Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444451
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-05-31
Brief Title:
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Participants With Severe Alopecia Areata
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Phase 2 Randomized Double-blind Placebo--controlled Parallel Group 3-arm Multinational Multicenter Proof-of-concept Study to Evaluate the Efficacy and Safety of Amlitelimab Monotherapy by Subcutaneous Injection in Adult Participants With Severe Alopecia Areata
Status:
RECRUITING
Status Verified Date:
2024-07
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 a parallel Phase 2 multinational multicenter randomized double-blind placebo-controlled 3-arm study to investigate the efficacy and safety of subcutaneous SC injections of amlitelimab treatment as monotherapy in participants aged 18 years and older with severe alopecia areata AA At the end of the treatment period all participants will have the option to enter a separate study the open-label extension OLE study once eligibility is confirmed
The study duration will be up to 56 weeks for participants not entering the OLE including a 2-to-4-week screening a 36-week randomized double-blind period and a 16-week safety follow-up For participants entering the OLE the DRI18180 study duration will be up to 40 weeks including a 2-to-4-week screening a 36-week randomized double-blind period The total number of visits will be up to 12 visits or 11 visits for those entering the OLE study
The study duration will be up to 56 weeks for participants not entering the OLE including a 2-to-4-week screening a 36-week randomized double-blind period and a 16-week safety follow-up For participants entering the OLE the DRI18180 study duration will be up to 40 weeks including a 2-to-4-week screening a 36-week randomized double-blind period The total number of visits will be up to 12 visits or 11 visits for those entering the OLE 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 |
|---|---|---|---|
| 2024-511225-64 | REGISTRY | None | None |
| U1111-1295-6359 | REGISTRY | ICTRP | None |