Ignite Creation Date:
2024-05-06 @ 2:00 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04183335
Status:
COMPLETED
Last Update Posted:
2022-12-12
First Post:
2019-11-27
Brief Title:
Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable LIBERTY-PN PRIME
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Double Blind Placebo-controlled Multi-center Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Prurigo Nodularis Who Are Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable
Status:
COMPLETED
Status Verified Date:
2022-11
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:
Primary Objective
To demonstrate the efficacy of dupilumab on itch response in participants with prurigo nodularis PN inadequately controlled on topical prescription therapies or when those therapies are not advisable
Secondary Objectives
To demonstrate the efficacy of dupilumab on additional itch endpoints in participants with PN inadequately controlled on topical prescription therapies or when those therapies are not advisable
To demonstrate efficacy of dupilumab on skin lesions of PN To demonstrate the improvement in health-related quality of life To evaluate safety outcome measures To evaluate immunogenicity of dupilumab
To demonstrate the efficacy of dupilumab on itch response in participants with prurigo nodularis PN inadequately controlled on topical prescription therapies or when those therapies are not advisable
Secondary Objectives
To demonstrate the efficacy of dupilumab on additional itch endpoints in participants with PN inadequately controlled on topical prescription therapies or when those therapies are not advisable
To demonstrate efficacy of dupilumab on skin lesions of PN To demonstrate the improvement in health-related quality of life To evaluate safety outcome measures To evaluate immunogenicity of dupilumab
Detailed Description:
The duration of study for each participant included 2-4 weeks of screening period 24 weeks of treatment period and 12 weeks of post treatment period
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1241-8153 | REGISTRY | ICTRP | None |
| 2019-003774-41 | EUDRACT_NUMBER | None | None |