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HyperlipidemiaPhase 3SPIRE-HRNCT01968954

Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects With Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events

A Phase 3 study testing Bococizumab (PF-04950615;RN316) in people with Hyperlipidemia, run by Pfizer at 103 sites in 9 countries.

Completed

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

Official record
Search all trials

Trial summary

This study is a multicenter, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of Bococizumab (PF-04950615;RN316) to lower LDL-C. 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)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
711 participants
Where
103 sitesin 9 countries
Study dates
Oct 2013to Apr 2016
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

  • Treated with a statin.
  • Fasting LDL-C > 70 mg/dL and triglyceride <=400 mg/dL.
  • High or very high risk of incurring a cardiovascular event.

Who cannot join

  • Pregnant or breastfeeding females.
  • Cardiovascular or cerebrovascular event of procedures during the past 30 days.
  • Congestive heart failure NYHA class IV.
  • Poorly controlled hypertension.

Trial locations and contacts

103 sites in 9 countries.

103 sites in 9 countries

United States58 sites

  • Radiant Research, Inc

    Akron, Ohio, 44311

  • Comunity Clinical Research Center

    Anderson, Indiana, 46011

  • Integrated Medical Research, PC

    Ashland, Oregon, 97520

  • American Health Network of Indiana, LLC

    Avon, Indiana, 46123

  • Achieve Clinical Research, LLC

    Birmingham, Alabama, 35216

  • Cardiovascular Associates of the Southeast, LLC

    Birmingham, Alabama, 35243

  • Internal Medicine and Pediatric Associates of Bristol, PC

    Bristol, Tennessee, 37620

  • PMG Research of Raleigh, LLC d/b/a PMG Research of Cary

    Cary, North Carolina, 27518

  • Medical Research South,LLC

    Charleston, South Carolina, 29407

  • Rapid Medical Research, Inc.

    Cleveland, Ohio, 44122

  • Expresscare Clinical Research

    Colorado Springs, Colorado, 80909

  • 3 rd Coast Research Associates

    Corpus Christi, Texas, 78413

  • Diagnamics, Inc.

    Encinitas, California, 92024

  • Encompass Clinical Research North Coast

    Encinitas, California, 92024

  • Horizon Research Group of Opelousas, LLC

    Eunice, Louisiana, 70535

  • Internal Medicine Associates

    Eunice, Louisiana, 70535

  • Evanston Premier Healthcare Research LLC

    Evanston, Illinois, 60201

  • MD Studies, Inc.

    Fountain Valley, California, 92708

  • Harleysville Medical Associates

    Harleysville, Pennsylvania, 19438

  • Eastern Research, Inc.

    Hialeah, Florida, 33013

  • Texas Center For Drug Development, Inc.

    Houston, Texas, 77081

  • Pioneer Research Solutions, Inc.

    Houston, Texas, 77099

  • Protenium Clinical Research

    Hurst, Texas, 76054

  • Midwest Institute for Clinical Research

    Indianapolis, Indiana, 46260

  • East Coast Institute for Research, LLC at Northeast Florida Endocrine & Diabetes Associates

    Jacksonville, Florida, 32204

  • Care Partners Clinical Research, LLC

    Jacksonville, Florida, 32277

  • Alliance Research Centers

    Laguna Hills, California, 92653

  • Prime Care Clinical Research

    Laguna Hills, California, 92653

  • Utah Cardiology, P.C.

    Layton, Utah, 84041

  • Prestige Clinical Research Center Inc

    Miami, Florida, 33133

  • Allina Health System, dba Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

  • University of MN, Lillehei Clinical Trials Unit

    Minneapolis, Minnesota, 55455

  • Montana Medical Research Inc.

    Missoula, Montana, 59808

  • Berkeley Family Practice

    Moncks Corner, South Carolina, 29461

  • Edgewater Medical Research

    New Smyrna Beach, Florida, 32169

  • National Clinical Research - Norfolk, Inc.

    Norfolk, Virginia, 23502

  • Providence Clinical Research

    North Hollywood, California, 91606

  • Soundview Medical Associates

    Norwalk, Connecticut, 06851

  • South Oklahoma Heart Research LLC

    Oklahoma City, Oklahoma, 73135

  • The Office of Daniel G. Williams, MD

    Perrysburg, Ohio, 43551

  • Perelman Center for Advanced Medicine Heart & Vascular Center

    Philadelphia, Pennsylvania, 19104

  • Columbia Research Group, Inc.

    Portland, Oregon, 97239

  • Beacon Clinical Research, LLC

    Quincy, Massachusetts, 02169

  • San Diego Family Care

    San Diego, California, 92111

  • Fellows Research Alliance, Inc.

    Savannah, Georgia, 31406

  • SouthCoast Medical Group

    Savannah, Georgia, 31406

  • Premier Clinical Research

    Spokane, Washington, 99202

  • St. Joseph's Medical Associates

    Stockton, California, 95204

  • Gulfcoast Medical Research Center, LLC

    Tampa, Florida, 33607

  • Southwest Heart Group

    Tucson, Arizona, 85710

  • ARA-Arizona Research Associates

    Tucson, Arizona, 85712

  • Orange County Research Center

    Tustin, California, 92780

  • Clinical Research Advantage, Inc./Cassidy Medical Group - Vista

    Vista, California, 92083

  • Elite Clinical Trials

    Wildomar, California, 92595

  • Great Lakes Medical Research, LLC

    Willoughby, Ohio, 44094

  • Clinical Trials of America, Inc.

    Winston-Salem, North Carolina, 27103

  • Berks Cardiologists, Ltd.

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Poland13 sites

  • Synexus Polska Sp. z o.o. Oddzial w Gdyni

    Gdynia, 81-384

  • SYNEXUS Polska Sp. z o.o. Oddzial w Katowicach

    Katowice, Masovian Voivodeship, 40-040

  • NZOZ Terapia Optima

    Katowice, Silesian Voivodeship, 40-752

  • Niepubliczny Zaklad Opieki Zdrowotnej CEREO-MED Sp. z o.o.

    Lodz, 92-003

  • Medicus w Opolu Sp z o.o.

    Opole, 45-706

  • Medicome Sp. z o.o.

    Oświęcim, 32-600

  • Synexus Polska Sp. z o.o Oddzial w Poznaniu

    Poznan, 60-702

  • Centrum Medyczne Ogrodowa Sp. z o.o.

    Skierniewice, 96-100

  • Centrum Medyczne "SOPMED" Sp. z o.o.

    Sopot, 81-756

  • Synexus Polska Sp. z o.o. Oddzial w Warszawie

    Warsaw, 01-192

  • Centrum Medyczne AMED

    Warsaw, 01-518

  • CSK MSW w Warszawie, Klinika Kardiologii Zachowawczej i Nadcisnienia Tetniczego

    Warsaw, 02-507

  • Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

    Wroclaw, 50-088

Other trials in Poland

South Korea9 sites

  • Yonsei University Wonju Severance Christian Hospital

    Gangwon-Do, 220-701

  • Chonnam National University Hospital

    Gwangju, 501-757

  • Seoul National University Hospital

    Seoul, 110-744

  • Severance Hospital, Yonsei University Health System

    Seoul, 120-752

  • Gangnam Sevrance Hospital, Yeonsei University Health System

    Seoul, 135-720

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 137-701

  • Ajou University Hospital

    Suwon, 443-380

  • The Catholic University of Korea, Uijeongbu St. Mary's Hospital

    Uijeongbu-si, Gyeonggi-do, 480-717

  • Ulsan University Hospital

    Ulsan, 682-714

Other trials in South Korea

Canada6 sites

  • Ecogene-21

    Chicoutimi, Quebec, G7H 7K9

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • Diex Research Montreal Inc.

    Montreal, Quebec, H4N 3C5

  • ALPHA Recherche Clinique

    Québec, Quebec, G3K 2P8

  • Centre Hospitalier Universitaire de Sherbrooke (CHUS)

    Sherbrooke, Quebec, J1H 5N4

  • Medexa Recherche

    Victoriaville, Quebec, G6P 6P6

Other trials in Canada

Italy5 sites

  • IRCCS Ospedale San Raffaele

    Milan, MI, 20132

  • IRCCS Centro Cardiologico Fondazione Monzino

    Milan, MI, 20138

  • IRCCS Istituto Auxologico Italiano

    Milan, MI, 20145

  • Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"

    Palermo, PA, 90127

  • Dipartimento di Medicina Interna e Specialita Mediche Policlinico Umberto I

    Roma, RM, 00161

Other trials in Italy

Germany4 sites

  • Klinische Forschung Berlin-Mitte GmbH

    Berlin, 10117

  • Klinische Forschung Hannover - Mitte GmbH

    Hanover, 30159

  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH

    Ludwigshafen, 67063

  • Klinische Forschung Schwerin GmbH

    Schwerin, 19055

Other trials in Germany

Australia3 sites

  • Australian Clinical Research Network

    Maroubra, New South Wales, 2035

  • Core Research Group Pty Ltd

    Milton, Queensland, 4064

  • The Avenue Cardiovascular Centre

    St Kilda East, Victoria, 3183

Other trials in Australia

Czechia3 sites

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Kardiologie a interni lekarstvi

    Prague, 158 00

  • Lekarsky dum Ormiga

    Zlín, 760 01

Other trials in Czechia

Hong Kong2 sites

  • The Chinese University of Hong Kong

    Shatin

  • Department of Medicine & Therapeutics-The Chinese University of Hong Kong

    Shatin, NT

Other trials in Hong Kong

About this study

Official title: A Phase 3 Double-blind,Randomized, Placebo-controlled,Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events

This study is a multicenter, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of Bococizumab (PF-04950615;RN316) to lower LDL-C.

Conditions
Hyperlipidemia
Being tested
Bococizumab (PF-04950615;RN316), Placebo
Keywords
mixed dyslipidemia, high risk of cardiovascular events
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

    Also called RN316

    150 mg every 2 weeks, subcutaneous injection, 12 months

  • PlaceboOther

    subcutaneous injection, every 2 weeks for 12 months

Study groups in NCT01968954
Study groupRoleWhat they receive
Bococizumab (PF-04950615;RN316)ExperimentalNot described
Receives: Drug: Bococizumab (PF-04950615;RN316)
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

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

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

    Measured: Baseline, Week 12

Secondary outcomes (27)

  1. Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52

    Measured: Baseline, Week 12, 24, 52

  2. Percent Change From Baseline in Non- High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52

    Measured: Baseline, Week 12, 24, 52

  3. Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52

    Measured: Baseline, Week 12, 24, 52

  4. Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52

    Measured: Baseline, Week 12, 24, 52

  5. Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52

    Measured: Baseline, Week 12, 24, 52

  6. Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Primary Hyperlipidemia

    Participants with primary hyperlipidemia are defined as participants with triglycerides (TG) level less than (<) 200 milligram per decilitre (mg/dL) (2.26 millimoles per litre [mmol/L]) at pre-randomization.

    Measured: Baseline, Week 12

  7. Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Mixed Dyslipidemia

    Participants with mixed dyslipidemia are defined as TG level greater than or equal to (>=) 200 mg/dL (2.26 mmol/L) at pre-randomization.

    Measured: Baseline, Week 12

  8. Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52

    Measured: Baseline, Week 24, 52

  9. Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off

    Percent change from baseline in fasting LDL-C among participants with TG cut-off of <200 mg/dL and >=200 mg/dL (2.26 mmol/L) were reported in this outcome measure.

    Measured: Baseline, Week 24, 52

  10. Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52

    Measured: Baseline, Week 12, 24, 52

  11. Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52

    Measured: Baseline, Week 12, 24, 52

  12. Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52

    Measured: Baseline, Week 12, 24, 52

  13. Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52

    Measured: Baseline, Week 12, 24, 52

  14. Absolute Change From Baseline in Fasting Low Density Lipoprotein-C (LDL-C) at Week 12 by Trigylceride Cut-Off

    Absolute change from baseline among participants with TG cut-off of <200 mg/dL and >=200 mg/dL (2.26 mmol/L) were reported in this outcome measure.

    Measured: Baseline, Week 12

  15. Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52

    Measured: Baseline, Week 12, 24, 52

  16. Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52

    Measured: Baseline, Week 12, 24, 52

  17. Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52

    Measured: Baseline, Week 12, 24, 52

  18. Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52

    Measured: Baseline, Week 12, 24, 52

  19. Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52

    Measured: Baseline, Week 12, 24, 52

  20. Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52

    Measured: Baseline, Week 12, 24, 52

  21. Absolute Change From Baseline in Ratio of Fasting Total Cholesterol to High Density Lipoprotein-Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52

    Measured: Baseline, Week 12, 24, 52

  22. Absolute Change From Baseline in Ratio of Apolipoprotein B to ApolipoproteinA-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52

    Measured: Baseline, Week 12, 24, 52

  23. Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Litre) at Week 12, 24 and 52

    Measured: Week 12, 24 and 52

  24. Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Litre) at Week 12, 24 and 52

    Measured: Week 12, 24 and 52

  25. Plasma PF-04950615 Concentrations at Week 12, 24 and 52

    Measured: Week 12, 24, 52

  26. Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions

    Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia's, polysynovitis, fever and if severe then included glomerulonephritis as well. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, pain, pruritus and rash. Participants with type 1 or type 3 hypersensitivity reactions and participants with injection site reactions were reported in this outcome measure.

    Measured: Baseline up to the end of study (up to 58 weeks)

  27. 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 >=6.23 were considered to be ADA positive and participants with their nAb titer >=1.58 were considered to be nAb positive.

    Measured: Baseline up to the end of study (up to 58 weeks)

Timeline

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

  1. First posted24 Oct 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionApr 2016
  4. Study completionApr 2016

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
711 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01968954
Sponsor's protocol ID
B1481019
Other IDs
2013-002642-37, SPIRE-HR
Acronym
SPIRE-HR
Status last verified
Mar 2017
First submitted
21 Oct 2013
Last updated
17 May 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

  • McCush F, Wang E, Yunis C, Schwartz P, Baltrukonis D. Anti-drug Antibody Magnitude and Clinical Relevance Using Signal to Noise (S/N): Bococizumab Case Study. AAPS J. 2023 Sep 2;25(5):85. doi: 10.1208/s12248-023-00846-x.

    PubMed 37658997

  • Chasman DI, Hyde CL, Giulianini F, Danning RD, Wang EQ, Hickling T, Ridker PM, Loomis AK. Genome-wide pharmacogenetics of anti-drug antibody response to bococizumab highlights key residues in HLA DRB1 and DQB1. Sci Rep. 2022 Mar 11;12(1):4266. doi: 10.1038/s41598-022-07997-5.

    PubMed 35277540

  • Wang EQ, Bukowski JF, Yunis C, Shear CL, Ridker PM, Schwartz PF, Baltrukonis D. Assessing the Potential Risk of Cross-Reactivity Between Anti-Bococizumab Antibodies and Other Anti-PCSK9 Monoclonal Antibodies. BioDrugs. 2019 Oct;33(5):571-579. doi: 10.1007/s40259-019-00375-0.

    PubMed 31529318

  • Ridker PM, Rose LM, Kastelein JJP, Santos RD, Wei C, Revkin J, Yunis C, Tardif JC, Shear CL; Studies of PCSK9 Inhibition and the Reduction of vascular Events (SPIRE) Investigators. Cardiovascular event reduction with PCSK9 inhibition among 1578 patients with familial hypercholesterolemia: Results from the SPIRE randomized trials of bococizumab. J Clin Lipidol. 2018 Jul-Aug;12(4):958-965. doi: 10.1016/j.jacl.2018.03.088. Epub 2018 Apr 3.

    PubMed 29685591

  • 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) in people with Hyperlipidemia, run by Pfizer at 103 sites in 9 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 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in United States, Poland, South Korea, Canada, Italy and 4 more countries. 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 17 May 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 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 NCT01968954, which also lists 6 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 17 May 2017.

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