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Een langdurige studie van het geneesmiddel genaamd Abrocitinib bij kinderen van 2 jaar en ouder met matig tot ernstig eczeem

12 oktober 2026 bijgewerkt door: Pfizer

Een fase 3, multicenter, langdurige, open labelstudie ter evaluatie van de veiligheid en werkzaamheid van schap-schoktinib, met of zonder actuele medicijnen toegediend aan pediatrische deelnemers van 2 jaar en ouder met matige tot ernstige atopische dermatitis

This 24-month study will assess the long-term safety and efficacy of liquid abrocitinib oral suspension with or without topical medications in children 2 years of age or older with moderate-to-severe atopic dermatitis. The study will enroll two groups: participants who have completed other abrocitinib studies and participants who have never participated in abrocitinib studies.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Phase 3, open-label study to assess the long-term safety and efficacy of liquid abrocitinib oral suspension with or without topical medications in children ≥2 years of age with moderate-to-severe atopic dermatitis (AD). This study will enroll participants in two cohorts: an extension cohort of participants who previously completed prior abrocitinib studies, and a de novo cohort of participants (6 to <12 years of age) who have not participated in previous abrocitinib studies. Study duration will be up to 2 years (or commercial availability, whichever occurs earlier). The study will enroll a maximum of approximately 500 participants with moderate-to-severe Atopic Dermatitis from study sites globally (extension cohort will enroll up to 320 participants; de novo cohort will enroll approximately 180 participants). All participants will receive the study intervention abrocitinib oral suspension.

Studietype

Ingrijpend

Inschrijving (Geschat)

450

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
      • Shanghai, China, 200062
        • Werving
        • Shanghai Children's Hospital
      • Shanghai, China, 200092
        • Werving
        • Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100045
        • Werving
        • Beijing Children's hospital, Capital Medical University
    • Guangdong
      • Shenzhen, Guangdong, China, 518026
        • Werving
        • Shenzhen Children's Hospital
    • Hunan
      • Changsha, Hunan, China, 410007
        • Werving
        • Hunan Children's Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China, 330000
        • Nog niet aan het werven
        • Dermatology Hospital of Jiangxi Province
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Werving
        • Hangzhou Third People's Hospital
  • Hongarije
    • Baranya
      • Pécs, Baranya, Hongarije, 7632
        • Werving
        • Pécsi Tudományegyetem Klinikai Központ
    • Bekes County
      • Békéscsaba, Bekes County, Hongarije, 5600
        • Werving
        • Trial Pharma Kft.
    • Pest County
      • Budapest, Pest County, Hongarije, 1033
        • Werving
        • Clinexpert Kft.
  • Japan
      • Fukuoka, Japan, 811-1394
        • Werving
        • Fukuoka National Hospital
      • Fukuoka, Japan, 819-0042
        • Werving
        • Saruta Dermatology Clinic
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 220-6208
        • Werving
        • Queen's square Medical Facilities Queen's square Dermatology and Allergology
    • Osaka
      • Sakai, Osaka, Japan, 593-8324
        • Werving
        • Dermatology and Ophthalmology Kume Clinic
    • Tokyo
      • Setagaya-ku, Tokyo, Japan, 157-0066
        • Werving
        • Sasamoto Children's Clinic
  • Mexico
      • Chihuahua City, Mexico, 31238
        • Nog niet aan het werven
        • Servicios Hospitalarios de Mexico S.A. DE C.V.
    • Mexico City
      • Mexico City, Mexico City, Mexico, 06720
        • Nog niet aan het werven
        • Hospital Infantil de Mexico Federico Gomez
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64718
        • Nog niet aan het werven
        • Eukarya Pharmasite S.C.
    • Veracruz Ignacio de LA Llave
      • Veracruz, Veracruz Ignacio de LA Llave, Mexico, 91900
        • Nog niet aan het werven
        • Arké SMO S.A de C.V
  • Polen
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Polen, 20-573
        • Werving
        • LUXDERM Specjalistyczny Gabinet Dermatologiczny prof. dr hab. n. med. Dorota Krasowska
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polen, 02-625
        • Werving
        • Centrum Medyczne Evimed
    • Silesian Voivodeship
      • Chorzów, Silesian Voivodeship, Polen, 41-500
        • Werving
        • DERMAPOLIS Medical Dermatology Center dr n. med. Edyta Gebska
      • Katowice, Silesian Voivodeship, Polen, 40-611
        • Nog niet aan het werven
        • Centrum Medyczne Angelius Provita
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Polen, 90-436
        • Werving
        • Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
    • Świętokrzyskie Voivodeship
      • Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Polen, 27-400
        • Werving
        • Dermedic Jacek Zdybski
  • Spanje
      • Zaragoza, Spanje, 50009
        • Werving
        • Hospital Universitario Miguel Servet
    • A Coruña [LA Coruña]
      • Santiago de Compostela, A Coruña [LA Coruña], Spanje, 15706
        • Werving
        • CHUS - Hospital Clinico Universitario
    • Barcelona
      • Granollers, Barcelona, Spanje, 08402
        • Werving
        • Hospital General de Granollers
  • Verenigde Staten
    • Alabama
      • Birmingham, Alabama, Verenigde Staten, 35244
        • Werving
        • Cahaba Dermatology & Skin Health Center
    • Arkansas
      • North Little Rock, Arkansas, Verenigde Staten, 72117
        • Werving
        • Arkansas Research Trials
    • California
      • San Diego, California, Verenigde Staten, 92123
        • Nog niet aan het werven
        • Investigational Drug Service - Rady Childrens Hospital-San Diego
      • San Diego, California, Verenigde Staten, 92123
        • Nog niet aan het werven
        • University of California, San Diego/ Rady Children's Hospital - San Diego
    • Florida
      • Jacksonville, Florida, Verenigde Staten, 32256
        • Werving
        • Solutions Through Advanced Research
    • Idaho
      • Meridian, Idaho, Verenigde Staten, 83646
        • Nog niet aan het werven
        • Ada West Research - Meridian
    • Indiana
      • Indianapolis, Indiana, Verenigde Staten, 46250
        • Werving
        • Dawes Fretzin Clinical Research Group, LLC
    • Missouri
      • St Louis, Missouri, Verenigde Staten, 63104
        • Werving
        • Saint Louis University
    • South Carolina
      • Charleston, South Carolina, Verenigde Staten, 29425
        • Werving
        • Medical University of South Carolina - South Carolina Translational Research Nexus Clinic
      • Greenville, South Carolina, Verenigde Staten, 29607
        • Werving
        • Tribe Clinical Research, LLC
    • Texas
      • San Antonio, Texas, Verenigde Staten, 78235
        • Nog niet aan het werven
        • Texas Dermatology and Laser Specialists

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

2 jaar tot 11 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria for the Extension Cohort:

1. Participants who have completed the treatment phase of the qualifying parent study (age 2 to <12 years old).

• No contraception methods are required for male participants. Female participants must not be pregnant or breastfeeding and, if the participant is of child-bearing potential, must use a highly effective form of contraception (i.e., abstinence) during the study intervention period and for at least 28 days after the last dose of study intervention.

Inclusion Criteria for the De Novo Cohort:

Age

  1. Children aged 6 to <12 years at the time of informed consent/assent.

    • No contraception methods are required for male participants.

    Disease Characteristics:

  2. Participants who meet all of the following AD criteria:

    • A documented diagnosis of chronic AD for at least 6 months prior to screening and confirmed at screening and baseline visits according to the Hanifin and Rajka criteria; and
    • A diagnosis of moderate-to-severe AD at the baseline visit (must fulfill all of the following criteria: BSA ≥10%, vIGA ≥3, EASI ≥16, and WI-NRS ≥4); and
    • Documented history (within 6 months of the screening visit) of inadequate response to treatment with topical medical therapy for AD (eg, TCS and TCI), for at least 4 weeks and are candidates for systemic therapy.

    Other Inclusion Criteria:

  3. Body weight ≥15 kg

Exclusion Criteria for the Extension Cohort:

Medical Conditions:

  1. Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

    If the participant has SDQ total score ≥17, the investigator should exclude the child or refer them to a pediatric MHP to determine if it is safe to participate in the study. A copy or summary of the evaluation should be placed in the site source documents.

    Prior/Concomitant Therapy:

  2. Required use of any prohibited concomitant treatments outlined in Section 6.9.3 and Appendix 9 of study protocol.

  3. Required vaccination with live attenuated vaccines during study treatment and for 6 weeks after discontinuing study treatment.

    Diagnostic Assessments:

  4. Ongoing adverse event in the parent studies which in the opinion of the investigator, or sponsor, is an ongoing safety concern OR the participant is currently triggering safety monitoring criteria.

  5. Discontinued from treatment early in the parent studies OR triggered a discontinuation criterion at any point during the parent studies OR meets exclusion criteria from the parent studies which in the opinion of the investigator, or sponsor, is an ongoing safety concern.

Exclusion Criteria for the De Novo Cohort

Medical Conditions:

  1. Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

    If the participant has SDQ total score ≥17, the investigator should exclude them or refer the child to a pediatric MHP to determine if it is safe to participate in the study. A copy or summary of the evaluation should be placed in the site source documents.

  2. Have any of the following medical conditions:

    • Infections:

      • Skin infections that require treatment with systemic antimicrobials within 2 weeks prior to Day 1 (baseline) or have superficial skin infections within 1 week of Day 1.
      • History of systemic infection requiring hospitalization or parenteral antimicrobial therapy or as otherwise judged clinically significant by the investigator within 1 month prior to Day 1.
      • Have a history (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent localized, dermatomal herpes zoster.
      • Infection with HIV, hepatitis B, and/or hepatitis C
      • Evidence of active TB or inadequately treated latent TB.

    • Skin Conditions:

      - Including but not limited to psoriasis, seborrheic dermatitis or lupus on Day 1 that would interfere with evaluation of AD or response to treatment.

    • Other Conditions:

      • Documented history of skeletal dysplasia.
      • Documented history of retinal detachment.
      • History of or conditions associated with thrombocytopenia, coagulopathy or platelet dysfunction.
      • Prior history of leukemia, lymphoma, sarcoma or any other malignancy.
      • Immunodeficiency disorder or a first-degree relative with a hereditary immunodeficiency.
      • Any other medical conditions that in the investigator's judgment make the participant inappropriate for the study.

    Prior/Concomitant Therapy:

  3. Prior treatment with a systemic JAK inhibitor for AD.

  4. Live attenuated vaccination within 6 weeks prior to Day 1 or require vaccination with live attenuated vaccines during treatment or within 6 weeks after the last dose of study intervention.

  5. Concomitant use of strong inhibitors and inducers of CYP2C19 enzymes and strong inducers of CYP2C9 enzymes is not allowed in the study.

    Prior/Concurrent Clinical Study Experience:

  6. Previous administration of an investigational drug within 30 days or 5 half lives, whichever is longer, of Day 1.

    Diagnostic Assessments:

  7. Hepatic and/or renal and/or hematological abnormalities defined as:

    • AST >2 x ULN
    • Hemoglobin <10 g/dL
    • ALT >2 x ULN
    • ANC <1000/mm3
    • Total bilirubin ≥1.5 x ULN
    • ALC <500/mm3
    • eGFR <60 mL/min/1.73 m2
    • Platelets <150,000 /mm3

    Other Exclusion Criteria:

  8. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Extension

Patients who have completed other abrocitinib studies
Geneesmiddel: Abrocitinib

Abrocitinib administered as liquid oral suspension.

Andere namen:
  • PF-04965842
Experimenteel: De novo

Patients who have not participated other abrocitinib studies
Geneesmiddel: Abrocitinib

Abrocitinib administered as liquid oral suspension.

Andere namen:
  • PF-04965842

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events (AEs) that lead to study discontinuation
Tijdsspanne: 0-24 months

The number of the treatment emergent adverse events, serious adverse events and adverse events leading to discontinuation among patients with moderate-to-severe disease treated with abrocitinib regardless of discontinuation from study treatment.
0-24 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants With Clinically Significant Laboratory Abnormalities
Tijdsspanne: 0-24 months

The number of clinically significant laboratory abnormalities among participants with moderate-to-severe disease treated with abrocitinib.
0-24 months
Response based on achieving Validated Investigator's Global Assessment (vIGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a 2 -point reduction from baseline at all scheduled time points
Tijdsspanne: Baseline, 24 months

Proportion of responders based on vIGA at all scheduled time points in patients with moderate-to-severe disease treated with abrocitinib
Baseline, 24 months
Percentage of Response based on achieving a ≥4 point improvement from baseline in the Worst Itch Numerical Rating Scale (WI-NRS) at all scheduled time points in participants aged ≥2 to <6 years
Tijdsspanne: 0-24 months

Percentage of responders based on achieving an improvement ≥4 points from baseline at all scheduled time points in the WI-NRS (in patients aged ≥2 to <6 years) with moderate-to-severe disease treated with abrocitinib.
0-24 months
Percentage of Response based on achieving a ≥4-point improvement from baseline in the WSI-NRS at all scheduled time points in participants aged ≥6 to 12 years
Tijdsspanne: 0-24 months

Percentage of responders based on achieving an improvement ≥4 points from baseline at all scheduled time points in the WSI-NRS (in patients aged ≥6 to 12 years) with moderate-to-severe disease treated with abrocitinib.
0-24 months
Percentage of Responders based on achieving Eczema Area and Severity Index (EASI)-50, EASI-90 and EASI-100 at all scheduled time points in participants with moderate-to-severe disease treated with abrocitinib
Tijdsspanne: 0-24 months

Percentage of response based on achieving ≥50%, ≥90%, 100% improvement from parent study baseline in the EASI total score (EASI-50, EASI-90, EASI-100) at all scheduled time points.
0-24 months
Percent Change from Baseline (CFB) in EASI total score at all scheduled time points.
Tijdsspanne: 0-24 months

Mean percent CFB in EASI total score at all scheduled time points in patients with moderate-to-severe disease treated with abrocitinib
0-24 months
Percentage of Participants with Flares
Tijdsspanne: 0-24 months

Percentage of participants reporting flares in patients with moderate-to-severe disease treated with abrocitinib.
0-24 months
CFB in the percentage Body Surface Area (BSA) affected at all scheduled time points
Tijdsspanne: 0-24 months

Mean CFB in BSA affected at all scheduled time points in patients with moderate-to-severe disease treated with abrocitinib.
0-24 months
CFB in Children's Dermatology Life Quality Index (CDLQI) at all scheduled time points.
Tijdsspanne: 0-24 months

Mean CFB in CDLQI at all scheduled time points in participants aged ≥4 to <16 years with moderate-to-severe disease treated with abrocitinib.
0-24 months
CFB in in Infants' Dermatitis Quality of Life (IDQOL) Index at all scheduled time points
Tijdsspanne: 0-24 months

Mean CFB in IDQOL Index or CDQLI depending on age at all scheduled time points in participants aged <4 years with moderate-to-severe disease treated with abrocitinib
0-24 months
CFB in Patient-Oriented Eczema Measure (POEM) at all scheduled time points
Tijdsspanne: 0-24 months

Mean CFB in POEM at all scheduled time points in participants with moderate-to-severe disease treated with abrocitinib.
0-24 months
CFB in Dermatitis Family Impact (DFI) at all scheduled time points
Tijdsspanne: 0-24 months

Mean CFB in DFI at all scheduled time points in participants with moderate-to-severe disease treated with abrocitinib.
0-24 months
CFB in Patient Global Impression of Severity (PGIS) at all scheduled time points
Tijdsspanne: 0-24 months

Mean CFB in PGIS (in patients aged 6 to <12 years) at all scheduled time points in patients with moderate-to-severe disease treated with abrocitinib.
0-24 months
CFB in Observer Reported Global Impression of Severity (OGIS) at all scheduled time points
Tijdsspanne: 0-24 months

Mean CFB in OGIS (in patients aged 2 to <6 years) at all scheduled time points in patients with moderate-to-severe disease treated with abrocitinib
0-24 months
CFB in the the EuroQol- 5 Dimension Youth (EQ-5D-Y)
Tijdsspanne: 0-24 months

Mean CFB in EQ-5D-Y at all scheduled time points in patients with moderate-tosevere AD treated with abrocitinib versus placebo.
0-24 months
Number of topical corticosteroid and /or topical calcineurin inhibitor free days
Tijdsspanne: 0-24 months

Mean number of days free from topical corticosteroids and /or topical calcineurin inhibitor use in patients with moderate-to-severe disease treated with abrocitinib.
0-24 months
Percentage of Participants Achieving satisfactory response in Tdap/DTaP and/or pneumococcal antibody titers as appropriate in participants who receive Tdap/DTaP and/or pneumococcal vaccinations
Tijdsspanne: 0-24 months

For patients that receive Tdap/ DTap and/or pneumococcal vaccinations during the study, the proportion of patients treated with abrocitinib who achieve satisfactory immunogenicity at 4 weeks after receiving the vaccinations.
0-24 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Pfizer

Onderzoekers

  • Studie directeur: Pfizer CT.gov Call Center, Pfizer

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

2 december 2025

Primaire voltooiing (Geschat)

22 februari 2032

Studie voltooiing (Geschat)

22 februari 2032

Studieregistratiedata

Eerst ingediend

29 januari 2025

Eerst ingediend dat voldeed aan de QC-criteria

29 januari 2025

Eerst geplaatst (Werkelijk)

4 februari 2025

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

12 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • B7451031
  • 2023-509124-18-00 (Register-ID: CTIS (EU))
  • 2023 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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