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Effectiveness and Safety of Abrocitinib in Children 6 to Under 12 Years with Moderate-to-Severe Atopic Dermatitis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is investigating the effectiveness and safety of abrocitinib in children aged 6 to less than 12 years who have moderate-to-severe atopic dermatitis. Atopic dermatitis, also known as atopic eczema, is a chronic inflammatory skin condition that causes itchy, red, swollen, and cracked skin. The purpose of the study is to evaluate how well abrocitinib works compared to placebo when used alongside background topical medications in treating this condition.

The study will last for 16 weeks and follows a randomized, double-blind design where some participants will receive abrocitinib while others will receive placebo. Throughout the study, researchers will monitor how the treatment affects the severity and extent of eczema symptoms, including the intensity of itching and overall skin appearance. They will also track improvements in quality of life and sleep patterns in the participating children.

Participants in the study will continue using their regular topical medications for eczema while adding either abrocitinib or placebo. The study will also assess how children respond to the taste and experience of taking the medication, as well as monitoring for any side effects or safety concerns that might arise during treatment.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Screening and Baseline Assessment
Your child will be evaluated to confirm they meet the study criteria, including having moderate-to-severe atopic dermatitis (also called atopic eczema) for at least 1 year.
The doctor will check if your child's condition covers at least 10% of their body surface area and meets other required severity measures.
Your child must weigh at least 15 kg (about 33 pounds) to participate.
Step 2
Randomization
Your child will be randomly assigned to receive either abrocitinib (the study medication) or a placebo (a substance that looks like the medication but contains no active drug).
Neither you, your child, nor the study doctor will know which treatment your child is receiving during the study.
Step 3
Treatment Period (16 Weeks)
Your child will take the assigned study medication as an oral suspension (liquid medicine taken by mouth) for 16 weeks.
Throughout the study, your child will continue using their regular topical medications (creams or ointments applied to the skin) for eczema.
Step 4
Regular Study Visits
Your child will attend several scheduled visits throughout the 16-week period.
At these visits, the doctor will evaluate your child's skin condition using several measurements:
- vIGA (validated Investigator's Global Assessment): a score that rates the overall severity of eczema
- EASI (Eczema Area and Severity Index): measures the extent and severity of eczema
- WI-NRS (Worst Itch Numerical Rating Scale): measures how intense the itching is
The doctor will also check what percentage of your child's body surface area is affected by eczema.
Step 5
Quality of Life Assessments
Your child will complete questionnaires about how eczema affects their quality of life (CDLQI) and their symptoms (POEM).
You will complete a questionnaire about how your child's condition impacts your family (DFI).
Information about your child's sleep and scratching at night will be collected.
Step 6
Safety Monitoring
Throughout the study, your child will have regular laboratory tests to monitor for any changes that might indicate side effects.
Any side effects or new health issues will be recorded and evaluated.
If your child receives certain vaccines during the study period (diphtheria, tetanus, pertussis, or pneumococcal vaccines), their immune response to these vaccines will be monitored.
Step 7
Medication Experience Assessment
Your child will complete an Acceptability and Palatability Questionnaire to rate how the medication tastes and their overall experience taking it.
Step 8
Study Completion
After completing the 16-week treatment period, your child will have a final assessment of their eczema condition.
The doctor will evaluate if your child's eczema has improved, measuring whether they've achieved clear or almost clear skin and reductions in itch intensity.

Who can join the trial?

8 criteria

Children between the ages of 6 and less than 12 years old when consent is given
Body weight of at least 15 kg (about 33 pounds)
Have been diagnosed with chronic atopic dermatitis (a type of eczema causing dry, itchy, inflamed skin) for at least 1 year before screening
check
Have moderate-to-severe atopic dermatitis that meets all these conditions:
- Affects at least 10% of body surface area
- Score of 3 or higher on the vIGA (validated Investigator Global Assessment - a scale doctors use to rate eczema severity)
- Score of 16 or higher on the EASI (Eczema Area and Severity Index - another measurement of eczema severity)
- Score of 4 or higher on the WI-NRS (Worst Itch Numerical Rating Scale - a measure of itching severity)
- Have documented history (within 6 months before screening) of not responding well to topical treatments for atopic dermatitis (like steroid creams or non-steroid ointments) used for at least 4 weeks, and are suitable candidates for systemic therapy (medication taken by mouth or injection that works throughout the body)

Who cannot join the trial?

10 criteria

You cannot participate if you had a failed treatment with a JAK inhibitor (a specific type of medication that affects your immune system) for atopic dermatitis.
You cannot join if you have any medical condition that could be made worse by taking the study drug or that could affect the study results.
You cannot participate if you have an active infection that requires treatment.
You cannot join if you have had a malignancy (cancer) in the past 5 years, except for certain skin cancers that have been completely removed.
You cannot be in the study if you have had a major heart or blood vessel problem like a heart attack, stroke, or blood clot within the last 6 months.
You cannot participate if you have tuberculosis or other serious infections.
You cannot join if you are pregnant or breastfeeding.
You cannot participate if you have previously been in this specific study.
You cannot join if you have recently received certain vaccines or medications that might interfere with the study treatment.
You cannot participate if you have certain blood test abnormalities that would make the study unsafe for you.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Provita Sp. z o.o.
Katowice, Poland
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Technische Universitaet Dresden
Dresden, Germany
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Universidade De Santiago De Compostela
Santiago De Compostela, Spain

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Investigated drugs

Abrocitinib
is a medication that works by targeting certain proteins in the body that contribute to inflammation. It is being studied for the treatment of atopic dermatitis (also known as eczema), which is a skin condition that causes red, itchy, and inflamed skin. In this trial, it's being tested in children between 6 and 12 years old who have moderate-to-severe atopic dermatitis.
Topical medications
are treatments that are applied directly to the skin. In this study, these medications are used as background treatment alongside the main study medication. These may include creams, ointments, or lotions that help moisturize the skin or reduce inflammation.

Abrocitinib

What is already known about the treatment

Abrocitinib - An oral medication administered as a tablet that inhibits Janus kinase 1 (JAK1) enzymes to reduce inflammation in the body. Currently approved for treating moderate-to-severe atopic dermatitis in adults and adolescents, with ongoing clinical trials exploring its use in children aged 6 to under 12. Abrocitinib works at the molecular level by blocking specific signaling pathways that trigger inflammatory responses in the skin, thereby reducing itching, redness, and skin lesions associated with atopic dermatitis. It belongs to the pharmacological class of JAK inhibitors, representing a newer targeted approach to treating inflammatory skin conditions compared to traditional therapies.

Investigated diseases

Atopic Dermatitis Atopic dermatitis is a chronic inflammatory skin condition characterized by dry, itchy, and inflamed skin. It typically appears as red, scaly patches that may ooze or crust over, particularly in the creases of the elbows, knees, neck, and wrists. The condition often begins in childhood and follows a relapsing and remitting course, with periods of flare-ups alternating with periods of improvement. Atopic dermatitis is associated with intense itching, which can lead to scratching that worsens skin damage and inflammation. In moderate-to-severe cases, the affected skin areas are more extensive, with more pronounced symptoms that significantly impact daily activities and quality of life.