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

Conditions

• Severe Alopecia Areata

Eligibility Criteria

Sex

ALL

Age

6 Years - 11 Years

Healthy Volunteers

Not accepted

Interventions

• Ritlecitinib higher dose — DRUG
  Study intervention will be provided as oral capsules centrally by the sponsor in high-density polyethylene (HDPE) bottles.
• Ritlecitinib lower dose — DRUG
  Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.
• Placebo — DRUG
  Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.

Study Details

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 Dates

First listed

Jun 19, 2025

Start date

Jul 31, 2025

Status verified

Jun 2026

Primary completion

Dec 2, 2026

Completion

Jan 6, 2027

Study Design

Enrollment

208 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ritlecitinib higher dose
  Participants will receive 1 ritlecitinib higher dose capsule once a day (QD) and 1 placebo lower dose capsule once a day (QD) orally for 24 weeks.
• Experimental: Ritlecitinib lower dose
  Participants will receive 1 ritlecitinib lower dose capsule QD and 1 placebo higher dose capsule QD orally for 24 weeks.
• Placebo Comparator: Placebo
  Participants will receive 1 placebo higher dose capsule QD and 1 placebo lower dose capsule QD orally for 24 weeks.

Primary Outcome Measure

For US and Countries Following US Analysis Plan: Response based on achieving an absolute Severity of Alopecia Tool (SALT) score ≤20. [ Time Frame: Week 24 ]

Locations (27)

Find similar trials in Irvine, CA

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