A Long-Term Study to Learn About The Study Medicine Called Ritlecitinib in Children With Severe Alopecia Areata.

Conditions

• Severe Alopecia Areata

Eligibility Criteria

Sex

ALL

Age

6 Years - 14 Years

Healthy Volunteers

Not accepted

Interventions

• Ritlecitinib higher dose — DRUG
  Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.
• Ritlecitinib lower dose — DRUG
  Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.

Study Details

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.

Key Dates

Start date

Sep 10, 2025

Status verified

Apr 2026

Primary completion

Jun 26, 2030

Completion

Jun 26, 2030

Study Design

Enrollment

140 participants (estimated)

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 QD orally for up to 3 years. Participants who meet the protocol-defined treatment discontinuation criteria based on not achieving the required efficacy threshold will be switched to placebo but will remain in the study. Those participants will receive 1 placebo higher dose capsule QD and 1 placebo lower dose capsule QD.
• Experimental: Ritlecitinib lower dose
  Participants will receive 1 ritlecitinib lower dose capsule once a day (QD) and 1 placebo higher dose capsule QD orally for up to 3 years. Participants who meet the protocol-defined treatment discontinuation criteria based on not achieving the required efficacy threshold will be switched to placebo but will remain in the study. Those participants will receive 1 placebo higher dose capsule QD and 1 placebo lower dose capsule QD.

Primary Outcome Measure

Incidence of treatment-emergent adverse events (AEs). [ Time Frame: From the time participant signs informed consent/assent, through and including a minimum of 28 calendar days after the last administration of the study intervention (up to approximately 3 years). ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (18)

Find similar trials in Encinitas, CA

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