Ignite Creation Date:
2024-05-06 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04681729
Status:
COMPLETED
Last Update Posted:
2024-02-21
First Post:
2020-12-18
Brief Title:
Dupilumab for the Treatment of Chronic Inducible Cold Urticaria in Patients Who Remain Symptomatic Despite the Use of H1-antihistamine LIBERTY-CINDU CUrIADS
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Multi-center Parallel-group Study of Dupilumab in Patients With Chronic Inducible Cold Urticaria Who Remain Symptomatic Despite the Use of H1-antihistamine Treatment
Status:
COMPLETED
Status Verified Date:
2023-05-02
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 in adult and adolescent participants with primary acquired chronic inducible cold urticaria ColdU who remain symptomatic despite the use of an H1-antihistamine
Secondary Objectives
To demonstrate the efficacy of dupilumab on primary acquired chronic inducible ColdU disease control To demonstrate the efficacy of dupilumab on primary acquired chronic inducible ColdU local signs and symptoms hiveswheals itch burning sensation and pain after provocation test To demonstrate the efficacy of dupilumab on primary acquired chronic inducible ColdU disease activity To demonstrate improvement in health-related quality-of-life and overall disease status and severity To evaluate the ability of dupilumab in reducing the proportion of participants who require rescue therapy To evaluate the proportion of participants with cold exposure triggered urticaria To evaluate safety outcome measures To evaluate immunogenicity of dupilumab
To demonstrate the efficacy of dupilumab in adult and adolescent participants with primary acquired chronic inducible cold urticaria ColdU who remain symptomatic despite the use of an H1-antihistamine
Secondary Objectives
To demonstrate the efficacy of dupilumab on primary acquired chronic inducible ColdU disease control To demonstrate the efficacy of dupilumab on primary acquired chronic inducible ColdU local signs and symptoms hiveswheals itch burning sensation and pain after provocation test To demonstrate the efficacy of dupilumab on primary acquired chronic inducible ColdU disease activity To demonstrate improvement in health-related quality-of-life and overall disease status and severity To evaluate the ability of dupilumab in reducing the proportion of participants who require rescue therapy To evaluate the proportion of participants with cold exposure triggered urticaria 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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1246-6913 | REGISTRY | ICTRP | None |
| 2020-003756-33 | EUDRACT_NUMBER | None | None |