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    Summary
    EudraCT Number:2014-004633-96
    Sponsor's Protocol Code Number:D3461C00005
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-05-28
    Trial 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 ConcernedGermany - PEI
    A.2EudraCT number2014-004633-96
    A.3Full title of the trial
    A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus
    A.4.1Sponsor's protocol code numberD3461C00005
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02446912
    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 SponsorAstraZeneca AB
    B.1.3.4CountryUnited Kingdom
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointClinical Trial Transparency
    B.5.3 Address:
    B.5.3.1Street AddressKarlebyhus, Astraallén
    B.5.3.2Town/ city Södertälje
    B.5.3.3Post code151 85
    B.5.3.4CountrySweden
    B.5.6E-mailClinicalTrialTransparency@astrazeneca.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 nameAnifrolumab
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAnifrolumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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.IMP: 2
    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 nameAnifrolumab
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAnifrolumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Systemic Lupus Erythematosus

    E.1.1.1Medical condition in easily understood language
    Lupus, an autoimmune disease
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    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
    To evaluate the effect of anifrolumab 300 mg compared to placebo on disease activity as
    measured by the difference in the proportion of subjects who achieve an SLE Responder Index of ≥4 (SRI[4]) at Week 52
    E.2.2Secondary objectives of the trial
    1. To evaluate the effect of anifrolumab 300mg compared to placebo on:
    a. The proportion of subjects with SRI(4) at Week 52 in the IFN test-high sub-group
    b. The proportion of subjects who achieve an OCS dose ≤7.5 mg/day at Week 40, which is maintained through Week 52 in the sub-group of subjects with baseline OCS ≥10 mg/day
    c. The proportion of subjects with a ≥50% reduction in CLASI activity score at Week 12 in the sub-group of subjects with baseline CLASI activity score ≥10
    d. The proportion of subjects with SRI(4) at Week 24
    e. The annualised flare rate through 52 weeks
    2. To evaluate the effect of anifrolumab 150 mg compared to placebo on disease activity as
    measured by the difference in the proportion of subjects who achieve SRI(4) at Week 52
    3. To evaluate the safety and tolerability of anifrolumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Aged 18 through 70 years at the time of screening
    2. Completion of all screening procedures needed to determine subject
    eligibility and stratification within 30 days after signing the Informed
    Consent Form (ICF)
    3. Diagnosis of paediatric or adult SLE with a diagnosis of SLE according
    to the ACR 1982 revised criteria ≥24 weeks prior to signing the ICF
    4. Currently receiving at least 1 of the following:
    (a) Where prednisone is the single standard of care medication, a dose
    of oral prednisone ≥7.5 mg/day but ≤40 mg/day (or prednisone
    equivalent) for a minimum of 8 weeks prior to Day 1. In addition, the
    dose of oral prednisone or prednisone equivalent the subject is taking
    must be stable for a minimum of 2 weeks prior to randomisation.
    (b) Where prednisone is not the single standard of care medication, a
    dose of oral prednisone ≤40 mg/day (or prednisone equivalent) for a
    minimum of 2 weeks prior to signing of the ICF. In addition, the dose of
    oral prednisone or prednisone equivalent the subject is taking must be
    stable for a minimum of 2 weeks prior to randomisation.
    (c) Any of the following medications administered for a minimum of 12
    weeks prior to signing the informed consent, and at a stable dose for a
    minimum of 8 weeks prior to signing the informed consent through Day
    1:
    (i) Azathioprine ≤200 mg/day
    (ii) Antimalarial (eg, chloroquine, hydroxychloroquine, quinacrine)
    (iii) Mycophenolate mofetil ≤2 g/day or mycophenolic acid ≤1.44 g/day
    (iv) Oral, subcutaneous (SC), or intramuscular methotrexate ≤25
    mg/week
    (v) Mizoribine ≤150 mg/day
    5. Fulfils at least 4 of the 11 ACR modified 1982 classification criteria for
    SLE, at least 1 of which must be:
    (a) Positive antinuclear antibody (ANA) test at screening by
    immunofluorescent assay (IFA) at the central laboratory with titre ≥
    1:80; OR
    (b) Anti-dsDNA antibodies at screening elevated to above normal
    (including indeterminate), as per the central laboratory; OR
    (c) Anti-Smith (anti-Sm) antibody at screening elevated to above normal
    as per the central laboratory
    6. At Screening, Disease Activity Adjudication Group confirmation of:
    - SLEDAI-2K Criteria: SLEDAI-2K score ≥6 points and "Clinical" SLEDAI-
    2K score ≥4 points. The "Clinical" SLEDAI-2K is the SLEDAI-2K
    assessment score without the inclusion of points attributable to any
    urine or laboratory results including immunologic measures.
    7. Meets all of the following TB criteria:
    (i) No history of active TB prior to any Screening visit
    (ii) No history of latent TB prior to initial Screening visit, with the
    exception of latent TB with documented completion of appropriate
    treatment. Subjects with no history of latent TB prior to the initial
    Screening visit, but who are diagnosed with latent TB during screening,
    may be considered eligible if appropriate treatment is initiated prior to
    randomisation. Such subjects may be re-screened if necessary to allow
    for local guidelines on latent TB treatment initiation.
    8. Day 1 "Clinical" SLEDAI-2K score ≥4 points
    9. OCS dose stable for at least 2 weeks prior to randomisation
    10. Stable SLE SOC treatment at the time of randomisation
    11. Women of child-bearing potential must have a negative serum β-hCG test at screening and a negative urine pregnancy test at randomisation (Day 1), prior to administration of investigational product
    12. In the opinion of the Investigator, must be able to comprehend the
    ICF and all protocol related assessments, such that the patient can
    complete all study required documents, procedures, and outcome
    measures.
    E.4Principal exclusion criteria
    1. Receipt of any of the following:
    (a) Where prednisone is the single standard of care medication, any new
    oral prednisone therapy (or equivalent) any time in the 8 weeks prior to
    Day 1, OR any change in/discontinuation of current oral prednisone dose
    (or equivalent) anytime within the 2 weeks prior to randomisation
    (b) Where prednisone is not the single standard of care medication:
    (i) Any addition of a new oral prednisone therapy (or equivalent) any
    time from 2 weeks prior to signing of the informed consent form through
    Day 1, OR any change in/discontinuation of current oral prednisone dose
    (or equivalent) anytime within 2 weeks prior randomisation
    (ii) Any addition of a new dose of any of the following anytime in the 12
    weeks prior to signing of the informed consent through Day 1, or change
    in/discontinuation of current dose anytime in the 8 weeks prior to
    signing of the informed consent through Day 1: azathioprine; any
    antimalarial (eg, chloroquine, hydroxychloroquine, quinacrine);
    mycophenolate mofetil/mycophenolic acid; oral, SC, or intramuscular
    methotrexate; mizoribine
    2. Receipt of any of the following:
    (a) Azathioprine >200 mg/day
    (b) Mycophenolate mofetil >2 g/day or mycophenolic acid >1.44 g/day
    (c) Oral, SC, or intramuscular methotrexate >25 mg/week
    (d) Mizoribine >150 mg/day
    (e) Any change in route of administration of oral, SC, or intramuscular
    methotrexate anytime within the 8 weeks prior to signing of the
    informed consent through Day 1
    3. Receipt of any investigational product (small molecule or biologic
    agent) within 4 weeks or 5 half-lives prior to signing of the ICF,
    whichever is greater
    4. Receipt of epratuzumab or tabalumab ≤26 weeks prior to signing the
    ICF, or belimumab <12 weeks prior to signing the ICF
    5. Receipt of any of the following:
    (a) Intra-articular, intramuscular or IV glucocorticosteroids within 6
    weeks prior to Day 1
    6. History of, or current diagnosis of, a clinically significant non SLErelated
    vasculitis syndrome.
    7. Active severe or unstable neuropsychiatric SLE
    8. Active severe SLE-driven renal disease
    9. Diagnosis (within 1 year of signing the ICF) of mixed connective
    tissue disease or any history of overlap syndromes of SLE and SSc.
    10. History of, or current, inflammatory joint or skin disease other than
    SLE
    11. History of any non-SLE disease that has required treatment with oral
    or parenteral corticosteroids for more than 2 weeks within the 24 weeks
    prior to signing the ICF
    12. Known history of a primary immunodeficiency, splenectomy, or any
    underlying condition that predisposes the subject to infection, or a
    positive result for human immunodeficiency virus (HIV) infection
    confirmed by central laboratory at screening. Subjects refusing HIV
    testing during the screening period will not be eligible for study
    participation.
    13. Confirmed positive test for hepatitis B or hepatitis C
    14. Any severe herpes infection at any time prior to Week 0 (Day 1)
    15. Opportunistic infection requiring hospitalisation or intravenous
    antimicrobial treatment within 3 years prior to randomization
    16. History of cancer, apart from:
    (a) Squamous or basal cell carcinoma of the skin treated with
    documented success
    (b) Cervical cancer in situ that has been successfully treated
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the difference in proportions of subjects
    achieving Systemic Lupus Erythematosus Responder Index SRI(4) at
    Week 52 comparing anifrolumab to placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    E.5.2Secondary end point(s)
    1a. The composite endpoint SRI4 will be the measure of this objective.
    1b. Maintained OCS reduction defined by the following criteria:
    - Achieve an OCS dose of ≤7.5 mg/day prednisone or equivalent by
    Week 40 and
    - Maintain an OCS dose ≤7.5 mg/day prednisone or equivalent from
    Week 40 to Week 52 and
    - No discontinuation of investigational product or use of restricted
    medications beyond the protocol-allowed threshold before assessment
    1c. 50% reduction in CLASI activity score compared to baseline defined
    by the following criteria:
    - Achieve ≥50% reduction of CLASI activity score at Week 12 compared
    to baseline and
    - No discontinuation of investigational product or use of restricted
    medications beyond the protocol-allowed threshold before assessment
    1d. The composite endpoint SRI4 will be the measure of this objective
    1e. Annualised flare rate with flare defined as either 1 or more new
    BILAG-2004 A or 2 or more new BILAG-2004 B items compared to the
    previous visit
    2. The composite endpoint SRI4 will be the measure of this objective
    3. The following safety data will be collected: vital signs, physical
    examination, 12-lead ECG, haematology, clinical chemistry, urinalysis, CSSRS, PHQ-8, SLEDAI 2K Flare Index, and reported AEs
    E.5.2.1Timepoint(s) of evaluation of this end point
    1a. - Week 52
    1b. - Week 52
    1c. - Week 12
    1d. - Week 24
    1e. - Weeks 0- 52
    2. - Week 52
    3. - Weeks 0-52
    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 Yes
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 trial3
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA66
    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
    Argentina
    Australia
    Brazil
    Chile
    Colombia
    Germany
    Hungary
    Israel
    Italy
    Korea, Republic of
    New Zealand
    Peru
    Poland
    Romania
    Taiwan
    Ukraine
    United Kingdom
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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: 338
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 112
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 131
    F.4.2.2In the whole clinical trial 450
    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)
    Subjects who participate in this study may have the option of entering a separate long-term extension study, if eligible.
    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 Decision2015-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-18
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