Long-Term Study of Abrocitinib Oral Suspension in Children 2 to 11 Years With Moderate to Severe Atopic Dermatitis

What this Trial Is About

This research aims to evaluate the long-term safety and effectiveness of liquid abrocitinib oral suspension, with or without topical medications, in children aged 2 years and older who have moderate-to-severe atopic dermatitis. The study is a Phase 3, open-label trial enrolling approximately 500 participants globally, including those who have previously completed abrocitinib studies and those new to this treatment. The study duration extends up to 2 years or until the medicine becomes commercially available, whichever comes first. Participants will receive abrocitinib oral suspension throughout the study. The trial enrolls two groups an extension cohort of children aged 2 to under 12 years who have completed prior abrocitinib studies, and a de novo cohort of children aged 6 to under 12 years who have not been in previous abrocitinib trials. Both groups may use topical medications alongside the study drug as needed. During the study, participants will be regularly assessed for safety by monitoring adverse events, laboratory abnormalities, and other health measures. Researchers will evaluate skin condition improvements using various scales such as the Validated Investigators Global Assessment vIGA, Worst Itch Numerical Rating Scale WI-NRS, and Eczema Area and Severity Index EASI. Quality of life and other patient-reported outcomes will also be tracked. The study includes follow-up to track treatment effects and safety over the full 24 months.

A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema