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A Study of Ritlecitinib for Severe Alopecia Areata in Children

This study is looking into the safety and effects of a medicine called ritlecitinib for children aged 6 to 11 years old who have severe alopecia areata (a condition that causes hair loss). You might be able to join if you have at least 50% scalp hair loss due to alopecia areata and have either received two doses of the chickenpox vaccine or had chickenpox before. For those in Europe and the UK, you also need to have tried other alopecia areata treatments that didn't work. Participants will receive either ritlecitinib (at a higher or lower dose) or a placebo (a pill with no medicine in it). The study will measure how much your hair grows back after 24 weeks to see if ritlecitinib is effective. The study is currently unclear on its recruitment status.

Study design
This is an interventional study with three groups: two receiving ritlecitinib at different doses and one receiving a placebo. It plans to enroll 208 participants.
What's involved
Participants will receive study medication for 24 weeks. Eligibility will be assessed at screening and baseline visits.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome for hair regrowth is measured at Week 24.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07029711

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

Active, Not Recruiting
PHASE3Ages 6–11InterventionalTreatment
Pfizer
~208 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:Ritlecitinib higher doseRitlecitinib lower dosePlacebo

At a glance

Recruiting sites
0 of 83 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
For US and Countries Following US Analysis Plan: Response based on achieving an absolute Severity of Alopecia Tool (SALT) score ≤20.
Measured over Week 24
+1 more outcome measured

Conditions

Severe Alopecia Areata

Explore related trials

Alopecia

Where it's being run

83 sites across 43 states
Illinois8
France7
Texas5
Masovian Voivodeship5
Czechia4
Nebraska3
Beijing Municipality3
Italy3

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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 both screening and baseline visits, without evidence of terminal hair regrowth within the previous 12 months.
For study participants in the EU/UK only: History of clinical response failure to AA treatment (such as topical, off-label pharmacologic, or hairpiece prosthetics)
Documented evidence of having received varicella vaccination (2 doses), OR evidence of prior exposure to varicella zoster virus (VZV) based on serological testing (ie, a positive VZV Immunoglobulin G (IgG) antibody (Ab) result) at screening.

Exclusion

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 as Epstein-Barr virus (EBV) related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
Clinically significant depression per PROMIS Parent Proxy Short Form - Depressive symptoms (T-score ≥70).
Any evidence of untreated or inadequately treated active or latent Mycobacterium tuberculosis (TB) infection; history (one or more episodes) of severe or serious cytomegalovirus (CMV) infection, herpes zoster (shingles) or disseminated herpes simplex; infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
Vaccination with live attenuated replication-competent vaccine within 6 weeks of first dose of study intervention.

What this trial measures

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

    The difference in proportions of participants with the SALT ≤20 response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.

  • For EU/UK and Countries Following EU/UK Analysis Plan: Response based on achieving an absolute SALT score ≤10.Week 24

    The difference in proportions of participants with the SALT ≤10 response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria.