RECRUITING

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

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.

Conditions

Eczema
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Related Conditions:

Eczema

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Eczema
Intervention / Treatment

-

Contacts and Locations

Birmingham

Cahaba Dermatology & Skin Health Center, LLC, Birmingham, Alabama, United States, 35244

North Little Rock

Arkansas Research Trials, North Little Rock, Arkansas, United States, 72117

Miami

Miami Dermatology and Laser Research, Miami, Florida, United States, 33133

Indianapolis

Dawes Fretzin Clinical Research Group, LLC, Indianapolis, Indiana, United States, 46250

Dublin

Centricity Research Dublin Multispecialty, Dublin, Ohio, United States, 43016

Greenville

Tribe Clinical Research, LLC, Greenville, South Carolina, United States, 29607

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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:
  • * 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.

Ages Eligible for Study

6 Years to 11 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pfizer,

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

2027-05-02