A Long-Term Study to Learn About The Study Medicine Called Ritlecitinib in Children With Severe Alopecia Areata.
Key facts
- Where
- Albuquerque, Aurora, Austin, Charleston, Corpus Christi, El Paso, Hershey, Indianapolis, Irvine, Marriottsville, Miami, Milwaukee, Omaha, Pflugerville, Portland, San Antonio, Santa Ana, Skokie, Washington D.C., and Waterford, United StatesSee the 23 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 14 years old?
Source: NCT07029828, who can take part
Where in United States
- University of New Mexico Health Sciences CenterAlbuquerque, United StatesTaking people
- University of New Mexico-IDS PharmacyAlbuquerque, United StatesTaking people
- Children's Hospital ColoradoAurora, United StatesTaking people
- Dell Children's Medical CenterAustin, United StatesNot yet recruiting
- Medical University of South Carolina - South Carolina Translational Research Nexus ClinicCharleston, United StatesTaking people
- Driscoll Children's HospitalCorpus Christi, United StatesTaking people
- 3A ResearchEl Paso, United StatesTaking people
- Penn State Health Milton S. Hershey Medical CenterHershey, United StatesTaking people
- Dawes Fretzin Clinical Research Group, LLCIndianapolis, United StatesTaking people
- University of California, IrvineIrvine, United StatesTaking people
- Kindred Hair and Skin CenterMarriottsville, United StatesNot yet recruiting
- Pediatric Skin ResearchMiami, United StatesTaking people
- Children's WisconsinMilwaukee, United StatesNot yet recruiting
- Medical College of WisconsinMilwaukee, United StatesNot yet recruiting
- Ear, Nose & Throat Consultants, LLCOmaha, United StatesTaking people
- Skin Specialists, PC dba Schlessinger MDOmaha, United StatesTaking people
- Austin Institute for Clinical ResearchPflugerville, United StatesTaking people
- Northwest Dermatology InstitutePortland, United StatesTaking people
- Texas Dermatology and Laser SpecialistsSan Antonio, United StatesTaking people
- Southern California Clinical ResearchSanta Ana, United StatesTaking people
- Endeavor Health Clinical OperationsSkokie, United StatesTaking people
- Children's National HospitalWashington D.C., United StatesTaking people
- Michigan Dermatology InstituteWaterford, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Pfizer
- Trial code
- NCT07029828EU 2024-515439-31-00
- Record updated
- 15 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Participants with alopecia areata (AA) (including alopecia totalis [AT] and alopecia universalis [AU]) who completed the studies B7981027 or B7981031; For participants originating from Study B7981031: At least 50% scalp hair loss due to AA (ie, a SALT score of ≥50) at both the Screening and Baseline visits.
Exclusion: Exclusion criteria for participants originating from Study B7981027 with ≤ 30 Days between last dose in Study B7981027 and first visit of Study B7981028; During Study B7981027 or in the period between the last dose of study intervention in Study B7981027 and the first dose of study intervention of Study B7981028, presence of safety events that would require permanent discontinuation based on the B7981028 protocol; Study participants discontinued from Study B7981027 due to issues other than safety-related events and considered by the investigator for enrolment in Study B7981028 must have resolution of the issue(s) resulting in discontinuation from the parent study prior to enrolment in Study B7981028; Exclusion criteria for participants originating from Study B7981031 or from Study B7981027 with >30 Days between last dose in Study B7981027 and first visit of Study B7981028; During Study B7981031 or Study B7981027 or in the period between the last dose of study intervention in Study B7981031 or Study B7981027 and the first dose of study intervention of Study B7981028, presence of safety events that would require permanent discontinuation based on the B7981028 protocol; Any present malignancies or history of malignancies or lymphoproliferative disorders; Evidence of untreated or inadequately treated active or latent Mycobacterium tuberculosis (TB) infection, history (one or more episodes) of severe or serious cytomegalovirus (CMV), herpes zoster (shingles) or disseminated herpes simplex, infection with hepatitis B virus (HBV) or hepatitis C virus (HCV); -.