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An Open Label Extension Study of CTI-1601 in Subjects With Friedreich's Ataxia — Jive  

Friedreich Ataxia Clinical Trial

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 Friedreich's Ataxia

Clinical Trial 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 Friedreich's 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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06447025
Study type Interventional
Source Larimar Therapeutics, Inc.
Contact
Status Enrolling by invitation
Phase Phase 2
Start date January 25, 2024
Completion date January 2027
View Details
See also
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