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NCT02632786 · ClinicalTrials.gov registry record · Phase 2
The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis
A Phase 2 study, sponsored by Prothena Biosciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 129
- Enrollment target
NCT02632786: Completed Phase 2 study, sponsored by Prothena Biosciences.
NCT02632786 is a Phase 2 study that has completed, run by Prothena Biosciences. The registered enrollment target is 129 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02632786, a Phase 2 study, has completed, sponsored by Prothena Biosciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 129 participants
- Enrollment target
Study 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.
Primary Outcome
N-terminal pro-brain natriuretic peptide (NT-proBNP ) best response (Response or Non-Response \[Stable, Progression\]) from baseline through 12 months of treatment. Cardiac best response, as assessed by NT-proBNP alone, is defined as the most favorable category among response (ie, decrease in NT-proBNP from baseline of \>30% and \>300 ng/L), stable (ie, neither response nor progression), and progression (ie, increase in NT-proBNP from baseline of \>30% and \>300 ng/L) across all visits after the
Interventions
- DRUG Placebo
- DRUG NEOD001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2016-03 |
| Est. Completion | 2018-03 |
| Phase | Phase 2 |
What the finished NCT02632786 record still lists
NCT02632786 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02632786 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02632786 about?
NCT02632786 is a clinical study titled "The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis". 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...
What is the current status of trial NCT02632786?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 129 participants. The study started on 2016-03. Estimated completion is 2018-03.
What interventions are being tested in trial NCT02632786?
The interventions under investigation include: Placebo (DRUG), NEOD001 (DRUG).
Who is sponsoring clinical trial NCT02632786?
This trial is sponsored by Prothena Biosciences, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02632786's enrollment target sits among peer trials
129 553rd of 2000 higher than 1,448 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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