Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06544499
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Double-Blinded Placebo-Controlled Parallel-Arm Study Followed by an Open-Label Arm to Evaluate the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
advance NEXT
Brief Summary:
The main purpose of this study is to look at the effect efficacy and safety of efgartigimod IV in participants with primary immune thrombocytopenia ITP After an up to 2 weeks screening period eligible participants will be randomized in a 21 ratio to receive either efgartigimod IV or placebo IV respectively during the double-blinded treatment period DBTP At the end of the treatment period up to 24 weeks all participants will receive efgartigimod IV during the first 52-week open-label treatment period OLTP1 At the end of the first OLTP1 participants may begin a second 52-week OLTP2 After the OLTP2 the participants will enter a follow-up period approximately 8 weeks while off study drug The participants will be in the study for up to 138 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None