A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia
SPIRE-FH
A 52 Week, Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Heterozygous Familial Hypercholesterolemia
3 other identifiers
interventional
370
11 countries
88
Brief Summary
This is a multicenter, randomized study in subjects with heterozygous familial hypercholesterolemia receiving highly effective statins to assess the safety, efficacy 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 P50-P75 for phase_3
Started Oct 2013
88 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
First Submitted
Initial submission to the registry
October 21, 2013
CompletedStudy Start
First participant enrolled
October 23, 2013
CompletedFirst Posted
Study publicly available on registry
October 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2016
CompletedResults Posted
Study results publicly available
May 19, 2017
CompletedJune 26, 2017
May 1, 2017
2.5 years
October 21, 2013
April 7, 2017
May 31, 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 (28)
Percent Change From Baseline in Total Cholesterol (TC) at Week 12
Baseline, Week 12
Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12
Baseline, Week 12
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12
Baseline, Week 12
Percent Change From Baseline in Lipoprotein (a) at Week 12
Baseline, Week 12
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Baseline, Week 12
- +23 more secondary outcomes
Study Arms (2)
Bococizumab (PF-04950615;RN316)
EXPERIMENTALBococizumab (PF-04950615;RN316)
Placebo
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.
- Heterozygous familial hypercholesterolemia.
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 (88)
IMD Medical Group
Los Angeles, California, 90020, United States
Hartford Hospital, JB704
Hartford, Connecticut, 06102, United States
Best Quality Research, Inc.
Hialeah, Florida, 33016, United States
Medical Research Center
Miami, Florida, 33144, United States
Premier Research Associate, Inc
Miami, Florida, 33165, United States
Columbus Clinical Services, LLC
Miami, Florida, 33174, United States
NewPhase Clinical Trials, Corp.
Miami Beach, Florida, 33140, United States
Om Medical
Las Vegas, Nevada, 89119, United States
The University of North Carolina at Chapel Hill Center for Heart & Vascular Care
Chapel Hill, North Carolina, 27599-7075, United States
The University of North Carolina Hospitals - Clinical and Translational Research Center Clinic
Chapel Hill, North Carolina, 27599-7600, United States
Metabolic and Atherosclerosis Research Center
Cincinnati, Ohio, 45227, United States
Oklahoma Heart Hospital Physicians
Oklahoma City, Oklahoma, 73120, United States
Oklahoma Heart Hospital Research Foundation
Oklahoma City, Oklahoma, 73120, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
OnSite Clinical Solutions, LLC
Gaffney, South Carolina, 29340, United States
Galenos Research
Dallas, Texas, 75251, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Pioneer Research Solutions, Inc.
Houston, Texas, 77099, United States
Pioneer Research Solutions, Inc.
Sugar Land, Texas, 77479, United States
Focus Clinical Research, LLC
Draper, Utah, 84020, United States
Burke Internal Medicine & Research
Burke, Virginia, 22015, United States
SHAT in Cardiology EAD
Pleven, 5800, Bulgaria
UMHAT "Sveti Georgi" EAD, Clinic of Cardiology
Plovdiv, 4002, Bulgaria
Second MHAT - Sofia EAD
Sofia, 1202, Bulgaria
MHAT "Sveta Anna", Clinic of Internal Diseases
Sofia, 1709, Bulgaria
St. Paul's Hospital, Healthy Heart
Vancouver, British Columbia, V6Z 1Y6, Canada
Discovery Clinical Services Ltd.
Victoria, British Columbia, V8T 5G4, Canada
Asper Clinical Research Institute
Winnipeg, Manitoba, R2H 2A6, Canada
Health Sciences Centre
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
Ecogene-21
Chicoutimi, Quebec, G7H 7K9, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Institut de Recherches Cliniques de Montreal
Montreal, Quebec, H2W 1R7, Canada
Clinique des maladies lipidiques de Quebec Inc
Québec, Quebec, G1V 4W2, Canada
Helsinki Central University Hospital
Helsinki, 00014, Finland
Pohjois-Karjala Projekti Saatio/Ita-Suomen
Joensuu, 80100, Finland
Pohjois-Karjala Projekti Saatio
Joensuu, 80100, Finland
Laakarikeskus Aava Kerava/Aava Kerava Medical Center
Kerava, 04200, Finland
Oulu University Hospital
Oulu, 90220, Finland
Division of Medicine Turku University Hospital
Turku, 20520, Finland
Policlinico "Paolo Giaccone"
Palermo, PA, 90127, Italy
Ospedale "Santa Maria della Misericordia"
Perugia, PG, 06156, Italy
Ospedale di Circolo e Fondazione Macchi
Varese, VA, 21100, Italy
Azienda Ospedaliero Universitaria "Federico II" di Napoli
Napoli, 80131, Italy
St. Franciscus Gasthuis
Rotterdam, South Holland, 3045 PM, Netherlands
Admiraal de Ruyter ziekenhuis
Goes, Zeeland, 4462 RA, Netherlands
Academic Medical Center
Amsterdam, 1105 AZ, Netherlands
Amphia Hospital
Breda, 4818 CK, Netherlands
Deventer Ziekenhuis
Deventer, 7416 SE, Netherlands
Rotterdam Research Institute
Rotterdam, 3039 BD, Netherlands
Albert Schweitzer Hospital
Sliedrecht, 3361 XV, Netherlands
Hagaziekenhuis
The Hague, 2545 CH, Netherlands
UMC Utrecht
Utrecht, 3584 CX, Netherlands
Oslo Universitetssykehus HF
Oslo, 0373, Norway
Oslo Universitetssykehus HF, Ulleval
Oslo, 0450, Norway
NZOZ Vitamed
Bydgoszcz, 85-079, Poland
NZOZ Centrum Zdrowia i Profilaktyki Dabie Sp zo.o.
Krakow, 31-567, Poland
NZOZ Przychodnia Specjalistyczna Andrzej Wittek Henryk Rudzki S.C
Ruda Śląska, 41-709, Poland
IATROS International
Bloemfontein, Free State, 9301, South Africa
Unitas hospital
Centurion, Gauteng, 0157, South Africa
Midrand Medical Centre
Halfway House, Gauteng, 1685, South Africa
Medipark Centre for Clinical Research
Pretoria, Gauteng, 0158, South Africa
Jongaie Research
Pretoria, Gauteng, 0183, South Africa
Synexus Watermeyer Clinical Research Centre
Pretoria, Gauteng, 0184, South Africa
Roodepoort Medicross Clinical Research Centre
Roodepoort, Gauteng, 1724, South Africa
Chelmsford Medical Centre 3
Durban, KwaZulu-Natal, 4001, South Africa
Tiervlei Trial Centre, Karl Bremer Hospital
Bellville, Cape Town, Western Cape, 7530, South Africa
TREAD Research cc.
Parow, Cape Town, Western Cape, 7500, South Africa
Synexus Helderberg Clinical Research Centre
Somerset West, Western Cape, 7130, South Africa
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Clinico Universitario, Santiago de Compostela
Santiago de Compostela, Galicia, 15706, Spain
Hospital Universitario Sant Joan de Reus
Reus, Tarragona, 43204, Spain
Hospital Clinic
Barcelona, 08036, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007, Spain
Fundacion Jimenez Diaz; Servicio de Medicina Interna
Madrid, 28040, Spain
Hospital Clinico San Carlos; U. de Lipidos; Medicina Interna III
Madrid, 28040, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Clinico Universitario Miguel Servet; Medicina Interna
Zaragoza, 50009, Spain
Clinical Trials Pharmacy, 4th Floor Inpatient Pharmacy
Manchester, Greater Manchester, M13 9WL, United Kingdom
Pennine Acute Hospitals NHS Trust
Oldham, Greater Manchester, OL1 2JH, United Kingdom
East and North Hertfordshire NHS Trust
Stevenage, Hertfordshire, SG1 4AB, United Kingdom
Burton Hospitals NHS Foundation Trust
Burton-on-Trent, Staffordshire, DE13 0RB, United Kingdom
Heart of England NHS Foundation Trust
Birmingham, West Midlands, B9 5SS, United Kingdom
Royal Free London NHS Foundation Trust
London, NW3 2QG, United Kingdom
Central Manchester University Hospitals NHS Foundation Trust
Manchester, M13 9WL, United Kingdom
Peterborough and Stamford Hospitals NHS Foundation Trust
Peterborough, PE3 9GZ, United Kingdom
Related Publications (5)
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: 35277540DERIVEDRidker 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
Interventions
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 23, 2013
Primary Completion
April 15, 2016
Study Completion
April 15, 2016
Last Updated
June 26, 2017
Results First Posted
May 19, 2017
Record last verified: 2017-05