drugset / Trial / NCT02632786

The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis

NCT02632786

Phase 2 Completed 129 enrolled Prothena Biosciences Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a global, multicenter, Phase 2b, randomized, double-blind, placebo-controlled, two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered intravenously in adults with AL amyloidosis who had a hematologic response to previous treatment for their amyloidosis (e.g., chemotherapy, autologous stem cell transplant \[ASCT\]) and have persistent cardiac dysfunction.

Timeline

Start
2016-03
Primary completion
2018-03
Completion
2018-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Birtamimab Monoclonal antibody 24 mg/kg Intravenous

Indications