A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis (AFFIRM-AL)
A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis (AFFIRM-AL)
ClinicalTrials.gov ID: NCT04973137
Sponsor: Prothena Biosciences Ltd.
Information provided by: Prothena Biosciences Ltd. (Responsible Party)
Last Update Posted: 2023-08-07
Brief Summary:
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.
Detailed Description:
This is a Phase 3 multicenter, global, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of birtamimab in Mayo Stage IV patients with AL amyloidosis. The primary objective is to evaluate the efficacy of birtamimab by assessing time to all-cause mortality. All patients will receive bortezomib-containing chemotherapy regimen as standard of care.
Approximately 150 newly diagnosed Mayo Stage IV patients with AL amyloidosis will be enrolled and randomized in a 2:1 ratio to birtamimab or placebo. Subjects will remain on study until study completion, when the pre-defined number of events (all-cause mortality) have been reached.
OFFICIAL TITLE
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
INTERVENTION / TREATMENT
Drug: Birtamimab
Other: Placebo
Drug: Standard of Care Chemotherapy
| Category | Value |
|---|---|
| Study Start (Actual) | 2021-08-30 |
| Primary Completion (Estimated) | 2024-06 |
| Study Completion (Estimated) | 2024-06 |
| Enrollment (Estimated) | 150 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
NEOD001-301
|