Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374212
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-04-15
Brief Title:
Anifrolumab for Hidradenitis Suppurativa
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
A Prospective Open-label Trial Examining the Efficacy and Safety of Anifrolumab for Hidradenitis Suppurativa HS
Status:
RECRUITING
Status Verified Date:
2024-04
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:
This clinical trial aims to study if a drug called anifrolumab works to treat Hidradenitis Suppurativa HS as well as its effect in quality of life before and after treatment Anifrolumab is a monoclonal antibody that inhibits several processes that have been shown to be involved in the development of HS
The study lasts approximately 40 weeks separated into a screening treatment and follow-up phase Researchers determine if it is safe for the you to receive the drug and if you are eligible for the study during Screening If eligible for the study the treatment phase lasts 24 weeks or six months with one follow-up visit 12 weeks after the last visit in the treatment phase
During the treatment phase participants will be asked to come to clinic every two weeks for the first month of treatment and monthly thereafter for a total of eight treatment visits Participants will be asked to
Complete questionnaires asking about the effect of HS in their daily lives and their perception of HS and treatment received
Receive related medical evaluation
Receive the study drug intravenously
Stay 20 minutes after the infusion for monitoring
The study lasts approximately 40 weeks separated into a screening treatment and follow-up phase Researchers determine if it is safe for the you to receive the drug and if you are eligible for the study during Screening If eligible for the study the treatment phase lasts 24 weeks or six months with one follow-up visit 12 weeks after the last visit in the treatment phase
During the treatment phase participants will be asked to come to clinic every two weeks for the first month of treatment and monthly thereafter for a total of eight treatment visits Participants will be asked to
Complete questionnaires asking about the effect of HS in their daily lives and their perception of HS and treatment received
Receive related medical evaluation
Receive the study drug intravenously
Stay 20 minutes after the infusion for monitoring
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