A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Severe Alopecia Areata

In brief

The purpose of this study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the possible treatment of severe alopecia areata. Alopecia areata is a condition that causes hair loss. This study is seeking participants who have: * at least 50% scalp hair loss due to alopecia areata. * received varicella vaccination (2 doses) or have been infected by varicella zoster virus before based on blood test reports. * history of clinical response failure to alopecia areata treatment (for children in EU/UK only). All participants in this study will receive either study medicine (ritlecitinib) or placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. One-third of participants will receive ritlecitinib higher dose, one-third participants will receive ritlecitinib lower dose, and one-third participants will receive placebo. The study medicine is a capsule that is taken by mouth. It is taken once each day at home. The study will compare the experiences of participants receiving ritlecitinib to participants receiving placebo. This will help see if ritlecitinib is safe and effective. Participants will take part in this study for 6 months. During this time, they will have 8 study visits at the study clinic. The study team will also call participants about 8 times over the phone.

Key facts

Study ID

NCT07029711

Run by

Pfizer

People needed

208

Starts

2025-07-31

Expected to finish

2027-01-06

Last updated by the study team

2026-06-17

Who can join

Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A diagnosis of AA (including alopecia totalis (AT) and alopecia universalis (AU)) with at least 50% scalp hair loss due to AA (ie, SALT score of ≥50) at both screening and baseline visits, without evidence of terminal hair regrowth within the previous 12 months.
• For study participants in the EU/UK only: History of clinical response failure to AA treatment (such as topical, off-label pharmacologic, or hairpiece prosthetics)
• Documented evidence of having received varicella vaccination (2 doses), OR evidence of prior exposure to varicella zoster virus (VZV) based on serological testing (ie, a positive VZV Immunoglobulin G (IgG) antibody (Ab) result) at screening.

You may not qualify if…

• Other (non-AA) types of alopecia, including any known congenital cause of AA.
• Pre-existing hearing loss.
• Any present or history of malignancies or lymphoproliferative disorder such as Epstein-Barr virus (EBV) related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
• Clinically significant depression per PROMIS Parent Proxy Short Form - Depressive symptoms (T-score ≥70).
• Any evidence of untreated or inadequately treated active or latent Mycobacterium tuberculosis (TB) infection; history (one or more episodes) of severe or serious cytomegalovirus (CMV) infection, herpes zoster (shingles) or disseminated herpes simplex; infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
• Vaccination with live attenuated replication-competent vaccine within 6 weeks of first dose of study intervention.

Where it is running

• Southern California Clinical Research — Santa Ana, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Pediatric Skin Research — Miami, Florida, United States
• Endeavor Health Clinical Operations — Evanston, Illinois, United States
• Endeavor Health Clinical Operations — Skokie, Illinois, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• Kindred Hair and Skin Center — Marriottsville, Maryland, United States
• Michigan Dermatology Institute — Waterford, Michigan, United States
• Ear, Nose and Throat Consultants, LLC — Omaha, Nebraska, United States
• Skin Specialists, PC dba Schlessinger MD — Omaha, Nebraska, United States
• Complete Behavior Health (Dr. Brittany Marshall, Licensed Psychologist) — Papillion, Nebraska, United States
• University of New Mexico Health Sciences Center — Albuquerque, New Mexico, United States
• University of New Mexico-IDS Pharmacy — Albuquerque, New Mexico, United States
• Regents of the University of New Mexico — Albuquerque, New Mexico, United States
• Northwest Dermatology Institute — Portland, Oregon, United States
• Penn State Health Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Medical University of South Carolina Department of Dermatology and Dermatologic Surgery — Charleston, South Carolina, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Dell Children's Medical Center — Austin, Texas, United States
• Driscoll Children's Hospital — Corpus Christi, Texas, United States
• 3A Research - West Location — El Paso, Texas, United States
• Austin Institute for Clinical Research — Pflugerville, Texas, United States
• Texas Dermatology and Laser Specialists — San Antonio, Texas, United States
• UCI Dermatology Clinical Research — Irvine, California, United States

Full record on ClinicalTrials.gov

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