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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Pfizer
Study ID
NCT06807268
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 11 Years
Healthy Volunteers
Not accepted

Interventions

  • Abrocitinib — DRUG
    Abrocitinib administered as liquid oral suspension.
  • Placebo — OTHER
    Placebo administered as liquid oral suspension.

Study Details

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.

Key Dates

Start date
Jul 24, 2025
Status verified
May 2026
Primary completion
May 2, 2027
Completion
May 2, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Abrocitinib
    Abrocitinib administered as liquid oral suspension.
  • Placebo Comparator: Matching Placebo
    Placebo administered as liquid oral suspension.

Primary Outcome Measure

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 [ Time Frame: At week 12 ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Cahaba Dermatology & Skin Health Center, LLCBirminghamAlabama35244-
Arkansas Research TrialsNorth Little RockArkansas72117-
Investigational Drug Service - Rady Childrens Hospital-San DiegoSan DiegoCalifornia92123-
University of California, San Diego/Rady Children's Hospital-San Diego; Pediatric & Adolescent DermSan DiegoCalifornia92123-
Solutions Through Advanced ResearchJacksonvilleFlorida32256-
Dawes Fretzin Clinical Research Group, LLCIndianapolisIndiana46250-
Saint Louis University - Department of DermatologySt LouisMissouri63104-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Tribe Clinical Research, LLCGreenvilleSouth Carolina29607-
Texas Dermatology and Laser SpecialistsSan AntonioTexas78235-

Find similar trials in Birmingham, AL

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Cahaba Dermatology & Skin Health Center, LLC· Birmingham, ALArkansas Research Trials· North Little Rock, ARInvestigational Drug Service - Rady Childrens Hospital-San Diego· San Diego, CAUniversity of California, San Diego/Rady Children's Hospital-San Diego; Pediatric & Adolescent Derm· San Diego, CASolutions Through Advanced Research· Jacksonville, FLDawes Fretzin Clinical Research Group, LLC· Indianapolis, IN

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