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Study of abrocitinib oral suspension for children aged 2 years and older with moderate to severe atopic dermatitis to evaluate long-term safety and effectiveness

Verified siteInvestigationalNo placebo

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What is this trial about?

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

This clinical study focuses on children aged 2 years and older who have moderate-to-severe atopic dermatitis, also known as eczema. This is a long-lasting skin condition that causes itching, redness, and inflammation of the skin. The study will test a medicine called abrocitinib (also known as PF-04965842), which will be given as an oral suspension that can be taken by mouth.

The purpose of this research is to evaluate how safe abrocitinib is when used for a long time in children with this skin condition. During the study, participants may receive the study medication either alone or together with other skin treatments that are applied directly to the skin. The medication will be given using a special measuring device (oral syringe) to ensure the correct dose is taken.

The study will last for 24 months, during which time doctors will regularly check the children's health and how well the treatment is working. The medicine will be given as a liquid that can be taken by mouth, with a maximum daily dose of 100 mg/ml. Throughout the study, doctors will monitor any changes in the skin condition and keep track of any side effects that may occur.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial qualification
The study is for children aged 2 years and older with moderate to severe eczema (atopic dermatitis)
To qualify, you must have completed a previous treatment phase in a parent study
Your child must weigh at least 15 kg (33 pounds)
Your child must have had eczema for at least 6 months before screening
Step 2
Medical condition requirements
Your child's eczema must affect at least 10% of their body surface
Previous treatment with skin medications (topical treatments) must have been used for at least 4 weeks without adequate improvement
The condition must be confirmed through specific medical assessments at the beginning of the study
Step 3
Treatment phase
Your child will receive abrocitinib as an oral suspension (liquid medicine taken by mouth)
The medicine may be given with or without additional skin treatments
The study will monitor how well the medicine works and any side effects that may occur
Regular assessments will track improvements in itching, scratching, and the extent of eczema
Step 4
Ongoing evaluations
Regular checks of your child's skin condition will be performed
Blood tests will be conducted to monitor safety
Quality of life assessments will be completed throughout the study
The impact of eczema on family life will be evaluated
Some participants may receive vaccines during the study to assess immune response
Step 5
Study duration
The study is long-term, running from late 2025 to early 2032
Regular visits to the study center will be required throughout this period
The number of days without using additional skin treatments will be recorded

Who can join the trial?

10 criteria

Must have previously completed treatment in the parent study and be between 2 and 12 years old
Must be between 6 and 12 years old when joining this study
Must have been diagnosed with chronic atopic dermatitis (a long-lasting skin condition causing itching and inflammation) for at least 6 months
Must have moderate-to-severe atopic dermatitis with:
- At least 10% of body surface affected
- Moderate to severe symptoms as assessed by doctor
- Significant disease severity score (EASI score of 16 or higher)
- Significant itching (score of 4 or higher)
- Must have tried topical treatments (medicines applied to the skin) for at least 4 weeks without adequate improvement
- Must weigh at least 15 kilograms
- Both boys and girls can participate

Who cannot join the trial?

12 criteria

Children younger than 2 years old cannot participate in the study
Patients who do not have moderate to severe atopic dermatitis (a chronic inflammatory skin condition causing itchy, red, and scaly rashes)
Patients who cannot commit to long-term follow-up visits required by the study
Patients currently participating in other clinical trials
Patients with known allergies or hypersensitivity to abrocitinib (the study medication) or its components
Patients with serious or uncontrolled medical conditions that could interfere with the study
Patients who have received live vaccines within 4 weeks before starting the study
Patients with active or chronic infections
Patients with a history of cancer
Patients taking medications that could interact with the study drug
Patients with significant liver or kidney problems
Patients who are pregnant or breastfeeding

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Verified sites

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

Trial locations

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Investigated drugs

Abrocitinib is a medication used to treat moderate to severe atopic dermatitis (a type of eczema). It works by reducing inflammation in the skin and helping to control itching and redness. This medication belongs to a class of drugs called JAK inhibitors, which work by blocking certain signals in the body that cause inflammation. Topical medications (applied directly to the skin) may be used alongside abrocitinib. These may include various creams, ointments, or lotions that help manage the symptoms of atopic dermatitis. The specific topical medications are not named in the trial but are used as supportive treatments to help control skin inflammation and symptoms.

Abrocitinib

What is already known about the treatment

Abrocitinib – An oral JAK1 inhibitor medication administered in tablet form for the treatment of moderate-to-severe atopic dermatitis (eczema). The drug works by blocking Janus kinase 1 (JAK1) signaling pathways that are involved in inflammation, helping to reduce itching, redness, and skin lesions associated with atopic dermatitis. As a member of the JAK inhibitor class of medications, abrocitinib represents a targeted approach to treating inflammatory skin conditions, particularly in cases where traditional therapies have not provided adequate relief. The medication has shown promise in clinical trials for pediatric patients aged 2 years and older, and can be used either alone or in combination with topical medications for enhanced therapeutic effect.

Investigated diseases

Atopic Dermatitis - A chronic inflammatory skin condition that causes dry, itchy, and inflamed skin. The condition typically appears in patches on various parts of the body, with symptoms including redness, swelling, and intense itching. Atopic dermatitis commonly begins in childhood and follows a pattern of flare-ups and remissions. The condition affects the skin's barrier function, making it more sensitive to irritants and allergens. The severity can range from mild to severe, with moderate-to-severe cases showing more extensive skin involvement and more intense symptoms.