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A Long-Term Study to Learn About The Study Medicine Called Ritlecitinib in Children With Severe Alopecia Areata.
Sponsor: Pfizer
Summary
The purpose of this clinical trial is to learn about long-term safety and long-term effects of the study medicine (called ritlecitinib) for the potential treatment of severe alopecia areata, a condition that causes hair loss. This study is seeking participants who have: * previously completed one of Pfizer's pediatric studies for Alopecia Areata (B7981027 or B7981031). * at least 50% scalp hair loss due to alopecia areata (for participants enrolling from the study B7981031). * received varicella vaccination (2 doses) or have been infected by varicella zoster virus before based on blood test reports. All participants in this study will receive the study medicine (ritlecitinib). Participants who received ritlecitinib higher or lower doses in the parent Study B7981027 will continue receiving the same ritlecitinib dose in this trial. Participants who received placebo in the parent Study B7981027 and all participants from parent Study B7981031 will receive either higher or lower dose of ritlecitinib in this trial. The study medicine is a capsule that is taken by mouth. It is taken 1 time each day at home. The study will help see if ritlecitinib is safe and effective. Participants will take part in this study for a duration of up to 3 years (36 months). During this time, they will have 17 study visits at the study clinic. The study team will also call participants once a month over the phone.
Official title: A LONG-TERM, DOUBLE-BLIND EXTENSION STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF RITLECITINIB IN PARTICIPANTS WITH SEVERE ALOPECIA AREATA WHO PREVIOUSLY COMPLETED STUDIES B7981027 OR B7981031
Key Details
Gender
All
Age Range
6 Years - 14 Years
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2025-09-10
Completion Date
2030-06-26
Last Updated
2025-10-01
Healthy Volunteers
No
Conditions
Interventions
Ritlecitinib higher dose
Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.
Ritlecitinib lower dose
Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.
Locations (4)
Pediatric Skin Research
Miami, Florida, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Northwest Dermatology Institute
Portland, Oregon, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States