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
Pfizer
Summary
The purpose of this study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the possible treatment of severe alopecia areata. Alopecia areata is a condition that causes hair loss. This study is seeking participants who have: * at least 50% scalp hair loss due to alopecia areata. * received varicella vaccination (2 doses) or have been infected by varicella zoster virus before based on blood test reports. * history of clinical response failure to alopecia areata treatment (for children in EU/UK only). All participants in this study will receive either study medicine (ritlecitinib) or placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. One-third of participants will receive ritlecitinib higher dose, one-third participants will receive ritlecitinib lower dose, and one-third participants will receive placebo. The study medicine is a capsule that is taken by mouth. It is taken once each day at home. The study will compare the experiences of participants receiving ritlecitinib to participants receiving placebo. This will help see if ritlecitinib is safe and effective. Participants will take part in this study for 6 months. During this time, they will have 8 study visits at the study clinic. The study team will also call participants about 8 times over the phone.
Description
Study B7981027 is being conducted to assess efficacy and safety of ritlecitinib in pediatric participants 6 to \<12 years of age with severe AA. The primary objective of this study is to evaluate the efficacy of ritlecitinib compared to placebo in pediatric participants with severe AA on regrowth of lost scalp hair. The secondary objectives are to evaluate safety, tolerability, acceptability and palatability of ritlecitinib and to evaluate the effect of ritlecitinib on patient centered outcomes. This study will have 3 treatment arms, including 2 ritlecitinib dosage levels (higher and lower do…
Eligibility
- Age range
- 6–11 years
- Sex
- All
- Healthy volunteers
- No
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 ser…
Interventions
- DrugRitlecitinib higher dose
Study intervention will be provided as oral capsules centrally by the sponsor in high-density polyethylene (HDPE) bottles.
- DrugRitlecitinib lower dose
Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.
- DrugPlacebo
Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.
Locations (80)
- California Dermatology & Clinical Research InstituteEncinitas, California
- University of California - IrvineIrvine, California
- Investigational Drug Service - Rady Children's Hospital-San DiegoSan Diego, California
- University of California, San Diego/Rady Children's Hospital-San Diego;San Diego, California
- Southern California Clinical ResearchSanta Ana, California
- Children's Hospital ColoradoAurora, Colorado