Phase 3Recruiting
TRITON-PN: A Study to Evaluate the Efficacy and Safety of Nucresiran in Patients With Hereditary Transthyretin Amyloidosis With Polyneuropathy
TRITON-PN: A Phase 3, Global, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Nucresiran in Patients With Hereditary Transthyretin-Mediated Amyloidosis With Polyneuropathy (hATTR-PN)
- Sponsor
- Alnylam Pharmaceuticals (Industry)
- Enrolment
- 125 planned
- Conditions
- Hereditary Transthyretin-Mediated Amyloidosis With Polyneuropathy; hATTR-PN
- Interventions
- Nucresiran; Vutrisiran
- Ages
- adults, older adults
- Registry
- NCT07223203, CTIS2025-522544-40-00
Full record on ClinicalTrials.gov
From the registry
The purpose of this study is to: * Determine the efficacy of nucresiran in patients with hATTR-PN by evaluating the effect on neurologic impairment, quality of life, nutritional status, disability, and gait speed * Demonstrate superiority of nucresiran compared to in-study vutrisiran with respect to serum transthyretin (TTR) levels
Primary outcomes
- Change from Baseline in the Modified Neuropathy Impairment Score +7 (mNIS+7) Compared to the External Placebo Group from the APOLLO Study (NCT01960348) at Month 9
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered