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Janus Kinase (JAK) Inhibitor

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

Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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]
Awards & highlights
No Placebo-Only Group

Summary

This trial tests Ritlecitinib in children with severe hair loss. It aims to understand how the medicine is processed by the body and its effects. Blood samples will be taken to gather this information. The goal is to find the right dose for future studies. Ritlecitinib has shown promising results in treating alopecia areata in previous studies.

Eligible Conditions
  • Alopecia Areata

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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]
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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] for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area Under the Plasma Concentration-Time Profile Over the Dosing Interval of 24 Hours, at Steady State (AUC24ss/AUCtau) of Ritlecitinib on Day 7
Secondary study objectives
Apparent Oral Clearance (CL/F) of Ritlecitinib
Apparent Volume of Distribution (Vz/F) of Ritlecitinib
Change From Baseline in B Lymphocytes on Day 7
+9 more

Side effects data

From 2023 Phase 1 trial • 15 Patients • NCT05650333
7%
Nausea
7%
Vomiting
7%
Urticaria
7%
Myalgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ritlecitinib 20 mg QD

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ritlecitinib 20 mgExperimental Treatment1 Intervention
Participants will receive Ritlecitinib 20 mg by mouth once daily (QD).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ritlecitinib 20 mg
2023
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,669 Previous Clinical Trials
17,861,909 Total Patients Enrolled
14 Trials studying Alopecia Areata
86,057 Patients Enrolled for Alopecia Areata
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,553 Previous Clinical Trials
14,902,911 Total Patients Enrolled
7 Trials studying Alopecia Areata
2,951 Patients Enrolled for Alopecia Areata
~5 spots leftby Dec 2025
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