Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547216
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Phase 2 Open-label Extension Study of AOC 1020 in Adults With Facioscapulohumeral Muscular Dystrophy FSHD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Open-label Extension Study to Evaluate the Long-Term Safety Tolerability Efficacy and Pharmacokinetics of AOC 1020 Administered Intravenously to Adult Participants With Facioscapulohumeral Muscular Dystrophy FSHD
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-06
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:
FORTITUDE-OLE
Brief Summary:
A Phase 2 Open-label Extension Study to Evaluate the Long-Term Safety Tolerability Efficacy and Pharmacokinetics of AOC 1020 Administered Intravenously to Adult Participants with Facioscapulohumeral Muscular Dystrophy FSHD
Detailed Description:
This study will continue to evaluate the safety tolerability PK and efficacy of AOC 1020 in participants who were treated in the randomized placebo-controlled Phase 12 AOC 1020-CS1 clinical study
Participants from AOC 1020-CS1 are eligible to enroll in AOC 1020-CS2 if they have satisfactorily completed AOC 1020-CS1 All participants who enroll in AOC 1020-CS2 will receive AOC 1020 regardless of whether they received AOC 1020 or placebo in AOC 1020-CS1 Dosing will occur quarterly ie every 13 weeks
The total duration of active treatment in AOC 1020-CS2 is approximately 24 months Once participants have completed active treatment they will be followed through a 9-month safety follow-up period which consists of a minimum of quarterly visits which may be telehealth visits to monitor for adverse events AEs concomitant medications and pregnancy status as applicable Total duration on study is up to approximately 33 months 2 years 9 months excluding the potential 3-month screening period
Participants from AOC 1020-CS1 are eligible to enroll in AOC 1020-CS2 if they have satisfactorily completed AOC 1020-CS1 All participants who enroll in AOC 1020-CS2 will receive AOC 1020 regardless of whether they received AOC 1020 or placebo in AOC 1020-CS1 Dosing will occur quarterly ie every 13 weeks
The total duration of active treatment in AOC 1020-CS2 is approximately 24 months Once participants have completed active treatment they will be followed through a 9-month safety follow-up period which consists of a minimum of quarterly visits which may be telehealth visits to monitor for adverse events AEs concomitant medications and pregnancy status as applicable Total duration on study is up to approximately 33 months 2 years 9 months excluding the potential 3-month screening period
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