Bococizumab (PF-04950615;RN316)

DRUG4 trials

Sponsors

Pfizer

Conditions

Heterozygous Familial HypercholesterolemiaHypercholesterolemiaHyperlipidemia

Phase 2

Dose Ranging Study Of Bococizumab (PF-04950615; RN316) In Hypercholesterolemic Japanese Subjects

CompletedNCT02055976

PfizerHypercholesterolemia

Start: 2014-03-31End: 2015-01-31Updated: 2019-02-08

Phase 3

Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects With Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events

CompletedNCT01968954

PfizerHyperlipidemia

Start: 2013-10-31End: 2016-04-30Updated: 2017-05-17

A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia

CompletedNCT01968980

PfizerHeterozygous Familial Hypercholesterolemia

Start: 2013-10-23End: 2016-04-15Updated: 2017-06-26

Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins

CompletedNCT02135029

PfizerHyperlipidemia

Start: 2014-06-30End: 2015-11-30Updated: 2017-12-14

Related Papers

Genome-wide pharmacogenetics of anti-drug antibody response to bococizumab highlights key residues in HLA DRB1 and DQB1

Scientific Reports2022-03-116 citations

Pharmacokinetics and exploratory efficacy biomarkers of bococizumab, an anti-PCSK9 monoclonal antibody, in hypercholesterolemic Japanese subjects

International Journal of Clinical Pharmacology and Therapeutics2019-09-249 citations

Assessing the Potential Risk of Cross-Reactivity Between Anti-Bococizumab Antibodies and Other Anti-PCSK9 Monoclonal Antibodies

BioDrugs2019-09-1610 citations

Cardiovascular event reduction with PCSK9 inhibition among 1578 patients with familial hypercholesterolemia: Results from the SPIRE randomized trials of bococizumab.

2018-04-0347 citations

Abstract 23073: Cardiovascular Efficacy of PCSK9 Inhibition Among 1,578 Patients With Familial Hypercholesterolemia: The SPIRE Clinical Trials FH Analysis

Circulation2017-11-141 citations

Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab

New England Journal of Medicine2017-03-17355 citations

Efficacy and Safety of Bococizumab (RN316/PF-04950615), a Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9, in Hypercholesterolemic Japanese Subjects Receiving a Stable Dose of Atorvastatin or Treatment-Naive　― Results From a Randomized, Placebo-Controlled, Dose-Ranging Study ―

Circulation Journal2017-01-0116 citations