Ritlecitinib for Scarring Alopecia
Trial Summary
What is the purpose of this trial?
Alopecia could be subdivided into two main groups of diseases: non-scarring alopecia, such as male pattern baldness, or alopecia areata (AA), in which hair follicles are preserved, yet quiescent, and scarring alopecia, also known as cicatricial alopecia (CA), in which hair follicles are irreversibly destroyed. CA leads to scarred areas, most commonly on the scalp, that cannot re-grow hair. Despite being a long-term condition, that often has significant impact on patients' well-being, available effective treatments for these diseases are lacking. In addition, the molecular abnormalities causing CA are largely unknown. The research team will be administering a new investigational drug (a JAK3/TEC inhibitor), ritlecitinib, which has shown statistically significant improvement in scalp hair loss for AA patients in a proof of concept and phase 2b/3 studies (B7981015 AA study). This is an open-label clinical trial. CA patients will be asked to provide small samples of skin and blood throughout the treatment period, to find out how they respond to the drug, and to attempt to better understand these diseases.
Research Team
Emma Guttman-Yassky
Principal Investigator
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
Adults over 18 with scarring alopecia for at least 6 months, in good health, and not pregnant or breastfeeding can join. They must test negative for TB, agree to use effective contraception if applicable, and have no acute infections or planned surgeries. Excluded are those with certain systemic diseases causing hair loss, psychiatric conditions affecting study compliance, a history of severe allergies to drug components or recent use of immunosuppressive medications.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Ritlecitinib, starting with 200 mg once-daily for 8 weeks, followed by 100 mg once daily for the remaining 40 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ritlecitinib
Ritlecitinib is already approved in European Union, United States for the following indications:
- Severe alopecia areata
- Severe alopecia areata
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Who Is Running the Clinical Trial?
Emma Guttman
Lead Sponsor
Pfizer
Industry Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University