RecruitingPhase 3NCT06807268

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

A 16-WEEK, MULTICENTER, INTERVENTIONAL, PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ABROCITINIB IN CHILDREN 6 TO LESS THAN 12 YEARS OF AGE WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS


Sponsor

Pfizer

Enrollment

150 participants

Start Date

Jul 24, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 6 YearsMax Age: 11 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Abrocitinib and Placebo for people with eczema. The study is currently recruiting participants at 41 locations. People eligible for this study include aged 6 Years to 11 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAbrocitinib

Abrocitinib administered as liquid oral suspension.

OTHERPlacebo

Placebo administered as liquid oral suspension.


Locations(42)

Cahaba Dermatology & Skin Health Center, LLC

Birmingham, Alabama, United States

Arkansas Research Trials

North Little Rock, Arkansas, United States

Investigational Drug Service - Rady Childrens Hospital-San Diego

San Diego, California, United States

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

San Diego, California, United States

Solutions Through Advanced Research

Jacksonville, Florida, United States

Ada West Research

Meridian, Idaho, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

Saint Louis University - Department of Dermatology

St Louis, Missouri, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Tribe Clinical Research, LLC

Greenville, South Carolina, United States

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

Beijing Children's hospital, Capital Medical University

Beijing, Beijing Municipality, China

Shenzhen Children's Hospital

Shenzhen, Guangdong, China

Hunan Children's Hospital

Changsha, Hunan, China

Dermatology Hospital of Jiangxi Province

Nanchang, Jiangxi, China

Shanghai Children's Hospital

Shanghai, Shanghai Municipality, China

Hangzhou Third People's Hospital

Hangzhou, Zhejiang, China

Shanghai Children's Hospital

Shanghai, China

Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine

Shanghai, China

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, Germany

Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden

Dresden, Saxony, Germany

Pécsi Tudományegyetem Klinikai Központ

Pécs, Baranya, Hungary

Trial Pharma Kft.

Békéscsaba, Bekes County, Hungary

Clinexpert Kft.

Budapest, Pest County, Hungary

University of Pecs

Pécs, Hungary

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

Yokohama, Kanagawa, Japan

Dermatology and Ophthalmology Kume Clinic

Sakai, Osaka, Japan

Sasamoto Children's Clinic

Setagaya-ku, Tokyo, Japan

Fukuoka National Hospital

Fukuoka, Japan

Saruta Dermatology Clinic

Fukuoka, Japan

Eukarya Pharmasite S.C.

Monterrey, Nuevo León, Mexico

Arke SMO S.A. de C.V.

Veracruz, Veracruz, Mexico

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

Chihuahua City, Mexico

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

Lublin, Lublin Voivodeship, Poland

Centrum Medyczne Evimed

Warsaw, Masovian Voivodeship, Poland

DERMAPOLIS Medical Dermatology Center dr n. med. Edyta Gebska

Chorzów, Silesian Voivodeship, Poland

Centrum Medyczne Angelius Provita

Katowice, Silesian Voivodeship, Poland

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

Lodz, Łódź Voivodeship, Poland

Dermedic Jacek Zdybski

Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland

CHUS - Hospital Clinico Universitario

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

Hospital General de Granollers

Granollers, Barcelona [barcelona], Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

View Full Details on ClinicalTrials.gov

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NCT06807268


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