Phase 2Completed
The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis
A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis Who Have Persistent Cardiac Dysfunction
- Sponsor
- Prothena Biosciences Ltd. (Industry)
- Enrolment
- 129 enrolled
- Conditions
- AL Amyloidosis
- Interventions
- NEOD001; Placebo
- Ages
- adults, older adults
- Registry
- NCT02632786
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Number of Participants With Cardiac Response and Non-Response
History
Results first posted
Last registry update
Primary completion
Started
Registered