A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL Amyloidosis (CARES)
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: AL Amyloidosis
In brief
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 IIIa AL amyloidosis.
Key facts
- Study ID
- NCT04512235
- Run by
- Alexion Pharmaceuticals, Inc.
- People needed
- 281
- Starts
- 2020-11-03
- Expected to finish
- 2027-04-08
- Last updated by the study team
- 2026-06-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Research Site — Duarte, California, United States
- Research Site — Palo Alto, California, United States
- Research Site — San Francisco, California, United States
- Research Site — Jacksonville, Florida, United States
- Research Site — Weston, Florida, United States
- Research Site — Indianapolis, Indiana, United States
- Research Site — New Orleans, Louisiana, United States
- Research Site — Baltimore, Maryland, United States
- Research Site — Boston, Massachusetts, United States
- Research Site — Boston, Massachusetts, United States
- Research Site — Boston, Massachusetts, United States
- Research Site — Detroit, Michigan, United States
- Research Site — Rochester, Minnesota, United States
- Research Site — St Louis, Missouri, United States
- Research Site — New York, New York, United States
- Research Site — New York, New York, United States
- Research Site — Rochester, New York, United States
- Research Site — Chapel Hill, North Carolina, United States
- Research Site — Durham, North Carolina, United States
- Research Site — Winston-Salem, North Carolina, United States
- Research Site — Cleveland, Ohio, United States
- Research Site — Columbus, Ohio, United States
- Research Site — Portland, Oregon, United States
- Research Site — Philadelphia, Pennsylvania, United States
- Research Site — Scottsdale, Arizona, United States
Full record on ClinicalTrials.gov
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