THE
TRITON‑PN
STUDY
TRITON‑PN is a phase 3, global, randomized, open-label study to evaluate the efficacy and safety of nucresiran in patients with hereditary ATTR amyloidosis with polyneuropathy.
HCP Page
Study objectives
The primary objective of the study is to evaluate the efficacy of nucresiran, administered subcutaneously, twice yearly, by evaluating its effect on neurologic impairment in patients with hereditary ATTR amyloidosis with polyneuropathy.
Change from baseline in the Modified Neuropathy Impairment Score +7 (mNIS +7) will be compared to an external placebo group from a previous study.
Secondary objectives of the study are to evaluate the efficacy of nucresiran on health-related quality of life, nutritional status, disability, gait speed, and reduction of serum TTR levels when compared to in-study vutrisiran.
TRITON-PN
Study participation will span up to 50 months (62 months for individuals of childbearing potential). This time period will include:
A Screening Period
Up to 42 days
A Treatment Period
18 months
A Treatment Extension Period
Up to 18 months
A Follow-up Period
Up to 12 months
(24 months for individuals of childbearing potential)
