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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• California Dermatology & Clinical Research Institute
  Encinitas, California, United States Recruiting
• University of California - Irvine
  Irvine, California, United States Recruiting
• Investigational Drug Service - Rady Children's Hospital-San Diego
  San Diego, California, United States Recruiting
• University of California, San Diego/Rady Children's Hospital-San Diego;
  San Diego, California, United States Recruiting
• Southern California Clinical Research
  Santa Ana, California, United States Recruiting
• Children's Hospital Colorado
  Aurora, Colorado, United States Recruiting

+30 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.