Back to Trials
NCT06807268PHASE3Recruiting

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

Pfizer

Start Date

7/24/2025

Completion Date

5/2/2027

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.

Detailed Description

Different questionnaires will be used to find out how the participant's eczema is doing during the research study. An electronic diary, which looks like a cellular phone, will be used to collect the questionnaire information and other research study-related information. It will also be used to remind participants to take the test medicine each day and to fill out the questionnaires. Participants will also be asked to wear something on their wrist that looks like a children's wristwatch so we can know when they are scratching their skin because of their atopic dermatitis. Laboratory tests, physical examinations and vital signs (height, weight, temperature, blood pressure and heart rate) will be conducted before and during the research study to monitor your child's health. Participants will need to come to the clinic for research study visits and at other times during the research study, the research study doctor or nurse will call the participants to find out the participant is doing.

Eligibility Criteria

Age Range: 6 years to 11 years

Inclusion Criteria Children aged 6 to \<12 years at the time of informed consent/assent. • 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 Other Inclusion Criteria: Body weight ≥15 kg Exclusion Criteria 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. * 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: Prior treatment with a systemic JAK inhibitor for AD. 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. Concomitant use of strong inhibitors and inducers of CYP2C19 enzymes, strong inducers of CYP2C9 enzymes, P-gp substrates with narrow therapeutic index and sensitive CYP2C19 substrates is not allowed in the study. Prior/Concurrent Clinical Study Experience: Previous administration of an investigational drug within 30 days or 5 half lives, whichever is longer, of Day 1.

Interventions

DRUG

Abrocitinib

OTHER

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Eczema

Locations

Cahaba Dermatology & Skin Health Center, LLC

Birmingham, Alabama 35244

United States

Arkansas Research Trials

North Little Rock, Arkansas 72117

United States

Investigational Drug Service - Rady Childrens Hospital-San Diego

San Diego, California 92123

United States

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

San Diego, California 92123

United States

Solutions Through Advanced Research

Jacksonville, Florida 32256

United States

Ada West Research

Meridian, Idaho 83646

United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana 46250

United States

Saint Louis University - Department of Dermatology

St Louis, Missouri 63104

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

Tribe Clinical Research, LLC

Greenville, South Carolina 29607

United States

Texas Dermatology and Laser Specialists

San Antonio, Texas 78235

United States

Beijing Children's hospital, Capital Medical University

Beijing, Beijing Municipality 100045

China

Shenzhen Children's Hospital

Shenzhen, Guangdong 518026

China

Hunan Children's Hospital

Changsha, Hunan 410007

China

Dermatology Hospital of Jiangxi Province

Nanchang, Jiangxi 330000

China

Shanghai Children's Hospital

Shanghai, Shanghai Municipality 200040

China

Hangzhou Third People's Hospital

Hangzhou, Zhejiang 310009

China

Shanghai Children's Hospital

Shanghai, 200062

China

Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine

Shanghai, 200092

China

Universitätsklinikum Münster

Münster, North Rhine-Westphalia 48149

Germany

Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden

Dresden, Saxony 01307

Germany

Pécsi Tudományegyetem Klinikai Központ

Pécs, Baranya 7632

Hungary

Trial Pharma Kft.

Békéscsaba, Bekes County 5600

Hungary

Clinexpert Kft.

Budapest, Pest County 1033

Hungary

University of Pecs

Pécs, 7622

Hungary

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

Yokohama, Kanagawa 220-6208

Japan

Dermatology and Ophthalmology Kume Clinic

Sakai, Osaka 593-8324

Japan

Sasamoto Children's Clinic

Setagaya-ku, Tokyo 157-0066

Japan

Fukuoka National Hospital

Fukuoka, 811-1394

Japan

Saruta Dermatology Clinic

Fukuoka, 819-0042

Japan

Eukarya Pharmasite S.C.

Monterrey, Nuevo León 64718

Mexico

Arke SMO S.A. de C.V.

Veracruz, Veracruz 91900

Mexico

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

Chihuahua City, 31238

Mexico

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

Lublin, Lublin Voivodeship 20-573

Poland

Centrum Medyczne Evimed

Warsaw, Masovian Voivodeship 02-625

Poland

DERMAPOLIS Medical Dermatology Center dr n. med. Edyta Gebska

Chorzów, Silesian Voivodeship 41-500

Poland

Centrum Medyczne Angelius Provita

Katowice, Silesian Voivodeship 40-611

Poland

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

Lodz, Łódź Voivodeship 90-436

Poland

Dermedic Jacek Zdybski

Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship 27-400

Poland

CHUS - Hospital Clinico Universitario

Santiago de Compostela, A Coruña [LA Coruña] 15706

Spain

Hospital General de Granollers

Granollers, Barcelona [barcelona] 08402

Spain

Hospital Universitario Miguel Servet

Zaragoza, 50009

Spain