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Uno studio per osservare come i pazienti adolescenti con dermatite atopica grave nonostante lesioni cutanee meno estese (area dell'eczema e punteggio dell'indice di gravità < 16) rispondono al trattamento con dupilumab (AD-BEASCUITS)

11 agosto 2026 aggiornato da: Sanofi

Uno studio osservazionale prospettico su pazienti adolescenti con dermatite atopica grave nonostante lesioni cutanee meno estese (area dell'eczema e punteggio dell'indice di gravità < 16) trattati con dupilumab

Negli adolescenti trattati con dupilumab, gli studi clinici hanno mostrato un miglioramento significativo dei segni e dei sintomi della dermatite atopica (AD), con un buon profilo di sicurezza. In questi studi clinici sono stati arruolati solo pazienti con punteggio EASI (Eczema Area and Severity Index) maggiore o uguale a (≥) 16 e l’efficacia sulle aree sensibili/visibili non è stata valutata in modo specifico. Sono quindi necessari ulteriori dati sull’efficacia di dupilumab nei partecipanti adolescenti con punteggio EASI da moderato a lieve e prurito grave e/o AD localizzato per comprendere meglio i potenziali benefici clinici di dupilumab in queste popolazioni.

Si tratta di uno studio osservazionale (non interventistico) multicentrico italiano, della durata di 52 settimane, che raccoglierà dati sulle caratteristiche dei partecipanti adolescenti (di età compresa tra 12 e 17 anni) che soffrono di AD grave con punteggio EASI inferiore a (<) 16, idonei per trattamento sistemico con dupilumab secondo i criteri di rimborsabilità italiani. Studierà l'efficacia e la sicurezza nel mondo reale di dupilumab in questa popolazione, l'effetto di dupilumab sul prurito, sul sonno, sulla qualità della vita e sui risultati correlati, sull'AD localizzato in aree sensibili/visibili e sulle condizioni atopiche coesistenti negli adolescenti. partecipanti che ricevono dupilumab per l'AD. Documenterà inoltre la soddisfazione del trattamento con dupilumab e l’interruzione di dupilumab nei partecipanti allo studio.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Si prevede che il periodo di osservazione individuale durerà fino a 52 settimane.

Tipo di studio

Osservativo

Iscrizione (Stimato)

230

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Trial Transparency email recommended (Toll free for US & Canada)
  • Numero di telefono: option 6 800-633-1610
  • Email: contact-us@sanofi.com

Luoghi di studio

  • Italia
      • Bologna, Italia, 40138
        • Reclutamento
        • Investigational Site Number: 002
      • Brescia, Italia, 25123
        • Reclutamento
        • Investigational Site Number: 006
      • Florence, Italia, 50139
        • Reclutamento
        • Investigational Site Number: 004
      • Milan, Italia, 20122
        • Reclutamento
        • Investigational Site Number: 001
      • Naples, Italia, 80131
        • Reclutamento
        • Investigational Site Number: 010
      • Naples, Italia, 80138
        • Reclutamento
        • Investigational Site Number: 011
      • Roma, Italia, 00133
        • Reclutamento
        • Investigational Site Number: 005
      • Roma, Italia, 00168
        • Reclutamento
        • Investigational Site Number: 009
      • Verona, Italia, 37134
        • Reclutamento
        • Investigational Site Number: 014

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Partecipanti adolescenti (di età compresa tra 12 e 17 anni) che soffrono di AD grave con punteggio EASI <16, idonei al trattamento sistemico con dupilumab secondo i criteri di rimborso italiani.

Descrizione

Criterio di inclusione:

  • Maschio o femmina, di età compresa tra 12 e 17 anni alla visita basale
  • Pazienti con AD a cui è stato prescritto dupilumab secondo i criteri di rimborso dell'Agenzia Italiana del Farmaco (AIFA) e che soddisfano i seguenti criteri:

Pazienti con EASI <16 e

  1. Indice di qualità della vita dermatologica infantile (CDLQI) ≥ 10 o
  2. Scala di valutazione numerica del picco del prurito (PP-NRS) ≥ 7 o

  3. localizzazione in aree visibili o sensibili (testa/collo/mani o genitali)

    • Pazienti in grado di comprendere e completare i questionari relativi allo studio
    • Fornito consenso informato firmato o consenso dei genitori/rappresentante legalmente accettabile e consenso del paziente, ove applicabile

Criteri di esclusione:

  • Uso precedente di dupilumab entro 6 mesi prima dell'ingresso nello studio
  • Pazienti che attualmente partecipano a qualsiasi studio clinico interventistico che modifichi la cura del paziente
  • Qualsiasi condizione che, a giudizio dello sperimentatore, possa interferire con la capacità del paziente di partecipare allo studio (ad esempio, abuso di sostanze)

Le informazioni di cui sopra non intendono contenere tutte le considerazioni rilevanti per una potenziale partecipazione a una sperimentazione clinica.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Droga: Dupilumab
Questo studio non somministrerà alcun trattamento, si limiterà ad osservare il trattamento come prescritto nella pratica clinica del mondo reale.
Altri nomi:
  • SAR231893 (REGN668), Dupixent®

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Children and Adolescents: Percentage (%) change from baseline in Eczema Area and Severity Index (EASI) score
Lasso di tempo: Baseline, Weeks 4, 16 and 52

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
Children and Adolescents: Percentage (%) of participants with EASI-50
Lasso di tempo: Weeks 4, 16, 52

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
Children and Adolescents: Percentage (%) of participants with EASI-75
Lasso di tempo: Weeks 4, 16, 52

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
Children and Adolescents: Percentage (%) of participants with EASI-90
Lasso di tempo: Weeks 4, 16, 52

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
Children and Adolescents: Change from baseline in Patient Oriented Eczema Measure (POEM) score
Lasso di tempo: Baseline, Weeks 4, 16, 52
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.
Baseline, Weeks 4, 16, 52
Children and Adolescents: Percentage (%) of children (6-11 years) and adolescents with a ≥ 6-point improvement from baseline in POEM score
Lasso di tempo: Baseline, Weeks 4, 16, 52
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.
Baseline, Weeks 4, 16, 52
Children and Adolescents: Percentage of Infants (6 months-5 years) with a ≥ 3-point Improvement From Baseline in POEM score
Lasso di tempo: Baseline, Weeks 4, 6 and 52
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.
Baseline, Weeks 4, 6 and 52
Children and Adolescents: Percentage (%) of participants with adverse events
Lasso di tempo: Baseline to Week 52
Baseline to Week 52
Children only: Mean Absolute Change from Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score
Lasso di tempo: Baseline, Weeks 4,6 and 52

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
Children only: Percentage Change from Baseline in SCORAD
Lasso di tempo: Baseline, Weeks 4, 16 and 52

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
Adolescents: Percentage (%) change from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) at 4, 16, 52 weeks
Lasso di tempo: Baseline, Weeks 4, 16 and 52
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.
Baseline, Weeks 4, 16 and 52
Adolescents: Participant assessment: Percentage (%) of participants with a ≥4-point improvement from baseline in PP-NRS at 4, 16, 52 weeks
Lasso di tempo: Baseline, Weeks 4, 16 and 52
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.
Baseline, Weeks 4, 16 and 52
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
Lasso di tempo: Weeks 4, 16 and 52
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.
Weeks 4, 16 and 52
Children: Absolute Change from Baseline in SCORAD itch VAS
Lasso di tempo: Baseline, Weeks 4, 16 and 52

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
Children: Percentage of Patients with Mild or no Itch (SCORAD itch VAS < 4)
Lasso di tempo: Baseline, Weeks 4, 16 and 52

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
Adolescents: Percentage (%) change from baseline in Sleep Disturbance Numerical Rating Scale (SD-NRS) at 4, 16, 52 weeks
Lasso di tempo: Baseline, Weeks 4, 16 and 52
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".
Baseline, Weeks 4, 16 and 52
Children: Mean Absolute Change from Baseline in SCORAD sleep VAS
Lasso di tempo: Baseline, Weeks 4, 16, and 52

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
Children: Percentage Change from Baseline in SCORAD Sleep VAS
Lasso di tempo: Baseline, Weeks 4, 16 and 52

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
Adolescents: Percentage (%) change from baseline in Children's Dermatology Life Quality Index (CDLQI) at 4, 16, 52 weeks
Lasso di tempo: Baseline, Weeks 4, 16 and 52
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.
Baseline, Weeks 4, 16 and 52
Adolescents: Percentage (%) of participants who achieve a ≥6-point reduction from baseline in CDLQI score at 4, 16, 52 weeks
Lasso di tempo: Baseline, Weeks 4, 16 and 52
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.
Baseline, Weeks 4, 16 and 52
Adolescents: Percentage of Participants with cDLQI Score of 0-1
Lasso di tempo: Weeks 4, 16 and 52
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.
Weeks 4, 16 and 52
Adolescents: Percentage (%) of Participants with CDLQI Score of < 6 at 4, 16, 52 weeks (only patients with CDLQI ≥ 10 at baseline)
Lasso di tempo: Weeks 4, 16 and 52
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.
Weeks 4, 16 and 52
Children: Mean Absolute Change from Baseline cDLQI / Infants' Dermatitis Quality of Life Index (iDQoL) (for patients ˂ 4 years of age)
Lasso di tempo: Weeks 4, 16 and 52
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.
Weeks 4, 16 and 52
Children: Percentage of Participants who Achieve a ≥ 6-point Reduction from Baseline in cDLQI / iDQoL (for patients ˂ 4 years of age)
Lasso di tempo: Weeks 4, 16 and 52
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.
Weeks 4, 16 and 52
Children: Percentage of Participants with cDLQI / iDQoL (for patients ˂ 4 years of age) Score of 0-1
Lasso di tempo: Weeks 4, 16 and 52
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.
Weeks 4, 16 and 52
Children: Percentage of Participants with cDLQI / iDQoL (for patients ˂ 4 years of age) score < 6
Lasso di tempo: Weeks 4, 16 and 52
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.
Weeks 4, 16 and 52
Adolescents: Percentage (%) change from baseline in Hospital Anxiety and Depression Scale (HADS) at 4, 16, 52 weeks
Lasso di tempo: Baseline, Weeks 4, 16 and 52
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.
Baseline, Weeks 4, 16 and 52
Children: Percentage (%) Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) score
Lasso di tempo: Baseline, Weeks 4, 16 and 52
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.
Baseline, Weeks 4, 16 and 52
Adolescents: Percentage (%) change from baseline Atopic Dermatitis Control Tool (ADCT) score at 4, 16, 52 weeks
Lasso di tempo: Baseline, Weeks 4, 16 and 52
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.
Baseline, Weeks 4, 16 and 52
Adolescents: Participant assessment: Percentage (%) of participants with ADCT < 7 at 4, 16, 52 weeks
Lasso di tempo: Weeks 4, 16 and 52
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.
Weeks 4, 16 and 52
Children and Adolescents: Percentage (%) change from baseline the Dermatitis Family Impact (DFI) questionnaire at 4, 16, 52 weeks
Lasso di tempo: Baseline, Weeks 4, 16 and 52
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.
Baseline, Weeks 4, 16 and 52
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
Lasso di tempo: Baseline, Weeks 4, 16 and 52
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.
Baseline, Weeks 4, 16 and 52
Adolescents: Percentage (%) of Participants with PGA Genitals 0/1 and at least a 2-point Improvement from Baseline
Lasso di tempo: Baseline, Weeks 4, 16 and 52
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.
Baseline, Weeks 4, 16 and 52
Children and Adolescents: Time to Discontinuation and Reasons for Discontinuation
Lasso di tempo: Baseline up to Week 52
Baseline up to Week 52
Mean Time to First TCS/TCI Discontinuation.
Lasso di tempo: Baseline up to Week 52
Baseline up to Week 52
Children: Percentage of Patients that Discontinue Topical Corticosteroids (TCS) and Topical Calcineurin Inhibitors (TCI)
Lasso di tempo: Baseline, Weeks 4, 16 and 52
Baseline, Weeks 4, 16 and 52
Adolescents: Participant assessment: Mean score of Treatment Satisfaction Questionnaire for Medication (TSQM-9) score at 4, 16, 52 weeks
Lasso di tempo: Weeks 4, 16 and 52
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.
Weeks 4, 16 and 52
Adolescents: Percentage (%) change from baseline in Asthma Control Questionnaire (ACQ-6) at 4, 16, 52 weeks in participants with concomitant asthma
Lasso di tempo: Baseline, Weeks 4, 16 and 52
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.
Baseline, Weeks 4, 16 and 52
Children: Mean Absolute Change from Baseline in Pediatric Asthma Questionnaire (PAQ)
Lasso di tempo: Weeks 4, 16 and 52
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".
Weeks 4, 16 and 52
Children: Percentage Change from Baseline in Pediatric Asthma Questionnaire (PAQ)
Lasso di tempo: Weeks 4, 16 and 52
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".
Weeks 4, 16 and 52
Children and Adolescents: Percentage (%) change from baseline in Total Nasal Symptoms Score (TNSS) at 4, 16, 52 weeks in participants with concomitant chronic rhinitis
Lasso di tempo: Baseline, Weeks 4, 16 and 52
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.
Baseline, Weeks 4, 16 and 52

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sanofi

Collaboratori

Regeneron Pharmaceuticals

Investigatori

  • Direttore dello studio: Clinical Sciences & Operations, Sanofi

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

30 novembre 2023

Completamento primario (Stimato)

31 marzo 2028

Completamento dello studio (Stimato)

31 marzo 2028

Date di iscrizione allo studio

Primo inviato

20 dicembre 2023

Primo inviato che soddisfa i criteri di controllo qualità

20 dicembre 2023

Primo Inserito (Effettivo)

5 gennaio 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • OBS18015
  • U1111-1290-5921 (Identificatore di registro: ICTRP)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

I ricercatori qualificati possono richiedere l'accesso ai dati a livello del paziente e ai relativi documenti di studio, tra cui il rapporto dello studio clinico, il protocollo dello studio con eventuali modifiche, il modulo vuoto del rapporto del caso, il piano di analisi statistica e le specifiche del set di dati. I dati a livello del paziente verranno resi anonimi e i documenti dello studio verranno oscurati per proteggere la privacy dei partecipanti allo studio. Ulteriori dettagli sui criteri di condivisione dei dati di Sanofi, sugli studi ammissibili e sul processo di richiesta di accesso sono disponibili all'indirizzo: https://vivli.org

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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