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Eine Studie zur Bewertung der Wirksamkeit und Sicherheit von Tralokinumab in Kombination mit topischen Kortikosteroiden bei Kindern und Säuglingen mit mittelschwerer bis schwerer atopischer Dermatitis (TRAPEDS 2)

6. November 2026 aktualisiert von: LEO Pharma

Eine multizentrische Phase-3-Studie zur Bewertung der Wirksamkeit und Sicherheit von Tralokinumab in Kombination mit topischen Kortikosteroiden bei Kindern (im Alter von 2 bis 3 Jahren).

The purpose of this trial is to test whether treatment with tralokinumab (administered subcutaneous injections [SC]) in combination with topical corticosteroids (TCS) is safe and effective to treat moderate-to-severe atopic dermatitis (AD) in children and infants. This will be judged by a range of assessments that rate the severity and extent of atopic dermatitis and its symptoms, as well as general health status and quality of life. The trial will last for up to 4 years. There will be visits every 2 weeks for the first year and every 6 weeks thereafter. Some of the visits will be conducted by phone.

The study involves two different age groups: children aged 2 to under 12 years and infants aged 6 months to under 2 years. This trial compares tralokinumab +TCS to placebo + TCS for children with moderate-to-severe AD and evaluates tralokinumab + TCS for infants with moderate-to-severe AD. Infants will not receive placebo. All subjects will go through a screening process, which is the first part of the trial and will last up to 4 weeks. During this period, it will be checked if the child or infant meets the criteria to participate in the trial.

The children will be randomly assigned to receive tralokinumab + TCS or placebo + TCS for the initial 16 weeks, with the treatment being double-blinded. During the first 16 weeks, children will have a 2 out of 3 chance of getting tralokinumab and a 1 out of 3 chance of getting placebo. Thereafter, all subjects will receive tralokinumab + TCS. The infants will receive tralokinumab + TCS as open-label treatment for the entire treatment period, meaning that the participants will know they are receiving tralokinumab. After stopping treatment, all participants will enter a 4-week safety follow-up period.

Studienübersicht

Status

Status

Zeigt den aktuellen Rekrutierungsstatus oder den erweiterten Zugriffsstatus an.
Rekrutierung

Bedingungen

Bedingungen

Die Krankheit, Störung, das Syndrom, die Krankheit oder die Verletzung, die untersucht wird. Auf ClinicalTrials.gov können die Bedingungen auch andere gesundheitsbezogene Themen wie Lebensdauer, Lebensqualität und Gesundheitsrisiken umfassen.

Intervention / Behandlung

Intervention / Behandlung

Ein Prozess oder eine Handlung, die im Mittelpunkt einer klinischen Studie steht. Interventionen umfassen Medikamente, medizinische Geräte, Verfahren, Impfstoffe und andere Produkte, die entweder in der Erprobungsphase oder bereits verfügbar sind. Interventionen können auch nicht-invasive Ansätze umfassen, wie z. B. Aufklärung oder eine Änderung der Ernährung und Bewegung.

Studientyp

Studientyp

Beschreibt die Art einer klinischen Studie. Zu den Studientypen gehören Interventionsstudien (auch klinische Studien genannt), Beobachtungsstudien (einschließlich Patientenregister) und erweiterter Zugang.
Interventionell

Einschreibung (Geschätzt)

Einschreibung

Die Anzahl der Teilnehmer an einer klinischen Studie. Die „erwartete“ Einschreibung ist die Zielzahl an Teilnehmern, die die Forscher für die Studie benötigen.
195

Phase

Phase

Das Stadium einer klinischen Studie, in der ein Medikament oder ein biologisches Produkt untersucht wird, basierend auf Definitionen, die von der U.S. Food and Drug Administration (FDA) entwickelt wurden. Die Phase richtet sich nach dem Ziel der Studie, der Anzahl der Teilnehmer und anderen Merkmalen. Es gibt fünf Phasen: Frühe Phase 1 (früher als Phase 0 aufgeführt), Phase 1, Phase 2, Phase 3 und Phase 4. Nicht zutreffend wird verwendet, um Studien ohne von der FDA definierte Phasen zu beschreiben, einschließlich Studien zu Geräten oder Verhaltensinterventionen.
  • Phase 3

Kontakte und Standorte

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

Studienkontakt

Studienkontakt

Der Name und die Kontaktinformationen der Person, die Fragen zur Registrierung für eine klinische Studie beantworten kann. Jeder Standort, an dem die Studie durchgeführt wird, kann auch einen bestimmten Ansprechpartner haben, der diese Fragen möglicherweise besser beantworten kann.

Studienorte

  • Belgien
      • Brussels, Belgien, 1020
        • Zurückgezogen
        • Leo Pharma Investigational site
      • Ghent, Belgien, 9000
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
      • Leuven, Belgien, 3000
        • Zurückgezogen
        • Leo Pharma Investigational site
      • Liège, Belgien, 4000
        • Zurückgezogen
        • Leo Pharma Investigational site
  • Deutschland
      • Buxtehude, Deutschland, 21614
        • Zurückgezogen
        • Leo Pharma Investigational site
      • Dresden, Deutschland, 01307
        • Zurückgezogen
        • Leo Pharma Investigational site
      • Mainz, Deutschland, 55131
        • Zurückgezogen
        • Leo Pharma Investigational site
      • Osnabrück, Deutschland, 49074
        • Zurückgezogen
        • Leo Pharma Investigational site
      • Tübingen, Deutschland, 72076
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
      • Wuppertal, Deutschland, 42283
        • Zurückgezogen
        • Leo Pharma Investigational site
  • Irland
      • Cork, Irland, T12 DFK4
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
      • Crumlin, Irland, D12N512
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
  • Italien
      • Ancona, Italien, 60126
        • Zurückgezogen
        • Leo Pharma Investigational site
      • Brescia, Italien, 25123
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
      • Padova, Italien, 35128
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
      • Roma, Italien, 00168
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
      • Rome, Italien, 00165
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
  • Kanada
      • Burlington, Kanada, L7L 6W6
        • Rekrutierung
        • Leo Pharma Investigational site
      • Calgary, Kanada, Calgary
        • Zurückgezogen
        • Leo Pharma Investigational site
      • Calgary, Kanada, T2J 7E1
        • Rekrutierung
        • Leo Pharma Investigational site
      • Edmonton, Kanada, T5J 3S9
        • Rekrutierung
        • Leo Pharma Investigational site
      • Edmonton, Kanada, T6G 1C3
        • Rekrutierung
        • Leo Pharma Investigational site
      • Hamilton, Kanada, L8S 1G5
        • Rekrutierung
        • Leo Pharma Investigational site
      • Niagara Falls, Kanada, L2H 1H5
        • Rekrutierung
        • Leo Pharma Investigational site
      • Saskatoon, Kanada, S7K 2C1
        • Rekrutierung
        • Leo Pharma Investigational site
      • Windsor, Kanada, N8X2G1
        • Rekrutierung
        • Leo Pharma Investigational site
      • Winnipeg, Kanada, R3M 3Z4
        • Rekrutierung
        • Leo Pharma Investigational site
  • Kroatien
      • Rijeka, Kroatien, 51000
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
      • Zagreb, Kroatien, 10000
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
      • Zagreb, Kroatien, 10000
        • Zurückgezogen
        • Leo Pharma Investigational site
  • Niederlande
      • Utrecht, Niederlande, 3584 CW
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
  • Polen
      • Gdansk, Polen, 80-546
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
      • Krakow, Polen, 30-002
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
      • Lodz, Polen, 90-436
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
      • Ostrowiec Świętokrzyski, Polen, 27-400
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
      • Rzeszów, Polen, 35-055
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
      • Tarnów, Polen, 33-100
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
      • Warsaw, Polen, 02-953
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
      • Warsaw, Polen, 02-962
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
  • Rumänien
      • Brasov, Rumänien, 500091
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
      • Iași, Rumänien, 700259
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
  • Spanien
      • Alicante, Spanien, 03010
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
      • Madrid, Spanien, 28046
        • Zurückgezogen
        • Leo Pharma Investigational site
      • Valencia, Spanien, 46014
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
  • Südkorea
      • Ansan-si, Südkorea, 15355
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
      • Gwangju, Südkorea, 61453
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
      • Seoul, Südkorea, 02447
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
      • Seoul, Südkorea, 03080
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
      • Seoul, Südkorea, 03722
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
      • Seoul, Südkorea, 05030
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
      • Seoul, Südkorea, 06273
        • Zurückgezogen
        • Leo Pharma Investigational site
      • Seoul, Südkorea, 06591
        • Zurückgezogen
        • Leo Pharma Investigational site
      • Seoul, Südkorea, 139-711
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
  • Vereinigte Staaten
    • Alabama
      • Birmingham, Alabama, Vereinigte Staaten, 35209
        • Rekrutierung
        • Leo Pharma Investigational site
    • Arkansas
      • North Little Rock, Arkansas, Vereinigte Staaten, 72117
        • Rekrutierung
        • Leo Pharma Investigational site
    • California
      • Palo Alto, California, Vereinigte Staaten, 94304
        • Rekrutierung
        • Leo Pharma Investigational site
      • Sacramento, California, Vereinigte Staaten, 95816
        • Rekrutierung
        • Leo Pharma Investigational site
      • San Diego, California, Vereinigte Staaten, 92108
        • Zurückgezogen
        • Leo Pharma Investigational site
      • San Diego, California, Vereinigte Staaten, 92123
        • Rekrutierung
        • Leo Pharma Investigational site
    • Florida
      • Jacksonville, Florida, Vereinigte Staaten, 32256
        • Rekrutierung
        • Leo Pharma Investigational site
      • Miami, Florida, Vereinigte Staaten, 33156
        • Rekrutierung
        • Leo Pharma Investigational site
      • Tampa, Florida, Vereinigte Staaten, 33613
        • Rekrutierung
        • Leo Pharma Investigational site
    • Georgia
      • Macon, Georgia, Vereinigte Staaten, 31217
        • Rekrutierung
        • Leo Pharma Investigational site
    • Michigan
      • Waterford, Michigan, Vereinigte Staaten, 48328
        • Rekrutierung
        • Leo Pharma Investigational site
    • Oklahoma
      • Tulsa, Oklahoma, Vereinigte Staaten, 74136
        • Rekrutierung
        • Leo Pharma Investigational site
    • Oregon
      • Portland, Oregon, Vereinigte Staaten, 97239
        • Rekrutierung
        • Leo Pharma Investigational site
    • South Carolina
      • Charleston, South Carolina, Vereinigte Staaten, 27420
        • Rekrutierung
        • Leo Pharma Investigational site
    • Virginia
      • Norfolk, Virginia, Vereinigte Staaten, 23502
        • Rekrutierung
        • Leo Pharma Investigational site
  • Vereinigtes Königreich
      • Lincoln, Vereinigtes Königreich, LN2 5QY
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
      • London, Vereinigtes Königreich, WC1N 3JH
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
      • Sheffield, Vereinigtes Königreich, S10 2TH
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site
      • Southampton, Vereinigtes Königreich, SO16 6YD
        • Aktiv, nicht rekrutierend
        • Leo Pharma Investigational site

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

Zulassungskriterien

Die wichtigsten Voraussetzungen, die Personen erfüllen müssen, die an einer klinischen Studie teilnehmen möchten, bzw. welche Eigenschaften sie mitbringen müssen. Auswahlkriterien bestehen sowohl aus Einschlusskriterien (die erforderlich sind, damit eine Person an der Studie teilnehmen kann) als auch aus Ausschlusskriterien (die eine Person an der Teilnahme hindern). Arten von Zulassungskriterien umfassen, ob eine Studie gesunde Freiwillige akzeptiert, Alters- oder Altersgruppenanforderungen hat oder durch das Geschlecht begrenzt ist.

Studienberechtigtes Alter

6 Monate bis 11 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Age 6 months to <12 years at screening.
  • Body weight ≥9 kg at screening.
  • Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
  • History of AD for: ≥12 months for subjects aged ≥6 years at screening and ≥3 months for subjects aged 6 months to <6 years at screening.
  • Documented inadequate response to mid-strength TCS within 6 months before the screening visit.
  • AD involvement of ≥10% body surface area at screening and baseline according to component A of SCORAD.
  • An EASI score of ≥16 at screening and baseline.
  • An IGA score of ≥3 at screening and baseline.
  • A Child Worst Itch NRS average score of ≥4 (subjects aged ≥6 years at screening) or a Scratch ObsRO average score of ≥4 (subjects aged <6 years at screening) during the week prior to baseline.

Exclusion Criteria:

  • Treatment with the topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), topical phosphodiesterase-4 inhibitors (PDE-4), and topical Janus kinase inhibitors (JAK) within 1 week prior to baseline.
  • Treatment with bleach baths within 1 week prior to baseline.
  • Treatment with the immunomodulatory medications systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, Janus kinase inhibitors) and systemic corticosteroids (excludes inhaled, ophthalmic, or intranasal delivery) within 4 weeks prior to baseline.
  • Use of tanning beds or phototherapy within 4 weeks prior to baseline.
  • Treatment with a live (attenuated) or non-live vaccine within 30 days prior to the baseline visit.
  • Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment such as seborrheic dermatitis, active skin infection, scabies, cutaneous T cell lymphoma, or psoriasis.
  • Clinically significant active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals or antiprotozoal within 2 weeks before the baseline visit.
  • History of past or current hepatitis B or C including a positive hepatitis B or C test at screening.

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm

Teilnehmergruppe / Arm

Eine Gruppe oder Untergruppe von Teilnehmern an einer klinischen Studie, die gemäß dem Protokoll der Studie eine bestimmte Intervention/Behandlung oder keine Intervention erhält.
Intervention / Behandlung

Intervention / Behandlung

Ein Prozess oder eine Handlung, die im Mittelpunkt einer klinischen Studie steht. Interventionen umfassen Medikamente, medizinische Geräte, Verfahren, Impfstoffe und andere Produkte, die entweder in der Erprobungsphase oder bereits verfügbar sind. Interventionen können auch nicht-invasive Ansätze umfassen, wie z. B. Aufklärung oder eine Änderung der Ernährung und Bewegung.
Experimental: Tralokinumab + TCS for subjects aged 2 to <12 years

Dose and dosing frequency for each subject will depend on the subject's body weight.
Arzneimittel: Tralokinumab + TCS

The trial medication will be given under the skin (SC). Dose and dosing frequency for each subject will depend on the subject's body weight. Subjects who will receive treatment every two weeks will receive a loading dose corresponding to a double dose at baseline. Subjects who will receive treatment every 4 weeks will receive a staggered loading dose at baseline and Week 2. After the loading dose, they will continue to receive treatment every 4 weeks. The dose and dosing frequency will be adjusted according to the subject's body weight at weeks 16, 32, 52, 64, 88, 112, 136, 160, and 184.
Experimental: Placebo + TCS for subjects aged 2 to <12 years

Dose and dosing frequency for each subject will depend on the subject's body weight.
Arzneimittel: Placebo + TCS

The trial medication will be given under the skin (SC). Dose and dosing frequency for each subject will depend on the subject's body weight. Subjects who will receive treatment every two weeks will receive a loading dose corresponding to a double dose at baseline. Subjects who will receive treatment every 4 weeks will receive a staggered loading dose at baseline and Week 2. After the loading dose, they will continue to receive treatment every 4 weeks. The dose and dosing frequency will be adjusted according to the subject's body weight at weeks 16, 32, 52, 64, 88, 112, 136, 160, and 184.
Experimental: Tralokinumab + TCS for subjects aged 6 months to <2 years

Dose and dosing frequency for each subject will depend on the subject's body weight.
Arzneimittel: Tralokinumab + TCS

The trial medication will be given under the skin (SC). Dose and dosing frequency for each subject will depend on the subject's body weight. Subjects who will receive treatment every two weeks will receive a loading dose corresponding to a double dose at baseline. Subjects who will receive treatment every 4 weeks will receive a staggered loading dose at baseline and Week 2. After the loading dose, they will continue to receive treatment every 4 weeks. The dose and dosing frequency will be adjusted according to the subject's body weight at weeks 16, 32, 52, 64, 88, 112, 136, 160, and 184.

Was misst die Studie?

Primäre Ergebnismessungen

Primäre Ergebnismessungen

Im Protokoll einer klinischen Studie die geplante Ergebnismessung, die für die Bewertung der Wirkung einer Intervention/Behandlung am wichtigsten ist. Die meisten klinischen Studien haben einen primären Endpunkt, aber einige haben mehr als einen.
Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening.
Zeitfenster: At week 16

The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
At week 16
Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
Zeitfenster: At week 16

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
At week 16

Sekundäre Ergebnismessungen

Sekundäre Ergebnismessungen

Im Protokoll einer klinischen Studie ein geplantes Ergebnismaß, das nicht so wichtig ist wie das primäre Ergebnismaß für die Bewertung der Wirkung einer Intervention, aber dennoch von Interesse ist. Die meisten klinischen Studien haben mehr als einen sekundären Endpunkt.
Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Vorhandensein von behandlungsbedingten Anti-Arzneimittel-Antikörpern (ja/nein) bei Probanden im Alter von 2 bis <12 Jahren beim Screening.
Zeitfenster: Vom Ausgangswert bis zur 16. Woche
Vom Ausgangswert bis zur 16. Woche
Vorhandensein von behandlungsbedingten Anti-Arzneimittel-Antikörpern (ja/nein) bei Probanden im Alter von 6 Monaten bis <2 Jahren zum Zeitpunkt des Screenings.
Zeitfenster: Vom Ausgangswert bis zur 16. Woche
Vom Ausgangswert bis zur 16. Woche
Einsatz einer Rettungsbehandlung (ja/nein) bei Probanden im Alter von 2 bis <12 Jahren zum Zeitpunkt des Screenings.
Zeitfenster: Vom Ausgangswert bis zur 16. Woche
Vom Ausgangswert bis zur 16. Woche
Einsatz einer Rettungsbehandlung (ja/nein) bei Probanden im Alter von 6 Monaten bis <2 Jahren zum Zeitpunkt des Screenings.
Zeitfenster: Vom Ausgangswert bis zur 16. Woche
Vom Ausgangswert bis zur 16. Woche
Prozentuale Veränderung der betroffenen Körperoberfläche (KOF) bei Probanden im Alter von 2 bis <12 Jahren beim Screening.
Zeitfenster: Vom Ausgangswert bis Woche 52
Vom Ausgangswert bis Woche 52
Prozentuale Veränderung der betroffenen Körperoberfläche (KOF) bei Probanden im Alter von 6 Monaten bis <2 Jahren beim Screening.
Zeitfenster: Vom Ausgangswert bis Woche 52
Vom Ausgangswert bis Woche 52
Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
Zeitfenster: At week 16

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
At week 16
Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
Zeitfenster: At week 16

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
At week 16
Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 6 month to <2 years at screening.
Zeitfenster: At week 16

The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
At week 16
Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
Zeitfenster: At week 16

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
At week 16
Having at least 50% reduction in EASI score in subjects aged 2 to <12 years at screening.
Zeitfenster: At week 16

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
At week 16
Having at least 50% reduction in EASI score in subjects aged 6 month to <2 years at screening.
Zeitfenster: At week 16

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
At week 16
Percent change in EASI in subjects aged 2 to <12 years at screening.
Zeitfenster: From baseline to week 16

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
From baseline to week 16
Percent change in EASI in subjects aged 6 month to <2 years at screening.
Zeitfenster: From baseline to week 16

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
From baseline to week 16
Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 2 to <12 years at screening.
Zeitfenster: From baseline to week 16

The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis. The maximum total score is 103, with higher values indicating more severe disease.
From baseline to week 16
Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 6 month to <2 years at screening.
Zeitfenster: From baseline to week 16

The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis. The maximum total score is 103, with higher values indicating more severe disease.
From baseline to week 16
Percent change in affected BSA in subjects aged 2 to <12 years at screening.
Zeitfenster: From baseline to week 16

BSA is a body surface area.
From baseline to week 16
Percent change in affected BSA in subjects aged 6 month to <2 years at screening.
Zeitfenster: From baseline to week 16

BSA is a body surface area.
From baseline to week 16
Percent change in Children's Dermatology Life Quality Index (CDLQI) for subjects aged 4 to <12 years at screening.
Zeitfenster: From baseline to Week 16

The CDLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
From baseline to Week 16
Reduction in Child Worst Itch numeric rating score (NRS) (weekly average) ≥4 for subjects aged 6 to <12 years at screening.
Zeitfenster: From baseline to Week 16

The Child Worst Itch NRS assesses 'worst itch today' and 'worst itch last night' using a numerical rating scale from 0 to 10, where 0 represents 'Not itchy at all' and 10 represents 'Very itchy'.
From baseline to Week 16
Reduction in Scratch Observer-Reported Outcome (ObsRO) (weekly average) ≥4 for subjects aged 2 to <6 years at screening.
Zeitfenster: From baseline to week 16

The Scratch ObsRO NRS assesses 'worst scratching during the past 24 hours' using a numerical rating scale from 0 to 10, where 0 represents 'No scratching' and 10 represents 'Worst scratching possible'.
From baseline to week 16
Reduction in Scratch Observer-Reported Outcome (ObsRO) (weekly average) ≥4 for subjects aged 6 months to <2 years years at screening.
Zeitfenster: From baseline to week 16

The Scratch ObsRO NRS assesses 'worst scratching during the past 24 hours' using a numerical rating scale from 0 to 10, where 0 represents 'No scratching' and 10 represents 'Worst scratching possible'.
From baseline to week 16
Reduction of ≥4 in Child Worst Itch NRS (weekly average) for subjects aged 6 to <12 years at screening or Scratch ObsRO (weekly average) for subjects aged 2 to <6 years at screening.
Zeitfenster: From baseline to week 16

The Child Worst Itch NRS assesses 'worst itch today' and 'worst itch last night' using a numerical rating scale from 0 to 10, where 0 represents 'Not itchy at all' and 10 represents 'Very itchy'.

The Scratch ObsRO NRS assesses 'worst scratching during the past 24 hours' using a numerical rating scale from 0 to 10, where 0 represents 'No scratching' and 10 represents 'Worst scratching possible'.
From baseline to week 16
Percent change in Patient-Oriented Eczema Measure (POEM) in subjects aged 2 to <12 years at screening.
Zeitfenster: From baseline to week 16

The POEM is a validated questionnaire used to assess disease symptoms in atopic eczema patients in both clinical practice and clinical trials. The tool consists of 7 items each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Subjects will score how often they have experienced each symptom over the previous week on a 5-point categorical response scale (0 = 'no days'; 1 = '1 to 2 days'; 2 = '3 to 4 days'; 3 = '5 to 6'days; 4 = 'every day'). The total score is the sum of the 7 items (range 0 to 28) and reflects disease-related morbidity; a high score is indicative of a worse disease severity.
From baseline to week 16
Percent change in Patient-Oriented Eczema Measure (POEM) in subjects aged 6 month to <2 years at screening.
Zeitfenster: From baseline to week 16

The POEM is a validated questionnaire used to assess disease symptoms in atopic eczema patients in both clinical practice and clinical trials. The tool consists of 7 items each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Subjects will score how often they have experienced each symptom over the previous week on a 5-point categorical response scale (0 = 'no days'; 1 = '1 to 2 days'; 2 = '3 to 4 days'; 3 = '5 to 6'days; 4 = 'every day'). The total score is the sum of the 7 items (range 0 to 28) and reflects disease-related morbidity; a high score is indicative of a worse disease severity.
From baseline to week 16
Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 2 to <12 years at screening.
Zeitfenster: From baseline to week 16

The POEM is a validated questionnaire used to assess disease symptoms in atopic eczema patients in both clinical practice and clinical trials. The tool consists of 7 items each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Subjects will score how often they have experienced each symptom over the previous week on a 5-point categorical response scale (0 = 'no days'; 1 = '1 to 2 days'; 2 = '3 to 4 days'; 3 = '5 to 6'days; 4 = 'every day'). The total score is the sum of the 7 items (range 0 to 28) and reflects disease-related morbidity; a high score is indicative of a worse disease severity.
From baseline to week 16
Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 6 month to <2 years at screening.
Zeitfenster: From baseline to week 16

The POEM is a validated questionnaire used to assess disease symptoms in atopic eczema patients in both clinical practice and clinical trials. The tool consists of 7 items each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Subjects will score how often they have experienced each symptom over the previous week on a 5-point categorical response scale (0 = 'no days'; 1 = '1 to 2 days'; 2 = '3 to 4 days'; 3 = '5 to 6'days; 4 = 'every day'). The total score is the sum of the 7 items (range 0 to 28) and reflects disease-related morbidity; a high score is indicative of a worse disease severity.
From baseline to week 16
Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening.
Zeitfenster: From baseline to week 16

The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
From baseline to week 16
Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening.
Zeitfenster: From baseline to week 16

The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
From baseline to week 16
Change in Child Worst Itch NRS (weekly average) for subjects aged 6 to <12 years at screening.
Zeitfenster: From baseline to week 16

The Scratch ObsRO NRS assesses 'worst scratching during the past 24 hours' using a numerical rating scale from 0 to 10, where 0 represents 'No scratching' and 10 represents 'Worst scratching possible'.
From baseline to week 16
Change in Scratch Observer-Reported Outcome (ObsRO) (weekly average) in subjects aged 2 to <6 years at screening.
Zeitfenster: From baseline to week 16

The Scratch ObsRO NRS assesses 'worst scratching during the past 24 hours' using a numerical rating scale from 0 to 10, where 0 represents 'No scratching' and 10 represents 'Worst scratching possible'.
From baseline to week 16
Change in Scratch Observer-Reported Outcome (ObsRO) (weekly average) in subjects aged 6 month to <2 years at screening.
Zeitfenster: From baseline to week 16

The Scratch ObsRO NRS assesses 'worst scratching during the past 24 hours' using a numerical rating scale from 0 to 10, where 0 represents 'No scratching' and 10 represents 'Worst scratching possible'.
From baseline to week 16
Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥6 for subjects aged 4 to <12 years at screening.
Zeitfenster: From baseline to week 16

The CDLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
From baseline to week 16
Number of treatment-emergent adverse events (AEs) per subject aged 2 to <12 years at screening.
Zeitfenster: From baseline to week 16

An adverse event (AE) is any unexpected medical issue that happens to a person who is taking a medication or participating in a study. It could be a symptom, disease, or abnormal test result, even if it's not necessarily caused by the medication being used.
From baseline to week 16
Number of treatment-emergent adverse events (AEs) per subject aged 6 month to <2 years at screening.
Zeitfenster: From baseline to week 16

An adverse event (AE) is any unexpected medical issue that happens to a person who is taking a medication or participating in a study. It could be a symptom, disease, or abnormal test result, even if it's not necessarily caused by the medication being used.
From baseline to week 16
Number of TCS free days in subjects aged 2 to <12 years at screening.
Zeitfenster: From baseline to week 16

TCS- tropical corticosteroids.
From baseline to week 16
Number of TCS free days in subjects aged 6 month to <2 years at screening.
Zeitfenster: From baseline to week 16

TCS- tropical corticosteroids.
From baseline to week 16
Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening.
Zeitfenster: At week 52

The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
At week 52
Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 6 month to <2 years at screening.
Zeitfenster: At week 52

The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
At week 52
Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
Zeitfenster: At week 52

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
At week 52
Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
Zeitfenster: At week 52

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
At week 52
Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
Zeitfenster: At week 52

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
At week 52
Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
Zeitfenster: At week 52

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
At week 52
Percent change in EASI in subjects aged 2 to <12 years at screening.
Zeitfenster: From baseline to week 52

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
From baseline to week 52
Percent change in EASI in subjects aged 6 month to <2 years at screening.
Zeitfenster: From baseline to week 52

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
From baseline to week 52
Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 2 to <12 years at screening.
Zeitfenster: From baseline to week 52

The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis. The maximum total score is 103, with higher values indicating more severe disease.
From baseline to week 52
Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 6 month to <2 years at screening.
Zeitfenster: From baseline to week 52

The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis. The maximum total score is 103, with higher values indicating more severe disease.
From baseline to week 52
Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening.
Zeitfenster: From baseline to week 52

The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
From baseline to week 52
Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening.
Zeitfenster: From baseline to week 52

The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
From baseline to week 52
Percent change in Children's Dermatology Life Quality Index (CDLQI) in subjects aged 4 to <12 years at screening.
Zeitfenster: From baseline to week 52

The CDLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
From baseline to week 52
Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥6 for subjects aged 4 to <12 years at screening.
Zeitfenster: From baseline to week 52

The CDLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
From baseline to week 52
Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 2 to <12 years at screening.
Zeitfenster: From baseline to week 52

The POEM is a validated questionnaire used to assess disease symptoms in atopic eczema patients in both clinical practice and clinical trials. The tool consists of 7 items each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Subjects will score how often they have experienced each symptom over the previous week on a 5-point categorical response scale (0 = 'no days'; 1 = '1 to 2 days'; 2 = '3 to 4 days'; 3 = '5 to 6'days; 4 = 'every day'). The total score is the sum of the 7 items (range 0 to 28) and reflects disease-related morbidity; a high score is indicative of a worse disease severity.
From baseline to week 52
Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 6 month to <2 years at screening.
Zeitfenster: From baseline to week 52

The POEM is a validated questionnaire used to assess disease symptoms in atopic eczema patients in both clinical practice and clinical trials. The tool consists of 7 items each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Subjects will score how often they have experienced each symptom over the previous week on a 5-point categorical response scale (0 = 'no days'; 1 = '1 to 2 days'; 2 = '3 to 4 days'; 3 = '5 to 6'days; 4 = 'every day'). The total score is the sum of the 7 items (range 0 to 28) and reflects disease-related morbidity; a high score is indicative of a worse disease severity.
From baseline to week 52
Number of treatment-emergent adverse events (AEs) per subject aged 2 to <12 years at screening.
Zeitfenster: From week 16 to 52

An adverse event (AE) is any unexpected medical issue that happens to a person who is taking a medication or participating in a study. It could be a symptom, disease, or abnormal test result, even if it's not necessarily caused by the medication being used.
From week 16 to 52
Number of treatment-emergent adverse events (AEs) per subject aged 6 month to <2 years at screening.
Zeitfenster: From week 16 to 52

An adverse event (AE) is any unexpected medical issue that happens to a person who is taking a medication or participating in a study. It could be a symptom, disease, or abnormal test result, even if it's not necessarily caused by the medication being used.
From week 16 to 52
Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 2 to <12 years at screening.
Zeitfenster: From week 16 to 52

It measures whether the developed antibodies in response to the treatment have any effect on the safety and effectiveness of the treatment.
From week 16 to 52
Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 6 month to <2 years at screening.
Zeitfenster: From week 16 to 52

It measures whether the developed antibodies in response to the treatment have any effect on the safety and effectiveness of the treatment.
From week 16 to 52
Number of treatment-emergent adverse events (AEs) per subject aged 2 to <12 years at screening.
Zeitfenster: From week 52 to end of treatment

An adverse event (AE) is any unexpected medical issue that happens to a person who is taking a medication or participating in a study. It could be a symptom, disease, or abnormal test result, even if it's not necessarily caused by the medication being used.
From week 52 to end of treatment
Number of treatment-emergent adverse events (AEs) per subject aged 6 month to <2 years at screening.
Zeitfenster: From week 52 to end of treatment

An adverse event (AE) is any unexpected medical issue that happens to a person who is taking a medication or participating in a study. It could be a symptom, disease, or abnormal test result, even if it's not necessarily caused by the medication being used.
From week 52 to end of treatment
Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening.
Zeitfenster: At week 100

The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
At week 100
Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 6 month to <2 years at screening.
Zeitfenster: At week 100

The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
At week 100
Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
Zeitfenster: At week 100

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
At week 100
Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
Zeitfenster: At week 100

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
At week 100
Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
Zeitfenster: At week 100

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
At week 100
Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
Zeitfenster: At week 100

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
At week 100
Percent change in EASI in subjects aged 2 to <12 years at screening.
Zeitfenster: From baseline to week 100

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
From baseline to week 100
Percent change in EASI in subjects aged 6 month to <2 years at screening.
Zeitfenster: From baseline to week 100

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
From baseline to week 100
Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening.
Zeitfenster: From baseline to week 100

The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
From baseline to week 100
Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening.
Zeitfenster: From baseline to week 100

The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
From baseline to week 100
Percent change in Children's Dermatology Life Quality Index (CDLQI) for subjects aged 4 to <12 years at screening.
Zeitfenster: From baseline to week 100

The CDLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
From baseline to week 100
Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥ 6 for subjects aged 4 to <12 years at screening.
Zeitfenster: From baseline to week 100

The CDLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
From baseline to week 100
Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening.
Zeitfenster: At week 148

The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
At week 148
Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 6 month to <2 years at screening.
Zeitfenster: At week 148

The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
At week 148
Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
Zeitfenster: At week 148

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
At week 148
Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
Zeitfenster: At week 148

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
At week 148
Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
Zeitfenster: At week 148

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
At week 148
Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
Zeitfenster: At week 148

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
At week 148
Percent change in EASI in subjects aged 2 to <12 years at screening.
Zeitfenster: From baseline to week 148

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
From baseline to week 148
Percent change in EASI in subjects aged 6 month to <2 years at screening.
Zeitfenster: From baseline to week 148

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
From baseline to week 148
Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening.
Zeitfenster: From baseline to week 148

The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
From baseline to week 148
Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening.
Zeitfenster: From baseline to week 148

The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
From baseline to week 148
Percent change in Children's Dermatology Life Quality Index (CDLQI) for subjects aged 4 to <12 years at screening.
Zeitfenster: From baseline to week 148

The CDLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
From baseline to week 148
Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥ 6 for subjects aged 4 to <12 years at screening.
Zeitfenster: From baseline to week 148

The CDLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
From baseline to week 148
Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening.
Zeitfenster: At week 196

The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
At week 196
Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 6 month to <2 years at screening.
Zeitfenster: At week 196

The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
At week 196
Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
Zeitfenster: At week 196

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
At week 196
Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
Zeitfenster: At week 196

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
At week 196
Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
Zeitfenster: At week 196

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
At week 196
Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
Zeitfenster: At week 196

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
At week 196
Percent change in EASI in subjects aged 2 to <12 years at screening.
Zeitfenster: From baseline to week 196

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
From baseline to week 196
Percent change in EASI in subjects aged 6 month to <2 years at screening.
Zeitfenster: From baseline to week 196

The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
From baseline to week 196
Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening.
Zeitfenster: From baseline to week 196

The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
From baseline to week 196
Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening.
Zeitfenster: From baseline to week 196

The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
From baseline to week 196
Percent change in Children's Dermatology Life Quality Index (CDLQI) for subjects aged 4 to <12 years at screening.
Zeitfenster: From baseline to week 196

The CDLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
From baseline to week 196
Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥ 6 for subjects aged 4 to <12 years at screening.
Zeitfenster: From baseline to week 196

The CDLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
From baseline to week 196

Mitarbeiter und Ermittler

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

Sponsor

Sponsor

Die Organisation oder Person, die die Studie initiiert und die Autorität und Kontrolle über die Studie hat.
LEO Pharma

Ermittler

Ermittler

Ein Forscher, der an einer klinischen Studie beteiligt ist. Zu den verwandten Begriffen gehören Studienleiter, Unterprüfer am Standort, Studienleiter, Studienleiter und Studienleiter.
  • Studienleiter: Medical Expert, LEO Pharma

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)

Studienbeginn

Das tatsächliche Datum, an dem der erste Teilnehmer in eine klinische Studie aufgenommen wurde. Das „voraussichtliche“ Studienstartdatum ist das Datum, von dem die Forscher glauben, dass es das Studienstartdatum sein wird.
10. Juni 2024

Primärer Abschluss (Tatsächlich)

Primärer Abschluss

Das Datum, an dem der letzte Teilnehmer einer klinischen Studie untersucht wurde oder eine Intervention erhalten hat, um endgültige Daten für das primäre Ergebnis zu sammeln. Ob die klinische Studie protokollgemäß endete oder beendet wurde, hat keinen Einfluss auf dieses Datum. Bei klinischen Studien mit mehr als einem primären Ergebnismaß mit unterschiedlichen Abschlussdaten bezieht sich dieser Begriff auf das Datum, an dem die Datenerhebung für alle primären Ergebnismaße abgeschlossen ist. Das „erwartete“ primäre Abschlussdatum ist das Datum, von dem die Forscher glauben, dass es das primäre Abschlussdatum für die Studie sein wird.
16. Oktober 2026

Studienabschluss (Geschätzt)

Studienabschluss

Das Datum, an dem der letzte Teilnehmer an einer klinischen Studie untersucht wurde oder eine Intervention/Behandlung erhielt, um endgültige Daten für die primären Ergebnismaße, sekundären Ergebnismaße und Nebenwirkungen zu sammeln (d. h. der letzte Besuch des letzten Teilnehmers). Das „voraussichtliche“ Abschlussdatum der Studie ist das Datum, von dem die Forscher glauben, dass es das Abschlussdatum der Studie sein wird.
28. April 2028

Studienanmeldedaten

Zuerst eingereicht

Zuerst eingereicht

Das Datum, an dem der Studiensponsor oder Prüfer zum ersten Mal einen Studienbericht bei ClinicalTrials.gov eingereicht hat. Zwischen dem Datum der ersten Einreichung und der Verfügbarkeit des Datensatzes auf ClinicalTrials.gov (dem ersten veröffentlichten Datum) liegt in der Regel eine Verzögerung von einigen Tagen.
8. März 2024

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

Das Datum, an dem der Studiensponsor oder Prüfer zum ersten Mal einen Studienbericht einreicht, der den Qualitätskontrollkriterien (QC) der National Library of Medicine (NLM) entspricht. Der Sponsor oder Prüfer muss möglicherweise einen Studienbericht ein- oder mehrmals überarbeiten und einreichen, bevor die QC-Überprüfungskriterien von NLM erfüllt sind. Es liegt in der Verantwortung des Sponsors oder Prüfers, sicherzustellen, dass die Studienaufzeichnung mit den NLM-QC-Überprüfungskriterien übereinstimmt.
8. März 2024

Zuerst gepostet (Tatsächlich)

Zuerst gepostet

Das Datum, an dem der Studienbericht zum ersten Mal auf ClinicalTrials.gov verfügbar war, nachdem die Qualitätskontrolle (QC) der National Library of Medicine (NLM) abgeschlossen wurde. Zwischen dem Datum, an dem der Studiensponsor oder Prüfer den Studienbericht eingereicht hat, und dem ersten veröffentlichten Datum liegt in der Regel eine Verzögerung von einigen Tagen.
15. März 2024

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

Letztes Update gepostet

Das letzte Datum, an dem Änderungen an einem Studienbericht auf ClinicalTrials.gov verfügbar gemacht wurden. Es kann eine Verzögerung zwischen der Übermittlung der Änderungen an ClinicalTrials.gov durch den Sponsor oder Prüfer der Studie (Datum der letzten eingereichten Aktualisierung) und dem Datum der letzten Veröffentlichung der Aktualisierung geben.
9. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

Das letzte Datum, an dem der Studiensponsor oder Prüfer Änderungen an einem Studienbericht eingereicht hat, die mit den Qualitätskontrollkriterien (QC) der National Library of Medicine (NLM) übereinstimmen. Es liegt in der Verantwortung des Sponsors oder Prüfers, sicherzustellen, dass die Studienaufzeichnung mit den NLM-QC-Überprüfungskriterien übereinstimmt.
6. November 2026

Zuletzt verifiziert

Zuletzt verifiziert

Das letzte Datum, an dem der Studiensponsor oder Prüfer die Informationen über eine klinische Studie auf ClinicalTrials.gov als richtig und aktuell bestätigt hat. Wenn eine Studie den Rekrutierungsstatus Recruiting hat; noch keine Rekrutierung; oder aktiv, keine Rekrutierung wurde innerhalb der letzten 2 Jahre nicht bestätigt, der Rekrutierungsstatus der Studie wird als unbekannt angezeigt.
1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

Andere Studien-ID-Nummern

Andere Identifikatoren oder ID-Nummern als die NCT-Nummer, die einer klinischen Studie vom Sponsor der Studie, Geldgebern oder anderen zugewiesen werden. Diese Nummern können eindeutige Kennungen von anderen Studienregistern und Zuschussnummern der National Institutes of Health enthalten.
  • LP0162-1336
  • U1111-1285-6559 (Andere Kennung: World Health Organization (WHO))
  • 2023-503630-44-00 (Ctis)
  • 2023 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

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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