Long-term ritlecitinib treatment for children with severe alopecia areata

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, double-blind long-term extension enrolls children with severe alopecia areata who completed parent studies B7981027 or B7981031 to continue or begin ritlecitinib treatment for up to an additional three years. Participants who continued active dosing in the parent study generally keep the same dose, while prior placebo recipients and those from one parent study are randomized 1:1 to higher or lower ritlecitinib doses. The primary objective is to monitor long-term safety and tolerability, with secondary objectives focused on long-term efficacy, durability of response, and patient-centered outcomes. Regular evaluations at set months determine continuation and treatment effects over time.

Why it matters

Who can join: the full rules

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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Where it's running

• University of California~ Irvine
  Irvine, California, United States Recruiting
• Southern California Clinical Research
  Santa Ana, California, United States Recruiting
• Children's Hospital Colorado
  Aurora, Colorado, United States Recruiting
• Children's National Hospital
  Washington D.C., District of Columbia, United States Recruiting
• Pediatric Skin Research
  Miami, Florida, United States Recruiting
• Endeavor Health Clinical Operations
  Skokie, Illinois, United States Recruiting

+17 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Litfulo capsule for people with severe alopecia areata in routine care

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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.