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Janus Kinase (JAK) Inhibitor

Ritlecitinib 20 mg for Alopecia Areata

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 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on day 7
Awards & highlights

Study Summary

This trial studies how a medicine called Ritlecitinib affects children (6-12 yrs) with alopecia areata (scalp hair loss) over 10 weeks, with 20mg daily doses & blood tests.

Eligible Conditions
  • Alopecia Areata

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on day 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on day 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the plasma concentration time profile over the dosing interval 24 hrs, at steady-state (AUC24) on Day 7
Secondary outcome measures
Apparent Oral Clearance (CL/F)
Apparent Volume of Distribution (Vz/F)
Change from baseline in interferon gamma, IP-10 and lymphocyte subsets (T cell, B cell, and NK cells)
+12 more

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
4,575 Previous Clinical Trials
10,923,086 Total Patients Enrolled
13 Trials studying Alopecia Areata
86,019 Patients Enrolled for Alopecia Areata
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,482 Previous Clinical Trials
8,099,348 Total Patients Enrolled
6 Trials studying Alopecia Areata
2,912 Patients Enrolled for Alopecia Areata

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 70 and younger admissible for this research program?

"This medical study will consider children between the ages of 6 and 11 to be eligible participants."

Answered by AI

Is Ritlecitinib 20 mg a safe treatment option for individuals?

"Our estimations gave Ritlecitinib 20 mg a score of 1 due to its Phase 1 trial status, implying limited evidence regarding efficacy and safety."

Answered by AI

Does this research endeavor need additional participants?

"Clinicaltrials.gov suggests that this trial is currently seeking volunteers; the entry was initially posted on March 2nd, 2023 and revised on March 14th of the same year."

Answered by AI

How many individuals are being administered treatments within this clinical experiment?

"Correct. Data hosted on clinicaltrials.gov verifies that this medical study, which was first posted on March 2nd 2023, is actively recruiting people to take part in the trial. A total of 15 participants are sought from 5 separate medical centres."

Answered by AI

To whom is this research opportunity available?

"To be eligible for participation in this trial, individuals should possess alopecia areata and be between the ages of 6 to 11. Currently, approximately 15 participants are sought after."

Answered by AI

How many physical locations can one access this research?

"There are 5 active study locations for this clinical trial, including the Pediatric Skin Research LLC in Coral Gables, Dawes Fretzin Clinical Research Group LLC in Indianapolis, and Vital Prospects Clinical Research Institute PC in Tulsa. Moreover, there are an additional five sites hosting this research."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Texas Dermatology and Laser Specialists
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
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
2023. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05650333.
~7 spots leftby May 2025
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