CompletedPhase 2

Dual JAK1/TYK2 Inhibitor for Cicatricial Alopecia

United States50 participantsStarted 2021-05-19

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 study team's research involves administrating patients a new investigational drug (a combined TYK/JAK inhibitor) which has been shown to be safe and well tolerated in clinical studies to date, and is being investigated in other conditions, such as AA. 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 active CA (LPP/FFA or CCCA). for at least 6 months from screening visit. Diagnosis will be confirmed clinically at screening visit. * Subject has a negative Tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test (QFT) at screening. * Subject is judged to be in otherwise good overall health following a detailed medical and medication history, physical examination, and laboratory testing. Exclusion Criteria: * Subject's cause of hair loss is indeterminable and/or they have concomitant causes of alopecia, such pregnancy-related, drug-induced, telogen effluvium, or advanced androgenetic alopecia. * Subject has a history of CA for ≥ 7 years since their disease onset, severe fibrosing disease, or very rapid hair loss. * Subject has a history of moderate to severe keloids on the scalp, as determined by clinical examination at screening. * Other scalp disease that may impact assessment (eg, scalp psoriasis, dermatitis, etc). * Subject is pregnant or breastfeeding. Female subjects of childbearing potential must agree to use two effective methods (one of which is a highly effective method) of contraception throughout the study and for at least 28 days after the last dose of investigational product. Women of childbearing…

What they're measuring

Incidence and Severity of Treatment-Emergent adverse events

Timeframe: Week 48

Changes from baseline in CCL5 gene expression level in response to PF-06700841

Timeframe: Week 12 and Week 24

Changes from baseline in CXCR3 gene expression level in response to PF-06700841

Timeframe: Week 12 and Week 24

Trial details

NCT IDNCT05076006

SponsorEmma Guttman

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-30