Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06407934
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-05-06
Brief Title:
A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Monotherapy Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Phase 3 Multinational Multicenter Randomized Double-blind Placebo-controlled Parallel Group 48-week Extension Study to Evaluate the Treatment Response and Safety of Two Amlitelimab Dose Regimens Administered as Monotherapy by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
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:
ESTUARY
Brief Summary:
This is a multinational multicenter randomized double-blind placebo-controlled parallel Phase 3 study for treatment of participants aged 12 years and older diagnosed with moderate-to-severe atopic dermatitis AD
The main objective of this study is to evaluate if those participants who received amlitelimab dose 1 in the parent studies EFC17559 COAST-1 EFC17560 COAST 2 EFC17561 SHORE and were responders can maintain their response either remaining at dose 1 or switching to dose 2 of amlitelimab compared to treatment withdrawal
Study details include
The study duration will be up to 64 weeks for participants not entering the LTS17367 RIVER-AD study including a 48-week randomized double-blind period and a 16-week safety follow-up
The study duration will be up to 48 weeks for participants entering the LTS17367 RIVER-AD study at the Week 48 visit of EFC17600 ESTUARY
The total treatment duration will be up to 48 weeks The total number of visits will be up to 14 visits or 13 visits for those entering LTS17367 RIVER-AD study
The main objective of this study is to evaluate if those participants who received amlitelimab dose 1 in the parent studies EFC17559 COAST-1 EFC17560 COAST 2 EFC17561 SHORE and were responders can maintain their response either remaining at dose 1 or switching to dose 2 of amlitelimab compared to treatment withdrawal
Study details include
The study duration will be up to 64 weeks for participants not entering the LTS17367 RIVER-AD study including a 48-week randomized double-blind period and a 16-week safety follow-up
The study duration will be up to 48 weeks for participants entering the LTS17367 RIVER-AD study at the Week 48 visit of EFC17600 ESTUARY
The total treatment duration will be up to 48 weeks The total number of visits will be up to 14 visits or 13 visits for those entering LTS17367 RIVER-AD study
Detailed Description:
None
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 |
|---|---|---|---|
| 2023-508096-36 | REGISTRY | CTIS | None |
| U1111-1290-9215 | REGISTRY | None | None |