RecruitingAtopic Dermatitis
A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema
Eligible age
2–11 yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
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About this study
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.
Sponsor: Pfizer
You may qualify if…
- ✓ 1\. Participants who have completed the treatment phase of the qualifying parent study (age 2 to \<12 years old).
- ✓ No contraception methods are required for male participants. Female participants must not be pregnant or breastfeeding and, if the participant is of child-bearing potential, must use a highly effective form of contraception (i.e., abstinence) during the study intervention period and for at least 28 days after the last dose of study intervention.
- ✓ Age
- ✓ 1. Children aged 6 to \<12 years at the time of informed consent/assent.
- ✓ No contraception methods are required for male participants.
- ✓ Disease Characteristics:
- ✓ 2. Participants who meet all of the following AD criteria:
- ✓ A documented diagnosis of chronic AD for at least 6 months prior to screening and confirmed at screening and baseline visits according to the Hanifin and Rajka criteria; and
You may not qualify if…
- ✕ Medical Conditions:
- ✕ 1. 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 the child or refer them 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.
- ✕ Prior/Concomitant Therapy:
- ✕ 2. Required use of any prohibited concomitant treatments outlined in Section 6.9.3 and Appendix 9 of study protocol.
- ✕ 3. Required vaccination with live attenuated vaccines during study treatment and for 6 weeks after discontinuing study treatment.
- ✕ Diagnostic Assessments:
- ✕ 4. Ongoing adverse event in the parent studies which in the opinion of the investigator, or sponsor, is an ongoing safety concern OR the participant is currently triggering safety monitoring criteria.
Where it's recruiting
Alabama
Birmingham
Arkansas
North Little Rock
California
San Diego
Florida
Jacksonville
Indiana
Indianapolis
South Carolina
Greenville
Source: ClinicalTrials.gov · NCT06807281 · last updated 2026-04-07