A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata (NCT07029711)
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF RITLECITINIB IN PEDIATRIC PARTICIPANTS 6 TO LESS THAN 12 YEARS OF AGE WITH SEVERE ALOPECIA AREATA
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: UCI Dermatology Clinical Research — Irvine, California
Age range: 6 Years to 11 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (83 Sites)
Showing the first 25 of 83 sites.
- UCI Dermatology Clinical Research — Irvine, California
- Southern California Clinical Research — Santa Ana, California
- Children's Hospital Colorado — Aurora, Colorado
- Children's National Medical Center — Washington D.C., District of Columbia
- Pediatric Skin Research — Miami, Florida
- Endeavor Health Audiology -CHICAGO — Chicago, Illinois
- Endeavor Health Behavioral Health - Evanston — Evanston, Illinois
- Endeavor Health Clinical Operations — Evanston, Illinois
- Endeavor Health Audiology -LAKE BLUFF — Lake Bluff, Illinois
- Endeavor Health Audiology-NORTHBROOK — Northbrook, Illinois
- Endeavor Health Audiology-SKOKIE — Skokie, Illinois
- Endeavor Health Clinical Operations — Skokie, Illinois
- Endeavor Health Lab Services - Old Orchard — Skokie, Illinois
- Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana
- Kindred Hair and Skin Center — Marriottsville, Maryland
- Michigan Dermatology Institute — Waterford, Michigan
- Ear, Nose and Throat Consultants, LLC — Omaha, Nebraska
- Skin Specialists, PC dba Schlessinger MD — Omaha, Nebraska
- Complete Behavior Health (Dr. Brittany Marshall, Licensed Psychologist) — Papillion, Nebraska
- University of New Mexico Health Sciences Center — Albuquerque, New Mexico
- University of New Mexico-IDS Pharmacy — Albuquerque, New Mexico
- Northwest Dermatology Institute — Portland, Oregon
- Penn State Health Milton S. Hershey Medical Center — Hershey, Pennsylvania
- Medical University of South Carolina Department of Dermatology and Dermatologic Surgery — Charleston, South Carolina
- Dell Children's Medical Center — Austin, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Severe Alopecia Areata
Explore by condition: All Severe Alopecia Areata clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.