At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 25 enrolled / 25 target
Drug / intervention
ALXN2060drug
Likely dose
ALXN2060 800 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Prospective, Multicenter, Open Label, 2-Part Study of the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of ALXN2060 in Japanese Participants With Symptomatic Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
In Brief
A Phase 3 clinical trial evaluating ALXN2060 for Symptomatic Transthyretin Amyloid Cardiomyopathy. Completed, enrolled 25 participants across 11 sites.
Signals
Enrollment appears stalled
Detailed Summary
This prospective study is designed to evaluate the efficacy, safety, and tolerability of ALXN2060 (also known as AG10), as well as to establish its pharmacokinetic and pharmacodynamic profile in Japanese participants with symptomatic ATTR-CM administered on a background of stable heart failure therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
CollaboratorsEidos Therapeutics, a BridgeBio company
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedNov 2020
Enrollment StartNov 2020
Primary CompletionNov 2023
Study CompletionAug 2025
TodayJul 2026
First PostedNov 9, 2020
Enrollment StartNov 13, 2020
Primary CompletionNov 8, 2023
Study CompletionAug 21, 2025
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 5.6 years ago
Arms & Interventions
ALXN2060experimental
Participants will receive ALXN2060.
Drug: ALXN2060
Interventions
ALXN2060drug
ALXN2060 tablets will be administered twice daily at a dose of 800 milligrams.