Ignite Creation Date:
2024-05-06 @ 2:00 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04180488
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2019-11-25
Brief Title:
Dupilumab for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine and Who Are naïve to Intolerant of or Incomplete Responders to Omalizumab LIBERTY-CSU CUPID
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Master Protocol of Three Randomized Double-blind Placebo Controlled Multi-center Parallel-group Studies of Dupilumab in Patients With Chronic Spontaneous Urticaria CSU Who Remain Symptomatic Despite the Use of H1 Antihistamine Treatment in Patients naïve to Omalizumab and in Patients Who Are Intolerant or Incomplete Responders to Omalizumab
Status:
ACTIVE_NOT_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:
Primary Objective
To demonstrate the efficacy of dupilumab in study participants with CSU who remain symptomatic despite the use of H1 antihistamine Study A and C omalizumab naïve Study B omalizumab intolerant or incomplete responders
Secondary Objectives
To demonstrate the efficacy of dupilumab on urticaria activity composite endpoint and itch or hives separately at various timepoints To demonstrate the efficacy of dupilumab on angioedema To demonstrate the efficacy of dupilumab on urticaria control 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 patients who require treatment with oral corticosteroids OCS To evaluate safety outcome measures To evaluate immunogenicity of dupilumab
To demonstrate the efficacy of dupilumab in study participants with CSU who remain symptomatic despite the use of H1 antihistamine Study A and C omalizumab naïve Study B omalizumab intolerant or incomplete responders
Secondary Objectives
To demonstrate the efficacy of dupilumab on urticaria activity composite endpoint and itch or hives separately at various timepoints To demonstrate the efficacy of dupilumab on angioedema To demonstrate the efficacy of dupilumab on urticaria control 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 patients who require treatment with oral corticosteroids OCS To evaluate safety outcome measures To evaluate immunogenicity of dupilumab
Detailed Description:
The duration of study for each participant will include 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 |
|---|---|---|---|
| 2019-003775-19 | EUDRACT_NUMBER | ICTRP | None |
| U1111-1241-8208 | REGISTRY | None | None |