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Ritlecitinib for severe alopecia areata in children aged 6 to <12

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF RITLECITINIB IN PEDIATRIC PARTICIPANTS 6 TO LESS THAN 12 YEARS OF AGE WITH SEVERE ALOPECIA AREATA

Phase 3 Interventional Pfizer · NCT07029711

This trial will test whether a once-daily oral capsule of ritlecitinib helps children aged 6 to under 12 with severe alopecia areata regain scalp, eyebrow, and eyelash hair compared with placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment225 (estimated)
Ages6 Years to 11 Years
SexAll
SponsorPfizer Industry-sponsored
Drugs / interventionsritlecitinib
Locations80 sites (Encinitas, California and 79 other locations)
Trial IDNCT07029711 on ClinicalTrials.gov

What this trial studies

This Phase 3, randomized interventional trial enrolls pediatric participants aged 6 to under 12 with severe alopecia areata (≥50% scalp hair loss) and documented varicella immunity. Participants are randomized into three arms: higher-dose ritlecitinib, lower-dose ritlecitinib, or matched placebo, with medication taken once daily for 24 weeks. Efficacy is measured by scalp hair regrowth using the Severity of Alopecia Tool (SALT) and eyebrow/eyelash assessments, along with multiple patient-reported outcomes. The study plans to enroll at least 225 participants with a target of at least 30% recruited from Europe.

Who should consider this trial

Good fit: Children aged 6 to under 12 with severe alopecia areata (SALT ≥50), documented prior varicella vaccination or positive VZV IgG, and who meet other protocol criteria are ideal candidates.

Not a fit: Patients with non-alopecia areata hair loss, pre-existing hearing loss, a history of certain malignancies or lymphoproliferative disorders, or without varicella immunity may not receive benefit or may be excluded.

Why it matters

Potential benefit: If successful, ritlecitinib could help children with severe alopecia areata regrow hair and improve related quality-of-life measures.

How similar studies have performed: Other JAK inhibitor programs for alopecia areata have shown clinical benefit in older adolescents and adults, supporting testing in a pediatric population.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 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 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 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.

Where this trial is running

Encinitas, California and 79 other locations

+30 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Severe Alopecia AreataAlopecia areataChildrenRitlecitinib
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.