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

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL

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

Brief 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.

Detailed Summary:

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.

Sponsor: Attralus, Inc.

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Attralus, Inc.

Dates:
Date Received: June 29, 2023
Date Started: September 21, 2023
Date Completion: September 21, 2023
Last Updated: October 19, 2023
Last Verified: October 01, 2023