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
Status: Recruiting
Location: See all (40) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 11
Healthy Volunteers: f
View:
⁃ • 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
Locations
United States
Alabama
Cahaba Dermatology & Skin Health Center, LLC
RECRUITING
Birmingham
Arkansas
Arkansas Research Trials
RECRUITING
North Little Rock
California
Investigational Drug Service - Rady Childrens Hospital-San Diego
RECRUITING
San Diego
University of California, San Diego/Rady Children's Hospital-San Diego; Pediatric & Adolescent Derm
RECRUITING
San Diego
Florida
Solutions Through Advanced Research
RECRUITING
Jacksonville
Indiana
Dawes Fretzin Clinical Research Group, LLC
RECRUITING
Indianapolis
Missouri
Saint Louis University - Department of Dermatology
RECRUITING
St Louis
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Tribe Clinical Research, LLC
RECRUITING
Greenville
Texas
Texas Dermatology and Laser Specialists
NOT_YET_RECRUITING
San Antonio
Other Locations
China
Beijing Children's hospital, Capital Medical University
RECRUITING
Beijing
Hunan Children's Hospital
RECRUITING
Changsha
Hangzhou Third People's Hospital
RECRUITING
Hangzhou
Dermatology Hospital of Jiangxi Province
RECRUITING
Nanchang
Shanghai Children's Hospital
RECRUITING
Shanghai
Shanghai Children's Hospital
RECRUITING
Shanghai
Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine
RECRUITING
Shanghai
Shenzhen Children's Hospital
RECRUITING
Shenzhen
Germany
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
RECRUITING
Dresden
Universitätsklinikum Münster
NOT_YET_RECRUITING
Münster
Hungary
Clinexpert Kft.
RECRUITING
Budapest
Pécsi Tudományegyetem Klinikai Központ
RECRUITING
Pécs
University of Pecs
RECRUITING
Pécs
Japan
Fukuoka National Hospital
RECRUITING
Fukuoka
Saruta Dermatology Clinic
RECRUITING
Fukuoka
Dermatology and Ophthalmology Kume Clinic
RECRUITING
Sakai
Sasamoto Children's Clinic
RECRUITING
Setagaya-ku
Queen's square Medical Facilities Queen's square Dermatology and Allergology
RECRUITING
Yokohama
Mexico
Servicios Hospitalarios de México S.A. de C.V. (Hospital Angeles Chihuahua)
NOT_YET_RECRUITING
Chihuahua City
Eukarya Pharmasite S.C.
NOT_YET_RECRUITING
Monterrey
Arke SMO S.A. de C.V.
NOT_YET_RECRUITING
Veracruz
Poland
DERMAPOLIS Medical Dermatology Center dr n. med. Edyta Gebska
RECRUITING
Chorzów
Centrum Medyczne Angelius Provita
RECRUITING
Katowice
Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
RECRUITING
Lodz
LUXDERM Specjalistyczny Gabinet Dermatologiczny prof. dr hab. n. med. Dorota Krasowska
RECRUITING
Lublin
Dermedic Jacek Zdybski
RECRUITING
Ostrowiec Świętokrzyski
Centrum Medyczne Evimed
RECRUITING
Warsaw
Spain
Hospital General de Granollers
RECRUITING
Granollers
CHUS - Hospital Clinico Universitario
RECRUITING
Santiago De Compostela
Hospital Universitario Miguel Servet
RECRUITING
Zaragoza
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Backup
Nancy A Sherman, BA
Nancy.Sherman@Pfizer.com
2127332323
Time Frame
Start Date:2025-07-24
Estimated Completion Date:2027-05-02
Participants
Target number of participants:150
Treatments
Experimental: Abrocitinib
Abrocitinib administered as liquid oral suspension.