Phase 3Terminated
A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis (AFFIRM-AL)
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
- Sponsor
- Prothena Biosciences Ltd. (Industry)
- Enrolment
- 208 enrolled
- Conditions
- Light Chain (AL) Amyloidosis
- Interventions
- Birtamimab; Placebo; Standard of Care Chemotherapy
- Ages
- adults, older adults
- Registry
- NCT04973137
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Time to All-cause Mortality for the Double Blind Phase
History
Results first posted
Last registry update
Study completion
Primary completion
Started
Registered