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Ritlecitinib 20 mg for Alopecia Areata

Nicklaus Children's Hospital, Miami, FL
Alopecia AreataRitlecitinib 20 mg - Drug
Eligibility
6 - 11
All Sexes

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

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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Study Objectives

1 Primary · 15 Secondary · Reporting Duration: 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7

Day 7
Apparent Volume of Distribution (Vz/F)
Area under the plasma concentration time profile over the dosing interval 24 hrs, at steady-state (AUC24) on Day 7
Maximum Observed Plasma Concentration (Cmax)
Terminal elimination Half-Life (t1/2)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Baseline through Day 7
Clinically significant abnormalities in clinical laboratory values
Clinically significant abnormalities in vital signs
Incidence of AEs leading to discontinuation
Week 5
Incidence of treatment emergent adverse event (TEAE)
Week 5
Incidence of Serious AEs (SAEs)
Incidence of Treatment related AEs
Day 1 and 7
For overall mouthfeel, percent of participants reporting how the medicine felt on the scale from 1-5 will be reported.
For overall taste, percent of participants reporting likeability on the scale from 1-5 will be reported
For overall volume, percent of participants reporting likeability of the amount of medicine taken on the scale from 1-5 will be reported.
Day 7
Apparent Oral Clearance (CL/F)
Change from baseline in interferon gamma, IP-10 and lymphocyte subsets (T cell, B cell, and NK cells)

Trial Safety

Phase-Based Safety

1 of 3

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1
SADBE 5%
2
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2
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Ritlecitinib 20 mg
1 of 1

Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: Ritlecitinib 20 mg · No Placebo Group · Phase 1

Ritlecitinib 20 mg
Drug
Experimental Group · 1 Intervention: Ritlecitinib 20 mg · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on day 7

Who is running the clinical trial?

PfizerLead Sponsor
4,406 Previous Clinical Trials
25,778,460 Total Patients Enrolled
12 Trials studying Alopecia Areata
85,168 Patients Enrolled for Alopecia Areata
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,346 Previous Clinical Trials
23,430,732 Total Patients Enrolled
5 Trials studying Alopecia Areata
2,063 Patients Enrolled for Alopecia Areata

Eligibility Criteria

Age 6 - 11 · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Texas100.0%
What site did they apply to?
Texas Dermatology and Laser Specialists100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
How many prior treatments have patients received?
0100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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