RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A 16-WEEK, MULTICENTER, INTERVENTIONAL, PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ABROCITINIB IN CHILDREN 6 TO LESS THAN 12 YEARS OF AGE WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

Quick Facts

Study Start:2025-06-30
Study Completion:2027-05-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06807268

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 11 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Infections:
  2. * 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.
  3. * 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.
  4. * Have a history (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent localized, dermatomal herpes zoster.
  5. * Infection with HIV, hepatitis B, and/or hepatitis C
  6. * Evidence of active TB or inadequately treated latent TB.
  7. * Skin Conditions:
  8. * Other Conditions:
  9. * Documented history of skeletal dysplasia.
  10. * Documented history of retinal detachment.
  11. * History of or conditions associated with thrombocytopenia, coagulopathy or platelet dysfunction.
  12. * Prior history of leukemia, lymphoma, sarcoma or any other malignancy.
  13. * Immunodeficiency disorder or a first-degree relative with a hereditary immunodeficiency.
  14. * Any other medical conditions that in the investigator's judgment make the participant inappropriate for the study.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

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

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

Cahaba Dermatology & Skin Health Center, LLC
Birmingham, Alabama, 35244
United States
Arkansas Research Trials
North Little Rock, Arkansas, 72117
United States
Miami Dermatology and Laser Research
Miami, Florida, 33133
United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
United States
Centricity Research Dublin Multispecialty
Dublin, Ohio, 43016
United States
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-30
Study Completion Date2027-05-02

Study Record Updates

Study Start Date2025-06-30
Study Completion Date2027-05-02

Terms related to this study

Keywords Provided by Researchers

  • Dermatitis

Additional Relevant MeSH Terms

  • Eczema