Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06298552
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-03-01
Brief Title:
A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients with Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis
Sponsor:
argenx
Organization:
argenx
Study Overview
Official Title:
A Randomized Double-Blinded Placebo-Controlled Phase 3 Parallel-Group Design Study Evaluating the Efficacy and Safety of Efgartigimod IV in Adult Participants with Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis
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:
ADAPT SERON
Brief Summary:
The primary purpose of this study is to measure the efficacy and safety of efgartigimod intravenously IV compared to placebo in participants with Acetylcholine Receptor Binding Antibody AChR-Ab seronegative Generalized Myasthenia Gravis gMG Other objectives are to assess long-term efficacy safety and tolerability of efgartigimod
Study will consist of
Screening
Part A participants will be randomized to receive either efgartigimod IV or placebo
Part B participants completing part A will receive open-label efgartigimod IV
Study will consist of
Screening
Part A participants will be randomized to receive either efgartigimod IV or placebo
Part B participants completing part A will receive open-label efgartigimod IV
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 |
|---|---|---|---|
| 2024-511796-15-00 | OTHER | CTIS number | None |