NCT05951049

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Attralus, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 description

The study will enroll subjects with systemic amyloidosis who have participated in AT02-001 study and will also directly enroll AL participants with renal disease who did not participate in study AT02-001. 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.

Conditions

• Amyloidosis; Systemic

Interventions

Type	Name	Description
DRUG	AT02	Dosage Form: Solution for injection/infusion Dosage level: Different dose levels of AT02 Route of Administration: Intravenous use

Timeline

• Start date: 2023-09-21
• Primary completion: 2026-02-28
• Completion: 2026-02-28
• First posted: 2023-07-18
• Last updated: 2025-08-24

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study