Efficacy, Safety, Tolerability And Actual Use Study Of Bococizumab And An Autoinjector (Pre-Filled Pen) In Subjects With Hyperlipidemia Or Dyslipidemia (SPIRE-AI)

November 20, 2017 updated by: Pfizer

A 12 Week, Phase 3, Double-blind, Randomized, Placebo-controlled, Parallel Group Study To Assess The Efficacy, Safety, Tolerability And Actual Use Of Bococizumab And An Autoinjector (Pre-filled Pen) In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia

This study is a multicenter, randomized study in subjects with high cholesterol receiving statins to assess the efficacy to lower LDL-C, the safety, tolerability and actual use of bococizumab and an autoinjector (pre-filled pen).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

299

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

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Radiant Research Incorporated
    • California
      • Lincoln, California, United States, 95648
        • Clinical Trial Research
      • Los Angeles, California, United States, 90057
        • National Research Institute
      • Northridge, California, United States, 91324
        • California Medical Research Associates Inc.
      • Sacramento, California, United States, 95821
        • Northern California Research
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research, Inc.
    • Florida
      • Atlantis, Florida, United States, 33462
        • ACRC - Cardiology
      • Coral Gables, Florida, United States, 33134
        • Clinical Research of South Florida
      • Fort Lauderdale, Florida, United States, 33308
        • InvesClinic, LLC
      • Miami, Florida, United States, 33133
        • Prestige Clinical Research Center, Inc.
      • Miami, Florida, United States, 33126
        • Clinical Research Of Miami, Inc.
      • Pembroke Pines, Florida, United States, 33024
        • A & R Research Group LLC
    • Georgia
      • Stockbridge, Georgia, United States, 30281
        • Clinical Research Atlanta
      • Woodstock, Georgia, United States, 30189
        • North Georgia Clinical Research
      • Woodstock, Georgia, United States, 30189
        • North Georgia Internal Medicine
    • Idaho
      • Meridian, Idaho, United States, 83646
        • Solaris Clinical Research
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Evanston Premier Healthcare Research,LLC
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Midwest Institute for Clinical Research
      • Valparaiso, Indiana, United States, 46383
        • Buynak Clinical Research, P.C.
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • L-MARC Research Center
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Omega Clinical Research Center
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • PharmQuest
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Sterling Research Group, Ltd.
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • PMG Research of Charleston
      • Summerville, South Carolina, United States, 29485
        • Palmetto Clinical Research
    • Texas
      • Houston, Texas, United States, 77081
        • Texas Center for Drug Development, Inc.
    • Virginia
      • Hopewell, Virginia, United States, 23860
        • Heart Care Associates, P.C.
      • Manassas, Virginia, United States, 20110
        • Manassas Clinical Research Center
      • Richmond, Virginia, United States, 23294
        • National Clinical Research-Richmond, Inc.
    • Washington
      • Renton, Washington, United States, 98057
        • Rainier Clinical Research Center, Inc.

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 >=70mg/dL and triglycerides <=400mg/dL

Exclusion Criteria:

  • Pregnant or breastfeeding females - Cardiovascular or cerebrovascular event or procedures during the past 90 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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Bococizumab 150mg
Bococizumab 150mg autoinjector (pre-filled pen)
Biological: Bococizumab 150mg
Bococizumab autoinjector (pre-filled pen) combination Product. 150mg every 2 weeks for 10 weeks, subcutaneous injection.
EXPERIMENTAL: Bococizumab 75mg
Bococizumab 75mg autoinjector (pre-filled pen)
Biological: Bococizumab 75mg
Bococizumab autoinjector (pre-filled pen) combination Product. 75mg every 2 weeks for 10 weeks, subcutaneous injection.
PLACEBO_COMPARATOR: Bococizumab 150mg placebo
Bococizumab 150mg placebo autoinjector (pre-filled pen)
Biological: Bococizumab 150mg placebo
Bococizumab placebo autoinjector (pre-filled pen) combination Product. 150mg placebo every 2 weeks for 10 weeks, subcutaneous injection.
PLACEBO_COMPARATOR: Bococizumab 75mg placebo
Bococizumab 75mg autoinjector (pre-filled pen)
Biological: Bococizumab 75mg placebo
Bococizumab placebo autoinjector (pre-filled pen) combination product. 75mg placebo every 2 weeks for 10 weeks, subcutaneous injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline at Week 12 in Fasting Low Density Lipoprotein Cholesterol (LDL-C) Level for Bococizumab 150 mg Dose Group and Matched Placebo
Time Frame: Baseline, Week 12
Baseline, Week 12
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 0 (Day 1)
Time Frame: Week 0 (Day 1)
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Week 0 (Day 1)
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 2
Time Frame: Week 2
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Week 2
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 4
Time Frame: Week 4
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Week 4
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 6
Time Frame: Week 6
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Week 6
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 8
Time Frame: Week 8
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Week 8
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 10
Time Frame: Week 10
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Week 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 75 mg Dose Group and Combined Bococizumab 150 mg and 75 mg Dose Group at Week 0 (Day 1), 2, 4, 6, 8 and 10
Time Frame: Week 0 (Day 1), 2, 4, 6, 8, 10
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Week 0 (Day 1), 2, 4, 6, 8, 10
Percentage of Injections That Met the Definition for Successful Assessment Using the Observer Assessment Tool (OAT) for Bococizumab 150 mg Dose, Bococizumab 75 mg Dose Group and Combined Bococizumab 150 mg and 75 mg Dose Group at Week 0 (Day 1), 4 and 8
Time Frame: Week 0 (Day 1), 4, 8
As per the OAT, a 'successful' injection was based on observer's response for the question - "Was the administration successful?''. Observer's response being 'Yes' corresponded to a successful injection.
Week 0 (Day 1), 4, 8
Percent Change From Baseline at Week 12 in Fasting Low Density Lipoprotein Cholesterol (LDL-C) Level for Bococizumab 75 mg Dose Group and Matched Placebo
Time Frame: Baseline, Week 12
Baseline, Week 12
Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12
Time Frame: Baseline, Week 12
Baseline, Week 12
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12
Time Frame: Baseline, Week 12
Baseline, Week 12
Percent Change From Baseline in Fasting Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12
Time Frame: Baseline, Week 12
Baseline, Week 12
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline up to 18 weeks
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug up to the follow up visit (up to 18 weeks), that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.
Baseline up to 18 weeks
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)
Time Frame: Baseline up to 18 weeks
Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. Participants with their ADA titer levels >=6.23 were considered as ADA positive and participants with their nAb titer level >=1.58 were considered as nAb positive.
Baseline up to 18 weeks
Plasma Concentration of Bococizumab at Week 12
Time Frame: Week 12
Week 12
Plasma Concentration of Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) at Week 12
Time Frame: Week 12
PCSK9 is an enzyme encoded by the PCSK9 gene in humans on chromosome. It is the 9th member of the proprotein convertase family of proteins that activate other proteins.
Week 12

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)

June 1, 2015

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

April 2, 2015

First Submitted That Met QC Criteria

May 27, 2015

First Posted (ESTIMATE)

June 1, 2015

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2017

Last Update Submitted That Met QC Criteria

November 20, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1481046
  • SPIRE-AI (OTHER: 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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