drugset / Trial / NCT03168906
Renal AL Amyloid Involvement and NEOD001
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Birtamimab | Monoclonal antibody | 24 mg/kg | Intravenous |