Efficacy and Safety of Acoramidis (AG10) in Subjects with Transthyretin Amyloid Polyneurophathy (ATTRibute-PN)
- Sponsor
- Eidos Therapeutics, a BridgeBio company
- Study ID
- NCT04882735
- Phase
- PHASE3
- Status
- Withdrawn
Conditions
- Transthyretin-Related (ATTR) Familial Amyloid Polyneuropathy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 90 Years
- Healthy Volunteers
- Not accepted
Interventions
- Acoramidis — DRUGTTR stabilizer administered orally twice daily (BID)
Study Details
Phase 3 efficacy and safety of acoramidis in subjects with symptomatic Transthyretin Amyloid Polyneuropathy (ATTR-PN)
Key Dates
- Start date
- Sep 8, 2021
- Status verified
- Jan 2022
- Primary completion
- Sep 30, 2026
- Completion
- Oct 31, 2026
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Acoramidis HCI 800 mg (two 400mg tablets)TTR stabilizer administered orally twice daily (BID)
Primary Outcome Measure
Change from baseline to Month 18 in mNIS+7 [ Time Frame: 18 Months ]