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A Study in Young People and Adults to Learn About the Medicine Ritlecitinib for Treatment of Patchy Hair Loss, Known by the Medical Term as Moderate Alopecia Areata

RecruitingPhase 3Ages 12 Years - anyAllPfizer
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In plain words

What the trial is, and whether it could suit you

The purpose of this clinical study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the potential treatment of moderate alopecia areata (AA). This study is seeking participants who are * 12 years or older (if permitted by the local IRB/EC and local regulatory health authority) * have AA with patchy hair loss. The current episode of hair loss has lasted for 6 months or longer but 10 years or less * do not have any other diseases or conditions affecting hair loss. Participants will have a 2 in 3 chance of receiving ritlecitinib 50 mg and a 1 in 3 chance of receiving placebo. The placebo looks like the study medicine but does not contain any active ingredients. Participants will not know what you have been assigned to receive. They will take ritlecitinib or placebo once daily by mouth at home for 24 weeks (6 months). After 24 weeks, the assigned tr

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion Criteria * 18 years or older (or the minimum age of consent in accordance with local regulations) at screening. Adolescents (12 to \<18 years of age at screening) are also eligible for this study, but only if permitted by the local IRB/EC and local regulatory health authority (if applicable). Where these approvals have not been granted, only participants 18 years of age and older at screening will be enrolled * Have a clinical diagnosis of AA with no other etiology of hair loss. * Have \>20% to \<50% hair loss of the scalp, as measured by SALT. * Current AA episode of hair loss โ‰ฅ6 months and โ‰ค10 years (Current episode is defined as the continuous period of AA-related scalp hair loss since the last time the subject had no visible scalp patches). Key Exclusion Criteria 1\. Diseases or conditions affecting hair loss, including: * Other types of alopecia (including, but not limited to, traction and scarring alopecia, telogen effluvium). Participants with androgenetic alopecia will be excluded. * Other scalp disease that may impact AA assessment (eg, scalp psoriasis, dermatitis, etc.). * Active systemic diseases that may cause hair loss (eg, lupus erythematosus, thyroiditis, systemic sclerosis, lichen planus, etc).
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What it tests

  • Ritlecitinib 100 mg
  • Ritlecitinib 50 mg
  • Placebo
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Where

38 sites
California Dermatology & Clinical Research Institute
Encinitas, United States
Skin Research of South Florida
Miami, United States
Endeavor Health
Skokie, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, United States
University of Iowa
Iowa City, United States
Cutaneous Translational Research Program, Johns Hopkins University School of Medicine
Baltimore, United States
Johns Hopkins Hospital Investigational Drug Services (IDS) Pharmacy
Baltimore, United States
Massachusetts General Hospital - Clinical Unit for Research Trials in Skin (CURTIS)
Boston, United States

โ€ฆand 30 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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