Ritlecitinib for Cicatricial Alopecia

Phase 2

Completed

• Conditions: Cicatricial Alopecia
• Interventions: Drug: PF-06651600

• Registration Number: NCT05549934
• Lead Sponsor: Emma Guttman

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-19
• Study First Submitted QC: 2022-09-19
• Study First Posted: 2022-09-22
• Study Start: 2022-12-15
• Primary Completion: 2025-03-20
• Study Completion: 2025-03-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PF-06651600 (Ritlecitinib)	PF-06651600	200 mg once-daily for 8 weeks and then 100 mg once daily for the remaining 40 weeks

Primary Outcome Measures

Name	Time	Method
Severity of Treatment-Emergent Adverse Events	Week 48	The adverse event will be categorized according to CTCAE guidelines when applicable
Number of Treatment-Emergent Adverse Events	Week 48	The adverse event will be described and categorized as Treatment-emergent, Serious, abnormal in vital signals, and abnormalities in laboratory parameters.
Change in Ct values of mRNA levels of CCL5 gene	Baseline to Week 48	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.

Secondary Outcome Measures

Name	Time	Method
Ct value of mRNA levels of CXCR3	Baseline to Week 48	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.
The Frontal Fibrosis Alopecia Severity Index (FFASI)	Week 48	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.
The Lichen Planopilaris Activity Index (LPPAI)	Week 24	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.
Change in Ct values of mRNA levels of CXCR3	Baseline to Week 24	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.

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States