Recruiting
Phase 3

Ritlecitinib

Sponsor:

Pfizer

Code:

NCT07029828

Conditions

Severe Alopecia Areata

Eligibility Criteria

Sex: All

Age: 6 - 14

Healthy Volunteers: Not accepted

Interventions

Ritlecitinib higher dose

Ritlecitinib lower dose

Study Details

Brief summary:

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.

Conditions

Severe Alopecia Areata

Study ID

NCT07029828

Start date

Sep 10, 2025

Status verified date

Apr, 2026

Completion date

Jun 26, 2030

Anticipated

Primary completion date

Jun 26, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 14

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Participants with alopecia areata (AA) (including alopecia totalis \[AT\] and alopecia universalis \[AU\]) who completed the studies B7981027 or B7981031.
2. For participants originating from Study B7981031: At least 50% scalp hair loss due to AA (ie, a SALT score of ≥50) at both the Screening and Baseline visits.

Exclusion Criteria:

1. Exclusion criteria for participants originating from Study B7981027 with ≤ 30 Days between last dose in Study B7981027 and first visit of Study B7981028

1. During Study B7981027 or in the period between the last dose of study intervention in Study B7981027 and the first dose of study intervention of Study B7981028, presence of safety events that would require permanent discontinuation based on the B7981028 protocol.
2. Study participants discontinued from Study B7981027 due to issues other than safety-related events and considered by the investigator for enrolment in Study B7981028 must have resolution of the issue(s) resulting in discontinuation from the parent study prior to enrolment in Study B7981028.
2. Exclusion criteria for participants originating from Study B7981031 or from Study B7981027 with >30 Days between last dose in Study B7981027 and first visit of Study B7981028

1. During Study B7981031 or Study B7981027 or in the period between the last dose of study intervention in Study B7981031 or Study B7981027 and the first dose of study intervention of Study B7981028, presence of safety events that would require permanent discontinuation based on the B7981028 protocol.
2. Any present malignancies or history of malignancies or lymphoproliferative disorders.
3. Evidence of untreated or inadequately treated active or latent Mycobacterium tuberculosis (TB) infection, history (one or more episodes) of severe or serious cytomegalovirus (CMV), herpes zoster (shingles) or disseminated herpes simplex, infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).

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Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Ritlecitinib higher dose

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

Ritlecitinib lower dose

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

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). ]
  • Incidence of Serious Adverse Events (SAEs) and AEs leading to permanent discontinuation from the study. [ 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 and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Locations

California Dermatology & Clinical Research Institute

Recruiting

Encinitas, California, United States, 92024

Pediatric Skin Research

Recruiting

Miami, Florida, United States, 33156

Dawes Fretzin Clinical Research Group, LLC

Recruiting

Indianapolis, Indiana, United States, 46250

Ear, Nose & Throat Consultants, LLC

Recruiting

Omaha, Nebraska, United States, 68144

Skin Specialists, PC dba Schlessinger MD

Recruiting

Omaha, Nebraska, United States, 68144

Complete Behavior Health (Dr. Brittany Marshall, Licensed Psychologist)

Recruiting

Papillion, Nebraska, United States, 68046

University of New Mexico Health Sciences Center

Recruiting

Albuquerque, New Mexico, United States, 87102

University of New Mexico-IDS Pharmacy

Recruiting

Albuquerque, New Mexico, United States, 87106

Regents of the University of New Mexico

Recruiting

Albuquerque, New Mexico, United States, 87131

Northwest Dermatology Institute

Recruiting

Portland, Oregon, United States, 97210

3A Research

Recruiting

El Paso, Texas, United States, 79902

Texas Dermatology and Laser Specialists

Recruiting

San Antonio, Texas, United States, 78218

More Information

Sponsor

Pfizer

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Keywords

  • Alopecia Areata
  • Children
  • Ritlecitinib
  • Long-term extension study

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pfizer on 2026-04-28.