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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Abrocitinib
DrugAbrocitinib administered as liquid oral suspension.
Placebo
Other interventionPlacebo administered as liquid oral suspension.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: AbrocitinibExperimental treatment 1 intervention
Group B: Matching PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 122
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 12Secondary outcomes
1
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 22
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 123
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 Source ClinicalTrials.gov