NCT05650333

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2023

Shorter than P25 for phase_1

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

March 2, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2023

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 8, 2024

Completed
Last Updated

October 8, 2024

Status Verified

June 1, 2024

Enrollment Period

5 months

First QC Date

December 6, 2022

Results QC Date

June 25, 2024

Last Update Submit

June 25, 2024

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

  • Area Under the Plasma Concentration-Time Profile Over the Dosing Interval of 24 Hours, at Steady State (AUC24ss/AUCtau) of Ritlecitinib on Day 7

    Linear-log trapezoidal method was used for evaluation. For the calculation of AUCtau, pre-dose concentration of Day 7 was used as an estimate for the concentration of 24 hours post-dose on Day 7.

    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]

Secondary Outcomes (16)

  • Maximum Observed Plasma Concentration (Cmax) of Ritlecitinib

    0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7

  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ritlecitinib

    0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7

  • Apparent Oral Clearance (CL/F) of Ritlecitinib

    0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7

  • Apparent Volume of Distribution (Vz/F) of Ritlecitinib

    0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7

  • Elimination Half-Life (t1/2) of Ritlecitinib

    0 (pre-dose), 0.5, 1, 3 and 8 hours post-dose on Day 7

  • +11 more secondary outcomes

Study Arms (1)

Ritlecitinib 20 mg

EXPERIMENTAL

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

Drug: Ritlecitinib 20 mg

Interventions

Ritlecitinib 20 mgDRUG

orally administered, Ritlecitinib 20 mg once daily (QD)

Ritlecitinib 20 mg

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Participants who are 6 to less than12 years old at the baseline visit.
  • A diagnosis of severe AA, including AT and AU, with ≥50% scalp hair loss due to AA (ie, a SALT score of ≥50) at both the Screening and Baseline visits, without evidence of terminal hair regrowth within the previous 12 months.

You may not qualify if:

  • A known congenital cause of AA, other systemic diseases that may cause hair loss (eg, lupus erythematosus, thyroiditis, systemic sclerosis, lichen planus, etc) or other etiology of hair loss (eg, telogen effluvium, androgenetic alopecia, etc).
  • Any present malignancies or history of malignancies, history of any lymphoproliferative disorder
  • History (one or more episodes) of CMV, varicella, herpes zoster (shingles) or disseminated herpes simplex.
  • Other medical or psychiatric condition (including recent \[within the past year\] or active suicidal ideation/behavior) that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Not up to date with all age appropriate vaccines (including 2-dose vaccination for varicella) or vaccination with attenuated live vaccine within 6 weeks of first dose of study medicine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

Pediatric Skin Research,LLC

Coral Gables, Florida, 33146, United States

Location

Nicklaus Children's Hospital

Miami, Florida, 33155, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87102, United States

Location

UNMH

Albuquerque, New Mexico, 87106, United States

Location

Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma, 74136, United States

Location

Northwest Dermatology Institute

Portland, Oregon, 97210, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

Related Publications (1)

  • Gonzalez ME, Browning J, Smith S, Plotka A, Zhu JD, Parvatini S, Huh Y, Wolk R. A Phase 1, Open-Label Study of the Pharmacokinetics of Ritlecitinib in Children Aged 6-12 Years With Alopecia Areata. Pediatr Dermatol. 2025 Jul-Aug;42(4):742-746. doi: 10.1111/pde.15895. Epub 2025 Feb 9.

    PMID: 39924925DERIVED

Related Links

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

AlopeciaHypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Centre
Organization
Pfizer Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2022

First Posted

December 14, 2022

Study Start

March 2, 2023

Primary Completion

August 11, 2023

Study Completion

August 11, 2023

Last Updated

October 8, 2024

Results First Posted

October 8, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Locations

US(9)