Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT04504825 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of AL Amyloidosis, sponsored by Alexion Pharmaceuticals.

Active
Registry status
Phase 3
Development phase
125
Enrollment target
20
Study locations

NCT04504825 is a Phase 3 study of AL Amyloidosis that is active but no longer recruiting, run by Alexion Pharmaceuticals. The registered enrollment target is 125 participants, below the 416-participant average among 15 other AL Amyloidosis trials with a reported enrollment target (70% lower). The trial reports 20 study locations across 13 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT04504825, a Phase 3 study of AL Amyloidosis, is active but no longer recruiting, sponsored by Alexion Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
125 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

AL Amyloidosis

Interventions

  • OTHER Placebo
  • DRUG CAEL-101
  • DRUG cyclophosphamide, bortezomib, and Dexamethasone (CyBorD) regimen

Study Locations (20)

California

  • Research Site - Duarte
  • Research Site - Palo Alto
  • Research Site - San Francisco

Massachusetts

  • Research Site - Boston
  • Research Site - Boston
  • Research Site - Boston

New York

  • Research Site - New York
  • Research Site - New York
  • Research Site - Rochester

Ohio

  • Research Site - Cleveland
  • Research Site - Columbus

Florida

  • Research Site - Weston

Indiana

  • Research Site - Indianapolis

Louisiana

  • Research Site - New Orleans

Michigan

  • Research Site - Detroit

Trial Details

FieldValue
Enrollment Target 125 participants
Start Date 2020-08-25
Est. Completion 2027-10-22
Phase Phase 3

Sponsor

Alexion Pharmaceuticals

162 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04504825

The ClinicalTrials.gov registry entry for NCT04504825 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 416-participant average among 15 other AL Amyloidosis trials with a reported enrollment target (70% lower). The listed sponsor is Alexion Pharmaceuticals, which has 162 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with AL Amyloidosis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT04504825 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Massachusetts, New York.

Frequently Asked Questions

What is clinical trial NCT04504825 about?

NCT04504825 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis (CARES)". 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, sp...

What is the current status of trial NCT04504825?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 125 participants. The study started on 2020-08-25. Estimated completion is 2027-10-22.

What conditions does trial NCT04504825 study?

This clinical trial studies the following conditions: AL Amyloidosis.

What interventions are being tested in trial NCT04504825?

The interventions under investigation include: Placebo (OTHER), CAEL-101 (DRUG), cyclophosphamide, bortezomib, and Dexamethasone (CyBorD) regimen (DRUG).

Who is sponsoring clinical trial NCT04504825?

This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04504825 being conducted?

This trial has 20 study locations across California, Florida, Indiana, Louisiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for AL Amyloidosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

AL Amyloidosis

All registered trials for this condition

California

All trials with a study site in California

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.