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Long-term ritlecitinib treatment for children with severe alopecia areata

A LONG-TERM, DOUBLE-BLIND EXTENSION STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF RITLECITINIB IN PARTICIPANTS WITH SEVERE ALOPECIA AREATA WHO PREVIOUSLY COMPLETED STUDIES B7981027 OR B7981031

Phase 3 Interventional Pfizer · NCT07029828

This study will give ritlecitinib to children who completed earlier Pfizer pediatric ritlecitinib studies to see if long-term treatment is safe and helps maintain or improve hair regrowth.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment140 (estimated)
Ages6 Years to 14 Years
SexAll
SponsorPfizer Industry-sponsored
Drugs / interventionsritlecitinib
Locations41 sites (Encinitas, California and 40 other locations)
Trial IDNCT07029828 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Children with severe alopecia areata who completed Pfizer pediatric studies B7981027 or B7981031, meet the varicella vaccination or prior infection requirement, and (for those from B7981031) have at least 50% scalp hair loss are eligible.

Not a fit: Children who did not complete the parent studies, have unresolved safety issues that required discontinuation, or cannot meet vaccination/health requirements are unlikely to benefit from enrolling.

Why it matters

Potential benefit: If successful, long-term ritlecitinib could maintain hair regrowth and offer a sustained, tolerable treatment option for children with severe alopecia areata.

How similar studies have performed: Ritlecitinib and other JAK inhibitors have produced positive hair regrowth results in prior trials, and this extension continues to build on those earlier findings.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Encinitas, California and 40 other locations

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 AreataChildrenRitlecitinibLong-term extension study
Last reviewed 2026-06-13 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.