Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06284954
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-02-22
Brief Title:
A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults with Dermatomyositis
Sponsor:
argenx
Organization:
argenx
Study Overview
Official Title:
A Phase 2 Randomized Double-Blinded Placebo-Controlled Multicenter Study to Evaluate the Safety Tolerability and Efficacy of Empasiprubart in Adults with Dermatomyositis
Status:
RECRUITING
Status Verified Date:
2024-08
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:
empacific
Brief Summary:
This study will evaluate the safety and efficacy of empasiprubart compared with placebo in adult participants with dermatomyositis DM
The study duration will be approximately 92 weeks for all participants After the screening period eligible participants will be randomized in a 21 ratio to receive either empasiprubart or placebo respectively during the treatment period duration of 25 weeks At the end of the treatment period all the participants will enter a safety follow-up period duration of 65 weeks
The study duration will be approximately 92 weeks for all participants After the screening period eligible participants will be randomized in a 21 ratio to receive either empasiprubart or placebo respectively during the treatment period duration of 25 weeks At the end of the treatment period all the participants will enter a safety follow-up period duration of 65 weeks
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 |
|---|---|---|---|
| 2023-508337-14 | OTHER | CTIS number | None |