Abrocitinib Treatment of Atopic Dermatitis in Children 2 to Less Than 6 Years of Age
ConditionAtopic Dermatitis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-5
SponsorPfizer
About this trial
This clinical study is designed to test how well a medicine called abrocitinib works and how safe it is for young children (ages 2 to under 6) who have moderate-to-severe eczema (also known as atopic dermatitis).Eczema is a skin condition that can cause the skin to be dry, itchy, have scaly patches, blisters and skin infections.
How the study works:
* Children will be randomly placed into two groups:
* 2 out of 3 will get the real medicine (abrocitinib). * 1 out of 3 will get a placebo (a look-alike liquid with no active medicine). * Neither the families nor the doctors will know which group each child is in (this is called double-blind).
This study is seeking for children:
* between 2 and under 6 years old. * Who have had eczema for at least 1 year. * Who have moderate-to-severe eczema at the start of the study, based on skin area affected and symptom scores.
The medicine is given once a day as a liquid. The amount given depends on the child's body weight. If the child's eczema doesn't improve enough between weeks 4 and 8, the dose might be increased (still without anyone knowing which group they're in), unless the child can't tolerate it.
All children will also use standard medicated creams during the study. The study will be up to 24 weeks long and there will be a screening period (up to 28 days) to make sure each child qualifies for the study.
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;
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 WSI-NRS ≥4).
a documented history within 6 months before the screening visit of inadequate response to treatment with topical medicated therapy for AD (eg, TCS and TCI) for at least 4 weeks, or;
required at least 1 systemic therapy for control of their disease.
Disqualifiers
Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Skin infections that require treatment with systemic antimicrobials within 2 weeks prior to Day 1 (Baseline), or have non-typical pediatric superficial skin infections (excluding common self-limiting viral conditions such as verruca vulgaris and molluscum contagiosum) 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
DrugAdministered orally
Placebo
DrugAdministered orally
Treatment groups
90 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 percentage of responders based on vIGA at Week 12 in participants with moderate-to-severe AD treated with abrocitinib versus placebo.
Time frame
Baseline, week 122
Response based on achieving ≥75% improvement from baseline in Eczema and Severity Index (EASI) at Week 12
The difference in percentage of responders based on EASI-75 at Week 12 in participants with moderate-to-severe AD treated with abrocitinib versus placebo
Time frame
Week 12Secondary outcomes
1
Change from baseline (CFB) in the Worst Scratch/Itch Numerical Rating Scale (WSI-NRS) at Week 2
The difference in mean CFB in WSI-NRS total score at Week 2 in participants with moderate-to-severe AD treated with abrocitinib versus placebo
Time frame
Baseline, Week 22
Response based on achieving at least a 4-point improvement from baseline in the WSI-NRS at Week 12
The difference in percentage of responders based on achieving at least a 4-point improvement from baseline in the WSI-NRS at Week 12 in participants with moderate-to-severe AD treated with abrocitinib versus placebo
Time frame
Week 123
Response based on achieving WSI-NRS <2 at Week 12
The difference in percentage of responders based on achieving WSI-NRS \<2 at Week 12 in participants with moderate-to-severe AD treated with abrocitinib versus placebo.
Time frame
Week 12Locations
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: