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Trial record 1 of 1 for:    NCT02458287
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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02458287
Recruitment Status : Completed
First Posted : June 1, 2015
Results First Posted : December 19, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE April 2, 2015
First Posted Date  ICMJE June 1, 2015
Results First Submitted Date  ICMJE October 9, 2017
Results First Posted Date  ICMJE December 19, 2017
Last Update Posted Date December 19, 2017
Actual Study Start Date  ICMJE June 2015
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2017)
  • 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 ]
  • 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 Was the medicine not flowing after needle withdrawn?"
  • 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 Was the medicine not flowing after needle withdrawn?"
  • 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?"
  • 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?"
  • 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?"
  • 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?"
Original Primary Outcome Measures  ICMJE
 (submitted: May 27, 2015)
  • Percentage change from baseline in LDL-C 150mg dose [ Time Frame: 12 weeks ]
    Low density lipoprotein (LDL-C) blood concentrations.
  • Delivery system success rate 150mg dose [ Time Frame: 0 weeks ]
    Percentage of subjects whose attempt to operate the system met the definition for successful assessed using the Participant Assessment Tool for the 150mg bococizumab dose
  • Delivery system success rate 150mg dose [ Time Frame: 2 weeks ]
    Percentage of subjects whose attempt to operate the system met the definition for successful assessed using the Participant Assessment Tool for the 150mg bococizumab dose
  • Delivery system success rate 150mg dose [ Time Frame: 4 weeks ]
    Percentage of subjects whose attempt to operate the system met the definition for successful assessed using the Participant Assessment Tool for the 150mg bococizumab dose
  • Delivery system success rate 150mg dose [ Time Frame: 6 weeks ]
    Percentage of subjects whose attempt to operate the system met the definition for successful assessed using the Participant Assessment Tool for the 150mg bococizumab dose
  • Delivery system success rate 150mg dose [ Time Frame: 8 weeks ]
    Percentage of subjects whose attempt to operate the system met the definition for successful assessed using the Participant Assessment Tool for the 150mg bococizumab dose
  • Delivery system success rate 150mg dose [ Time Frame: 10 weeks ]
    Percentage of subjects whose attempt to operate the system met the definition for successful assessed using the Participant Assessment Tool for the 150mg bococizumab dose
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2017)
  • 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?"
  • 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.
  • 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 ]
  • Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 [ Time Frame: 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 ]
  • 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.
  • 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.
  • Plasma Concentration of Bococizumab at Week 12 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2015)
  • Delivery system success rate 75mg dose [ Time Frame: 0, 2, 4, 6, 8 and 10 weeks ]
    Percentage of subjects whose attempt to operate the system met the definition for successful assessed using the Participant Assessment Tool for the 75mg and combined 150mg and 75mg bococizumab doses
  • Delivery system success rate Observer Assessment Tool [ Time Frame: 0, 4 and 8 weeks ]
    Percentage of subjects whose attempt to operate the system met the definition for successful assessed using the Observer Assessment Tool for the 75mg, 150mg and combined bococizumab doses
  • Percentage change from baseline in LDL-C 75mg dose [ Time Frame: 12 weeks ]
    Low density lipoprotein (LDL-C) blood concentrations
  • Change from baseline in Mean Total Cholesterol (TC) [ Time Frame: 12 weeks ]
    Mean Total Cholesterol (TC) for the bococizumab 150mg and 75mg doses compared to their respective placebos
  • Plasma bococizumab and PCSK9 concentrations [ Time Frame: 12 weeks ]
    Plasma bococizumab and PCK9 concentraions
  • Change from baseline in Apolipoprotein B (ApoB) [ Time Frame: 12 weeks ]
    Apolipoprotein B (ApoB) for the bococizumab 150mg and 75mg doses compared to their respective placebos
  • Change from baseline in non High Density Lipoprotein (HDL-C) [ Time Frame: 12 weeks ]
    Non High Density Lipoprotein (HDL-C) for the bococizumab 150mg and 75mg doses compared to their respective placebos
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy, Safety, Tolerability And Actual Use Study Of Bococizumab And An Autoinjector (Pre-Filled Pen) In Subjects With Hyperlipidemia Or Dyslipidemia
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hyperlipidemia
Intervention  ICMJE
  • Biological: Bococizumab 150mg
    Bococizumab autoinjector (pre-filled pen) combination Product. 150mg every 2 weeks for 10 weeks, subcutaneous injection.
  • Biological: Bococizumab 75mg
    Bococizumab autoinjector (pre-filled pen) combination Product. 75mg every 2 weeks for 10 weeks, subcutaneous injection.
  • Biological: Bococizumab 150mg placebo
    Bococizumab placebo autoinjector (pre-filled pen) combination Product. 150mg placebo every 2 weeks for 10 weeks, subcutaneous injection.
  • Biological: Bococizumab 75mg placebo
    Bococizumab placebo autoinjector (pre-filled pen) combination product. 75mg placebo every 2 weeks for 10 weeks, subcutaneous injection.
Study Arms  ICMJE
  • Experimental: Bococizumab 150mg
    Bococizumab 150mg autoinjector (pre-filled pen)
    Intervention: Biological: Bococizumab 150mg
  • Experimental: Bococizumab 75mg
    Bococizumab 75mg autoinjector (pre-filled pen)
    Intervention: Biological: Bococizumab 75mg
  • Placebo Comparator: Bococizumab 150mg placebo
    Bococizumab 150mg placebo autoinjector (pre-filled pen)
    Intervention: Biological: Bococizumab 150mg placebo
  • Placebo Comparator: Bococizumab 75mg placebo
    Bococizumab 75mg autoinjector (pre-filled pen)
    Intervention: Biological: Bococizumab 75mg placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 21, 2016)
299
Original Estimated Enrollment  ICMJE
 (submitted: May 27, 2015)
300
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02458287
Other Study ID Numbers  ICMJE B1481046
SPIRE-AI ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP