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    Summary
    EudraCT Number:2017-001717-92
    Sponsor's Protocol Code Number:TarIFNiRA
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-08-17
    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 ConcernedAustria - BASG
    A.2EudraCT number2017-001717-92
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled Phase II study to target the type I IFN receptor by administrating Anifrolumab in RA patients with a high IFN signature (TarIFNiRA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised, double-blind, placebo-controlled Phase II study to target the type I IFN receptor by administrating Anifrolumab in patients with rheumatoid arthritis who have a high interferon signature (TarIFNiRA)
    A.3.2Name or abbreviated title of the trial where available
    TarIFNiRA
    A.4.1Sponsor's protocol code numberTarIFNiRA
    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 SponsorMedical University of Vienna
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 organisationMedical University of Vienna
    B.5.2Functional name of contact pointSponsor
    B.5.3 Address:
    B.5.3.1Street AddressWähringer Gürtel 18-20
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.6E-mailthomas.karonitsch@meduniwien.ac.at
    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 (MEDI-546)
    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.3.9.3Other descriptive nameANIFROLUMAB
    D.3.9.4EV Substance CodeSUB128931
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 No
    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
    High IFN siganture in patients with rheumatoid arthritis
    E.1.1.1Medical condition in easily understood language
    Rheumatoid arthritis
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    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 efficacy of Anifrolumab compared to placebo on RA disease activity in patients with an increased type I IFN gene signature. (Achieving an ACR 20 response at week 24)
    E.2.2Secondary objectives of the trial
    To evaluate the effect of Anifrolumab compared to placebo on:
    •Absolute and relative change in the Simplified Disease Activity Index (SDAI) after 24 weeks
    •Absolute and relative change in Clinical Disease Activity Index (CDAI) at week 24 and at every visit before and after week 24
    •Absolute and relative change in Disease Activity Score 28 (DAS28) after 24 weeks
    •Achieving a EULAR response (good, moderate)
    •Achieving a SDAI response (50%, 70%, 85%)
    •Achieving a CDAI response (50%, 70%, 85%)
    •Achieving an ACR response (20%, 50%, 70%)
    •Change in quality of life (SF-36) and physical function (HAQ)
    •Change in pain, fatigue and sleep (visual analog scale, VAS)
    •Proportion achieving a low disease activity state (CDAI≤10, SDAI≤11) after 24 weeks
    •Proportion achieving a remission state (CDAI≤2.8; SDAI≤3.3; ACR/EULAR Boolean) after 24 weeks
    •Proportion achieving DAS28≤3.2 after 24 weeks
    •Change in Kessler Psychological Distress Scale (K10)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •18 - 70 years at screening
    •Written informed consent
    •Weigh ≥50.0 kg and ≤100.0 kg at screening
    •Diagnosis of RA according to the 2010 ACR/EULAR classification criteria for RA
    •at least one conventional synthetic (cs)DMARD (methotrexate (MTX), leflunomide, sulfasalazine (SSZ)) regularly for at least 12 weeks, with stable doses for at least 8 weeks.
    •moderately to severely active RA
    •Received at least one TNF-inhibitor (TNFi) but not more than 3 biological (b)DMARDs and discontinued treatment because of an insufficient response after at least 3 months.
    •Oral Glucocorticoids (OCS) are allowed at stable doses of ≤10 mg /day prednisone or equivalent, if already used before the screening visit, dose must be stable for at least 2 weeks
    •High type I IFN gene signature test
    •Seronegative for HIV, hep. B surface antigen and hep. C ¬antibodies
    •Negative serum β-hCG test at screening (females of childbearing potential only).
    •Females of childbearing potential must use 2 effective methods of avoiding pregnancy
    •All males (sterilised or non-sterilised) who are sexually active must use condom (with spermicide where commercially available)
    •Male subjects must not donate sperm during the course of the study and for 12 weeks after the last dose of the investigational product.
    •Females with an intact cervix must have documentation of a normal Pap smear with no documented malignancy
    •Meets all of the following tuberculosis (TB) criteria:
    -No history of latent or active TB, exception: latent TB with documented completion of appropriate treatment
    -No signs or symptoms suggestive of active TB
    -No recent contact with a person with active TB
    -Negative QuantiFERON-tuberculosis Gold [QFT-G] test for tuberculosis within 3 months prior to randomisation
    •A chest radiograph with no evidence of current active infection within 12 weeks prior to signing of the informed consent
    E.4Principal exclusion criteria
    General exclusion criteria:
    •Any condition that would interfere with evaluation of the investigational product or interpretation of patient safety or study results
    •Participation in another clinical study with an investigational product
    •Individuals involved with the conduct of the study, their employees, or immediate family members of such individuals
    •Lactating or pregnant females or females who intend to become pregnant
    •Current alcohol, drug or chemical abuse, or a history of such abuse
    •Major surgery within 8 weeks before signing ICF or elective major surgery planned during the study period
    •Low type I IFN transcript scores in peripheral whole blood (type I Interfern Gene signature test)
    •At screening (within 4 weeks before Week 0 [Day 0]), any of the following:
    -AST >2.0 × ULN
    -ALT >2.0 × ULN
    -Total bilirubin >ULN (unless due to Gilbert's syndrome)
    -Serum creatinine >2.0 mg/dL (or >181 μmol/L)
    -Urine protein/creatinine ratio >2.0 mg/mg (or >226.30 mg/mmol)
    -Neutrophil count <1000/μL (or <1.0 × 109/L)
    -Platelet count <150.000/μL (or <150 × 109/L)
    -Haemoglobin <8 g/dL (or <80 g/L)
    -Glycosylated haemoglobin (HbA1c) >8% (or >0.08) at screening (diabetic patients only)

    Exclusion criteria related to con. Med.:
    •Receipt of any investigational product (small molecule or biologic agent) within 4 weeks or 5 half lives prior to signing of the ICF.
    •Prior receipt of Anifrolumab
    •Prior receipt of a JAK-inhibitor
    •known history of allergy or reaction to any component of the investigational product
    •Regular use of >1 NSAID within 2 weeks prior to Day 0 OR receipt of fluctuating doses of a NSAID within 2 weeks prior to Day 0
    •Receipt of any of the following:
    -Intra-articular, intramuscular or intravenous glucocorticosteroids within 6 weeks prior to Day 0
    -Any live or attenuated vaccine within 8 weeks prior to signing the ICF
    -BCG vaccine within 1 year prior signing the ICF
    -Blood transfusion within 4 weeks prior signing the ICF

    Exclusion criteria related to other diseases:
    •History of any non RA disease that required treatment with oral or parenteral corticosteroids for > 2 weeks within the last 24 weeks prior signing the ICF

    Exclusion criteria related to infection and malignancy risk factors:
    •Splenectomy
    •Any severe herpes infection at any time prior to Day 0
    •Any herpes zoster infection that has not completely resolved within 12 weeks prior signing the ICF
    •Opportunistic infection requiring hospitalisation or parenteral antimicrobial treatment within 3 years of randomisation
    •Any of the following:
    -Clinically significant chronic infection within 8 weeks prior signing the ICF
    -Any infection requiring hospitalisation or treatment with intravenous anti infectives not completed at least 4 weeks prior signing the ICF
    •Any infection requiring oral anti-infectives (including antivirals) within 2 weeks prior to Day 0
    •History of cancer, apart from:
    -Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥3 months prior to Week 0 (Day 0)
    -Cervical cancer in situ treated with apparent success with curative therapy ≥1 year prior to Week 0 (Day 0)
    E.5 End points
    E.5.1Primary end point(s)
    Achieving an ACR response of ≥20% after 24 weeks of treatment is the primary endpoint in this study. The ACR 20% response will be summarized by treatment group and the difference between groups may be estimated. A non responder imputation method will be used for the handling of missing data, i.e., patients who discontinue from treatment and/or the study for any reason, as well as patients who require rescue medication beyond the protocol allowed threshold, will be imputed as non-responders.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    E.5.2Secondary end point(s)
    To evaluate the effect of Anifrolumab compared to placebo on:
    •Absolute and relative change in the Simplified Disease Activity Index (SDAI) after 24 weeks
    •Absolute and relative change in Clinical Disease Activity Index (CDAI) at week 24 and at every visit before and after week 24
    •Absolute and relative change in Disease Activity Score 28 (DAS28) after 24 weeks
    •Achieving a EULAR response (good, moderate)
    •Achieving a SDAI response (50%, 70%, 85%)
    •Achieving a CDAI response (50%, 70%, 85%)
    •Achieving an ACR response (20%, 50%, 70%)
    •Change in quality of life (SF-36) and physical function (HAQ)
    •Change in pain, fatigue and sleep (visual analog scale, VAS)
    •Proportion achieving a low disease activity state (CDAI≤10, SDAI≤11) after 24 weeks
    •Proportion achieving a remission state (CDAI≤2.8; SDAI≤3.3; ACR/EULAR Boolean) after 24 weeks
    •Proportion achieving DAS28≤3.2 after 24 weeks

    Safety and tolerability endpoints:
    AEs (including adverse events of special interest [AESIs]), vital signs, physical examination, 12-lead electrocardiograms (ECG), and clinical laboratory tests (haematology, clinical chemistry, urinalysis)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Screening to end of study
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 No
    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 trial2
    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 EEA3
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    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 months2
    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 months2
    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: 20
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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)
    standard medical care for rheumatoid arthritis
    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 Decision2017-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-05
    P. End of Trial
    P.End of Trial StatusOngoing
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