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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
tablets containing active drug (a combined JAK3/TEC inhibitor)
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Number of Treatment-Emergent Adverse Events
The adverse event will be described and categorized as Treatment-emergent, Serious, abnormal in vital signals, and abnormalities in laboratory parameters.
Time frame: Week 48
Severity of Treatment-Emergent Adverse Events
The adverse event will be categorized according to CTCAE guidelines when applicable
Time frame: Week 48
Change in Ct values of mRNA levels of CCL5 gene
Changes in mRNA Levels of CCL5 gene expression in skin biopsies quantified by normalized Ct values obtained by quantitative real-time PCR assay, measured at baseline and week 24. The unit of the outcome is called Ct value and it represents the number of amplification cycles to reach a level of fluorescence in the experiment. The Ct value is directly associated to the level of expression of a gene
Time frame: Baseline to Week 24
Change in Ct values of mRNA levels of CCL5 gene
Changes in mRNA Levels of CCL5 gene expression in skin biopsies quantified by normalized Ct values obtained by quantitative real-time PCR assay, measured at baseline and week 48. The unit of the outcome is called Ct value and it represents the number of amplification cycles to reach a level of fluorescence in the experiment. The Ct value is directly associated to the level of expression of a gene.
Time frame: Baseline to Week 48
Change in Ct values of mRNA levels of CXCR3
Changes in mRNA Levels of CXCR3 gene expression in skin biopsies quantified by normalized Ct values obtained by quantitative real-time PCR assay, measured at baseline and week 24. The unit of the outcome is called Ct value and it represents the number of amplification cycles to reach a level of fluorescence in the experiment. The Ct value is directly associated to the level of expression of a gene.
Time frame: Baseline to Week 24
Ct value of mRNA levels of CXCR3
Changes in mRNA Levels of CXCR3 gene expression in skin biopsies quantified by normalized Ct values obtained by quantitative real-time PCR assay, measured at baseline and week 48. The unit of the outcome is called Ct value and it represents the number of amplification cycles to reach a level of fluorescence in the experiment. The Ct value is directly associated to the level of expression of a gene.
Time frame: Baseline to Week 48
The Frontal Fibrosis Alopecia Severity Index (FFASI)
The Frontal Fibrosis Alopecia Severity Index utilizes clinical images of the entire hairline from a total score of 0-84, with higher score indicating more severity.
Time frame: Baseline
The Frontal Fibrosis Alopecia Severity Index (FFASI)
The Frontal Fibrosis Alopecia Severity Index utilizes clinical images of the entire hairline, from a total score of 0-84, with higher score indicating more severity.
Time frame: Week 24
The Frontal Fibrosis Alopecia Severity Index (FFASI)
The Frontal Fibrosis Alopecia Severity Index utilizes clinical images of the entire hairline, from a total score of 0-84, with higher score indicating more severity.
Time frame: Week 48
The Lichen Planopilaris Activity Index (LPPAI)
The Lichen Planopilaris Activity Index is a numeric composite index that aggregates symptoms and signs of pruritus, pain, burning, scalp erythema , perifollicular erythema, perifollicular scale , pull test and spreading. Symptoms and signs are measured in a 4-point scale (0-absent, 1-mild, 2-moderate and 3-severe). Full range from 0-10, higher score indicates more severity.
Time frame: Baseline
The Lichen Planopilaris Activity Index (LPPAI)
The Lichen Planopilaris Activity Index is a numeric composite index that aggregates symptoms and signs of pruritus, pain, burning, scalp erythema , perifollicular erythema, perifollicular scale , pull test and spreading. Symptoms and signs are measured in a 4-point scale (0-absent, 1-mild, 2-moderate and 3-severe). Full range from 0-10, higher score indicates more severity.
Time frame: Week 24
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