A Phase 3, Multicenter, Long-Term, Open Label Study Evaluating the Safety and Efficacy of Abrocitinib, With or Without Topical Medications Administered to Pediatric Participants Aged 2 Years and Older With Moderate-to-Severe Atopic Dermatitis
Pfizer
Summary
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.
Description
Phase 3, open-label study to assess the long-term safety and efficacy of liquid abrocitinib oral suspension with or without topical medications in children ≥2 years of age with moderate-to-severe atopic dermatitis (AD). This study will enroll participants in two cohorts: an extension cohort of participants who previously completed prior abrocitinib studies, and a de novo cohort of participants (6 to \<12 years of age) who have not participated in previous abrocitinib studies. Study duration will be up to 2 years (or commercial availability, whichever occurs earlier). The study will enroll a ma…
Eligibility
- Age range
- 2–11 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria for the Extension Cohort: 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. Inclusion Criteria for the De Novo Cohort: Age 1. Children aged 6 to \<12 years at the…
Interventions
- DrugAbrocitinib
Abrocitinib administered as liquid oral suspension.
Locations (31)
- Cahaba Dermatology & Skin Health CenterBirmingham, Alabama
- Arkansas Research TrialsNorth Little Rock, Arkansas
- Investigational Drug Service - Rady Childrens Hospital-San DiegoSan Diego, California
- University of California, San Diego/ Rady Children's Hospital - San DiegoSan Diego, California
- Solutions Through Advanced ResearchJacksonville, Florida
- Dawes Fretzin Clinical Research Group, LLCIndianapolis, Indiana