Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06101095
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2023-10-19
Brief Title:
A Study Assessing Esophageal Function and Remodeling With Dupilumab Compared With Placebo for 24 Weeks Followed by 104 Weeks Open Label in Adult Participants With EoE REMOdeling With Dupilumab in Eosinophilic Esophagitis Long-term Trial
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Phase 4 Randomized Multicenter Double-blind Parallel-group 24 Weeks Placebo-controlled Study Followed by 104 Weeks Open-label to Assess Dupilumab Efficacy on Esophageal Function and Remodeling in Adult Participants With Eosinophilic Esophagitis EoE
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:
This is parallel Phase 4 study which consists of a 24 week 05 years randomized double blind placebo controlled 2-arm treatment period followed by an open label segment of 104 weeks 2 years for a total of 128 weeks 25 years to evaluate the effect of dupilumab treatment on esophageal function and remodeling in adults with eosinophilic esophagitis
Duration of study period per participant
Screening period Up to 12 weeks before Week 0
Randomized double-blind period 24 weeks
Open label period 104 weeks
Post Investigational Medicinal Product IMP intervention follow-up period up to 12 weeks or until the participants switch to commercialized dupilumab whatever comes first
There will be ten 10 site visits and five 5 direct-to-participant IMP delivery visits except if prohibited by local regulatory authorities or if participant is not willing In this case IMP will be dispensed at the study site
Duration of study period per participant
Screening period Up to 12 weeks before Week 0
Randomized double-blind period 24 weeks
Open label period 104 weeks
Post Investigational Medicinal Product IMP intervention follow-up period up to 12 weeks or until the participants switch to commercialized dupilumab whatever comes first
There will be ten 10 site visits and five 5 direct-to-participant IMP delivery visits except if prohibited by local regulatory authorities or if participant is not willing In this case IMP will be dispensed at the study site
Detailed Description:
The duration per participant will be up to 152 weeks
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 |
|---|---|---|---|
| U1111-1280-5266 | REGISTRY | None | None |
| 2022-502491-23 | REGISTRY | CTIS | None |