Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects With Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events
SPIRE-HR
A Phase 3 Double-blind,Randomized, Placebo-controlled,Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events
3 other identifiers
interventional
711
9 countries
103
Brief Summary
This study is a multicenter, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of Bococizumab (PF-04950615;RN316) to lower LDL-C.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2013
103 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 21, 2013
CompletedFirst Posted
Study publicly available on registry
October 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedResults Posted
Study results publicly available
May 17, 2017
CompletedMay 17, 2017
March 1, 2017
2.5 years
October 21, 2013
April 6, 2017
April 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12
Baseline, Week 12
Secondary Outcomes (27)
Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52
Baseline, Week 12, 24, 52
Percent Change From Baseline in Non- High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52
Baseline, Week 12, 24, 52
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52
Baseline, Week 12, 24, 52
Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52
Baseline, Week 12, 24, 52
Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52
Baseline, Week 12, 24, 52
- +22 more secondary outcomes
Other Outcomes (3)
Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52
Baseline, Week 12, 24, 52
Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52
Baseline, Week 12, 24, 52
Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52
Baseline, Week 12, 24, 52
Study Arms (2)
Bococizumab (PF-04950615;RN316)
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
150 mg every 2 weeks, subcutaneous injection, 12 months
Eligibility Criteria
You may qualify if:
- Treated with a statin.
- Fasting LDL-C \> 70 mg/dL and triglyceride \<=400 mg/dL.
- High or very high risk of incurring a cardiovascular event.
You may not qualify if:
- Pregnant or breastfeeding females.
- Cardiovascular or cerebrovascular event of procedures during the past 30 days.
- Congestive heart failure NYHA class IV.
- Poorly controlled hypertension.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (103)
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216, United States
Cardiovascular Associates of the Southeast, LLC
Birmingham, Alabama, 35243, United States
Southwest Heart Group
Tucson, Arizona, 85710, United States
ARA-Arizona Research Associates
Tucson, Arizona, 85712, United States
Diagnamics, Inc.
Encinitas, California, 92024, United States
Encompass Clinical Research North Coast
Encinitas, California, 92024, United States
MD Studies, Inc.
Fountain Valley, California, 92708, United States
Alliance Research Centers
Laguna Hills, California, 92653, United States
Prime Care Clinical Research
Laguna Hills, California, 92653, United States
Providence Clinical Research
North Hollywood, California, 91606, United States
San Diego Family Care
San Diego, California, 92111, United States
St. Joseph's Medical Associates
Stockton, California, 95204, United States
Orange County Research Center
Tustin, California, 92780, United States
Clinical Research Advantage, Inc./Cassidy Medical Group - Vista
Vista, California, 92083, United States
Elite Clinical Trials
Wildomar, California, 92595, United States
Expresscare Clinical Research
Colorado Springs, Colorado, 80909, United States
Soundview Medical Associates
Norwalk, Connecticut, 06851, United States
Eastern Research, Inc.
Hialeah, Florida, 33013, United States
East Coast Institute for Research, LLC at Northeast Florida Endocrine & Diabetes Associates
Jacksonville, Florida, 32204, United States
Care Partners Clinical Research, LLC
Jacksonville, Florida, 32277, United States
Prestige Clinical Research Center Inc
Miami, Florida, 33133, United States
Edgewater Medical Research
New Smyrna Beach, Florida, 32169, United States
Gulfcoast Medical Research Center, LLC
Tampa, Florida, 33607, United States
Fellows Research Alliance, Inc.
Savannah, Georgia, 31406, United States
SouthCoast Medical Group
Savannah, Georgia, 31406, United States
Evanston Premier Healthcare Research LLC
Evanston, Illinois, 60201, United States
Comunity Clinical Research Center
Anderson, Indiana, 46011, United States
American Health Network of Indiana, LLC
Avon, Indiana, 46123, United States
Midwest Institute for Clinical Research
Indianapolis, Indiana, 46260, United States
Horizon Research Group of Opelousas, LLC
Eunice, Louisiana, 70535, United States
Internal Medicine Associates
Eunice, Louisiana, 70535, United States
Beacon Clinical Research, LLC
Quincy, Massachusetts, 02169, United States
Allina Health System, dba Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
University of MN, Lillehei Clinical Trials Unit
Minneapolis, Minnesota, 55455, United States
Montana Medical Research Inc.
Missoula, Montana, 59808, United States
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
Cary, North Carolina, 27518, United States
Clinical Trials of America, Inc.
Winston-Salem, North Carolina, 27103, United States
Radiant Research, Inc
Akron, Ohio, 44311, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122, United States
The Office of Daniel G. Williams, MD
Perrysburg, Ohio, 43551, United States
Great Lakes Medical Research, LLC
Willoughby, Ohio, 44094, United States
South Oklahoma Heart Research LLC
Oklahoma City, Oklahoma, 73135, United States
Integrated Medical Research, PC
Ashland, Oregon, 97520, United States
Columbia Research Group, Inc.
Portland, Oregon, 97239, United States
Harleysville Medical Associates
Harleysville, Pennsylvania, 19438, United States
Perelman Center for Advanced Medicine Heart & Vascular Center
Philadelphia, Pennsylvania, 19104, United States
Berks Cardiologists, Ltd.
Wyomissing, Pennsylvania, 19610, United States
Medical Research South,LLC
Charleston, South Carolina, 29407, United States
Berkeley Family Practice
Moncks Corner, South Carolina, 29461, United States
Internal Medicine and Pediatric Associates of Bristol, PC
Bristol, Tennessee, 37620, United States
3 rd Coast Research Associates
Corpus Christi, Texas, 78413, United States
Texas Center For Drug Development, Inc.
Houston, Texas, 77081, United States
Pioneer Research Solutions, Inc.
Houston, Texas, 77099, United States
Protenium Clinical Research
Hurst, Texas, 76054, United States
Utah Cardiology, P.C.
Layton, Utah, 84041, United States
National Clinical Research - Norfolk, Inc.
Norfolk, Virginia, 23502, United States
Premier Clinical Research
Spokane, Washington, 99202, United States
Australian Clinical Research Network
Maroubra, New South Wales, 2035, Australia
Core Research Group Pty Ltd
Milton, Queensland, 4064, Australia
The Avenue Cardiovascular Centre
St Kilda East, Victoria, 3183, Australia
Ecogene-21
Chicoutimi, Quebec, G7H 7K9, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Diex Research Montreal Inc.
Montreal, Quebec, H4N 3C5, Canada
ALPHA Recherche Clinique
Québec, Quebec, G3K 2P8, Canada
Centre Hospitalier Universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, J1H 5N4, Canada
Medexa Recherche
Victoriaville, Quebec, G6P 6P6, Canada
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Kardiologie a interni lekarstvi
Prague, 158 00, Czechia
Lekarsky dum Ormiga
Zlín, 760 01, Czechia
Klinische Forschung Berlin-Mitte GmbH
Berlin, 10117, Germany
Klinische Forschung Hannover - Mitte GmbH
Hanover, 30159, Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen, 67063, Germany
Klinische Forschung Schwerin GmbH
Schwerin, 19055, Germany
The Chinese University of Hong Kong
Shatin, Hong Kong
Department of Medicine & Therapeutics-The Chinese University of Hong Kong
Shatin, NT, Hong Kong
IRCCS Ospedale San Raffaele
Milan, MI, 20132, Italy
IRCCS Centro Cardiologico Fondazione Monzino
Milan, MI, 20138, Italy
IRCCS Istituto Auxologico Italiano
Milan, MI, 20145, Italy
Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"
Palermo, PA, 90127, Italy
Dipartimento di Medicina Interna e Specialita Mediche Policlinico Umberto I
Roma, RM, 00161, Italy
SYNEXUS Polska Sp. z o.o. Oddzial w Katowicach
Katowice, Masovian Voivodeship, 40-040, Poland
NZOZ Terapia Optima
Katowice, Silesian Voivodeship, 40-752, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, 81-384, Poland
Niepubliczny Zaklad Opieki Zdrowotnej CEREO-MED Sp. z o.o.
Lodz, 92-003, Poland
Medicus w Opolu Sp z o.o.
Opole, 45-706, Poland
Medicome Sp. z o.o.
Oświęcim, 32-600, Poland
Synexus Polska Sp. z o.o Oddzial w Poznaniu
Poznan, 60-702, Poland
Centrum Medyczne Ogrodowa Sp. z o.o.
Skierniewice, 96-100, Poland
Centrum Medyczne "SOPMED" Sp. z o.o.
Sopot, 81-756, Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, 01-192, Poland
Centrum Medyczne AMED
Warsaw, 01-518, Poland
CSK MSW w Warszawie, Klinika Kardiologii Zachowawczej i Nadcisnienia Tetniczego
Warsaw, 02-507, Poland
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw, 50-088, Poland
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu-si, Gyeonggi-do, 480-717, South Korea
Yonsei University Wonju Severance Christian Hospital
Gangwon-Do, 220-701, South Korea
Chonnam National University Hospital
Gwangju, 501-757, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 120-752, South Korea
Gangnam Sevrance Hospital, Yeonsei University Health System
Seoul, 135-720, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 137-701, South Korea
Ajou University Hospital
Suwon, 443-380, South Korea
Ulsan University Hospital
Ulsan, 682-714, South Korea
Related Publications (6)
Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2013-2026. doi: 10.1002/psp4.13050. Epub 2023 Nov 22.
PMID: 37994400DERIVEDMcCush F, Wang E, Yunis C, Schwartz P, Baltrukonis D. Anti-drug Antibody Magnitude and Clinical Relevance Using Signal to Noise (S/N): Bococizumab Case Study. AAPS J. 2023 Sep 2;25(5):85. doi: 10.1208/s12248-023-00846-x.
PMID: 37658997DERIVEDChasman DI, Hyde CL, Giulianini F, Danning RD, Wang EQ, Hickling T, Ridker PM, Loomis AK. Genome-wide pharmacogenetics of anti-drug antibody response to bococizumab highlights key residues in HLA DRB1 and DQB1. Sci Rep. 2022 Mar 11;12(1):4266. doi: 10.1038/s41598-022-07997-5.
PMID: 35277540DERIVEDWang EQ, Bukowski JF, Yunis C, Shear CL, Ridker PM, Schwartz PF, Baltrukonis D. Assessing the Potential Risk of Cross-Reactivity Between Anti-Bococizumab Antibodies and Other Anti-PCSK9 Monoclonal Antibodies. BioDrugs. 2019 Oct;33(5):571-579. doi: 10.1007/s40259-019-00375-0.
PMID: 31529318DERIVEDRidker PM, Rose LM, Kastelein JJP, Santos RD, Wei C, Revkin J, Yunis C, Tardif JC, Shear CL; Studies of PCSK9 Inhibition and the Reduction of vascular Events (SPIRE) Investigators. Cardiovascular event reduction with PCSK9 inhibition among 1578 patients with familial hypercholesterolemia: Results from the SPIRE randomized trials of bococizumab. J Clin Lipidol. 2018 Jul-Aug;12(4):958-965. doi: 10.1016/j.jacl.2018.03.088. Epub 2018 Apr 3.
PMID: 29685591DERIVEDRidker PM, Tardif JC, Amarenco P, Duggan W, Glynn RJ, Jukema JW, Kastelein JJP, Kim AM, Koenig W, Nissen S, Revkin J, Rose LM, Santos RD, Schwartz PF, Shear CL, Yunis C; SPIRE Investigators. Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab. N Engl J Med. 2017 Apr 20;376(16):1517-1526. doi: 10.1056/NEJMoa1614062. Epub 2017 Mar 17.
PMID: 28304227DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2013
First Posted
October 24, 2013
Study Start
October 1, 2013
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
May 17, 2017
Results First Posted
May 17, 2017
Record last verified: 2017-03