Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04502862
Status:
COMPLETED
Last Update Posted:
2024-01-26
First Post:
2020-08-04
Brief Title:
A Phase 4 Randomized Double-blind Placebo-controlledMulticenter Parallel-group Study of the Effect of Dupilumab on Sleep Disturbance in Patients With Uncontrolled Persistent Asthma
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Phase 4 Randomized Double-blind Placebo-controlled Multicenter Parallel-group Study of the Effect of Dupilumab on Sleep Disturbance in Patients With Uncontrolled Persistent Asthma
Status:
COMPLETED
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:
MORPHEO
Brief Summary:
Primary Objective
To assess the effect of dupilumab on sleep
Secondary Objectives
To evaluate the effect of dupilumab on additional patient reported sleep outcomes
To evaluate the effect of dupilumab on objective sleep assessment
To evaluate the effect of dupilumab on asthma symptoms
To evaluate the effect of dupilumab on lung function
To evaluate the safety of dupilumab
To assess the effect of dupilumab on sleep
Secondary Objectives
To evaluate the effect of dupilumab on additional patient reported sleep outcomes
To evaluate the effect of dupilumab on objective sleep assessment
To evaluate the effect of dupilumab on asthma symptoms
To evaluate the effect of dupilumab on lung function
To evaluate the safety of dupilumab
Detailed Description:
Study duration per participant will be approximately 16 weeks and up to 29 weeks including up to 5 weeks screening period a 12-week treatment period and up to 12 weeks post-treatment follow-up period or until the participant switches to commercialized dupilumab or other biologic product whichever comes first
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 |
|---|---|---|---|
| U1111-1249-6054 | REGISTRY | None | None |
| 2020-001217-20 | EUDRACT_NUMBER | ICTRP | None |