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Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins (SPIRE-SI)

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ClinicalTrials.gov Identifier: NCT02135029
Recruitment Status : Completed
First Posted : May 9, 2014
Results First Posted : December 14, 2017
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
This study is a multicenter, double blinded, active and placebo controlled randomized clinical trial to demonstrate a superior lipid lowering effect of Bococizumab (PF-04950615; RN316) compared to placebo in subjects who are statin intolerant.

Condition or disease Intervention/treatment Phase
Hyperlipidemia Drug: Bococizumab (PF-04950615;RN316) Drug: Atorvastatin Other: Placebo for Bococizumab (PF-04950615;RN316) Other: Placebo for atorvastatin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Double-blind, Double-dummy, Randomized, Placebo And Active Controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Dyslipidemia Who Are Intolerant To Statins
Actual Study Start Date : June 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Bococizumab (PF-04950615;RN316)
Bococizumab (PF-04950615;RN316)
 Drug: Bococizumab (PF-04950615;RN316)
150 mg every 2 weeks by subcutaneous injection for 24 weeks
Active Comparator: Atorvastatin Drug: Atorvastatin
Atorvastatin PO QD
Placebo Comparator: Placebo Other: Placebo for Bococizumab (PF-04950615;RN316)
150 mg every 2 weeks by subcutaneous injection for 24 weeks

Other: Placebo for atorvastatin
PO QD


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline, Week 12 ]

Secondary Outcome Measures :
  1. Percent Change From Baseline in Fasting Total Cholesterol (TC) at Weeks 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
  2. Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Weeks 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
  3. Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Weeks 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
  4. Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Weeks 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
  5. Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Weeks 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
  6. Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 [ Time Frame: Baseline, Week 24 ]
  7. Percent Change From Baseline in Fasting Triglycerides (TG) at Weeks 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
  8. Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Weeks 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
  9. Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Weeks 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
  10. Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Weeks 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
  11. Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline, Week 12 ]
  12. Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12 [ Time Frame: Baseline, Week 12 ]
  13. Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12 [ Time Frame: Baseline, Week 12 ]
  14. Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 [ Time Frame: Baseline, Week 12 ]
  15. Absolute Change From Baseline in Fasting Triglycerides (TG) at Week 12 [ Time Frame: Baseline, Week 12 ]
  16. Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12 [ Time Frame: Baseline, Week 12 ]
  17. Absolute Change From Baseline in Lipoprotein (A) (Lp[A]) at Week 12 [ Time Frame: Baseline, Week 12 ]
  18. Absolute Change From Baseline in Fasting Total Cholesterol (TC)/ High Density Lipoprotein Cholesterol (HDL-C) Ratio at Weeks 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
  19. Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB)/Apolipoprotein A-I (ApoA-I) Ratio at Weeks 12 And 24 [ Time Frame: Baseline, Week 12, 24 ]
  20. Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24 [ Time Frame: Week 12, 24 ]
  21. Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24 [ Time Frame: Week 12, 24 ]
  22. Plasma PF-04950615 Concentrations at Weeks 12 and 24 [ Time Frame: Week 12 and 24 ]
    Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.4 micrograms per milliliter [mcg/mL]) to zero. Participants who received PF-04950615 150 mg were evaluable for this outcome measure.

  23. Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations [ Time Frame: Baseline (Day 1) up to Week 30 ]
  24. Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (nAb) [ Time Frame: Baseline up to Week 30 ]
    Participants with at least one positive ADA titer greater than or equal to (>=) 6.23 or positive nAb titer >=4.32 were reported. Titers are expressed as log2 reciprocal dilution at assay cutpoint.

  25. Anti-drug Antibody (ADA) and Neutralizing Anti-body (nAb) Titer Level in Participants Who Tested Positive for ADA and nAb Respectively [ Time Frame: Week 4, 12, 24 and 30 (Follow-up) ]
    Titer levels of participants who tested positive for ADA and nAb are reported. Titers are expressed as log2 reciprocal dilution at assay cutpoint.

  26. Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations [ Time Frame: Baseline (Day 1) up to Week 30 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hyperlipidemia
  • Statin Intolerant
  • Fasting LDL-C > = 70 mg/dL Fasting TG < = 400 mg/dL

Exclusion Criteria:

  • Pregnant or breastfeeding females
  • Cardiovascular or cerebrovascular event or procedure within 90 days
  • Severe or life-threatening adverse events with past use of statins
  • Poorly controlled hypertension
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135029


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02135029    
Other Study ID Numbers: B1481030
STATIN INTOLERANT
SPIRE-SI ( Other Identifier: Alias Study Number )
First Posted: May 9, 2014    Key Record Dates
Results First Posted: December 14, 2017
Last Update Posted: December 14, 2017
Last Verified: November 2017
Keywords provided by Pfizer:
Hyperlipidemia
statin intolerance
Additional relevant MeSH terms:
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Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Bococizumab
 Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors