A Study to Learn About the Study Medicine (Called Ritlecitinib) For the Potential Treatment of Severe Alopecia Areata (AA) In Children 6 To Less Than 12 Years of Age

Part of paid clinical trials in Encinitas, California.

Sponsor
Pfizer
Study ID
NCT05650333
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of the study is to evaluate the pharmacokinetics (how the medicine is changed and eliminated from your body after you take it) and pharmacodynamics (effects of the medicine in the body) of the study medicine (called Ritlecitinib) in children of 6 to \<12 years of age with Alopecia Areata, a condition of scalp hair loss. 12 children with alopecia areata will be participating in this study. All participants will receive study medicine with a dose of 20 milligram (mg) orally once daily for 7 days. 5 blood samples will be collected on day 7 for pharmacokinetic evaluation and 2 blood samples each at screening and on Day 7 will be collected for pharmacodynamic evaluation. Participants will take part in the study for about 10 weeks.

Key Dates

Start date
Mar 2, 2023
Status verified
Jun 2024
Primary completion
Aug 11, 2023
Completion
Aug 11, 2023

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Ritlecitinib 20 mg
    Participants will receive Ritlecitinib 20 mg by mouth once daily (QD).

Primary Outcome Measure

Area Under the Plasma Concentration-Time Profile Over the Dosing Interval of 24 Hours, at Steady State (AUC24ss/AUCtau) of Ritlecitinib on Day 7 [ Time Frame: Day 7: 0 (pre-dose), 0.5, 1, 3, 8 and 24 hours [pre-dose concentration was used as an estimate for the concentration of 24 hours post dose] ]

Locations (9)

FacilityCityStateZIPSite coordinators
California Dermatology & Clinical Research InstituteEncinitasCalifornia92024-
Pediatric Skin Research,LLCCoral GablesFlorida33146-
Nicklaus Children's HospitalMiamiFlorida33155-
Dawes Fretzin Clinical Research Group, LLCIndianapolisIndiana46250-
University of New Mexico Health Sciences CenterAlbuquerqueNew Mexico87102-
UNMHAlbuquerqueNew Mexico87106-
Vital Prospects Clinical Research Institute, PCTulsaOklahoma74136-
Northwest Dermatology InstitutePortlandOregon97210-
Texas Dermatology and Laser SpecialistsSan AntonioTexas78218-

Find similar trials in Encinitas, CA

By research site
California Dermatology & Clinical Research Institute· Encinitas, CAPediatric Skin Research,LLC· Coral Gables, FLNicklaus Children's Hospital· Miami, FLDawes Fretzin Clinical Research Group, LLC· Indianapolis, INUniversity of New Mexico Health Sciences Center· Albuquerque, NMUNMH· Albuquerque, NM

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