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HyperlipidemiaPhase 3SPIRE-SINCT02135029

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

A Phase 3 study testing Bococizumab (PF-04950615;RN316) and Atorvastatin in people with Hyperlipidemia, run by Pfizer at 40 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hyperlipidemia
What is being tested?
Bococizumab (PF-04950615;RN316) and Atorvastatin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
184 participants
Where
40 sitesin 2 countries
Study dates
Jun 2014to Nov 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

40 sites in 2 countries.

40 sites in 2 countries

United States31 sites

  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610

  • PMG Research of Bristol

    Bristol, Tennessee, 37620

  • Dayton Heart Center

    Dayton, Ohio, 45414

  • Creekside Endocrine Associates, PC

    Denver, Colorado, 80209

  • NorthShore University HealthSystem - Evanston Hospital

    Evanston, Illinois, 60201

  • San Antonio Military Medical Center

    Fort Sam Houston, Texas, 78234-6200

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814

  • Office of Michelle Zaniewski MD., PA.

    Houston, Texas, 77090

  • The University of Iowa - College of Public Health - Preventive Intervention Center

    Iowa City, Iowa, 52242

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • PMG Research of Knoxville, LLC

    Knoxville, Tennessee, 37912

  • Watson Clinic Center for Research, Inc. (for Drug Shipment only)

    Lakeland, Florida, 33805

  • Utah Cardiology, P.C.

    Layton, Utah, 84041

  • Crescent City Clinical Research Center

    Metairie, Louisiana, 70006

  • Cardiovascular Research Center Of South Florida

    Miami, Florida, 33173

  • Allina Health System, dba Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

  • Health Care Centers of Illinois Mokena Medical Commons

    Mokena, Illinois, 60448

  • Advocate Medical Group Cardiology

    Normal, Illinois, 61761

  • Aspen Clinical Research LLC

    Orem, Utah, 84058

  • Advocate Medical Group Midwest Heart Specialists

    Park Ridge, Illinois, 60068

  • Clinical and Translational Research Center, Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104

  • St. Johns Center for Clinical Research

    Ponte Vedra, Florida, 32081

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Prairie Education & Research Cooperative (Administrative)

    Springfield, Illinois, 62701

  • Prairie Heart Institute

    Springfield, Illinois, 62701

  • St. John's Hospital

    Springfield, Illinois, 62769

  • The Iowa Clinic, PC

    West Des Moines, Iowa, 50266

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28401

  • Berks Cardiologists, Ltd.

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Canada9 sites

  • Ecogene-21

    Chicoutimi, Quebec, G7H 7K9

  • Corunna Medical Research Centre

    Corunna, Ontario, N0N 1G0

  • The Medical Arts Health Research Group

    Kelowna, British Columbia, V1Y 1V6

  • Omnispec clinical research inc.

    Mirabel, Quebec, J7J 2K8

  • The Office of Dr. James Cha

    Oshawa, Ontario, L1J 2K1

  • Kawartha Cardiology Clinical Trials

    Peterborough, Ontario, K9J 0B2

  • Clinique des maladies lipidiques de Quebec

    Québec, Quebec, G1V 4W2

  • Diex Research Sherbrooke Inc.

    Sherbrooke, Quebec, J1H 1Z1

  • Devonshire Clinical Research Inc.

    Woodstock, Ontario, N4S 5P5

Other trials in Canada

About this study

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

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.

Conditions
Hyperlipidemia
Being tested
Bococizumab (PF-04950615;RN316), Atorvastatin, Placebo for Bococizumab (PF-04950615;RN316), Placebo for atorvastatin
Keywords
Hyperlipidemia, statin intolerance
Medical subject headings
Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bococizumab (PF-04950615;RN316)Drug

    150 mg every 2 weeks by subcutaneous injection for 24 weeks

  • AtorvastatinDrug

    Atorvastatin PO QD

  • Placebo for Bococizumab (PF-04950615;RN316)Other

    150 mg every 2 weeks by subcutaneous injection for 24 weeks

  • Placebo for atorvastatinOther

    PO QD

Study groups in NCT02135029
Study groupRoleWhat they receive
Bococizumab (PF-04950615;RN316)ExperimentalBococizumab (PF-04950615;RN316)
Receives: Drug: Bococizumab (PF-04950615;RN316)
AtorvastatinActive comparatorNot described
Receives: Drug: Atorvastatin
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo for Bococizumab (PF-04950615;RN316); Other: Placebo for atorvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

    Measured: Baseline, Week 12

Secondary outcomes (26)

  1. Percent Change From Baseline in Fasting Total Cholesterol (TC) at Weeks 12 and 24

    Measured: Baseline, Week 12, 24

  2. Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Weeks 12 and 24

    Measured: Baseline, Week 12, 24

  3. Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Weeks 12 and 24

    Measured: Baseline, Week 12, 24

  4. Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Weeks 12 and 24

    Measured: Baseline, Week 12, 24

  5. Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Weeks 12 and 24

    Measured: Baseline, Week 12, 24

  6. Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24

    Measured: Baseline, Week 24

  7. Percent Change From Baseline in Fasting Triglycerides (TG) at Weeks 12 and 24

    Measured: Baseline, Week 12, 24

  8. Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Weeks 12 and 24

    Measured: Baseline, Week 12, 24

  9. Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Weeks 12 and 24

    Measured: Baseline, Week 12, 24

  10. Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Weeks 12 and 24

    Measured: Baseline, Week 12, 24

  11. Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

    Measured: Baseline, Week 12

  12. Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12

    Measured: Baseline, Week 12

  13. Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12

    Measured: Baseline, Week 12

  14. Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12

    Measured: Baseline, Week 12

  15. Absolute Change From Baseline in Fasting Triglycerides (TG) at Week 12

    Measured: Baseline, Week 12

  16. Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12

    Measured: Baseline, Week 12

  17. Absolute Change From Baseline in Lipoprotein (A) (Lp[A]) at Week 12

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Week 12, 24

  22. Plasma PF-04950615 Concentrations at Weeks 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.

    Measured: Week 12 and 24

  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

    Measured: Baseline (Day 1) up to Week 30

  24. Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (nAb)

    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.

    Measured: Baseline up to Week 30

  25. Anti-drug Antibody (ADA) and Neutralizing Anti-body (nAb) Titer Level in Participants Who Tested Positive for ADA and nAb Respectively

    Titer levels of participants who tested positive for ADA and nAb are reported. Titers are expressed as log2 reciprocal dilution at assay cutpoint.

    Measured: Week 4, 12, 24 and 30 (Follow-up)

  26. Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations

    Measured: Baseline (Day 1) up to Week 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
184 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02135029
Sponsor's protocol ID
B1481030
Other IDs
STATIN INTOLERANT, SPIRE-SI
Acronym
SPIRE-SI
Status last verified
Nov 2017
First submitted
7 May 2014
Last updated
14 Dec 2017
Data monitoring committee
Yes

Publications

  • Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2013-2026. doi: 10.1002/psp4.13050. Epub 2023 Nov 22.

    PubMed 37994400

  • 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.

    PubMed 28304227

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bococizumab (PF-04950615;RN316) and Atorvastatin in people with Hyperlipidemia, run by Pfizer at 40 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02135029, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2017.

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