Clinical Trials Logo
  1. Home
  2. Alopecia Areata
  3. NCT05650333

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

Alopecia Areata Clinical Trial

Official title:
AN INTERVENTIONAL PK, PD, PHASE 1, OPEN-LABEL STUDY TO INVESTIGATE PK AND PD OF MULTIPLE-DOSE RITLECITINIB IN CHILDREN 6 TO LESS THAN 12 YEARS OF AGE WITH SEVERE ALOPECIA AREATA

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05650333
Study type Interventional
Source Pfizer
Contact
Status Completed
Phase Phase 1
Start date March 2, 2023
Completion date August 11, 2023
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05051761 - Study to Evaluate the Safety and Efficacy of Jaktinib in Adults With Alopecia Areata Phase 3
Active, not recruiting NCT03570749 - A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata Phase 2/Phase 3
Completed NCT02812342 - Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants Phase 2
Completed NCT02350023 - Comparison of Topical Latanoprost vs Topical Corticosteroid in Treatment of Localized Alopecia Areata Phase 4
Completed NCT02018042 - An Open-Label Single-Arm Clinical Trial to Evaluate The Efficacy of Abatacept in Moderate to Severe Patch Type Alopecia Areata Phase 2
Terminated NCT01898806 - Intralesional Steroids in the Treatment of Alopecia Areata Phase 4
Recruiting NCT04011748 - Clinical Application of Stem Cell Educator Therapy in Alopecia Areata Phase 2
Active, not recruiting NCT04517864 - PLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA Phase 2
Not yet recruiting NCT05803070 - Topical Cetirizine in Treatment of Localized Alopecia Areata
Not yet recruiting NCT05496426 - A Study of KL130008 in Adults With Severe Alopecia Areata Phase 2
Completed NCT04147845 - Transepidermal Delivery of Triamcinolone Acetonide or Platelet Rich Plasma Using Either Fractional Carbon Dioxide Laser or Microneedling in Treatment of Alopecia Areata N/A
Terminated NCT03325296 - Efficacy of Twice Daily Application of LEO 124249 Ointment 30 mg/g for 12 Weeks on Eyebrow Alopecia Areata. Phase 2
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Enrolling by invitation NCT05745389 - CorEvitas Alopecia Areata (AA) Safety and Effectiveness Registry
Recruiting NCT04246372 - Tofacitinib for Immune Skin Conditions in Down Syndrome Phase 2
Not yet recruiting NCT06087796 - Topical Pentoxifylline; Metformin Versus Betamethasone in the Treatment of Alopecia Areata. Phase 1
Withdrawn NCT03532958 - Phase 2 Trial of BNZ-1 in Patients With Moderate to Severe Alopecia Areata Phase 2
Recruiting NCT02604888 - Efficacy Study of a Cosmetic Lotion in the Treatment of Alopecia Areata in Males and Females N/A
Terminated NCT01385839 - Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata N/A
Completed NCT00408798 - Treatment of Alopecia Areata of the Scalp With Intradermal Injections of Botulinum Toxin N/A