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NEOD001

DRUG6 trials

Sponsors

Prothena Biosciences Ltd., Tufts Medical Center

Conditions

AL AmyloidosisAmyloidosisPrimary AmyloidosisPrimary Systemic (AL) Amyloidosis

Phase 1

Phase 1/2, Open Label, Dose Escalation Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis
CompletedNCT01707264
Prothena Biosciences Ltd.Primary Amyloidosis
Start: 2013-04-30End: 2016-08-09Updated: 2018-08-28

Phase 2

Open-label Extension Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis
TerminatedNCT02613182
Prothena Biosciences Ltd.AL Amyloidosis
Start: 2016-02-29End: 2018-05-31Updated: 2019-05-16
The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis
CompletedNCT02632786
Prothena Biosciences Ltd.AL Amyloidosis
Start: 2016-03-31End: 2018-03-31Updated: 2019-04-05
Study in Subjects With Light Chain (AL) Amyloidosis
TerminatedNCT03154047
Prothena Biosciences Ltd.AL Amyloidosis
Start: 2017-06-14End: 2018-05-30Updated: 2019-03-26
Renal AL Amyloid Involvement and NEOD001
TerminatedNCT03168906
Tufts Medical CenterAmyloidosis
Start: 2017-07-05End: 2019-02-06Updated: 2020-09-09

Phase 3

The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis
TerminatedNCT02312206
Prothena Biosciences Ltd.Primary Systemic (AL) Amyloidosis
Start: 2015-02-28End: 2018-05-31Updated: 2023-11-14

Related Papers

Development of a high-affinity antibody specific to the predominant λ light chain amyloid subtype for AL amyloidosis immunotherapy
Blood2025-11-03
Gene Expression Sets and Renal Profiling from the Renal AL Amyloid Involvement and NEOD00 (RAIN) Trial.
2024-07-11
Pooled Analysis of Safety from Birtamimab Phase 1-3 Studies in Patients with Light Chain (AL) Amyloidosis
Blood2023-11-022 citations
Histologic and Molecular Correlates in Patients with AL Amyloidosis in Hematologic Remission but with Persistent Renal Disease
Blood2023-11-02
Birtamimab plus standard of care in light-chain amyloidosis: the phase 3 randomized placebo-controlled VITAL trial
Blood2023-06-2766 citations
P56 SURVIVAL BENEFIT OF BIRTAMIMAB IN MAYO STAGE IV AL AMYLOIDOSIS IN THE PHASE 3 VITAL STUDY WAS CONSISTENT ACROSS ALL KEY BASELINE VARIABLES
HemaSphere2023-05-011 citations
Survival Benefit of Birtamimab in Mayo Stage IV AL Amyloidosis in the Phase 3 VITAL Study Consistent after Adjustment for Key Baseline Variables
Blood2022-11-152 citations
Gene Expression Sets and Renal Profiling from the Rain (Renal AL Amyloid Involvement and NEOD00) Trial
Blood2022-11-15
NEOD001 Demonstrates Organ Biomarker Responses in Patients with Light Chain Amyloidosis and Persistent Organ Dysfunction: Results from the Expansion Cohort of a Phase 1/2 Study
Blood2016-12-0211 citations
The VITAL Amyloidosis Study: A Randomized, Double-Blind, Placebo-Controlled, Global, Phase 3 Study of NEOD001 in Patients with AL Amyloidosis and Cardiac Dysfunction
Blood2016-12-027 citations
Burden of AL Amyloidosis on Health-Related Quality of Life in Clinic-Based, Community-Based, and Trial-Based Studies
Blood2016-12-02
The PRONTO amyloidosis study: A randomized, double-blind, placebo-controlled, global, phase 2b study of NEOD001 in previously treated subjects with light chain amyloidosis and persistent cardiac dysfunction.
Journal of Clinical Oncology2016-05-206 citations
First-in-Human Phase I/II Study of NEOD001 in Patients With Light Chain Amyloidosis and Persistent Organ Dysfunction
Journal of Clinical Oncology2016-02-08204 citations
Cardiac and renal biomarker responses in a phase 1/2 study of NEOD001 in patients with AL amyloidosis and persistent organ dysfunction.
Journal of Clinical Oncology2015-05-2010 citations
The VITAL study: A randomized, double-blind, placebo-controlled, global, phase III study of NEOD001 in patients with AL amyloidosis and cardiac dysfunction.
Journal of Clinical Oncology2015-05-202 citations