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

Last updated: September 25, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

3

Condition

Alopecia

Hair Loss

Treatment

Ritlecitinib higher dose

Placebo

Ritlecitinib lower dose

Clinical Study ID

NCT07029711
B7981027
2024-515438-33-00
  • Ages 6-11
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A diagnosis of AA (including alopecia totalis (AT) and alopecia universalis (AU))with at least 50% scalp hair loss due to AA (ie, SALT score of ≥50) at bothscreening and baseline visits, without evidence of terminal hair regrowth within theprevious 12 months.

  • For study participants in the EU/UK only: History of clinical response failure to AAtreatment (such as topical, off-label pharmacologic, or hairpiece prosthetics)

  • Documented evidence of having received varicella vaccination (2 doses), OR evidenceof prior exposure to varicella zoster virus (VZV) based on serological testing (ie,a positive VZV Immunoglobulin G (IgG) antibody (Ab) result) at screening.

Exclusion

Exclusion Criteria:

  • Other (non-AA) types of alopecia, including any known congenital cause of AA.

  • Pre-existing hearing loss.

  • Any present or history of malignancies or lymphoproliferative disorder such asEpstein-Barr virus (EBV) related lymphoproliferative disorder, history of lymphoma,history of leukemia, or signs and symptoms suggestive of current lymphatic orlymphoid disease.

  • Clinically significant depression per PROMIS Parent Proxy Short Form - Depressivesymptoms (T-score ≥70).

  • Any evidence of untreated or inadequately treated active or latent Mycobacteriumtuberculosis (TB) infection; history (one or more episodes) of severe or seriouscytomegalovirus (CMV) infection, herpes zoster (shingles) or disseminated herpessimplex; infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).

  • Vaccination with live attenuated replication-competent vaccine within 6 weeks offirst dose of study intervention.

Study Design

Total Participants: 225
Treatment Group(s): 3
Primary Treatment: Ritlecitinib higher dose
Phase: 3
Study Start date:
July 31, 2025
Estimated Completion Date:
May 18, 2027

Study Description

Study B7981027 is being conducted to assess efficacy and safety of ritlecitinib in pediatric participants 6 to <12 years of age with severe AA. The primary objective of this study is to evaluate the efficacy of ritlecitinib compared to placebo in pediatric participants with severe AA on regrowth of lost scalp hair. The secondary objectives are to evaluate safety, tolerability, acceptability and palatability of ritlecitinib and to evaluate the effect of ritlecitinib on patient centered outcomes.

This study will have 3 treatment arms, including 2 ritlecitinib dosage levels (higher and lower doses) and 1 placebo arm. The participants will be assessed for study eligibility at the screening visit after informed consent/assent is obtained (as applicable).

Participants will receive study medication for a duration of 24 weeks.

At least 225 participants will be enrolled in the study. At least 30% of total study population will be recruited from Europe.

The efficacy assessments include Severity of Alopecia Tool (SALT), eyebrow and eyelash assessments. Patient reported outcomes including Patient's Global Impression of Change (PGI-C), Alopecia Areata Patient Priority Outcomes (AAPPO), Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy - Anxiety Short Form 8a and Depressive Symptoms Short Form 6a, Behavior Rating Inventory of Executive Function®, Second Edition (BRIEF®2), and modified Children's Dermatology Life Quality Index (CDLQI) will be assessed throughout the study. Pharmacokinetics of ritlecitinib will be evaluated using sparse sampling.

Safety monitoring will be performed to identify and monitor the known and potential risks of ritlecitinib.

Participants completing the 24-week treatment period of the study may have the option to enter the long-term extension (LTE) Study B7981028, if the eligibility criteria are met. Participants who complete the 24-week treatment period of the study but who are ineligible for the LTE study will undergo a 4-week off-treatment follow-up period.

Connect with a study center

  • Huashan Hospital, Fudan University

    Shanghai 1796236, Shanghai Municipality 1796231 200040
    China

    Site Not Available

  • Tohoku University Hospital

    Sendai 2111149, Miyagi 2111888 980-8574
    Japan

    Active - Recruiting

  • Niigata University Medical & Dental Hospital

    Niigata-shi, Niigata 951-8520
    Japan

    Site Not Available

  • Niigata University Medical & Dental Hospital

    Niigata 1855431, Niigata 1855429 951-8520
    Japan

    Active - Recruiting

  • Hamamatsu University Hospital

    Hamamatsu 1863289, Shizuoka 1851715 431-3192
    Japan

    Active - Recruiting

  • Kyorin University Hospital

    Mitaka 11790343, Tokyo 1850144 181-8611
    Japan

    Site Not Available

  • Osaka Metropolitan University Hospital

    Osaka 1853909, 545-8586
    Japan

    Active - Recruiting

  • Pediatric Skin Research

    Miami 4164138, Florida 4155751 33156
    United States

    Active - Recruiting

  • D&H Tamarac Research Center

    Tamarac 4174738, Florida 4155751 33321
    United States

    Active - Recruiting

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis 4259418, Indiana 4921868 46250
    United States

    Active - Recruiting

  • Ear, Nose and Throat Consultants, LLC

    Omaha, Nebraska 68144
    United States

    Active - Recruiting

  • Skin Specialists, PC

    Omaha, Nebraska 68144
    United States

    Site Not Available

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

    Papillion, Nebraska 68046
    United States

    Site Not Available

  • Ear, Nose and Throat Consultants, LLC

    Omaha 5074472, Nebraska 5073708 68144
    United States

    Active - Recruiting

  • Skin Specialists, PC dba Schlessinger MD

    Omaha 5074472, Nebraska 5073708 68144
    United States

    Active - Recruiting

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

    Papillion 5074792, Nebraska 5073708 68046
    United States

    Active - Recruiting

  • Northwest Dermatology Institute

    Portland 5746545, Oregon 5744337 97210
    United States

    Active - Recruiting

  • 3A Research - West Location

    El Paso 5520993, Texas 4736286 79902
    United States

    Active - Recruiting

  • Austin Institute for Clinical Research

    Pflugerville 4718711, Texas 4736286 78660
    United States

    Active - Recruiting

  • Texas Dermatology and Laser Specialists

    San Antonio 4726206, Texas 4736286 78218
    United States

    Active - Recruiting

  • AMR Clinical

    Layton 5777107, Utah 5549030 84041
    United States

    Site Not Available

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