drugset / Trial / NCT02632786
The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Birtamimab | Monoclonal antibody | 24 mg/kg | Intravenous |