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.
Different questionnaires will be used to find out how the participant's eczema is doing during the research study. An electronic diary, which looks like a cellular phone, will be used to collect the questionnaire information and other research study-related information. It will also be used to remind participants to take the test medicine each day and to fill out the questionnaires. Participants will also be asked to wear something on their wrist that looks like a children's wristwatch so we can know when they are scratching their skin because of their atopic dermatitis. Laboratory tests, physical examinations and vital signs (height, weight, temperature, blood pressure and heart rate) will be conducted before and during the research study to monitor your child's health. Participants will need to come to the clinic for research study visits and at other times during the research study, the research study doctor or nurse will call the participants to find out the participant is doing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
150
Abrocitinib administered as liquid oral suspension.
Placebo administered as liquid oral suspension.
Response based on achieving Validated Investigator's Global Assessment (vIGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points at Week 12
The difference in proportion of responders based on vIGA at Week 12 in patients with moderate-to-severe AD treated with abrocitinib versus placebo
Time frame: At week 12
Response based on achieving ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI)-75 at Week 12
The difference in proportion of responders based on EASI-75 at Week 12 in patients with moderate-to-severe AD treated with abrocitinib versus placebo
Time frame: At week 12
Change from Baseline (CFB) in the Worst Itch Numerical Rating Scale (WI-NRS) at Week 2
The difference in mean CFB in WI-NRS total score at Week 2 in patients with moderate-to-severe AD treated with abrocitinib versus placebo
Time frame: At week 2
Response based on achieving at least a 4-point improvement from baseline in the WI-NRS at Week 12
The difference in proportion of responders based on achieving at least a 4-point improvement from baseline in the WI-NRS at Week 12 in patients with moderate-to-severe AD treated with abrocitinib versus placebo
Time frame: At week 12
Response based on achieving WI-NRS <2 at Week 12
The difference in proportion of responders based on achieving WI-NRS \<2 at Week 12 in patients with moderate-to-severe AD treated with abrocitinib versus placebo
Time frame: At week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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