Birtamimab

DRUG2 trials

Sponsors

Prothena Biosciences Limited, Prothena Biosciences Ltd.

Conditions

Light Chain (AL) Amyloidosis

Phase 3

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

TerminatedNCT04973137

Prothena Biosciences Ltd.Light Chain (AL) Amyloidosis

Start: 2021-08-30End: 2025-06-20Updated: 2025-12-16

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

CompletedCTIS2024-511066-36-00

Prothena Biosciences LimitedLight Chain (AL) Amyloidosis

Start: 2021-10-13End: 2025-05-23Target: 157Updated: 2025-02-28

Related Papers

Development of a high-affinity antibody specific to the predominant λ light chain amyloid subtype for AL amyloidosis immunotherapy

Blood2025-11-03

Gene Expression Sets and Renal Profiling from the Renal AL Amyloid Involvement and NEOD00 (RAIN) Trial.

2024-07-11

The mechanism of action, pharmacological characteristics, and clinical utility of the amyloid depleter birtamimab for the potential treatment of AL amyloidosis.

2024-04-11

Pooled Analysis of Safety from Birtamimab Phase 1-3 Studies in Patients with Light Chain (AL) Amyloidosis

Blood2023-11-022 citations

Birtamimab plus standard of care in light-chain amyloidosis: the phase 3 randomized placebo-controlled VITAL trial

Blood2023-06-2766 citations

P56 SURVIVAL BENEFIT OF BIRTAMIMAB IN MAYO STAGE IV AL AMYLOIDOSIS IN THE PHASE 3 VITAL STUDY WAS CONSISTENT ACROSS ALL KEY BASELINE VARIABLES

HemaSphere2023-05-011 citations

Birtamimab in patients with Mayo stage IV AL amyloidosis: Rationale for confirmatory affirm-AL phase 3 study.

Journal of Clinical Oncology2022-06-0112 citations

Birtamimab in Patients with Mayo Stage IV AL Amyloidosis: Rationale for Confirmatory Affirm-AL Phase 3 Study Design

Blood2021-11-058 citations