A Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema

NCT06807268 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: B74510232023-509121-51-00
• Study Type: interventional
• Target: 150
• Locations: 8 countries
• Sites: 41

Brief Summary

This research study is being conducted to find out if the test medicine, abrocitinib, improves eczema and is safe for children 6 to \<12 years of age who have moderate-to-severe eczema. Research study participants who meet the study criteria will be assigned by chance (like the flip of a coin) to receive either abrocitinib test medicine or placebo (pretend medicine that looks just like the test medicine) for 16 weeks. The study will last for about 24 weeks in total.

Conditions

Eczema

Keywords

Dermatitis

Outcome Measures

Primary Outcomes (2)

• 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 reduction from baseline of ≥2 points at Week 12

  The difference in proportion of responders based on vIGA at Week 12 in patients with moderate-to-severe AD treated with abrocitinib versus placebo

  At week 12

• Response based on achieving ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI)-75 at Week 12

  The difference in proportion of responders based on EASI-75 at Week 12 in patients with moderate-to-severe AD treated with abrocitinib versus placebo

  At week 12

Secondary Outcomes (3)

• Change from Baseline (CFB) in the Worst Itch Numerical Rating Scale (WI-NRS) at Week 2

  At week 2

• Response based on achieving at least a 4-point improvement from baseline in the WI-NRS at Week 12

  At week 12

• Response based on achieving WI-NRS <2 at Week 12

  At week 12

Study Arms (2)

Abrocitinib

EXPERIMENTAL

Abrocitinib administered as liquid oral suspension.

Drug: Abrocitinib

Matching Placebo

PLACEBO COMPARATOR

Placebo administered as liquid oral suspension.

Other: Placebo

Interventions

Abrocitinib DRUG

Abrocitinib administered as liquid oral suspension.

Also known as: PF-04965842

Abrocitinib

Placebo OTHER

Placebo administered as liquid oral suspension.

Matching Placebo

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• No contraception methods are required for male participants. Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.
• Disease Characteristics:
• Participants who meet all of the following AD criteria:
• A documented diagnosis of chronic AD for at least 1 year prior to screening and confirmed at screening and baseline visits according to the Hanifin and Rajka criteria\[19\]; 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:

• Participants are excluded from the study if any of the following criteria apply:
• 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.
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (41)

Cahaba Dermatology & Skin Health Center, LLC

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

RECRUITING

University of California, San Diego/Rady Children's Hospital-San Diego; Pediatric & Adolescent Derm

San Diego, California, 92123, United States

RECRUITING

Solutions Through Advanced Research

Jacksonville, Florida, 32256, United States

RECRUITING

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

RECRUITING

Saint Louis University - Department of Dermatology

St Louis, Missouri, 63104, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Tribe Clinical Research, LLC

Greenville, South Carolina, 29607, United States

RECRUITING

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78235, United States

RECRUITING

Beijing Children's hospital, Capital Medical University

Beijing, Beijing Municipality, 100045, China

RECRUITING

Shenzhen Children's Hospital

Shenzhen, Guangdong, 518026, China

RECRUITING

Hunan Children's Hospital

Changsha, Hunan, 410007, China

RECRUITING

Dermatology Hospital of Jiangxi Province

Nanchang, Jiangxi, 330000, China

RECRUITING

Shanghai Children's Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Hangzhou Third People's Hospital

Hangzhou, Zhejiang, 310009, China

RECRUITING

Shanghai Children's Hospital

Shanghai, 200062, China

RECRUITING

Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine

Shanghai, 200092, China

RECRUITING

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

NOT YET RECRUITING

Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden

Dresden, Saxony, 01307, Germany

RECRUITING

Pécsi Tudományegyetem Klinikai Központ

Pécs, Baranya, 7632, Hungary

RECRUITING

Trial Pharma Kft.

Békéscsaba, Bekes County, 5600, Hungary

NOT YET RECRUITING

Clinexpert Kft.

Budapest, Pest County, 1033, Hungary

RECRUITING

University of Pecs

Pécs, 7622, Hungary

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

Saruta Dermatology Clinic

Fukuoka, 819-0042, Japan

RECRUITING

Eukarya Pharmasite S.C.

Monterrey, Nuevo León, 64718, Mexico

NOT YET RECRUITING

Arke SMO S.A. de C.V.

Veracruz, Veracruz, 91900, Mexico

NOT YET RECRUITING

Servicios Hospitalarios de México S.A. de C.V. (Hospital Angeles Chihuahua)

Chihuahua City, 31238, Mexico

NOT YET RECRUITING

LUXDERM Specjalistyczny Gabinet Dermatologiczny prof. dr hab. n. med. Dorota Krasowska

Lublin, Lublin Voivodeship, 20-573, Poland

RECRUITING

Centrum Medyczne Evimed

Warsaw, Masovian Voivodeship, 02-625, Poland

RECRUITING

DERMAPOLIS Medical Dermatology Center dr n. med. Edyta Gebska

Chorzów, Silesian Voivodeship, 41-500, Poland

RECRUITING

Centrum Medyczne Angelius Provita

Katowice, Silesian Voivodeship, 40-611, Poland

RECRUITING

Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak

Lodz, Łódź Voivodeship, 90-436, Poland

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

RECRUITING

Hospital General de Granollers

Granollers, Barcelona [barcelona], 08402, Spain

RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

RECRUITING

Related Links

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

MeSH Terms

Conditions

Eczema; Dermatitis

Interventions

abrocitinib

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

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

Nancy A Sherman, BA

CONTACT

2127332323; Nancy.Sherman@Pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: July 24, 2025
• Primary Completion (Estimated): May 2, 2027
• Study Completion (Estimated): May 2, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

ME (3); ES (3); PL (6); US (10); CN (8); HU (4); DE (2); JP (5)