A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema

NCT06807281 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: B74510312023-509124-18-00
• Study Type: interventional
• Target: 500
• Locations: 8 countries
• Sites: 26

Brief Summary

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.

Conditions

Atopic Dermatitis

Keywords

eczema; atopic dermatitis

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events (AEs) that lead to study discontinuation

  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

Secondary Outcomes (17)

• Number of Participants With Clinically Significant Laboratory Abnormalities

  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

  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

  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

  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

  0-24 months

Study Arms (2)

Extension

EXPERIMENTAL

Patients who have completed other abrocitinib studies

Drug: Abrocitinib

De novo

EXPERIMENTAL

Patients who have not participated other abrocitinib studies

Drug: Abrocitinib

Interventions

Abrocitinib DRUG

Abrocitinib administered as liquid oral suspension.

Also known as: PF-04965842

De novo; Extension

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. 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.
• Age
• Children aged 6 to \<12 years at the time of informed consent/assent.
• No contraception methods are required for male participants.
• Disease Characteristics:
• 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.
• Body weight ≥15 kg

You may not qualify if:

• Medical Conditions:
• 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:
• Required use of any prohibited concomitant treatments outlined in Section 6.9.3 and Appendix 9 of study protocol.
• Required vaccination with live attenuated vaccines during study treatment and for 6 weeks after discontinuing study treatment.
• Diagnostic Assessments:
• 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.
• Medical Conditions:
• 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.
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (26)

Cahaba Dermatology & Skin Health Center

Birmingham, Alabama, 35244, United States

RECRUITING

Arkansas Research Trials

North Little Rock, Arkansas, 72117, United States

RECRUITING

Investigational Drug Service - Rady Childrens Hospital-San Diego

San Diego, California, 92123, United States

NOT YET RECRUITING

University of California, San Diego/ Rady Children's Hospital - San Diego

San Diego, California, 92123, United States

NOT YET RECRUITING

Solutions Through Advanced Research

Jacksonville, Florida, 32256, United States

RECRUITING

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

NOT YET RECRUITING

Tribe Clinical Research, LLC

Greenville, South Carolina, 29607, United States

RECRUITING

Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine

Shanghai, 200092, China

NOT YET RECRUITING

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

NOT YET RECRUITING

Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden

Dresden, Saxony, 01307, Germany

NOT YET RECRUITING

Pécsi Tudományegyetem Klinikai Központ

Pécs, Baranya, 7632, Hungary

RECRUITING

Clinexpert Kft.

Budapest, Pest County, 1033, Hungary

NOT YET RECRUITING

Queen's square Medical Facilities Queen's square Dermatology and Allergology

Yokohama, Kanagawa, 220-6208, Japan

RECRUITING

Dermatology and Ophthalmology Kume Clinic

Sakai, Osaka, 593-8324, Japan

RECRUITING

Sasamoto Children's Clinic

Setagaya-ku, Tokyo, 157-0066, Japan

RECRUITING

Fukuoka National Hospital

Fukuoka, 811-1394, Japan

RECRUITING

Eukarya Pharmasite S.C.

Monterrey, Nuevo León, 64718, Mexico

NOT YET RECRUITING

Arké SMO S.A de C.V

Veracruz, Veracruz Ignacio de LA Llave, 91900, Mexico

NOT YET RECRUITING

Servicios Hospitalarios de Mexico S.A. DE C.V.

Chihuahua City, 31238, Mexico

NOT YET RECRUITING

Centrum Medyczne Evimed

Warsaw, Masovian Voivodeship, 02-625, Poland

NOT YET RECRUITING

DERMAPOLIS Medical Dermatology Center dr n. med. Edyta Gebska

Chorzów, Silesian Voivodeship, 41-500, Poland

NOT YET RECRUITING

Centrum Medyczne Angelius Provita

Katowice, Silesian Voivodeship, 40-611, Poland

NOT YET RECRUITING

Dermedic Jacek Zdybski

Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400, Poland

RECRUITING

CHUS - Hospital Clinico Universitario

Santiago de Compostela, A Coruña [LA Coruña], 15706, Spain

NOT YET RECRUITING

Hospital General de Granollers

Granollers, Barcelona, 08402, Spain

NOT YET RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

NOT YET RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

abrocitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: December 2, 2025
• Primary Completion (Estimated): February 22, 2032
• Study Completion (Estimated): February 22, 2032
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

PL (4); JP (4); US (7); DE (2); ES (3); HU (2); CN (1); ME (3)