drugset / Trial / NCT03168906

Renal AL Amyloid Involvement and NEOD001

NCT03168906

Phase 2 Terminated 12 enrolled Tufts Medical Center
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a 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 have a maintained hematologic response to their most recent treatment for AL amyloidosis (e.g., chemotherapy, autologous stem cell transplant \[ASCT\]) and have persistent renal dysfunction.

Timeline

Start
2017-07-05
Primary completion
2018-04-23
Completion
2019-02-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Birtamimab Monoclonal antibody 24 mg/kg Intravenous

Indications