Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447025
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-06
First Post:
2024-02-15
Brief Title:
An Open Label Extension Study of CTI-1601 in Subjects With Friedreichs Ataxia
Sponsor:
Larimar Therapeutics Inc
Organization:
Larimar Therapeutics Inc
Study Overview
Official Title:
Jive An Open Label Extension Study to Assess the Long-term Safety Efficacy Pharmacodynamics Pharmacokinetics and Tolerability of Subcutaneous CTI-1601 in Subjects With Friedreichs Ataxia
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-06
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:
Jive
Brief Summary:
This is an open-label extension OLE study designed to evaluate the long-term safety tolerability pharmacokinetics PK pharmacodynamics PD and clinical effects of subcutaneous SC administration of CTI-1601 also known as nomlabofusp in subjects with Friedreichs ataxia FRDA
The objectives of this OLE study are
To evaluate the safety of long-term subcutaneous SC administration of CTI-1601 in subjects with FRDA
To evaluate the PK of long-term subcutaneous SC administration of CTI-1601 in subjects with FRDA
To evaluate the effect of long-term subcutaneous SC administration of CTI-1601 in subjects with FRDA on
Tissue FXN concentrations
Clinical evaluations of FRDA
Gene Expression and select lipids
The objectives of this OLE study are
To evaluate the safety of long-term subcutaneous SC administration of CTI-1601 in subjects with FRDA
To evaluate the PK of long-term subcutaneous SC administration of CTI-1601 in subjects with FRDA
To evaluate the effect of long-term subcutaneous SC administration of CTI-1601 in subjects with FRDA on
Tissue FXN concentrations
Clinical evaluations of FRDA
Gene Expression and select lipids
Detailed Description:
This is an open label extension OLE study in patients with FRDA who participated in a prior clinical study of CTI-1601 to evaluate the safety PK PD and clinical effects of long-term daily administration of CTI-1601
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