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Eine Studie zur Beobachtung, wie jugendliche Patienten mit schwerer atopischer Dermatitis trotz weniger ausgedehnter Hautläsionen (Ekzembereich und Schweregradindex < 16) auf die Behandlung mit Dupilumab reagieren (AD-BEASCUITS)

11. August 2026 aktualisiert von: Sanofi

Eine prospektive Beobachtungsstudie an jugendlichen Patienten mit schwerer atopischer Dermatitis trotz weniger ausgedehnter Hautläsionen (Ekzemfläche und Schweregradindex-Score < 16), die Dupilumab erhalten

Bei Jugendlichen, die mit Dupilumab behandelt wurden, zeigten klinische Studien eine signifikante Verbesserung der Anzeichen und Symptome einer atopischen Dermatitis (AD) bei einem guten Sicherheitsprofil. In diese klinischen Studien wurden nur Patienten mit einem EASI-Wert (Eczema Area and Severity Index) von mindestens (≥) 16 aufgenommen, und die Wirksamkeit in empfindlichen/sichtbaren Bereichen wurde nicht speziell bewertet. Weitere Daten zur Wirksamkeit von Dupilumab bei jugendlichen Teilnehmern mit mäßigem bis leichtem EASI-Score und starkem Juckreiz und/oder lokalisierter AD sind daher erforderlich, um den potenziellen klinischen Nutzen von Dupilumab in diesen Populationen besser zu verstehen.

Hierbei handelt es sich um eine italienische multizentrische, 52-wöchige Beobachtungsstudie (nicht-interventionell), in der Daten zu den Merkmalen jugendlicher Teilnehmer (im Alter von 12 bis 17 Jahren) gesammelt werden, die an schwerer Alzheimer-Krankheit leiden und einen EASI-Wert von weniger als (<) 16 haben systemische Dupilumab-Behandlung gemäß italienischen Erstattungskriterien. Es wird die praktische Wirksamkeit und Sicherheit von Dupilumab in dieser Population, die Wirkung von Dupilumab auf Juckreiz (Pruritus), Schlaf, Lebensqualität und damit verbundene Ergebnisse, lokalisierte AD in empfindlichen/sichtbaren Bereichen und auf gleichzeitig bestehende atopische Erkrankungen bei Jugendlichen untersuchen Teilnehmer, die Dupilumab gegen AD erhalten. Es wird auch die Zufriedenheit mit der Dupilumab-Behandlung und das Absetzen von Dupilumab bei den Studienteilnehmern dokumentieren.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Der individuelle Beobachtungszeitraum soll bis zu 52 Wochen betragen.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

230

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Trial Transparency email recommended (Toll free for US & Canada)
  • Telefonnummer: option 6 800-633-1610
  • E-Mail: contact-us@sanofi.com

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Jugendliche (im Alter von 12 bis 17 Jahren), die an schwerer AD mit einem EASI-Score < 16 leiden, haben gemäß den italienischen Erstattungskriterien Anspruch auf eine systemische Dupilumab-Behandlung.

Beschreibung

Einschlusskriterien:

  • Männlich oder weiblich, im Alter zwischen 12 und 17 Jahren beim Erstbesuch
  • Patienten mit AD, denen Dupilumab gemäß den Erstattungskriterien der Agenzia Italiana del Farmaco (AIFA) verschrieben wurde und die folgenden Kriterien erfüllen:

Patienten mit EASI<16 und

  1. Kinderdermatologischer Lebensqualitätsindex (CDLQI) ≥ 10 oder
  2. Peak Pruritus Numerical Rating Scale (PP-NRS) ≥ 7 oder

  3. Lokalisierung in sichtbaren oder sensiblen Bereichen (Kopf/Hals/Hände oder Genitalien)

    • Patienten sind in der Lage, studienbezogene Fragebögen zu verstehen und auszufüllen
    • Unterschriebene Einverständniserklärung oder Einwilligung der Eltern/rechtlich zulässigen Vertreter und ggf. Zustimmung des Patienten vorgelegt

Ausschlusskriterien:

  • Vorherige Anwendung von Dupilumab innerhalb von 6 Monaten vor Studienbeginn
  • Patienten, die derzeit an einer interventionellen klinischen Studie teilnehmen, die die Patientenversorgung verändert
  • Jeder Zustand, der nach Ansicht des Prüfers die Fähigkeit des Patienten zur Teilnahme an der Studie beeinträchtigen könnte (z. B. Drogenmissbrauch)

Die oben genannten Informationen sollen nicht alle Überlegungen enthalten, die für eine mögliche Teilnahme an einer klinischen Studie relevant sind.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Arzneimittel: Dupilumab
In dieser Studie wird keine Behandlung durchgeführt, sondern nur die Behandlung beobachtet, wie sie in der realen klinischen Praxis vorgeschrieben ist.
Andere Namen:
  • SAR231893 (REGN668), Dupixent®

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Children and Adolescents: Percentage (%) change from baseline in Eczema Area and Severity Index (EASI) score
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline to Week 52
Baseline to Week 52
Children only: Mean Absolute Change from Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline up to Week 52
Baseline up to Week 52
Mean Time to First TCS/TCI Discontinuation.
Zeitfenster: Baseline up to Week 52
Baseline up to Week 52
Children: Percentage of Patients that Discontinue Topical Corticosteroids (TCS) and Topical Calcineurin Inhibitors (TCI)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Sanofi

Mitarbeiter

Regeneron Pharmaceuticals

Ermittler

  • Studienleiter: Clinical Sciences & Operations, Sanofi

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

30. November 2023

Primärer Abschluss (Geschätzt)

31. März 2028

Studienabschluss (Geschätzt)

31. März 2028

Studienanmeldedaten

Zuerst eingereicht

20. Dezember 2023

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. Dezember 2023

Zuerst gepostet (Tatsächlich)

5. Januar 2024

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • OBS18015
  • U1111-1290-5921 (Registrierungskennung: ICTRP)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Qualifizierte Forscher können Zugriff auf Daten auf Patientenebene und zugehörige Studiendokumente anfordern, einschließlich des klinischen Studienberichts, des Studienprotokolls mit etwaigen Änderungen, eines leeren Fallberichtsformulars, eines statistischen Analyseplans und der Datensatzspezifikationen. Daten auf Patientenebene werden anonymisiert und Studiendokumente werden geschwärzt, um die Privatsphäre der Studienteilnehmer zu schützen. Weitere Einzelheiten zu den Datenfreigabekriterien von Sanofi, förderfähigen Studien und dem Verfahren zur Beantragung des Zugriffs finden Sie unter: https://vivli.org

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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