At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 129 enrolled
Drug / intervention
NEOD001 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating NEOD001 and Placebo for AL Amyloidosis. Completed, enrolled 129 participants across 40 sites in 10 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAL Amyloidosis
CountriesAustralia, Austria, France, Germany, Greece, Israel, Italy, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 2015
Enrollment StartMar 2016
Primary CompletionMar 2018
TodayJul 2026
First PostedDec 17, 2015
Enrollment StartMar 1, 2016
Primary CompletionMar 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 10.5 years ago
Interventions
NEOD001drug
NEOD001 is a monoclonal antibody directed at soluble and insoluble light chain aggregates
Placebodrug
Saline Bag