Study of ALXN2220 versus Placebo in Adults with ATTR-CM - DepleTTR-CM
Study identifier:D6810C00001
ClinicalTrials.gov identifier:NCT06183931
EudraCT identifier:N/A
CTIS identifier:2023-506669-70-00
Recruiting
Official Title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Amyloid Depleter ALXN2220 in Adult Participants with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Medical condition
Transthyretin Amyloid Cardiomyopathy
Phase
Phase 3
Healthy volunteers
No
Study drug
ALXN2220, Placebo
Sex
All
Estimated Enrollment
1000
Study type
Interventional
Age
18 Years - 90 Years
Date
Study Start Date: 11 Jan 2024
Estimated Primary Completion Date: 31 Jul 2028
Estimated Study Completion Date: 30 Nov 2028
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Aug 2024 by Alexion Pharmaceuticals, Inc.
Sponsors
Alexion Pharmaceuticals, Inc.
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: ALXN2220 Participants will receive weight-based dose of ALXN2220 via intravenous (IV) infusion every 4 weeks (q4w) for at least 24 months up to a maximum of 48 months. | Drug: ALXN2220 Participants will receive ALXN2220 via IV infusion. |
| Placebo Comparator: Placebo Participants will receive placebo via IV infusion q4w for at least 24 months up to a maximum of 48 months. | Drug: Placebo Participants will receive placebo via IV infusion. |
