Abrocitinib Treatment of Atopic Dermatitis in Children 2 to Less Than 6 Years of Age

NCT07823595 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: B74510302025-523215-11-002025
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Atopic Dermatitis

Keywords

eczema

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, week 12

• 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

  Week 12

Secondary Outcomes (3)

• Change from baseline (CFB) in the Worst Scratch/Itch Numerical Rating Scale (WSI-NRS) at Week 2

  Baseline, Week 2

• Response based on achieving at least a 4-point improvement from baseline in the WSI-NRS at Week 12

  Week 12

• Response based on achieving WSI-NRS <2 at Week 12

  Week 12

Study Arms (2)

Abrocitinib

EXPERIMENTAL

Participants will receive liquid oral suspension of Abrocitinib.

Drug: Abrocitinib

Matching Placebo

PLACEBO COMPARATOR

Participants will receive liquid oral suspension of matching placebo.

Drug: Placebo

Interventions

Abrocitinib DRUG

Administered orally

Also known as: PF-04965842

Abrocitinib

Placebo DRUG

Administered orally

Matching Placebo

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 2 to \<6 years at the time of informed consent /assent.
• Disease Characteristics:
• All participants must meet all of the following 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;
• 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).
• For countries outside the US:
• Eligible participants must have:
• 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.
• For US only:
• Eligible participants are those whose disease is not adequately controlled with at least 1 systemic therapy or when the use of systemic therapies is inadvisable.
• Prior systemic therapies may include biologics such as dupilumab, oral agents such as corticosteroids, cyclosporine, methotrexate Note that an inadequate response to topical treatments alone is not sufficient for eligibility in the US.
• Body weight ≥10 kg.

You may not qualify if:

• 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.
• Evidence of active TB or inadequately treated latent TB.
• 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, sensitive P-gp substrates with narrow therapeutic index and sensitive CYP2C19 substrates with narrow therapeutic index are not allowed in the study.

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

abrocitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Nancy A Sherman, BA

CONTACT

2127332323; nancy.sherman@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 16, 2026
• Study Start (Estimated): May 1, 2027
• Primary Completion (Estimated): April 10, 2029
• Study Completion (Estimated): April 10, 2029
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL