Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06558279
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC in Adults with Ocular Myasthenia Gravis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-Blinded Placebo-Controlled Phase 3 Parallel-Group Design Study Evaluating the Efficacy and Safety of Efgartigimod PH20 SC Administered by Prefilled Syringe in Adult Participants with Ocular Myasthenia Gravis
Status:
RECRUITING
Status Verified Date:
2024-10
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:
ADAPT oculus
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of efgartigimod PH20 SC given by a pre-filled syringe in adult patients with ocular myasthenia gravis The study consists of a part A approximately 7 weeks and a part B up to 2 years In part A half of the participants will receive efgartigimod PH20 SC and the other half will receive placebo In part B all participants will receive efgartigimod PH20 SC The participants will be in the study for about up to 2 years and 12 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