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

May 31, 2017 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

370

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Pleven, Bulgaria, 5800
        • SHAT in Cardiology EAD
      • Plovdiv, Bulgaria, 4002
        • UMHAT "Sveti Georgi" EAD, Clinic of Cardiology
      • Sofia, Bulgaria, 1202
        • Second MHAT - Sofia EAD
      • Sofia, Bulgaria, 1709
        • MHAT "Sveta Anna", Clinic of Internal Diseases
  • Canada
      • Quebec, Canada, G1V 4W2
        • Clinique des Maladies Lipidiques de Quebec Inc
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital, Healthy Heart
      • Victoria, British Columbia, Canada, V8T 5G4
        • Discovery Clinical Services Ltd.
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • Asper Clinical Research Institute
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Health Sciences Centre
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Institute
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7K9
        • Ecogene-21
      • Montreal, Quebec, Canada, H2W 1R7
        • Institut de Recherches Cliniques de Montreal
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute
  • Finland
      • Helsinki, Finland, 00014
        • Helsinki Central University Hospital
      • Joensuu, Finland, 80100
        • Pohjois-Karjala Projekti Saatio/Ita-Suomen
      • Joensuu, Finland, 80100
        • Pohjois-Karjala Projekti Saatio
      • Kerava, Finland, 04200
        • Laakarikeskus Aava Kerava/Aava Kerava Medical Center
      • Oulu, Finland, 90220
        • Oulu University Hospital
      • Turku, Finland, 20520
        • Division of Medicine Turku University Hospital
  • Italy
      • Napoli, Italy, 80131
        • Azienda Ospedaliero Universitaria "Federico II" di Napoli
    • PA
      • Palermo, PA, Italy, 90127
        • Policlinico "Paolo Giaccone"
    • PG
      • Perugia, PG, Italy, 06156
        • Ospedale "Santa Maria della Misericordia"
    • VA
      • Varese, VA, Italy, 21100
        • Ospedale di Circolo e Fondazione Macchi
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academic Medical Center
      • Breda, Netherlands, 4818 CK
        • Amphia Hospital
      • Den Haag, Netherlands, 2545 CH
        • HagaZiekenhuis
      • Deventer, Netherlands, 7416 SE
        • Deventer Ziekenhuis
      • Rotterdam, Netherlands, 3039 BD
        • Rotterdam Research Institute
      • Sliedrecht, Netherlands, 3361 XV
        • Albert Schweitzer Hospital
      • Utrecht, Netherlands, 3584 CX
        • UMC Utrecht
    • Zeeland
      • Goes, Zeeland, Netherlands, 4462 RA
        • Admiraal de Ruyter Ziekenhuis
    • Zuid-holland
      • Rotterdam, Zuid-holland, Netherlands, 3045 PM
        • St. Franciscus Gasthuis
  • Norway
      • Oslo, Norway, 0450
        • Oslo Universitetssykehus HF, Ullevål
      • Oslo, Norway, 0373
        • Oslo universitetssykehus HF
  • Poland
      • Bydgoszcz, Poland, 85-079
        • NZOZ Vitamed
      • Krakow, Poland, 31-567
        • NZOZ Centrum Zdrowia i Profilaktyki Dabie Sp zo.o.
      • Ruda Slaska, Poland, 41-709
        • NZOZ Przychodnia Specjalistyczna Andrzej Wittek Henryk Rudzki S.C
  • South Africa
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Iatros International
    • Gauteng
      • Centurion, Gauteng, South Africa, 0157
        • Unitas Hospital
      • Halfway House, Gauteng, South Africa, 1685
        • Midrand Medical Centre
      • Pretoria, Gauteng, South Africa, 0184
        • Synexus Watermeyer Clinical Research Centre
      • Pretoria, Gauteng, South Africa, 0183
        • Jongaie Research
      • Pretoria, Gauteng, South Africa, 0158
        • Medipark Centre for Clinical Research
      • Roodepoort, Gauteng, South Africa, 1724
        • Roodepoort Medicross Clinical Research Centre
    • Kwa-zulu Natal
      • Durban, Kwa-zulu Natal, South Africa, 4001
        • Chelmsford Medical Centre 3
    • Western Cape
      • Bellville, Cape Town, Western Cape, South Africa, 7530
        • Tiervlei Trial Centre, Karl Bremer Hospital
      • Parow, Cape Town, Western Cape, South Africa, 7500
        • TREAD Research cc.
      • Somerset West, Western Cape, South Africa, 7130
        • Synexus Helderberg Clinical Research Centre
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínic
      • Cordoba, Spain, 14004
        • Hospital Universitario Reina Sofía
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon
      • Madrid, Spain, 28040
        • Fundacion Jimenez Diaz; Servicio de Medicina Interna
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos; U. de Lipidos; Medicina Interna III
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Zaragoza, Spain, 50009
        • Hospital Clinico Universitario Miguel Servet; Medicina Interna
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitario de Bellvitge
    • Galicia
      • Santiago de Compostela, Galicia, Spain, 15706
        • Hospital Clinico Universitario, Santiago de Compostela
    • Tarragona
      • Reus, Tarragona, Spain, 43204
        • Hospital Universitario Sant Joan de Reus
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Royal Free London NHS Foundation Trust
      • Manchester, United Kingdom, M13 9WL
        • Central Manchester University Hospitals NHS Foundation Trust
      • Peterborough, United Kingdom, PE3 9GZ
        • Peterborough and Stamford Hospitals NHS Foundation Trust
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M13 9WL
        • Clinical Trials Pharmacy, 4th Floor Inpatient Pharmacy
      • Oldham, Greater Manchester, United Kingdom, OL1 2JH
        • Pennine Acute Hospitals NHS Trust
    • Hertfordshire
      • Stevenage, Hertfordshire, United Kingdom, SG1 4AB
        • East and North Hertfordshire NHS Trust
    • Staffordshire
      • Burton-on-Trent, Staffordshire, United Kingdom, DE13 0RB
        • Burton Hospitals NHS Foundation Trust
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B9 5SS
        • Heart of England NHS Foundation Trust
  • United States
    • California
      • Los Angeles, California, United States, 90020
        • IMD Medical Group
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital, JB704
    • Florida
      • Hialeah, Florida, United States, 33016
        • Best Quality Research, Inc.
      • Miami, Florida, United States, 33144
        • Medical Research Center
      • Miami, Florida, United States, 33174
        • Columbus Clinical Services, LLC
      • Miami, Florida, United States, 33165
        • Premier Research Associate, Inc
      • Miami Beach, Florida, United States, 33140
        • NewPhase Clinical Trials, Corp.
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Om Medical
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7075
        • The University of North Carolina at Chapel Hill Center for Heart & Vascular Care
      • Chapel Hill, North Carolina, United States, 27599-7600
        • The University of North Carolina Hospitals - Clinical and Translational Research Center Clinic
    • Ohio
      • Cincinnati, Ohio, United States, 45227
        • Metabolic and Atherosclerosis Research Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Heart Hospital
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Heart Hospital Research Foundation
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Heart Hospital Physicians
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • South Carolina
      • Gaffney, South Carolina, United States, 29340
        • OnSite Clinical Solutions, LLC
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
      • Dallas, Texas, United States, 75251
        • Galenos Research
      • Houston, Texas, United States, 77099
        • Pioneer Research Solutions, Inc.
      • Sugar Land, Texas, United States, 77479
        • Pioneer Research Solutions, Inc.
    • Utah
      • Draper, Utah, United States, 84020
        • Focus Clinical Research, LLC
    • Virginia
      • Burke, Virginia, United States, 22015
        • Burke Internal Medicine & Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Pregnant or breastfeeding females.
  • Cardiovascular or cerebrovascular event of procedures during the past 30 days.
  • Congestive heart failure NYHA class IV.
  • Poorly controlled hypertension.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
subcutaneous injection every 2 weeks for 12 months
Experimental: Bococizumab (PF-04950615;RN316)
Drug: Bococizumab (PF-04950615;RN316)
150 mg every 2 weeks, subcutaneous injection, 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time Frame: Baseline, Week 12
Baseline, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12
Time Frame: Baseline, Week 12
Baseline, Week 12
Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12
Time Frame: Baseline, Week 12
Baseline, Week 12
Plasma PF-04950615 Concentrations at Week 12, 24 and 52
Time Frame: Week 12, 24, 52
Week 12, 24, 52
Percent Change From Baseline in Total Cholesterol (TC) at Week 12
Time Frame: Baseline, Week 12
Baseline, Week 12
Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12
Time Frame: Baseline, Week 12
Baseline, Week 12
Percent Change From Baseline in Lipoprotein (a) at Week 12
Time Frame: Baseline, Week 12
Baseline, Week 12
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Time Frame: Baseline, Week 12
Baseline, Week 12
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52
Time Frame: Baseline, Week 24, 52
Baseline, Week 24, 52
Percent Change From Baseline in Total Cholesterol (TC) at Week 24 and 52
Time Frame: Baseline, Week 24, 52
Baseline, Week 24, 52
Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 24 and 52
Time Frame: Baseline, Week 24, 52
Baseline, Week 24, 52
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 and 52
Time Frame: Baseline, Week 24, 52
Baseline, Week 24, 52
Percent Change From Baseline in Lipoprotein (a) at Week 24 and 52
Time Frame: Baseline, Week 24, 52
Baseline, Week 24, 52
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and 52
Time Frame: Baseline, Week 24, 52
Baseline, Week 24, 52
Percent Change From Baseline in Triglycerides (TG) at Week 12, 24 and 52
Time Frame: Baseline, Week 12, 24, 52
Baseline, Week 12, 24, 52
Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52
Time Frame: Baseline, Week 12, 24, 52
Baseline, Week 12, 24, 52
Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52
Time Frame: Baseline, Week 12, 24, 52
Baseline, Week 12, 24, 52
Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52
Time Frame: Baseline, Week 12, 24, 52
Baseline, Week 12, 24, 52
Absolute Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12
Time Frame: Baseline, Week 12
Baseline, Week 12
Absolute Change From Baseline in Total Cholesterol (TC) at Week 12
Time Frame: Baseline, Week 12
Baseline, Week 12
Absolute Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12
Time Frame: Baseline, Week 12
Baseline, Week 12
Absolute Change From Baseline in Lipoprotein (a) at Week 12
Time Frame: Baseline, Week 12
Baseline, Week 12
Absolute Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Time Frame: Baseline, Week 12
Baseline, Week 12
Absolute Change From Baseline in Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52
Time Frame: Baseline, Week 12, 24, 52
Baseline, Week 12, 24, 52
Absolute Change From Baseline in Ratio of Apolipoprotein B to Apolipoprotein A-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52
Time Frame: Baseline, Week 12, 24, 52
Baseline, Week 12, 24, 52
Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Liter) at Week 12, 24 and 52
Time Frame: Week 12, 24, 52
Week 12, 24, 52
Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Liter) at Week 12, 24 and 52
Time Frame: Week 12, 24, 52
Week 12, 24, 52
Number of Participants With Adverse Events Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions
Time Frame: Baseline up to the end of study (up to 58 weeks)
Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia, polysynovitis, fever and if severe then included glomerulonephritis as well. Injection site reaction is a reaction at the site of the subcutaneous injection and characterized by the symptoms of erythema, swelling, tenderness and warmth. Participants with any of the above type 1 or type 3 hypersensitivity reactions and participants with any of the above injection site reactions were reported in this outcome measure.
Baseline up to the end of study (up to 58 weeks)
Percentage of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)
Time Frame: Baseline up to the end of study (up to 58 weeks)
Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported in this outcome measure. ADA titer greater than or equal to (>=) 6.23 were considered as ADA positive and nAb titer level >=1.58 were considered as nAb positive.
Baseline up to the end of study (up to 58 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2013

Primary Completion (Actual)

April 15, 2016

Study Completion (Actual)

April 15, 2016

Study Registration Dates

First Submitted

October 21, 2013

First Submitted That Met QC Criteria

October 21, 2013

First Posted (Estimate)

October 24, 2013

Study Record Updates

Last Update Posted (Actual)

June 26, 2017

Last Update Submitted That Met QC Criteria

May 31, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1481021
  • 2013-002644-87 (EudraCT Number)
  • SPIRE-HF (Other Identifier: Alias Study Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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