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

NCT ID: NCT05650333

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-02
• Study Completion Date: 2023-08-11

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.

Detailed Description

This is an interventional, Pharmacokinetic (PK), Pharmacodynamic (PD), phase 1, open label study in children 6 to less than 12 years of age with ≥50% scalp hair loss due to severe alopecia areata. The purpose of the study is to collect data to support dose selection for subsequent studies in the same population.

Participants will be screened and, if all eligibility criteria are met, will receive the first dose of Investigational product within 28 days after the screening visit.

Participants will receive 20 mg ritlecitinib in one dose, daily, for 7 consecutive days. Blood samples for pharmacodynamic evaluation will be collected on screening and Day 7. Blood samples for pharmacokinetic evaluation will be collected on Day 7 at: 0 hr (pre-dose), 0.5 hr, 1 hr, 3 hrs, and 8 hrs after dosing.

At least 12 evaluable participants with respect to the primary endpoint will be enrolled in the study.

Participants and their parents/legal guardians will be required to visit the study site 3 times during the study (Screening, Day 1 and Day 7) A safety follow-up visit will be conducted by phone, 28 to 35 days after the last dose of ritlecitinib.

Conditions

Alopecia Areata

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Ritlecitinib 20 mg

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

Group Type: EXPERIMENTAL

Ritlecitinib 20 mg

Intervention Type: DRUG

orally administered, Ritlecitinib 20 mg once daily (QD)

Interventions

Ritlecitinib 20 mg

orally administered, Ritlecitinib 20 mg once daily (QD)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Participants who are 6 to less than12 years old at the baseline visit.

2. 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.

Exclusion Criteria

1. 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).

2. Any present malignancies or history of malignancies, history of any lymphoproliferative disorder

3. History (one or more episodes) of CMV, varicella, herpes zoster (shingles) or disseminated herpes simplex.

4. 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.

5. 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

California Dermatology & Clinical Research Institute

Encinitas, California, United States

Pediatric Skin Research,LLC

Coral Gables, Florida, United States

Nicklaus Children's Hospital

Miami, Florida, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, United States

UNMH

Albuquerque, New Mexico, United States

Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma, United States

Northwest Dermatology Institute

Portland, Oregon, United States

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39924925 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=B7981031

To obtain contact information for a study center near you, click here.

Other Identifiers

B7981031

Identifier Type: -

Identifier Source: org_study_id