Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06058156
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2023-09-21
Brief Title:
Phase 2 Study of SAR444656 in Adult Participants With Moderate to Severe Atopic Dermatitis
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Multinational Multicenter Double-blind Placebo-controlled Phase 2 Study to Evaluate Efficacy and Safety of SAR444656 in Adult Participants With Moderate to Severe Atopic Dermatitis
Status:
RECRUITING
Status Verified Date:
2024-09
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:
ADVANTA
Brief Summary:
This is a multinational multicenter double-blind placebo-controlled parallel-group Phase 2 3-arm study in adult participants with moderate to severe AD who are inadequately controlled with topical therapies or for whom such topical therapies are inadvisable and who are candidates for systemic therapy
Participants will be randomized to receive SAR444656 dose 1 SAR444656 dose 2 or matching placebo
Participants who meet inclusionexclusion criteria will be stratified for randomization by severity of AD moderate baseline EASI score 22 versus severe baseline EASI score 22
The total duration of study is approximately 24 weeks including 1 to 4 weeks for screening 16 weeks for double-blind study treatment and 4 weeks for follow-up
Participants will be randomized to receive SAR444656 dose 1 SAR444656 dose 2 or matching placebo
Participants who meet inclusionexclusion criteria will be stratified for randomization by severity of AD moderate baseline EASI score 22 versus severe baseline EASI score 22
The total duration of study is approximately 24 weeks including 1 to 4 weeks for screening 16 weeks for double-blind study treatment and 4 weeks for follow-up
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 |
|---|---|---|---|
| 2023-504346-66 | REGISTRY | None | None |
| U1111-1287-6919 | REGISTRY | ICTRP | None |