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    EudraCT Number:2011-000420-15
    Sponsor's Protocol Code Number:B0151006
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-15
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2011-000420-15
    A.3Full title of the trial
    Egy kettős vak, randomizált, placebo kontrollált, több központban végzett, dózis összehasonlító vizsgálat az PF-04236921 hatékonyságának és biztonságosságának meghatározására szisztémás lupus erythemotosusban (SLE) szenvedő betegek körében
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vizsgálat az PF-04236921 hatékonyságának és biztonságosságának meghatározására szisztémás lupus erythemotosusban (SLE) szenvedő betegek körében
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberB0151006
    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
    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 Centre
    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 number0018007181021
    B.5.5Fax number0013037391119
    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 nameNot applicable
    D.3.2Product code PF-04236921
    D.3.4Pharmaceutical form Powder 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.3.8INN - Proposed INNNot applicable
    D.3.9.2Current sponsor codePF-04236921
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number106
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 placeboPowder 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
    E.1.1.1Medical condition in easily understood language
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate and compare the efficacy of 3 dose levels of PF-04236921 to placebo in subjects with active SLE using the SLE Responder Index
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study include:
    - Evaluate the safety, tolerability, and immunogenicity of PF-04236921.
    - Evaluate and compare the clinical response to treatment and changes in disease activity
    using components of the SRI, modified SRI, and British Isles Lupus
    assessment group-based composite Lupus assessment (BICLA).
    - Characterize pharmacokinetics (PK) of PF-04236921 in subjects with SLE.
    - Assess patient reported outcomes including: global assessment of disease activity by visual
    analog scale (VAS), Medical Outcome Survey Short Form 36 (SF-36), European Quality
    of Life 5 Dimensions Questionnaire (EQ-5D), and Functional Assessment of Chronic
    Illness Therapy – Fatigue (FACIT-F).
    - Assess efficacy biomarkers (eg, anti-ds DNA).

    The exploratory objectives of the study are described within the protocol.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Evidence of a personally signed and dated informed consent form document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the study.
    2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    3. Male and/or female subjects between the ages of ≥18 and ≤75 years old at the time of signing of Informed Consent Form (ICF).
    4. Have a clinical diagnosis of SLE according to the 1997 update on the 1982 revised American College of Rheumatology (ACR) criteria.
    5. Have unequivocally positive anti-nuclear antibody (ANA) or antidsDNA
    test results by either:
    • Positive test result from within the study screening period. Screening results must be based on the study’s central laboratory results. A positive ANA test is defined as an ANA titer ≥1:80 and/or a positive anti dsDNA (> the ULN for the central laboratory reported result) serum antibody.
    • One positive historical test result that in the opinion of the investigator and the sponsor is unequivocally due to SLE. Historical documentation of a positive test of ANA (eg, ANA by HEp-2 titer, ANA by ELISA) or anti-dsDNA (eg, anti dsDNA by Farr assay or ELISA) must include the date and type of the test, the testing laboratory name, numerical reference range, and a key that explains values provided as positive versus negative OR negative, equivocal/borderline, positive. Only unequivocally positive values as defined in the laboratory’s reference range are acceptable; borderline values will not be accepted.
    6. Active disease at screening defined by both:
    • SLEDAI-2K score of ≥6, and
    • BILAG Level A disease in ≥1 organ system [except renal or central nervous system (CNS)] or BILAG B disease in ≥2 organ systems if no level A disease is present.
    7. Subjects who are receiving treatment for their SLE activity are on
    stable doses of SLE treatment (alone or in combination) for at least 30
    days prior to the Day 1 visit (first dose of study medication) as follows:
    • Corticosteroids (prednisone or prednisone equivalent, up to 25 mg/day). For those patients on alternating day doses of corticosteroids, use the average of two daily doses to calculate the average daily steroid dose.
    • Other immunosuppressive or immunomodulatory agents including methotrexate, azathioprine, leflunomide, mycophenolate (including mycophenolate mofetil, mycophenolate mofetil hydrochloride, and mycophenolate sodium), 6-mercaptopurine or thalidomide.
    • Anti-malarials (eg, hydroxychloroquine, chloroquine, quinacrine).
    • New SLE therapy must not be added within 60 days prior to Day 1; pre-existing SLE medications must be stable for at least 30 days prior to Day 1.
    • Corticosteroids may be added as new medication or their doses adjusted only up to 30 days prior to Day 1.
    8. All women of childbearing potential (WOCBP) must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result at baseline and prior to receiving each treatment.
    • WOCBP are defined as women who are biologically capable of becoming pregnant, including women who are using contraceptives or whose sexual partners are either sterile or using contraceptives.
    • Women of non childbearing (WONCBP) potential are defined as either females who are over the age of 60, females who are 45 to 60 years of age must be amenorrheic for at least 2 years PLUS have a serum FSH level within the laboratory’s reference range for postmenopausal, or females who are surgically sterile, such as after hysterectomy, bilateral oophorectomy, or tubal ligation (procedure performed ≥52 weeks before screening). This information must be documented in the subject’s source documents.
    • WONCBP do not require a serum and urine pregnancy test.
    9. Women of childbearing potential, as well as sexually active males agree that when sexually active to use highly effective contraceptive methods and abide by the timeframes noted in the Contraception section of the Lifestyle Guidelines.
    E.4Principal exclusion criteria
    1. Any prior history of treatment with PF-04236921, or anti-IL-6 agent.
    2. Have received any of the following within 364 days of Day 1: A biologic investigational agent other than those noted below (eg, abatacept or interferon alpha inhibitors). (Investigational agent is defined as any drug not approved for sale in the country in which it is being used) ;Have required 3 or more courses of systemic corticosteroids for concomitant conditions (eg, asthma, Crohn’s disease, ulcerative colitis, systemic vasculitis, atopic dermatitis) within 364 days of Day 1 (Topical or inhaled steroids are permitted).
    3. Received IV or oral cyclophosphamide within 180 days of Day 1.
    4 Have received any of the following within 90 days of Day 1: Anti-TNF therapy (eg, adalimumab, etanercept, infliximab); Interleukin-1 receptor antagonist (anakinra); Intravenous immunoglobulin (IVIG); High dose corticosteroids (>100 mg/day prednisone or equivalent) or pulse IV doses; Plasmapheresis.
    5. Have received any of the following within 60 days of Day 1: Any intramuscular, or intravenous steroid injection; Any new immunosuppressive/immunomodulatory agent, or anti-malarial agent. New inhaled and/or new topical immunosuppressive agents (eg, eye drops, topical creams) are allowed.
    6. Have received any of the following within 30 days of Day 1: A live vaccine; Any new or change in dose of a corticosteroid, any change in dose of a immunosuppressive / immunomodulatory or anti malarial agent; Any intraarticular steroid injection;
    7. Has been treated with any B-cell depleting agents such as rituximab (or other CD20+ directed therapies), epratuzumab, anti-CD52 [alemtuzumab], or TACI Ig, within the last 12 months unless it is determined that the B cell counts have normalized prior to their screening visit (eg, B cell counts are at least as high as the patient’s last value prior to receiving the B cell depleting agent). Subjects that have been treated with TACI Ig must have also normalized their plasma cells and serum immunoglobulin levels (returned to pre treatment levels).
    8. Has been treated with belimumab or any anti-Blyss (or anti BAFF) agent within the past 180 days.
    9. Have severe lupus kidney disease (defined by proteinuria ≥6 g/24 hour or equivalent using spot urine protein to creatinine ratio, or serum creatinine ≥2.0 mg/dL), or have active nephritis (eg, BILAG A renal disease), or have required hemodialysis or high-dose corticosteroid (>100 mg/day prednisone or equivalent) within 90 days of Day 1.
    10. Have active central nervous system (CNS) lupus (eg, BILAG A
    neurological disease and/or active, poorly controlled seizure disorder,
    acute confusional state, myelitis, stroke or stroke syndrome, cerebellar
    ataxia or dementia related to SLE, psychosis, organic brain syndrome,
    cerebrovascular accident [CVA], cerebritis or CNS vasculitis) requiring
    therapeutic intervention within 60 days of Day 1. Patients with BILAG B
    level neurologic disease, or manageable chorea are not excluded as long
    as they meet all other qualifying criteria for the study.
    11. Have a history of a major organ transplant (eg, heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant.
    12. Any major illness/condition or evidence of an unstable condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, immunologic disorder, or infectious illness) that in the investigator’s judgment, will substantially increase the risk to the subject if he or she participates in the study.
    13. Has a history of thromboses (venous or arterial) or other vascular complications within the last 6 months due to antiphopholipid syndrome or anticardiolipin antibodies; Note: Any subject being treated for recurrent antiphospholipid syndrome or anticardiolipin antibodies must be adequately anticoagulated according to current guidelines.
    14. Pregnant or breastfeeding women or women planning to become pregnant during study period.
    15. Known active or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, granulomatous disease on chest x-ray, and herpes zoster) that in the investigator’s judgment, will substantially increase the risk to the subject if he or she participates in the study.
    16. Known history of human immunodeficiency (HIV) based on documented history with positive serological test, or positive HIV serological test at screening. (Note: a documented negative HIV test within 12 months of screening is acceptable and does not need to be repeated).
    17. Positive test for hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (anti-HBcAb; also called anti-HBc), and/or hepatitis C antibody (HCVAb).
    For a full list of exclusion criteria please refer to the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is the proportion of subjects achieving the SLE Responder Index (SRI) at Week 24. The components of the SRI are the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K), the British Isles Lupus Assessment Group (BILAG) 2004, and the Physician’s Global Assessment (PhGA). In order to be classified as a responder, subjects must not meet the definition of a treatment failure (as per Section 5.6) and must meet all of the following compared with baseline:
    •≥4 point reduction in the SLEDAI 2K score, and
    •No new BILAG A organ domain score or 2 new BILAG B organ domain scores, and
    •No worsening (<0.3 point increase) in PhGA score.
    The composite endpoint is designed to assure that if improvements occur, they are not accompanied by clinically-relevant worsening. The SRI requires demonstration of improvement in disease activity as measured by at least a 4-point reduction in SLEDAI 2K score as the first step in identifying a responder. Since the SLEDAI 2K 4-point improvement threshold is based on a published threshold for clinical meaningfulness, and because reduction in the score generally requires normalization of a manifestation, not just improvement, an SRI response is also considered clinically meaningful. Once achieving at least a 4-point reduction in SLEDAI 2K, a subject must also show no worsening of disease as measured by BILAG and PhGA to be considered a responder. If either tool shows worsening, the subject is not considered a responder, despite an improvement in the SLEDAI 2K. All 3 of the components are needed to be scored as a responder. In addition, no increases in concomitant SLE medications beyond protocol-specified thresholds are allowed, since such medication changes are indicative of worsening disease and the subject will be considered a treatment failure.
    E.5.1.1Timepoint(s) of evaluation of this end point
    BILAG: Screening, Week 0, 4, 8, 12, 16, 20, 24, 28, 32, 36 44, 52
    SLEDAI 2K: Screening, Week 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 44, 52
    Physician Global Assessment: screening, Week 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 44, 52
    E.5.2Secondary end point(s)
    • Proportion of patients achieving SRI at all scheduled timepoints except
    Week 24.
    • Proportion of patients achieving modified SRI at all scheduled
    • Proportion of patients achieving BICLA response at all scheduled
    • Components and Disposition of SRI at Week 24.
    • Safety and tolerability of PF 04236921 dose levels versus placebo: laboratory tests, AEs, infections, ECGs and vital signs. The incidence of AEs, withdrawals due to AEs, and serious adverse events (SAEs) will be reported.
    • Percent of subjects who develop anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs), if observed.
    • Serum concentration of PF 04236921.
    • Percentage of subjects whose corticosteroid dose has been reduced by both ≥25% from baseline and to ≤7.5 mg/day during Weeks 12 through 24.
    • Percent of patients with normalized serologic activity (subgroup
    patients with abnormal at baseline) including IgG,immunglobulins, antidsDNA,
    C3 and C4.
    • Mean change in patient global VAS, EQ 5D, SF-36 PCS, MCS and Vitality
    Score –all domains over time including SF 6D, FACIT.

    The exploratory endpoints are described within the protocol.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety labs: week 0, 2, 4, 6, 8, 12, 16, 20, 24, 28 32, 36, 44, 52
    ECG: week 12, 24
    Vitals: week 0, 2, 4, 6, 8, 12, 16, 20, 24, 28 32, 36, 44
    AEs will be collected throughout the study
    Serum Anti-PF-04236921: week 0, 8, 16, 24, 32, 44
    Serum Pharmacokinetic: week 0, 2, 4, 6, 8, 12, 16, 20, 24, 28 32, 36, 44
    SF-36: week 0, 4, 8, 12, 16, 20, 24, 32, 52
    SF-6D: week 0, 4, 8, 12, 16, 20, 24, 32
    EQ-5D: week 0, 4, 8, 12, 16, 20, 24, 32, 52
    Facit-F: week 0, 4, 8, 12, 16, 20, 24, 32, 52
    Patient global assessment of disease activity scores VAS: week 0, 2, 4, 6, 8, 12, 16, 20, 24, 28 32, 36, 44, 52
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability, immunogenicity & pharmacodynamics
    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. 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 Yes
    E. trial design description
    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 trial4
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Korea, Republic of
    Moldova, Republic of
    United States
    E.8.7Trial has a data monitoring committee No
    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 as per protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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: 171
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 Yes
    F. of other specific vulnerable populations
    Sexually active males to use highly effective contraceptive methods
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 180
    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)
    Please see protocol
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-03-26
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