Ignite Creation Date:
2024-05-06 @ 6:05 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05549934
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-14
First Post:
2022-09-19
Brief Title:
Ritlecitinib for Cicatricial Alopecia
Sponsor:
Emma Guttman
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
A Pilot Study to Assess Safety and Biomarker Responses of Ritlecitinib JAK3TEC Inhibitor in Cicatricial Alopecia
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 JAK3TEC inhibitor ritlecitinib which has shown statistically significant improvement in scalp hair loss for AA patients in a proof of concept and phase 2b3 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None