A Study of AT-02 in Subjects With Systemic Amyloidosis.

Amyloidosis; Systemic Clinical Trial

Official title: A Phase 2, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of AT-02

Status Recruiting

Clinical Trial Summary

This is a Phase 2 open-label extension study to evaluate the long-term safety, tolerability, and clinical activity of AT-02. AT-02 is an investigational medicinal product being developed to treat systemic amyloidosis.

Clinical Trial Description

The study will enroll subjects with systemic amyloidosis who have participated in AT02-001 study. The study includes screening period (56 days), treatment period (week 104), follow up (week 112). The total duration of participant in study is up to 120 weeks. A Safety Review Committee (SRC) will periodically convene and review all available clinical and laboratory data during the study. A single SRC will monitor safety across all AT-02 studies to ensure that safety signals are assessed in aggregate. ;

Related Conditions & MeSH terms

• Amyloidosis
• Amyloidosis; Systemic

• NCT number: NCT05951049
• Study type: Interventional
• Source: Attralus, Inc.
• Contact: Scott Stephens
• Phone: +1-321-228-7400
• Email: sstephens@attralus.com
• Status: Recruiting
• Phase: Phase 2
• Start date: September 21, 2023
• Completion date: February 28, 2026