 52
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Children and Adolescents: Percentage (%) change from baseline the Dermatitis Family Impact (DFI) questionnaire at 4, 16, 52 weeks
Periodo de tiempo: Baseline, Weeks 4, 16 and 52
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The DFI is a 10-item disease specific questionnaire assessing the impact of having a child with AD on family Quality of Life (QoL).
The DFI questions are scored on a four-point Likert scale ranging from 0 to 3, and the total DFI score ranges from 0 to 30.
The time frame of reference is the past week, and a higher DFI score indicates greater impairment in family QoL as affected by AD.
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Baseline, Weeks 4, 16 and 52
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Children and Adolescents: Percentage (%) of Participants with Physician's Global Assessment (PGA) Face 0 or (/) 1, PGA Feet 0/1, PGA Hands 0/1, PGA Genitals 0/1 and at least a 2-point Improvement from Baseline
Periodo de tiempo: Baseline, Weeks 4, 16 and 52
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The PGA score is a measure used in clinical practice and clinical trials to assess the severity of a particular disease.
The PGA chosen for this study ranges from 0-5 point, and the following categories will be used: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.
In this study, the Investigator will be evaluating four PGA scores, including PGA face, PGA feet, PGA hands, and PGA genitalia, in order to assess the severity of the localized lesions in AD patients at baseline and at week 4, 16 and 52.
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Baseline, Weeks 4, 16 and 52
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Adolescents: Percentage (%) of Participants with PGA Genitals 0/1 and at least a 2-point Improvement from Baseline
Periodo de tiempo: Baseline, Weeks 4, 16 and 52
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The PGA score is a measure used in clinical practice and clinical trials to assess the severity of a particular disease.
The PGA chosen for this study ranges from 0-5 point, and the following categories will be used: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.
In this study, the Investigator will be evaluating four PGA scores, including PGA face, PGA feet, PGA hands, and PGA genitalia, in order to assess the severity of the localized lesions in AD patients at baseline and at week 4, 16 and 52.
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Baseline, Weeks 4, 16 and 52
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Children and Adolescents: Time to Discontinuation and Reasons for Discontinuation
Periodo de tiempo: Baseline up to Week 52
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Baseline up to Week 52
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Mean Time to First TCS/TCI Discontinuation.
Periodo de tiempo: Baseline up to Week 52
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Baseline up to Week 52
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Children: Percentage of Patients that Discontinue Topical Corticosteroids (TCS) and Topical Calcineurin Inhibitors (TCI)
Periodo de tiempo: Baseline, Weeks 4, 16 and 52
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Baseline, Weeks 4, 16 and 52
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Adolescents: Participant assessment: Mean score of Treatment Satisfaction Questionnaire for Medication (TSQM-9) score at 4, 16, 52 weeks
Periodo de tiempo: Weeks 4, 16 and 52
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The 9-item TSQM (TSQM-9) is a questionnaire to assess treatment satisfaction, with scores ranging between 9 and 59, and lower scores indicating lower satisfaction with treatment.
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Weeks 4, 16 and 52
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Adolescents: Percentage (%) change from baseline in Asthma Control Questionnaire (ACQ-6) at 4, 16, 52 weeks in participants with concomitant asthma
Periodo de tiempo: Baseline, Weeks 4, 16 and 52
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The ACQ-6 is a questionnaire that consists of six questions on a scale from 0 to 6 of symptoms.
The questions are about limitations due to asthma and symptoms in the past week.
A lower score corresponds with better asthma control.
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Baseline, Weeks 4, 16 and 52
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Children: Mean Absolute Change from Baseline in Pediatric Asthma Questionnaire (PAQ)
Periodo de tiempo: Weeks 4, 16 and 52
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The PAQ is a 6-item measure for parents or caregivers of children aged 0-11 years with clinician-diagnosed asthma, or those with recurrent viral-associated wheezing with risk factors for persistent asthma, to assess both symptom control and asthma-specific HRQoL impact.
The PAQ features two items that measure asthma exacerbations which use a recall period of "the past month" while the remaining asthma symptoms (coughing a lot, difficulty breathing, or noisy breathing from the chest) and asthma-specific HRQoL items use "the past week".
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Weeks 4, 16 and 52
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Children: Percentage Change from Baseline in Pediatric Asthma Questionnaire (PAQ)
Periodo de tiempo: Weeks 4, 16 and 52
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The PAQ is a 6-item measure for parents or caregivers of children aged 0-11 years with clinician-diagnosed asthma, or those with recurrent viral-associated wheezing with risk factors for persistent asthma, to assess both symptom control and asthma-specific HRQoL impact.
The PAQ features two items that measure asthma exacerbations which use a recall period of "the past month" while the remaining asthma symptoms (coughing a lot, difficulty breathing, or noisy breathing from the chest) and asthma-specific HRQoL items use "the past week".
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Weeks 4, 16 and 52
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Children and Adolescents: Percentage (%) change from baseline in Total Nasal Symptoms Score (TNSS) at 4, 16, 52 weeks in participants with concomitant chronic rhinitis
Periodo de tiempo: Baseline, Weeks 4, 16 and 52
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The TNSS is the sum of scores for each of nasal congestion, sneezing, nasal itching, and rhinorrhea using a four-point scale (0-3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity.
TNSS is calculated by adding the score for each of the symptoms to a total out of 12.
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Baseline, Weeks 4, 16 and 52
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Director de estudio: Clinical Sciences & Operations, Sanofi
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades Genéticas Congénitas
- Enfermedades del sistema inmunológico
- Hipersensibilidad, Inmediata
- Hipersensibilidad
- Enfermedades de la piel
- Enfermedades De La Piel Genéticas
- Enfermedades De La Piel Eccematosas
- Dermatitis
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Enfermedades de la piel y del tejido conectivo
- Dermatitis Atópica
- dupilumab
Otros números de identificación del estudio
Otros números de identificación del estudio
- OBS18015
- U1111-1290-5921 (Identificador de registro: ICTRP)
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
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