A Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema
ConditionEczema
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-11
SponsorPfizer
About this trial
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.
Eligibility criteria
Qualifiers
A documented diagnosis of chronic AD for at least 1 year prior to screening and confirmed at screening and baseline visits according to the Hanifin and Rajka criteria[19]; and
A diagnosis of moderate-to-severe AD at the baseline visit (must fulfill all of the following criteria: BSA ≥10%, vIGA ≥3, EASI ≥16, and WI-NRS ≥4); and
Documented history (within 6 months of the screening visit) of inadequate response to treatment with topical medical therapy for AD (eg, TCS and TCI), for at least 4 weeks and are candidates for systemic therapy
Disqualifiers
Skin infections that require treatment with systemic antimicrobials within 2 weeks prior to Day 1 (Baseline) or have superficial skin infections within 1 week of Day 1.
History of systemic infection requiring hospitalization or parenteral antimicrobial therapy or as otherwise judged clinically significant by the investigator within 1 month prior to Day 1.
Have a history (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent localized, dermatomal herpes zoster.
Infection with HIV, hepatitis B, and/or hepatitis C
Trial design
Treatments tested in this trial
- Abrocitinib
- Placebo
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov