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Clinical Trials in China / NCT06807268
Recruiting Phase 3

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

NCT06807268 · tracked via the Priya Life Science China tracker
Sponsor
Pfizer
Phase
Phase 3
Started
2025-07-24
Last updated
2026-09-04

Condition(s) studied

Eczema

Investigational drug(s) / intervention(s)

AbrocitinibPlacebo

Abrocitinib: Abrocitinib administered as liquid oral suspension.

Placebo: Placebo administered as liquid oral suspension.

Study 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

Sex
ALL
Min age
6 Years
Max age
11 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (46)

FacilityCityRegionStatus
Cahaba Dermatology & Skin Health Center, LLC Birmingham Alabama Recruiting
Arkansas Research Trials North Little Rock Arkansas Recruiting
Investigational Drug Service - Rady Childrens Hospital-San Diego San Diego California Recruiting
University of California, San Diego/Rady Children's Hospital-San Diego; Pediatric & Adolescent Derm San Diego California Recruiting
Solutions Through Advanced Research Jacksonville Florida Recruiting
Ada West Research Meridian Idaho Recruiting
Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana Recruiting
Saint Louis University - Department of Dermatology St Louis Missouri Recruiting
Medical University of South Carolina - Department of Dermatology Charleston South Carolina Recruiting
Medical University of South Carolina - South Carolina Translational Research Nexus Clinic Charleston South Carolina Recruiting
Medical University of South Carolina - Walton Research Building Charleston South Carolina Recruiting
Tribe Clinical Research, LLC Greenville South Carolina Recruiting
Texas Dermatology and Laser Specialists San Antonio Texas Recruiting
Beijing Children's hospital, Capital Medical University Beijing Beijing Municipality Recruiting
Shenzhen Children's Hospital Shenzhen Guangdong Recruiting
Hunan Children's Hospital Changsha Hunan Recruiting
Dermatology Hospital of Jiangxi Province Nanchang Jiangxi Recruiting
Shanghai Children's Hospital Shanghai Shanghai Municipality Recruiting
Hangzhou Third People's Hospital Hangzhou Zhejiang Recruiting
Shanghai Children's Hospital Shanghai China Recruiting
Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine Shanghai China Recruiting
Universitätsklinikum Münster Münster North Rhine-Westphalia Recruiting
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden Dresden Saxony Recruiting
Pécsi Tudományegyetem Klinikai Központ Pécs Baranya Recruiting
Trial Pharma Kft. Békéscsaba Bekes County Recruiting
Clinexpert Kft. Budapest Pest County Recruiting
University of Pecs Pécs Hungary Recruiting
Queen's square Medical Facilities Queen's square Dermatology and Allergology Yokohama Kanagawa Recruiting
Dermatology and Ophthalmology Kume Clinic Sakai Osaka Recruiting
Sasamoto Children's Clinic Setagaya-ku Tokyo Recruiting
Fukuoka National Hospital Fukuoka Japan Recruiting
Saruta Dermatology Clinic Fukuoka Japan Recruiting
Hospital Infantil de México Federico Gómez Mexico City Mexico City Not Yet Recruiting
Eukarya Pharmasite S.C. Monterrey Nuevo León Recruiting
Arke SMO S.A. de C.V. Veracruz Veracruz Recruiting
Servicios Hospitalarios de México S.A. de C.V. (Hospital Angeles Chihuahua) Chihuahua City Mexico Recruiting
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski spółka cywilna Krakow Lesser Poland Voivodeship Recruiting
LUXDERM Specjalistyczny Gabinet Dermatologiczny prof. dr hab. n. med. Dorota Krasowska Lublin Lublin Voivodeship Recruiting
Centrum Medyczne Evimed Warsaw Masovian Voivodeship Recruiting
DERMAPOLIS Medical Dermatology Center dr n. med. Edyta Gebska Chorzów Silesian Voivodeship Recruiting

+ 6 more sites — see the full list on the official registry below.

More Pfizer trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06807268 on ClinicalTrials.gov ↗ ← All trials in China