Une étude pour observer comment les patients adolescents atteints de dermatite atopique sévère malgré des lésions cutanées moins étendues (zone d'eczéma et score de l'indice de gravité < 16) réagissent au traitement par dupilumab (AD-BEASCUITS)
Une étude observationnelle prospective auprès de patients adolescents atteints de dermatite atopique sévère malgré des lésions cutanées moins étendues (zone d'eczéma et score de l'indice de gravité < 16) recevant du dupilumab
Chez les adolescents traités par dupilumab, les essais cliniques ont montré une amélioration significative des signes et symptômes de la dermatite atopique (MA), avec un bon profil de sécurité. Dans ces essais cliniques, seuls les patients présentant un score EASI (Eczéma Area and Severity Index) supérieur ou égal à (≥) 16 ont été recrutés, et l'efficacité sur les zones sensibles/visibles n'a pas été spécifiquement évaluée. Des données supplémentaires sur l'efficacité du dupilumab chez les participants adolescents présentant un score EASI modéré à léger et des démangeaisons sévères et/ou une MA localisée sont donc nécessaires pour mieux comprendre les avantages cliniques potentiels du dupilumab dans ces populations.
Il s'agit d'une étude observationnelle (non interventionnelle) multicentrique italienne de 52 semaines qui collectera des données sur les caractéristiques des participants adolescents (âgés de 12 à 17 ans) qui souffrent de MA sévère avec un score EASI inférieur à (<) 16, éligibles à traitement systémique par dupilumab selon les critères de remboursement italiens. Il étudiera l'efficacité et l'innocuité réelles du dupilumab dans cette population, l'effet du dupilumab sur les démangeaisons (prurit), le sommeil, la qualité de vie et les résultats associés, la MA localisée dans les zones sensibles/visibles et sur les conditions atopiques coexistantes chez les adolescents. les participants qui reçoivent du dupilumab pour la MA. Il documentera également la satisfaction du traitement par le dupilumab et l'arrêt du dupilumab chez les participants à l'étude.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Trial Transparency email recommended (Toll free for US & Canada)
- Numéro de téléphone: option 6 800-633-1610
- E-mail: contact-us@sanofi.com
Lieux d'étude
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Bologna, Italie, 40138
- Recrutement
- Investigational Site Number: 002
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Brescia, Italie, 25123
- Recrutement
- Investigational Site Number: 006
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Florence, Italie, 50139
- Recrutement
- Investigational Site Number: 004
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Milan, Italie, 20122
- Recrutement
- Investigational Site Number: 001
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Naples, Italie, 80131
- Recrutement
- Investigational Site Number: 010
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Naples, Italie, 80138
- Recrutement
- Investigational Site Number: 011
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Roma, Italie, 00133
- Recrutement
- Investigational Site Number: 005
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Roma, Italie, 00168
- Recrutement
- Investigational Site Number: 009
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Verona, Italie, 37134
- Recrutement
- Investigational Site Number: 014
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Critère d'intégration:
- Homme ou femme, âgé entre 12 et 17 ans lors de la visite initiale
- Patients atteints de MA à qui du dupilumab a été prescrit selon les critères de remboursement de l'Agenzia Italiana del Farmaco (AIFA) et remplissant les critères suivants :
Patients avec EASI<16 et
- Indice de qualité de vie en dermatologie infantile (CDLQI) ≥ 10 ou
- Échelle d'évaluation numérique du pic de prurit (PP-NRS) ≥ 7 ou
localisation dans des zones visibles ou sensibles (tête/cou/mains ou organes génitaux)
- Patients capables de comprendre et de remplir les questionnaires liés à l'étude
- Fourni un consentement éclairé signé ou un consentement parental/représentant légalement acceptable et l'assentiment du patient, le cas échéant
Critère d'exclusion:
- Utilisation antérieure du dupilumab dans les 6 mois précédant l'entrée à l'étude
- Patients participant actuellement à un essai clinique interventionnel modifiant les soins aux patients
- Toute condition qui, de l'avis de l'enquêteur, peut interférer avec la capacité du patient à participer à l'étude (par exemple, toxicomanie)
Les informations ci-dessus ne sont pas destinées à contenir toutes les considérations pertinentes à une participation potentielle à un essai clinique.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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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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Cette étude n'administrera aucun traitement, observera uniquement le traitement tel que prescrit dans la pratique clinique réelle.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Children and Adolescents: Percentage (%) change from baseline in Eczema Area and Severity Index (EASI) score
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Clinical Sciences & Operations, Sanofi
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies génétiques, innées
- Maladies du système immunitaire
- Hypersensibilité immédiate
- Hypersensibilité
- Maladies de la peau
- Maladies de la peau, Génétique
- Maladies de la peau, eczémateux
- Dermatite
- Maladies et anomalies congénitales, héréditaires et néonatales
- Maladies de la peau et du tissu conjonctif
- Dermatite atopique
- dupulumab
Autres numéros d'identification d'étude
- OBS18015
- U1111-1290-5921 (Identificateur de registre: ICTRP)
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
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