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NCT04504825 · ClinicalTrials.gov record · last posted 2026-07-02

A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis (CARES)

StatusActive, Not Recruiting
PhasePhase 3
Started2020-08-25
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from the ClinicalTrials.gov record
AL (or light chain) amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous system and digestive tract. The primary purpose of this study is to determine whether CAEL-101, a monoclonal antibody that removes AL amyloid deposits from tissues and organs, improves overall survival, reduces cardiovascular related hospitalizations and it is safe and well tolerated in patients with stage IIIb AL amyloidosis.

Protocol amendment history 1 change detected by DataLookout

2026-07-03
Primary endpoint(s) modified
WasA hierarchical combination of Time to All-cause Mortality and Frequency of Cardiovascular hospitalizations, Number of Participants with Treatment Emergent Adverse Events (TEAEs)
NowA Hierarchical Combination of Time to All-cause Mortality and Frequency of Cardiovascular Hospitalizations (CVHs) Analyzed by Win Ratio, Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Trial Details
NCT Number NCT04504825
Lead Sponsor Alexion Pharmaceuticals, Inc.
Conditions AL Amyloidosis
Enrollment 125 participants
Start Date 2020-08-25
Primary Completion 2025-05-10 (estimated)
Study Completion 2027-10-22 (estimated)
Updated on ClinicalTrials.gov 2026-07-02