Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517758
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-02-12
Brief Title:
A Phase III Study to Investigate Efficacy Safety and Tolerability of Iptacopan Compared With Placebo in Participants Aged 18 to 75 Years With gMG
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Phase III Study to Evaluate the Efficacy Safety and Tolerability of Iptacopan in Patients With Generalized Myasthenia Gravis gMG Followed by an Open Label Extension Phase
Status:
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:
None
Brief Summary:
The study is a randomized double-blind placebo-controlled multicenter Phase III study to evaluate efficacy safety and tolerability of iptacopan in patients with AChR gMG who are on stable SOC treatment Participants who meet the eligibility criteria will be randomized in a ratio of 11 to receive either iptacopan or matching placebo for 6 months 180 days while continuing on a stable SOC treatment The randomization will be stratified based on region
Detailed Description:
The study consists of a 6-month double-blind treatment period for the primary efficacy and safety analysis followed by a 24 month open label extension period A safety follow up assessment will be performed one 7 days after the last administration of study treatment and one 30 days after the last administration of study treatment for all participants
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