A Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema
Eligible age
6–11 yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
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About this study
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.
Sponsor: Pfizer
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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.
Where it's recruiting
Birmingham
North Little Rock
San Diego
Jacksonville
Indianapolis
St Louis
Charleston · Greenville
San Antonio
Source: ClinicalTrials.gov · NCT06807268 · last updated 2026-05-06