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    Summary
    EudraCT Number:2013-005418-37
    Sponsor's Protocol Code Number:PH-F8IL10-03/13
    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:2014-07-24
    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 number2013-005418-37
    A.3Full title of the trial
    A multicenter, randomized, double-blind, placebo-controlled phase II study to evaluate safety and clinical efficacy of two different doses of F8IL10 (Dekavil) administered subcutaneously to patients with active rheumatoid arthritis receiving Methotrexate.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter, placebo-controlled phase II study to evaluate safety and clinical efficacy of two different doses of F8IL10 administered subcutaneously to patients with active rheumatoid arthritis receiving Methotrexate.
    A.4.1Sponsor's protocol code numberPH-F8IL10-03/13
    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 SponsorPhilogen S.p.A.
    B.1.3.4CountryItaly
    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 supportPhilogen S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPhilogen S.p.A,
    B.5.2Functional name of contact pointNA
    B.5.3 Address:
    B.5.3.1Street AddressBellaria 35
    B.5.3.2Town/ citySovicille
    B.5.3.3Post code53018
    B.5.3.4CountryItaly
    B.5.4Telephone number39057717816
    B.5.5Fax number3905771781690
    B.5.6E-mailregulatory@philogen.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 nameDekavil
    D.3.2Product code F8IL10
    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 INNdekavil
    D.3.9.2Current sponsor codeF8IL10
    D.3.9.3Other descriptive nameF8IL10
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number3.75 to 20
    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 Yes
    D.3.11.13.1Other medicinal product typemonoclonal recombinant antibody in scFv format linked to interleukin 10 (IL-10)
    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
    Patients with active Rheumatoid Arthritis despite methotrexate therapy that had unsuccessful response to at least one anti-TNF treatment.
    E.1.1.1Medical condition in easily understood language
    Patients with active Rheumatoid Arthritis despite methotrexate therapy that had unsuccessful response to anti-TNF treatment.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10003268
    E.1.2Term Arthritis rheumatoid
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Mean change from baseline in DAS28-CRP between F8IL10 and placebo arms at week 9.
    E.2.2Secondary objectives of the trial
    -Safety and tolerability of subcutaneous F8IL10 administered with MTX
    -Patients proportion achieving ACR clinical response (ACR20, 50 &70) and time to onset of these criteria
    -Patients proportion achieving clinical remission and clinical low-disease activity according to DAS28-CRP (DAS28<2.6 and 2.6≤DAS28<3.2, respectively) and time to onset of these criteria
    -Patients proportion achieving clinical remission & clinical low-disease activity according to SDAI score (SDAI≤3.3 and SDAI≤11.0) and time to onset of these criteria
    -Patient proportion experiencing significant change from baseline in functional status (HAQ-DI & SF-36)
    -Clinical response Maintenance m(ACR, DAS28 and SDAI scores). ACR, DAS28 and SDAI scores must not change to a superior category. Categories are: 1) For ACR: ACR0, ACR20, ACR50 and ACR70. 2) For DAS 28 and SDAI score: Clinical Remission, Low disease activity, Moderate disease activity and High disease activity
    -F8IL10 Immunogenicity
    -PD profile of F8IL10
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patients aged ≥18 and < 75 years.
    2.Diagnosis of RA according to ACR/EULAR classification criteria (2010) with a disease duration exceeding 6 months.
    3.Active RA (DAS28 ≥ 3.2) for ≥ 3 months at time of signing informed consent despite MTX therapy (stable regimen of methotrexate 10-25 mg/week orally, subcutaneous or intramuscular injections: stable dosage from ≥ 8 weeks before screening).
    4.≥6 tender joints out of 68, ≥6 swollen joints aout of 66 nd serum CRP > 0.5 mg/dl at screening
    5.History of inadequate clinical response to at least one anti-TNF drug (applied for at least 3 months).
    6.Stable regimens of NSAIDs and/or oral corticosteroid (≤ 10 mg/day; prednisone equivalent) for a period ≥ 2 weeks prior to screening.
    7.All acute toxic effects of any prior therapy must have returned to classification “mild” according to CTCAE v.4.03 (published on June 14th 2010).
    8.Sufficient hematologic, liver and renal function:
    •Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, platelets ≥100 x10^9/L, haemoglobin (Hb) ≥ 10.0 g/dL.
    •Alkaline phosphatase (AP), alanine aminotransferase (ALT) and or aspartate aminotransferase (AST) ≤ 3 x upper limit of normal range (ULN), and total bilirubin ≤ 2.0 mg/dl (34.2 µmol/L).
    •Creatinine ≤ 1.5 ULN or 24 h creatinine clearance ≥ 50 mL/min.
    9.Documented negative test for HIV, HBV and HCV. For patients with serology documenting previous exposure to HBV (i.e., anti-HBs Ab with no history of vaccination and/or anti-HBc Ab) , negative serum HBV DNA is required.
    10.All female subjects must have negative pregnancy test results at the screening. Women of childbearing potential must be using simultaneously double-barrier or two acceptable methods of contraception (i.e. intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.) from the screening to three months following the last study drug administration. Pregnancy test will be repeated at the end of treatment visit.
    11.Male patients must agree to use simultaneously two acceptable methods of contraception (i.e. spermicidal gel plus condom) from the screening to three months following the last study drug administration
    12.Signed and dated Ethics Committee-approved Informed Consent Form indicating that the patient has been informed of all pertinent aspects of the study.
    13.Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
    14. Chest X rays performed (for other reasons than the present clinical trial) within a period of 3 months prior to the screening visit. However, in the case the patient performs the Quantiferon TB test during the screening visit, this period can be extended to 6 months.
    E.4Principal exclusion criteria
    1.Presence of active infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or would interfere with the study objectives or conduct.
    2.Pregnancy, lactation or unwillingness to use adequate contraceptive methods.
    3.Diagnosis of any other inflammatory arthritis or active autoimmune diseases other than RA.
    4.Last treatment with monoclonal antibodies (i.e., adalimumab, infliximab, golimumab, tocilizumab, certolizumab pegol) less than 8 weeks prior to first administration of study drugs. Last treatment with rituximab less than 16 weeks prior to first administration of study drugs. Last treatment with fusion proteins (i.e., abatacept, etanercept) less than 4 weeks prior to first administration of study drugs.
    5.Treatment with any immunosuppressant drug other than MTX and corticosteroids.
    6.Active or latent tuberculosis (TB).
    7.HIV infection.
    8.Acute or chronic HBV or HCV infection, as assessed by serology or serum HBV DNA .
    9.History or currently active primary or secondary immunodeficiency.
    10.Concurrent malignancy or history of malignancy from which the patient has been disease–free for less than 5 years.
    11.History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.
    12.Treatment with warfarin or other coumarin derivatives.
    13.Hearth insufficiency (> Grade II, NYHA criteria).
    14.Irreversible cardiac arrhythmias requiring permanent medication.
    15.Clinically significant (to clinical investigator’s discretion) abnormalities in baseline ECG analysis.
    16.Uncontrolled hypertension.
    17.Ischemic peripheral vascular disease (Grade IIb-IV).
    18.Severe diabetic retinopathy.
    19.Major trauma including surgery within 4 weeks prior to administration of study treatment.
    20.Known history of allergy or other intolerance to IL10, methotrexate, folic acid or other drugs based on human proteins/peptides/antibodies.
    21.Treatment with any investigational agent within the 6 weeks before study treatment.
    22.Immunization with a live/attenuated vaccine within 4 weeks prior to baseline or plan to receive vaccines during the study.
    23.Treatment with growth factors or immunomodulatory agents, including Anakinra, within 7 days of the administration of study drugs.
    24.Chronic pain disorders (not RA-related) that might interfere with pain evaluation.
    25.Patients requiring stable doses of corticosteroids > 10 mg/day (prednisone equivalent). Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions is not considered an exclusion criterion.
    26.Concurrent intra-articular corticosteroids treatment or patient who have received it within 2 weeks prior to randomization.
    27.History of alcohol, drug or chemical substance abuse within the 6 months prior to screening.
    28.Any condition that in the opinion of the investigator could hamper compliance with the study protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Mean change from baseline in DAS28-CRP between F8IL10 and placebo arms at week 9.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 9
    E.5.2Secondary end point(s)
    - Safety and tolerability of subcutaneous F8IL10 when administered in combination with MTX.
    - Proportion of patients achieving an ACR clinical response (ACR20, 50 and 70) and time to onset of these criteria.
    - Proportion of patients achieving clinical remission and clinical low- disease activity according to DAS 28-CRP (DAS28 < 2.6 and 2.6≤ DAS28 <3.2, respectively) and time to onset of these criteria.
    - Proportion of patients achieving clinical remission and clinical low-disease activity according to SDAI score (SDAI ≤ 3.3 and SDAI ≤ 11.0) and time to onset of these criteria.
    - Proportion of patients that experienced significant change from baseline in functional status (HAQ-DI and SF-36).
    - Maintenance of clinical response (ACR, DAS28 and SDAI scores).
    - Immunogenicity of F8IL10 (HAFA formation).
    - Pharmacodynamic profile of F8IL10.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety and tolerability: every study visit during all the study
    Proportion of patients achieving an ACR clinical response (ACR20, 50 and 70): Every week during treatment and every 4 weeks after EOT
    Patients achieving clinical remission and clinical low- disease activity according to DAS 28-CRP and SDAI : Every week during treatment and every 4 weeks after EOT
    Patients that experienced significant change from baseline in functional status (HAQ-DI and SF-36): Week 9 (EOT) and every 4 weeks after EOT
    Maintenance of clinical response (ACR, DAS28 and SDAI scores): every 4 weeks after W9 or EOT
    PD: screening, week 1, 5, 9, all FU visits
    F8IL10 HAFA formation: screening, week 1, 5, 9, all FU visits


    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Study of the formation of antibodies against anti- fusion protein F8IL10 (HAFA)
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Germany
    Italy
    Switzerland
    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
    LVLS
    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 months8
    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 months8
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 17
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 87
    F.4.2.2In the whole clinical trial 87
    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
    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 Decision2014-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-06-08
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