NCT06194825

EPIC-ATTR: A Study to Evaluate the Effect of Eplontersen on the Transthyretin Reduction and Long-term Safety in Chinese Subjects With Transthyretin Amyloid Cardiomyopathy

A Phase 3, Randomized Study, With Initial 24-week, Double-Blind and Placebo-Controlled Treatment Phase, Followed by An 80-week Open-label Extension Treatment Phase to Evaluate the Effect of Eplontersen on the Transthyretin Reduction and Long-Term Safety in Chinese Participants With Transthyretin Amyloid Cardiomyopathy (EPIC-ATTR)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the effect of eplontersen compared to placebo on the reduction of serum TTR concentration and long-term safety in Chinese participants with hereditary or wild-type transthyretin amyloid cardiomyopathy.

Detailed description

This is a Phase 3, randomized study, with initial 24-week double-blind and placebo-controlled treatment phase, then followed by an open-label extension treatment phase to evaluate the effect of eplontersen on the TTR reduction and long-term safety in Chinese participants with ATTR-CM. Eligible participants will be randomized in a 3:1 ratio to either eplontersen or placebo for a treatment period of 24 weeks. The double-blind treatment phase will be followed by 80-week open label treatment phase (Participants initially assigned to placebo will switch to eplontersen treatment at 24 weeks), to evaluate long term safety and tolerability of eplontersen treatment. This study will be performed in about 30 to 35 study centres in China mainland.

Conditions

• Transthyretin Amyloid Cardiomyopathy

Interventions

Type	Name	Description
DRUG	Eplontersen	Eplontersen by subcutaneous injection
DRUG	Placebo	Eplontersen-matching placebo by subcutaneous injection

Timeline

• Start date: 2023-12-01
• Primary completion: 2026-05-14
• Completion: 2027-01-05
• First posted: 2024-01-08
• Last updated: 2026-01-21

Locations

26 sites across 1 country: China

Regulatory

• FDA-regulated drug study