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

3 1 1

What is this study about?

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.

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

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

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

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

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Evimed Sp. z o.o.	Warsaw	Poland
Trial Pharma Kft.	Gyula	Hungary
Specjalistyczny gabinet dermatologiczny Aplikacyjno-Badawczy M. Brzewski, P. Brzewski S.C.	Cracow	Poland
Dermoklinika – Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak	Lodz	Poland

Other Sites

Site Name	City	Country
Hospital General De Granollers	Granollers	Spain
Clinexpert Kft.	Budapest	Hungary
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
University Of Pecs	Pecs	Hungary
University Of Szeged	Szeged	Hungary
LUXDERM Specjalistyczny Gabinet Dermatologiczny Prof. Dr. Hab. N. Med. Dorota Krasowska	Lublin	Poland
DERMEDIC Jacek Zdybski	Ostrowiec Swietokrzyski	Poland
Dyhmbyuatv Mgmnlnq Dxsahnrprnt Cmkxru Dx Nn Meuq Eliep Gpmvlb	Chorzow	Poland
Upkyugpxyhmviwfuvwaqj Mxicqxqi Aqv	Munster	Germany
Pbzwakk Sao z oenk	Katowice	Poland

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	05.11.2025
Hungary	Recruiting	05.11.2025
Poland	Recruiting	05.11.2025
Spain	Recruiting	05.11.2025

Trial locations

Investigated drugs:

Abrocitinib

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.

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.

Trial ID:

2023-509124-18-00

Protocol code:

B7451031

NCT ID:

NCT06807281

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?