Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06226610
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-26
First Post:
2024-01-18
Brief Title:
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Sponsor:
Akron Childrens Hospital
Organization:
Akron Childrens Hospital
Study Overview
Official Title:
A Phase 2 Double-Blind Randomized Placebo-Controlled Study to Assess the Efficacy of Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
The goal of this study is to test the efficacy of Dupixent in improving post-burn itching symptoms versus the current standard of care
Detailed Description:
Participants will receive six injections of Dupixent or placebo two 300 mg loading doses and one 300 mg dose every two weeks after that
In addition they will be asked to complete questionnaires to determine daily itch severity quality of life treatment benefit physical functioning and pain interference
Individual participants will require 13 weeks to complete all study visits
In addition they will be asked to complete questionnaires to determine daily itch severity quality of life treatment benefit physical functioning and pain interference
Individual participants will require 13 weeks to complete all study visits
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?:
True
Is an FDA AA801 Violation?:
None