Chofu

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.

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.