Actively Recruiting
Study of Abrocitinib Medicine for Children Ages 6 to Under 12 With Moderate-to-Severe Eczema
Led by Pfizer · Updated on 2026-07-22
150
Participants Needed
42
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research study is evaluating the medicine abrocitinib in children aged 6 to less than 12 years with moderate-to-severe eczema. The purpose is to find out if abrocitinib improves eczema symptoms and is safe for this age group. Participants will be randomly assigned to receive either abrocitinib or a placebo for 16 weeks. The study is conducted as a phase 3, randomized, double-blind trial and will last about 24 weeks in total. Participants will receive abrocitinib or placebo as a liquid oral suspension. During the study, an electronic diary resembling a cell phone will be used to collect questionnaire information, remind participants to take their medicine daily, and record research data. Participants will also wear a wrist device similar to a childrens wristwatch to monitor scratching caused by eczema. The study includes laboratory tests, physical exams, and vital sign checks before and throughout the study. Participants will visit the clinic for study visits and receive follow-up calls from study doctors or nurses to monitor their health. Questionnaires will assess eczema symptoms, and physical measures such as height, weight, temperature, blood pressure, and heart rate will be tracked. The main outcomes measured include improvements in eczema severity and itchiness at Week 12, with safety and health closely monitored during the entire 24-week study period.
CONDITIONS
Brief Title
A Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6 to less than 12 years at the time of consent
- Documented diagnosis of chronic atopic dermatitis for at least 1 year
- Moderate-to-severe atopic dermatitis at baseline (BSA ≥10%, vIGA ≥3, EASI ≥16, WI-NRS ≥4)
- History of inadequate response to topical medical therapy within 6 months prior to screening
- Body weight of at least 15 kg
You will not qualify if you...
- Any medical or psychiatric condition increasing study risk or inappropriate participation
- SDQ total score ≥17 without evaluation by pediatric mental health professional
- Skin infections requiring systemic antimicrobial treatment within 2 weeks prior to baseline or superficial infections within 1 week
- History of systemic infection requiring hospitalization or parenteral antimicrobial therapy within 1 month prior to baseline
- History of disseminated or recurrent herpes infections
- Infection with HIV, hepatitis B, or hepatitis C
- Active or inadequately treated latent tuberculosis
- Skin conditions interfering with evaluation (e.g., psoriasis, seborrheic dermatitis, lupus)
- History of skeletal dysplasia or retinal detachment
- History or conditions related to thrombocytopenia, coagulopathy, or platelet dysfunction
- Prior history of leukemia, lymphoma, sarcoma, or other malignancy
- Immunodeficiency disorder or first-degree relative with hereditary immunodeficiency
- Prior treatment with systemic JAK inhibitor for atopic dermatitis
- Live attenuated vaccination within 6 weeks prior to baseline or planned during treatment or within 6 weeks after last dose
- Use of strong CYP2C19 and CYP2C9 enzyme inhibitors or inducers and certain P-gp substrates
- Previous investigational drug use within 30 days or 5 half-lives before baseline
Research Team
P
Pfizer CT.gov Call Center
N
Nancy A Sherman, BA
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