CompletedPhase 2

Ritlecitinib for Cicatricial Alopecia

United States50 participantsStarted 2022-12-15

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

INCLUSION CRITERIA * Subjects of any gender, age 18 years or older, at the time of informed consent at Screening * Subjects who are willing and able to adhere to the study visit schedule and comply with protocol requirements. * Subject self-reports a history of at least 6 months of CA (LPP/FFA or CCCA). Diagnosis will be made clinically (according to the LPPAI37, FFASI36 and/or CHLG38). * Subject has a negative Tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test (QFT) at screening or within the last 12 months. * A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: * Is not a woman of childbearing potential (WOCBP) OR; * Is a WOCBP (all female participants, regardless of whether or not they have experienced/reported menarche, are considered WOCBP unless they are permanently sterile or confirmed infertile). A WOCBP who is sexually active must use a contraceptive method that is highly effective, with a failure rate of \<1%, during the intervention period and for at least 28 days after the last dose of study intervention. * And if a WOCBP, must have a negative highly sensitive serum pregnancy test at the screening visit and a negative urine pregnancy test at baseline performed before the first dose of study intervention. * Subject is judged to be in otherwise good overall health following a detailed medical and medication history, physical examination, and labora…

What they're measuring

Number of Treatment-Emergent Adverse Events

Timeframe: Week 48

Severity of Treatment-Emergent Adverse Events

Timeframe: Week 48

Change in Ct values of mRNA levels of CCL5 gene

Timeframe: Baseline to Week 24

Change in Ct values of mRNA levels of CCL5 gene

Timeframe: Baseline to Week 48

Trial details

NCT IDNCT05549934

SponsorEmma Guttman

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-20