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    The EU Clinical Trials Register currently displays   42564   clinical trials with a EudraCT protocol, of which   7007   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-003246-93
    Sponsor's Protocol Code Number:D3461C00008
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-12-13
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2016-003246-93
    A.3Full title of the trial
    A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab following subcutaneous administration in Adult Systemic Lupus Erythematosus Subjects with Type I Interferon test high result and active skin manifestations
    Wieloośrodkowe, randomizowane, prowadzone metodą podwójnie ślepej próby, kontrolowane z zastosowaniem placebo, badanie kliniczne fazy 2 mające na celu określenie farmakokinetyki, farmakodynamiki i bezpieczeństwa stosowania anifrolumabu podawanego podskórnie u dorosłych pacjentów z rozpoznaniem tocznia rumieniowatego układowego z wysokim wynikiem badania interferonu typu I i aktywnymi zmianami skórnymi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this study is to investigate how a new experimental medication called anifrolumab is distributed in the body when given as subcutaneous (under the skin) injections to subjects with the autoimmune disease called Systemic Lupus Erythematosus (SLE), also known as Lupus. The study will also explore if anifrolumab may improve Lupus skin symptoms.


    Celem badania jest poznanie jak nowy eksperymentalny lek o nazwie anifrolumab rozchodzi się wewnątrz organizmu po podaniu podskórnym (zastrzyk podawany pod skórę) u chorych z chorobą autom immunologiczną o nazwie toczeń rumieniowaty układowy, zwaną także toczniem. Badanie będzie także oceniało, czy anifrolumab
    może korzystnie wpłynąć na objawy skórne tocznia.
    A.4.1Sponsor's protocol code numberD3461C00008
    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.1.3.4CountrySweden
    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
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointClinical Trial Transparency
    B.5.3 Address:
    B.5.3.1Street AddressKarlebyhus, Astraallén
    B.5.3.2Town/ citySödertälje
    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.3.2Product code MEDI-546
    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.3.8INN - Proposed INNANIFROLUMAB
    D.3.9.1CAS number 1326232-46-5
    D.3.9.2Current sponsor codeMEDI-546
    D.3.9.3Other descriptive nameImmunoglobulin G1, anti-(human type I interferon receptor) (human monoclonal MEDI-546 heavy chain), disulfide with human monoclonal MEDI-546-chain, dimer
    D.3.9.4EV Substance CodeSUB128931
    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 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
    Systemic Lupus Erythematosus
    Toczeń rumieniowaty układowy
    E.1.1.1Medical condition in easily understood language
    Lupus, an autoimmune disease
    Toczeń, choroba autoimmunologiczna
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To characterize the pharmacokinetics and pharmacodynamics of anifrolumab.
    Scharakteryzowanie farmakokinetyki (PK) i farmakodynamiki (PD) anifrolumabu
    E.2.2Secondary objectives of the trial
    1. To characterize the safety and tolerability anifrolumab
    2. To characterize the immunogenicity of anifrolumab
    1.Scharakteryzowanie bezpieczeństwa i tolerancji anifrolumabu
    2.Scharakteryzowanie immunogenności anifrolumabu
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18 through 70 years
    2. Diagnosis of paediatric or adult SLE for > 24 weeks and fulfilling ≥4 of the 11 ACR classification criteria with at least one being:
    -Positive antinuclear antibody (ANA) or
    -Elevated anti-dsDNA antibodies or
    -anti-Smith (anti-Sm) antibodies
    3. Interferon high test result
    4. CLASI activity score ≥ 10
    5. Currently receiving at least 1 of the following for treatment of SLE:
    • Oral prednisone or equivalent of ≤40 mg/day) for a minimum of 2 weeks prior to signing the ICFand with stable dosefor at least 2 weeks prior to randomization
    • Any of the following medications for at least 12 weeks prior to signing the ICF, and at a stable doses for at least 8 weeks prior to randomization:
    (i) Azathioprine ≤200 mg/day
    (ii) Antimalarials (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
    6. Must not have signs of active or latent TB.
    7. Must not be pregnant or breastfeeding


    1.Wiek od 18 do 70 lat podczas oceny przesiewowej
    2.Rozpoznanie SLE u dziecka lub osoby dorosłej ≥24 tygodnie przed podpisaniem ICF
    oraz spełnienie co najmniej 4 z 11 kryteriów klasyfikacji ACR dla SLE, w tym co najmniej jednego spośród następujących kryteriów:
    •dodatni wynik badania w kierunku przeciwciał przeciwjądrowych (ANA)
    •podwyższony powyżej normy poziom przeciwciał anty-dsDNA
    •podwyższony powyżej normy poziom przeciwciał anty-Smith (anty-Sm)
    3.Podwyższony wynik badania IFN typu I
    4.Wynik oceny aktywności CLASI ≥10 podczas oceny przesiewowej
    5.Aktualne stosowanie, co najmniej 1 spośród następujących metod leczenia SLE:
    • prednizon doustny w dawce ≤40 mg/dobę lub równoważna dawka innego
    kortykosteroidu, przez co najmniej 2 tygodnie przed podpisaniem ICF; dawka prednizonu doustnego lub równoważna dawka innego kortykosteroidu musi pozostawać stabilna przez co najmniej 2 tygodnie przed randomizacją.
    • Dowolne spośród następujących leków podawane, przez co najmniej 12 tygodni przed podpisaniem ICF, przy utrzymaniu stabilnej dawki, przez co najmniej 8 tygodni przed randomizacją:
    (i) Azatiopryna ≤200 mg/dobę
    (ii) Leki przeciwmalaryczne (np. chlorochina, hydroksychlorochina, kwinakryna)
    (iii) Mykofenolan mofetylu ≤2 g/dobę lub kwas mykofenolowy ≤1,44 g/dobę
    (iv) Podawany doustnie, podskórne (SC) lub domięśniowo metotreksat ≤25 mg/tydzień
    (v) Mizorybina ≤150 mg/dobę
    6.Niewystępowanie w wywiadzie utajonej ani aktywnej gruźlicy
    7.Kobiety nie mogą być w ciąży ani karmić piersią
    E.4Principal exclusion criteria
    1. Active severe or unstable neuropsychiatric SLE
    2. Active severe SLE-driven renal disease
    3. Any severe herpes infection at any time
    4. HBV, HCV, or HIV infection.
    5. Known history of a primary immunodeficiency (splenectomy, or any underlying condition predisposing for infection
    6. Receipt of any investigation product within 4 weeks or 5 half -lives prior to signing of the ICF
    7. History of cancer, apart from:
    - Squamous or basal cell carcinoma of the skin if successfully treated
    - Cervical cancer in situ if successfully treated



    1.Aktywny ciężki lub niestabilny, neuropsychiatryczny SLE
    2.Aktywna, ciężka związana z SLE choroba nerek,
    3.Dowolne ciężkie zakażenie wirusem ospy wietrznej i półpaśca
    4.Potwierdzony dodatni wynik badania w kierunku zapalenia wątroby typu B,
    zapalenia wątroby typu C oraz zakażenia HIV
    5.Stwierdzony w wywiadzie pierwotny niedobór odporności (np. pospolity zmienny niedobór odporności), stan po splenektomii lub jakakolwiek choroba podstawowa, która predysponuje pacjenta do występowania zakażeń.
    6.Przyjmowanie jakiegokolwiek IP (małej cząsteczki lub leku biologicznego) w ciągu
    4 tygodni lub 5 okresów półtrwania przed podpisaniem ICF, w zależności od tego, który okres jest dłuższy.
    7.Nowotwór złośliwy w wywiadzie, z wyjątkiem:
    - raka płaskonabłonkowego lub podstawnokomórkowego skóry po doszczętnym leczeniu
    - raka in situ szyjki macicy po doszczętnym leczeniu
    E.5 End points
    E.5.1Primary end point(s)
    • Anifrolumab concentration and PK parameters, e.g., maximum concentration (Cmax) after first IP dose and trough concentration (Ctrough) after subsequent dosing. Additional PK parameters may be determined where appropriate.
    • 21-gene type I IFN signature score and neutralization ratio (relative to baseline)

    •Stężenia anifrolumabu i parametry PK, w tym maksymalne stężenie (Cmax) po podaniu pierwszej dawki i minimalne stężenie (Ctrough) po podaniu kolejnej dawki. Dodatkowe parametry PK mogą zostać dookreślone.
    •21-genowa sygnatura PD IFN typu 1 i wskaźnik neutralizacji (w odniesieniu do stanu wyjściowego)
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 Weeks
    12 tygodni
    E.5.2Secondary end point(s)
    Safety and tolerability variables including:
    • Adverse events (AEs) and serious adverse events (SAEs)
    • Adverse events of special interest (AESIs) including herpes zoster, influenza, opportunistic infections, tuberculosis (TB), malignancies, non-SLE related vasculitis, anaphylaxis, and major adverse cardiovascular events (MACE)
    • Laboratory variables
    • Physical examinations
    • Vital signs
    • ECG
    Immunogenicity as assessed by measurement of anti-drug antibodies (ADA).
    Zmienne dotyczące bezpieczeństwa i tolerancji, włączając:
    •Zdarzenia niepożądane (AE) i ciężkie zdarzenia niepożądane (SAE);
    •Zdarzenia niepożądane o szczególnym znaczeniu (AESI), w tym półpasiec, grypa, zakażenia oportunistyczne, ciężkie zakażenia nieoportunistyczne, gruźlica (TB), nowotwory złośliwe, zapalenie naczyń niezwiązane z SLE, anafilaksja i poważne zdarzenia niepożądane dotyczące układu sercowo-naczyniowego (MACE),
    •Parametry laboratoryjne,
    •Badania przedmiotowe,
    •Podstawowe parametry życiowe
    •Badania EKG
    Immunogenność oceniana na podstawie pomiaru przeciwciała przeciwko lekowi (ADA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 tygodnie
    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) 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.8.1.7.1Other trial design description
    Dane zostaną odślepione dla sponsora, kiedy wszyscy pacjenci zakończą wizytę w tygodniu 12.
    Sponsor will be unblinded after all patients complete week 12 visit.
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    Hungary
    Korea, Republic of
    Poland
    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
    Last Patient Last Visit
    LVLS (Last Visit Last Subject)
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 32
    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)
    None
    Nie dotyczy
    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 Decision2017-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-12-17
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