Actively Recruiting

Phase 3
Age: 2Years - 11Years
All Genders
NCT06807281

A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema

Led by Pfizer · Updated on 2026-04-07

500

Participants Needed

31

Research Sites

324 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This 24-month study will assess the long-term safety and efficacy of liquid abrocitinib oral suspension with or without topical medications in children 2 years of age or older with moderate-to-severe atopic dermatitis. The study will enroll two groups: participants who have completed other abrocitinib studies and participants who have never participated in abrocitinib studies.

CONDITIONS

Official Title

A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema

Who Can Participate

Age: 2Years - 11Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants aged 2 to less than 12 years who completed prior abrocitinib studies (extension cohort)
  • Female participants of childbearing potential must use effective contraception; males have no contraception requirements
  • Children aged 6 to less than 12 years who have not participated in prior abrocitinib studies (de novo cohort)
  • Documented chronic atopic dermatitis for at least 6 months, confirmed by criteria
  • Moderate-to-severe atopic dermatitis at baseline (specific clinical measures required)
  • History of inadequate response to topical therapies for atopic dermatitis
  • Body weight of at least 15 kg
Not Eligible

You will not qualify if you...

  • Any medical or psychiatric condition that increases risk or makes participation unsafe, including recent suicidal ideation or behavior
  • For extension cohort: ongoing safety concerns from parent studies or early discontinuation in parent studies
  • Use of prohibited concomitant treatments or live vaccines during study and for 6 weeks after
  • For de novo cohort: recent or active infections requiring treatment or hospitalization
  • History of disseminated or recurrent herpes infections
  • Infection with HIV, hepatitis B or C, or active/inadequately treated tuberculosis
  • Skin conditions like psoriasis or lupus that interfere with evaluation
  • History of skeletal dysplasia, retinal detachment, blood disorders, or malignancies
  • Immunodeficiency or family history of hereditary immunodeficiency
  • Prior systemic JAK inhibitor treatment for atopic dermatitis
  • Recent live attenuated vaccinations or need for such vaccines during study
  • Use of strong CYP2C19 and CYP2C9 enzyme inhibitors or inducers
  • Recent investigational drug use within 30 days or 5 half-lives
  • Abnormal liver, kidney, or blood test results beyond specified thresholds
  • Investigator site staff, their family, and sponsor employees involved in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 31 locations

1

Cahaba Dermatology & Skin Health Center

Birmingham, Alabama, United States, 35244

Actively Recruiting

2

Arkansas Research Trials

North Little Rock, Arkansas, United States, 72117

Actively Recruiting

3

Investigational Drug Service - Rady Childrens Hospital-San Diego

San Diego, California, United States, 92123

Not Yet Recruiting

4

University of California, San Diego/ Rady Children's Hospital - San Diego

San Diego, California, United States, 92123

Not Yet Recruiting

5

Solutions Through Advanced Research

Jacksonville, Florida, United States, 32256

Actively Recruiting

6

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States, 46250

Not Yet Recruiting

7

Tribe Clinical Research, LLC

Greenville, South Carolina, United States, 29607

Actively Recruiting

8

Hunan Children's Hospital

Changsha, Hunan, China, 410007

Not Yet Recruiting

9

Dermatology Hospital of Jiangxi Province

Nanchang, Jiangxi, China, 330000

Not Yet Recruiting

10

Hangzhou Third People's Hospital

Hangzhou, Zhejiang, China, 310009

Not Yet Recruiting

11

Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine

Shanghai, China, 200092

Actively Recruiting

12

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, Germany, 48149

Not Yet Recruiting

13

Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden

Dresden, Saxony, Germany, 01307

Not Yet Recruiting

14

Pécsi Tudományegyetem Klinikai Központ

Pécs, Baranya, Hungary, 7632

Actively Recruiting

15

Clinexpert Kft.

Budapest, Pest County, Hungary, 1033

Actively Recruiting

16

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

Yokohama, Kanagawa, Japan, 220-6208

Actively Recruiting

17

Dermatology and Ophthalmology Kume Clinic

Sakai, Osaka, Japan, 593-8324

Actively Recruiting

18

Sasamoto Children's Clinic

Setagaya-ku, Tokyo, Japan, 157-0066

Actively Recruiting

19

Fukuoka National Hospital

Fukuoka, Japan, 811-1394

Actively Recruiting

20

Eukarya Pharmasite S.C.

Monterrey, Nuevo León, Mexico, 64718

Not Yet Recruiting

21

Arké SMO S.A de C.V

Veracruz, Veracruz Ignacio de LA Llave, Mexico, 91900

Not Yet Recruiting

22

Servicios Hospitalarios de Mexico S.A. DE C.V.

Chihuahua City, Mexico, 31238

Not Yet Recruiting

23

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

Lublin, Lublin Voivodeship, Poland, 20-573

Not Yet Recruiting

24

Centrum Medyczne Evimed

Warsaw, Masovian Voivodeship, Poland, 02-625

Not Yet Recruiting

25

DERMAPOLIS Medical Dermatology Center dr n. med. Edyta Gebska

Chorzów, Silesian Voivodeship, Poland, 41-500

Actively Recruiting

26

Centrum Medyczne Angelius Provita

Katowice, Silesian Voivodeship, Poland, 40-611

Not Yet Recruiting

27

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

Lodz, Łódź Voivodeship, Poland, 90-436

Not Yet Recruiting

28

Dermedic Jacek Zdybski

Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland, 27-400

Actively Recruiting

29

CHUS - Hospital Clinico Universitario

Santiago de Compostela, A Coruña [LA Coruña], Spain, 15706

Not Yet Recruiting

30

Hospital General de Granollers

Granollers, Barcelona, Spain, 08402

Not Yet Recruiting

31

Hospital Universitario Miguel Servet

Zaragoza, Spain, 50009

Not Yet Recruiting

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Research Team

P

Pfizer CT.gov Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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