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    Summary
    EudraCT Number:2012-001226-10
    Sponsor's Protocol Code Number:B1481015
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-05-29
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2012-001226-10
    A.3Full title of the trial
    A PHASE 2B DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED,
    PARALLEL GROUP, DOSE-RANGING STUDY TO ASSESS THE EFFICACY,
    SAFETY AND TOLERABILITY OF PF-04950615 FOLLOWING MONTHLY AND TWICE MONTHLY SUBCUTANEOUS DOSING FOR SIX MONTHS IN
    HYPERCHOLESTEROLEMIC SUBJECTS ON A STATIN
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the efficacy, safety and tolerability of PF-04950615 following monthly and twice monthly injection dosing for six months in subjects on a statin with high cholesterol.
    A.3.2Name or abbreviated title of the trial where available
    B1481015
    A.4.1Sponsor's protocol code numberB1481015
    A.5.4Other Identifiers
    Name:US IND Number:104,872
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer Inc., 235 East 42nd Street, New York, NY 10017
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPfizer Inc., 235 East 42nd Street, New York, NY 10017
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18007181021
    B.5.5Fax number+13037391119
    B.5.6E-mailClinicalTrials.govCallCenter@pfizer.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePF-04950615
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codePF-04950615
    D.3.9.3Other descriptive nameRN316
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hyperlipidemia
    E.1.1.1Medical condition in easily understood language
    High Cholesterol
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10020667
    E.1.2Term Hyperlipidemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the LDL-C lowering effect of PF-04950615 administered subcutaneously at monthly intervals, or twice monthly intervals in hypercholesterolemic subjects whose LDL-cholesterol is ≥80 mg/dL on background treatment with a statin.

    Subjects will be randomized into 7 parallel groups. Five of these groups will receive PF 04950615 while two groups will receive placebo. PF 04950615 will be administered as different doses for each dose group in order to examine a dose or exposure response to study outcomes.

    Eligible subjects will be randomly assigned to a study treatment group in equal numbers per group, to receive PF 04950615 300mg once every 28 days (Q28D), 200mg once every 28 days (Q28D), placebo once every 28 days (Q28D), 150mg every 14 days (Q14D), 100 mg every 14 days (Q14D), 50 mg every 14 days (Q14D), or placebo every 14 days (Q14D).

    Additional information regarding Study Treatments is in Clinical Protocol Section 5.
    E.2.2Secondary objectives of the trial
    -Evaluate effect of PF-04950615 administered s.c. at monthly, or twice monthly intervals, on other lipid parameters, including ApoB, ApoA1, ApoAII, Lp(a) on a background of statins
    -Evaluate safety, tolerability & immunogenicity of PF-04950615 administered s.c. as monthly or twice monthly doses, on a background of statins
    -Assess injection site reaction & pain at the injection site following repeated s.c. monthly or twice monthly administration of PF-04950615 on a background of statins
    -Evaluate lipid changes, safety & tolerability of PF-04950615 administered s.c. as monthly, or twice monthly doses, in patients on low-dose statins
    -Evaluate effect of PF-04950615 administered s.c. monthly, or twice monthly, on total cholesterol, HDL-Cholesterol, Triglycerides (TG), and non-HDL-cholesterol on a background of statins
    -Assess steady-state pharmacokinetics of PF-04950615 following monthly, or twice monthly s.c. administration to hypercholesterolemic subjects on a background of statins
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females aged ≥18 years
    2. Subjects should be receiving a stable dose (at least 6 weeks) of any statin in the participating country and there should be no change in the dose of statin for the duration of this trial. Subjects are allowed to take lipid lowering drugs other than a statin (eg, fibrates, cholesterol absorption inhibitor, niacin, omega-3 fatty acids) if initiated, and if the dose has remained unchanged for at least 6 weeks prior to randomization (Day 1) and no dose adjustment for these medicines will be allowed for the duration of this trial.
    3. Lipids should meet the following criteria on a background treatment with a statin at 2 screening visits that occur at screening and at least 7 days prior to randomization on
    Day 1:
    -Fasting LDL-C ≥80 mg/dL (2.31 mmol/L);
    -Fasting TG ≤ 400 mg/dL (4.52 mmol/L).
    4. Subject’s fasting LDL-cholesterol must ≥80 mg/dL (2.31 mmol/L at the initial screening visit, and the value at the second visit within 7 days of randomization must be not lower than 20% of this initial value to meet eligibility criterion for this trial.
    5. Willing and able to comply with scheduled visits.
    6. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
    7. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    8. Females of childbearing potential must be using 2 highly effective methods of contraception and must agree to continue highly effective contraception for up to 63 days after the last dose of investigational drug administration.
    9. Female subjects who are not of childbearing potential (ie, meet at least one of the following criteria):
    -Have undergone hysterectomy or bilateral oophorectomy;
    -Have medically confirmed ovarian failure or
    -Are medically confirmed to be post-menopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; laboratory confirmation of estrogen levels may be indicated when in doubt.
    10. Male and female subjects of childbearing potential must agree to use 2 highly effective methods of contraception throughout the study and for at least 63 days after the last dose of assigned treatment. A subject is of childbearing potential if, in the
    opinion of the investigator, he/she is biologically capable of having children and is sexually active.
    E.4Principal exclusion criteria
    1.Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
    2.Participation in other studies within 3 months before the current study begins and/or during study participation
    3.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    4.Pregnant females; breastfeeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception.
    Exclusion Criteria Related to General Health
    1.History of a cardiovascular or cerebrovascular event or procedure (eg, MI, stroke, TIA, angioplasty) during the past 6 months.
    2.Subjects with congestive heart failure (CHF), NYHA functional classes III or IV
    3. Poorly controlled type 1 or type 2 diabetes mellitus (defined as HbA1c >9%). Subjects who have diabetes mellitus and are controlled on stable doses of anti-diabetic medication may be entered into the trial.
    4.Poorly controlled hypertension (uncontrolled hypertension is defined as the average of two systolic blood pressure measurements greater than 160 mm Hg or the average of two diastolic blood pressure measurements greater than 100 mm Hg, even with treatment).
    5.Plans to donate blood during the study.
    6.Past or current history of alcoholism or drug addiction according to DSM IV criteria, use of any recreational drugs within 12 months prior to Day 1.
    7.History of cancer within the last 5 years (except for cutaneous basal cell or squamous cell cancer resolved by excision).
    8.Medical history of positive testing for HIV.
    9.Any disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, central nervous, immune, or gastrointestinal
    systems or confound the interpretation of the study results.
    Exclusion Criteria Related to Medication
    1.Subjects with prior exposure to PF-04950615 and who test positive for anti-drug antibodies at baseline
    2.Subjects who have initiated lipid-lowering herbs or supplements within 30 days of Day1, and/or who are not on stable doses of such lipid-lowering herbs or supplements.
    3.Initiation of or change in non lipid-lowering prescription drugs, herbal medicine or supplements within 30 days of Day 1 (exception: initiation or change in multivitamins used for general health purposes are acceptable. Adjustments to hypertension medications to meet eligibility are permitted.
    4.Subjects on systemic corticosteroids (ie, oral, IV or IM) or mineralocorticoid replacement.
    5.Subjects taking prescription medications that are contraindicated with the use of statins. Refer to statin product labels for these medications.
    6.Treatment with an investigational drug within 45 days or 5 half-lives (whichever is longer) of Day 1.
    7.Treatment with a marketed monoclonal antibody within 6 months or 5 half-lives (whichever is longer) of Day 1.
    8.History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody (IgG protein) or molecules made of components of monoclonal antibodies (eg, Enbrel which is the Fc portion of an antibody or Lucentis which is a Fab.
    Exclusion Criteria Related to Laboratory Findings
    Abnormal tests can be repeated once (including LDL-C) for confirmation at the discretion of the Investigator (repeat only the abnormal test, not entire panel). In the event the repeated test is not confirmatory, a further repeat of the abnormal laboratory test is permissible.
    Abnormal laboratory tests may be repeated up to two times in order to confirm an abnormal laboratory test.
    1.Any abnormal hematology values, clinical chemistries, urinalysis, or ECGs judged by the Investigator or Sponsor as clinically significant.
    2.Positive hepatitis B surface antigen (HBsAg), HB core antibody (HBcAb), or hepatitis C antibody tests indicative of present or prior infection.
    3.Unexplained creatinine kinase (CK) >3.0 x ULN ALT or AST 2 X ULN.
    4.Direct bilirubin > ULN.
    5.TSH outside of normal range.
    6.Serum creatinine >1.8.mg/dL (>160 μmol/L).
    7.12-lead ECG demonstrating QTcF >480 msec at screening.
    8.Hemoglobin <12 g/dL (7.45 mmol/L) in men or <11 g/dL (6.83 mmol/L) in women.
    9.Positive screening pregnancy test.
    10.Fasting triglycerides >400 mg/dL (4.52 mmol/L).
    11.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the absolute change from baseline in LDL-cholesterol at the end of week 12 following randomization.
    E.5.1.1Timepoint(s) of evaluation of this end point
    end of week 12
    E.5.2Secondary end point(s)
    The following secondary endpoints will be assessed (as change and % change from baseline) at the end of week 12 following randomization:
    - LDL-C;
    - Total cholesterol;
    - ApoB;
    - ApoA1, ApoAII;
    - Lp(a);
    - HDL-cholesterol;
    - VLDL-cholesterol;
    - Triglycerides;
    - Non-HDL-cholesterol;
    - Safety Endpoints will include incidence of ADA, injection site reaction;
    - Plasma steady-state PF-04950615 pharmacokinetic parameters.
    - Proportion of subjects having LDL-C less than particular limits
    (<100 mg/dL, <70 mg/dL, <40 mg/dL, <25 mg/dL).
    E.5.2.1Timepoint(s) of evaluation of this end point
    end of week 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial7
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned15
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 245
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 105
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state53
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 53
    F.4.2.2In the whole clinical trial 350
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    UK expected normal treatment
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Comprehensive Local Research Network – Approval Pending
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-10-03
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