A Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-24

Study Completion Date

2027-05-02

Brief Summary

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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.

Detailed Description

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Different questionnaires will be used to find out how the participant's eczema is doing during the research study. An electronic diary, which looks like a cellular phone, will be used to collect the questionnaire information and other research study-related information. It will also be used to remind participants to take the test medicine each day and to fill out the questionnaires. Participants will also be asked to wear something on their wrist that looks like a children's wristwatch so we can know when they are scratching their skin because of their atopic dermatitis. Laboratory tests, physical examinations and vital signs (height, weight, temperature, blood pressure and heart rate) will be conducted before and during the research study to monitor your child's health. Participants will need to come to the clinic for research study visits and at other times during the research study, the research study doctor or nurse will call the participants to find out the participant is doing.

Conditions

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Eczema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Abrocitinib

Abrocitinib administered as liquid oral suspension.

Group Type EXPERIMENTAL

Abrocitinib

Intervention Type DRUG

Abrocitinib administered as liquid oral suspension.

Matching Placebo

Placebo administered as liquid oral suspension.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo administered as liquid oral suspension.

Interventions

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Abrocitinib

Abrocitinib administered as liquid oral suspension.

Intervention Type DRUG

Placebo

Placebo administered as liquid oral suspension.

Intervention Type OTHER

Other Intervention Names

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PF-04965842

Eligibility Criteria

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Inclusion Criteria

• No contraception methods are required for male participants. Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.

Disease Characteristics:

Participants who meet all of the following AD criteria:

* 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

Body weight ≥15 kg

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

Medical Conditions:

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.

If the participant has SDQ total score ≥17, the investigator should exclude them or refer the child to a pediatric MHP to determine if it is safe to participate in the study. A copy or summary of the evaluation should be placed in the site source documents.

Have any of the following medical conditions:

* Infections:

* 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
* Evidence of active TB or inadequately treated latent TB.
* Skin Conditions:

\- Including but not limited to psoriasis, seborrheic dermatitis or lupus on Day 1 that would interfere with evaluation of AD or response to treatment.
* Other Conditions:

* Documented history of skeletal dysplasia.
* Documented history of retinal detachment.
* History of or conditions associated with thrombocytopenia, coagulopathy or platelet dysfunction.
* Prior history of leukemia, lymphoma, sarcoma or any other malignancy.
* Immunodeficiency disorder or a first-degree relative with a hereditary immunodeficiency.
* Any other medical conditions that in the investigator's judgment make the participant inappropriate for the study.

Prior/Concomitant Therapy:

Prior treatment with a systemic JAK inhibitor for AD. Live attenuated vaccination within 6 weeks prior to Day 1 or require vaccination with live attenuated vaccines during treatment or within 6 weeks after the last dose of study intervention.

Concomitant use of strong inhibitors and inducers of CYP2C19 enzymes, strong inducers of CYP2C9 enzymes, P-gp substrates with narrow therapeutic index and sensitive CYP2C19 substrates is not allowed in the study.

Prior/Concurrent Clinical Study Experience:

Previous administration of an investigational drug within 30 days or 5 half lives, whichever is longer, of Day 1.

Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

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Pfizer CT.gov Call Center

Role: CONTACT

[email protected]

1-800-718-1021

Nancy A Sherman, BA

Role: CONTACT

[email protected]

2127332323

Other Identifiers

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2023-509121-51-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

B7451023

Identifier Type: -

Identifier Source: org_study_id

A Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Abrocitinib

Abrocitinib

Matching Placebo

Placebo

Interventions

Abrocitinib

Placebo

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Pfizer

Responsible Party

Principal Investigators

Pfizer CT.gov Call Center

Locations

Cahaba Dermatology & Skin Health Center, LLC

Arkansas Research Trials

Solutions Through Advanced Research

Miami Dermatology and Laser Research

Dawes Fretzin Clinical Research Group, LLC

Tribe Clinical Research, LLC

Beijing Children's hospital, Capital Medical University

Hunan Children's Hospital

Dermatology Hospital of Jiangxi Province

Hangzhou Third People's Hospital

Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine

Universitätsklinikum Münster

Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden

Pécsi Tudományegyetem Klinikai Központ

Clinexpert Kft.

Queen's square Medical Facilities Queen's square Dermatology and Allergology

Yoshioka Dermatology Clinic

Dermatology and Ophthalmology Kume Clinic

Sasamoto Children's Clinic

Fukuoka National Hospital

Eukarya Pharmasite S.C.

Servicios Hospitalarios de Mexico S.A. DE C.V.

LUXDERM Specjalistyczny Gabinet Dermatologiczny prof. dr hab. n. med. Dorota Krasowska

Centrum Medyczne Evimed

DERMAPOLIS Medical Dermatology Center dr n. med. Edyta Gebska

Centrum Medyczne Angelius Provita

Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak

Dermedic Jacek Zdybski

CHUS - Hospital Clinico Universitario

Hospital General de Granollers

Hospital Universitario Miguel Servet

Countries

Central Contacts

Pfizer CT.gov Call Center

Nancy A Sherman, BA

Related Links

Other Identifiers

2023-509121-51-00

B7451023