Trials / Completed
CompletedNCT02632786
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 129 (actual)
- Sponsor
- Prothena Biosciences Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NEOD001 | NEOD001 is a monoclonal antibody directed at soluble and insoluble light chain aggregates |
| DRUG | Placebo | Saline Bag |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2018-03-01
- Completion
- 2018-03-01
- First posted
- 2015-12-17
- Last updated
- 2019-04-05
- Results posted
- 2019-04-05
Locations
40 sites across 10 countries: United States, Australia, Austria, France, Germany, Greece, Israel, Italy, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02632786. Inclusion in this directory is not an endorsement.