Ignite Creation Date:
2024-05-06 @ 6:24 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05649098
Status:
RECRUITING
Last Update Posted:
2023-10-04
First Post:
2022-12-05
Brief Title:
Repurposing Dupilumab for Management of Pruritic Genetic Inflammatory Skin Disorders
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Repurposing Dupilumab for Management of Pruritic Genetic Inflammatory Skin Disorders a Single-Site Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-10
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:
Severe itch is a common symptom of many genetic skin disorders and leads to a negative impact on patient quality of life The investigators hypothesize that a intervention with dupilumab will improve itch in patients with pruritic genetic inflammatory skin disorders even those not recognized to be Th2-driven and b the administration of dupilumab will be well-tolerated regardless of underlying genetic skin disorder The total clinical study duration will be 26 months 104 Weeks The treatment period will include a 16-week open-label phase and a 20-month long-term extension phase for those who qualify and wish to continue
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