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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 is a Phase 2 study that has completed, run by Prothena Biosciences. The registered enrollment target is 129 participants.
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.
Interventions
- DRUG Placebo
- DRUG NEOD001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2016-03 |
| Est. Completion | 2018-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02632786
The ClinicalTrials.gov registry entry for NCT02632786 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Prothena Biosciences, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02632786 reports 0 study locations.
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.
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