A Long-Term Study to Learn About The Study Medicine Called Ritlecitinib in Children With Severe A… (NCT07029828) | Clinical Trial Compass
RecruitingPhase 3
A Long-Term Study to Learn About The Study Medicine Called Ritlecitinib in Children With Severe Alopecia Areata.
United States140 participantsStarted 2025-09-10
Plain-language summary
The purpose of this clinical trial is to learn about long-term safety and long-term effects of the study medicine (called ritlecitinib) for the potential treatment of severe alopecia areata, a condition that causes hair loss.
This study is seeking participants who have:
* previously completed one of Pfizer's pediatric studies for Alopecia Areata (B7981027 or B7981031).
* at least 50% scalp hair loss due to alopecia areata (for participants enrolling from the study B7981031).
* received varicella vaccination (2 doses) or have been infected by varicella zoster virus before based on blood test reports.
All participants in this study will receive the study medicine (ritlecitinib). Participants who received ritlecitinib higher or lower doses in the parent Study B7981027 will continue receiving the same ritlecitinib dose in this trial.
Participants who received placebo in the parent Study B7981027 and all participants from parent Study B7981031 will receive either higher or lower dose of ritlecitinib in this trial.
The study medicine is a capsule that is taken by mouth. It is taken 1 time each day at home.
The study will help see if ritlecitinib is safe and effective. Participants will take part in this study for a duration of up to 3 years (36 months). During this time, they will have 17 study visits at the study clinic. The study team will also call participants once a month over the phone.
Who can participate
Age range6 Years – 14 Years
SexALL
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Inclusion criteria
✓. Participants with alopecia areata (AA) (including alopecia totalis \[AT\] and alopecia universalis \[AU\]) who completed the studies B7981027 or B7981031.
✓. 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
✕. Exclusion criteria for participants originating from Study B7981027 with ≤ 30 Days between last dose in Study B7981027 and first visit of Study B7981028
✕. 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.
✕. 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.
✕. 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
What they're measuring
1
Incidence of treatment-emergent adverse events (AEs).
Timeframe: From the time participant signs informed consent/assent, through and including a minimum of 28 calendar days after the last administration of the study intervention (up to approximately 3 years).
2
Incidence of Serious Adverse Events (SAEs) and AEs leading to permanent discontinuation from the study.
Timeframe: From the time participant signs informed consent/assent, through and including a minimum of 28 calendar days after the last administration of the study intervention (up to approximately 3 years).
✕. 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.
✕. Any present malignancies or history of malignancies or lymphoproliferative disorders.
✕. 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).