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

NCT07029711 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2026-03-30

No results posted yet for this study

Summary

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.

Conditions

  • Severe Alopecia Areata

Interventions

DRUG

Ritlecitinib higher dose

Study intervention will be provided as oral capsules centrally by the sponsor in high-density polyethylene (HDPE) bottles.

DRUG

Ritlecitinib lower dose

Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.

DRUG

Placebo

Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2027-04-20
Completion
2027-05-18
FDA Drug
Yes

Countries

  • United States
  • Canada
  • China
  • Czechia
  • France
  • Italy
  • Japan
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07029711 on ClinicalTrials.gov