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

Primary Purpose

Hyperlipidemia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bococizumab 150mg
Bococizumab 75mg
Bococizumab 150mg placebo
Bococizumab 75mg placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia focused on measuring mixed dyslipidemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radiant Research Incorporated
  • Clinical Trial Research
  • National Research Institute
  • California Medical Research Associates Inc.
  • Northern California Research
  • Diablo Clinical Research, Inc.
  • ACRC - Cardiology
  • Clinical Research of South Florida
  • Invesclinic, LLC
  • Clinical Research of Miami, Inc.
  • Prestige Clinical Research Center, Inc.
  • A & R Research Group LLC
  • Clinical Research Atlanta
  • North Georgia Clinical Research
  • North Georgia Internal Medicine
  • Solaris Clinical Research
  • Evanston Premier Healthcare Research,LLC
  • Midwest Institute For Clinical Research
  • Buynak Clinical Research, P.C.
  • L-MARC Research Center
  • Omega Clinical Research Center
  • PharmQuest
  • Sterling Research Group, Ltd.
  • PMG Research Of Charleston
  • Palmetto Clinical Research
  • Texas Center for Drug Development, Inc.
  • Heart Care Associates, P.C.
  • Manassas Clinical Research Center
  • National Clinical Research-Richmond, Inc.
  • Rainier Clinical Research Center, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Bococizumab 150mg

Bococizumab 75mg

Bococizumab 150mg placebo

Bococizumab 75mg placebo

Arm Description

Bococizumab 150mg autoinjector (pre-filled pen)

Bococizumab 75mg autoinjector (pre-filled pen)

Bococizumab 150mg placebo autoinjector (pre-filled pen)

Bococizumab 75mg autoinjector (pre-filled pen)

Outcomes

Primary Outcome Measures

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
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)
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?"
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
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?"
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
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?"
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
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?"
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
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?"
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
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?"

Secondary Outcome Measures

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
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?"
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
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.
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
Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12
Percent Change From Baseline in Fasting Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)
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.
Plasma Concentration of Bococizumab at Week 12
Plasma Concentration of Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) at 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.

Full Information

First Posted
April 2, 2015
Last Updated
November 20, 2017
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02458287
Brief Title
Efficacy, Safety, Tolerability And Actual Use Study Of Bococizumab And An Autoinjector (Pre-Filled Pen) In Subjects With Hyperlipidemia Or Dyslipidemia
Acronym
SPIRE-AI
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
Keywords
mixed dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
299 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bococizumab 150mg
Arm Type
Experimental
Arm Description
Bococizumab 150mg autoinjector (pre-filled pen)
Arm Title
Bococizumab 75mg
Arm Type
Experimental
Arm Description
Bococizumab 75mg autoinjector (pre-filled pen)
Arm Title
Bococizumab 150mg placebo
Arm Type
Placebo Comparator
Arm Description
Bococizumab 150mg placebo autoinjector (pre-filled pen)
Arm Title
Bococizumab 75mg placebo
Arm Type
Placebo Comparator
Arm Description
Bococizumab 75mg autoinjector (pre-filled pen)
Intervention Type
Biological
Intervention Name(s)
Bococizumab 150mg
Intervention Description
Bococizumab autoinjector (pre-filled pen) combination Product. 150mg every 2 weeks for 10 weeks, subcutaneous injection.
Intervention Type
Biological
Intervention Name(s)
Bococizumab 75mg
Intervention Description
Bococizumab autoinjector (pre-filled pen) combination Product. 75mg every 2 weeks for 10 weeks, subcutaneous injection.
Intervention Type
Biological
Intervention Name(s)
Bococizumab 150mg placebo
Intervention Description
Bococizumab placebo autoinjector (pre-filled pen) combination Product. 150mg placebo every 2 weeks for 10 weeks, subcutaneous injection.
Intervention Type
Biological
Intervention Name(s)
Bococizumab 75mg placebo
Intervention Description
Bococizumab placebo autoinjector (pre-filled pen) combination product. 75mg placebo every 2 weeks for 10 weeks, subcutaneous injection.
Primary Outcome Measure Information:
Title
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
Title
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)
Description
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?"
Time Frame
Week 0 (Day 1)
Title
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
Description
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?"
Time Frame
Week 2
Title
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
Description
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?"
Time Frame
Week 4
Title
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
Description
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?"
Time Frame
Week 6
Title
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
Description
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?"
Time Frame
Week 8
Title
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
Description
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?"
Time Frame
Week 10
Secondary Outcome Measure Information:
Title
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
Description
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?"
Time Frame
Week 0 (Day 1), 2, 4, 6, 8, 10
Title
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
Description
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.
Time Frame
Week 0 (Day 1), 4, 8
Title
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
Title
Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12
Time Frame
Baseline, Week 12
Title
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12
Time Frame
Baseline, Week 12
Title
Percent Change From Baseline in Fasting Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12
Time Frame
Baseline, Week 12
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
Baseline up to 18 weeks
Title
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)
Description
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.
Time Frame
Baseline up to 18 weeks
Title
Plasma Concentration of Bococizumab at Week 12
Time Frame
Week 12
Title
Plasma Concentration of Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) at Week 12
Description
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.
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Radiant Research Incorporated
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Clinical Trial Research
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Facility Name
National Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
California Medical Research Associates Inc.
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Northern California Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Diablo Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
ACRC - Cardiology
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Clinical Research of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Invesclinic, LLC
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Clinical Research of Miami, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Prestige Clinical Research Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
A & R Research Group LLC
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
North Georgia Clinical Research
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
North Georgia Internal Medicine
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
Solaris Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Facility Name
Evanston Premier Healthcare Research,LLC
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Midwest Institute For Clinical Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Buynak Clinical Research, P.C.
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
L-MARC Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Omega Clinical Research Center
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
PharmQuest
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Sterling Research Group, Ltd.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
PMG Research Of Charleston
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Palmetto Clinical Research
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
Texas Center for Drug Development, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Heart Care Associates, P.C.
City
Hopewell
State/Province
Virginia
ZIP/Postal Code
23860
Country
United States
Facility Name
Manassas Clinical Research Center
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Facility Name
National Clinical Research-Richmond, Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Rainier Clinical Research Center, Inc.
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28304227
Citation
Ridker 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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1481046&StudyName=A%2012%20Week%2C%20Phase%203%2C%20Double-blind%2C%20Randomized%2C%20Placebo-controlled%2C%20Parallel%20Group%20Study%20To%20Assess%20The%20Efficacy%2C%20Safety%2C%20Tolerability%20And%20Actual%20Use%20Of%20Bococizumab%20And%20An%20Autoinjector%20%28pre-filled%20Pen%29%20In%20Subjects%20With%20Primary%20Hyperlipidemia%20Or%20Mixed%20Dyslipidemia
Description
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Efficacy, Safety, Tolerability And Actual Use Study Of Bococizumab And An Autoinjector (Pre-Filled Pen) In Subjects With Hyperlipidemia Or Dyslipidemia

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