Trial Profile

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

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 28 May 2025

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At a glance

Drugs Birtamimab (Primary) ; Aciclovir; Bortezomib; Cetirizine; Cyclophosphamide; Daratumumab; Dexamethasone; Paracetamol
Indications Amyloid light-chain amyloidosis
Focus Registrational; Therapeutic Use
Acronyms AFFIRM-AL
Sponsors Prothena

23 May 2025 Primary endpoint has not been met. (Time to all-cause mortality for the Double Blind Phase)
20 Feb 2025 According to a Prothena media release, company has Presented posters at AAIC 2024 and CTAD 2024 highlighting the clinical trial design of the ongoing Phase 1 ASCENT program
20 Feb 2025 According to a Prothena media release,has currently enrolled approximately 260 patients in the ASCENT clinical trials

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