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)
Response based on achieving Validated Investigator's Global Assessment (vIGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points at Week 12 — At week 12 The difference in proportion of responders based on vIGA at Week 12 in patients with moderate-to-severe AD treated with abrocitinib versus placebo
Response based on achieving ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI)-75 at Week 12 — At week 12 The difference in proportion of responders based on EASI-75 at Week 12 in patients with moderate-to-severe AD treated with abrocitinib versus placebo
Trial sites (46)
Facility
City
Region
Status
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.
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.
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