A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients with AL Amyloidosis

Description

A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis.

Conditions

Light Chain (AL) Amyloidosis

Study Overview

Study Details

Study overview

A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis.

A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care Vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis

A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients with AL Amyloidosis

Condition
Light Chain (AL) Amyloidosis
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California San Francisco, San Francisco, California, United States, 94143

Hartford

St. Francis Hospital, Hartford, Connecticut, United States, 06105

North Haven

Yale Cancer Center, North Haven, Connecticut, United States, 06473

Trumbull

Smilow Cancer Hospital Care Center at Trumbull, Trumbull, Connecticut, United States, 06611

Washington

MedStar Georgetown University Hospital, Washington, District of Columbia, United States, 20007

Weston

Cleveland Clinic Florida, Weston, Florida, United States, 33331

Goshen

Goshen Center for Cancer Care, Goshen, Indiana, United States, 46526

Bethesda

Johns Hopkins University, Bethesda, Maryland, United States, 20814-1422

Boston

Boston University School of Med., Boston, Massachusetts, United States, 02118

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Prothena Biosciences Ltd.,

    Study Record Dates

    2027-06