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    Summary
    EudraCT Number:2013-001999-38
    Sponsor's Protocol Code Number:TNF-K-006
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-07-11
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2013-001999-38
    A.3Full title of the trial
    A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy of Neovacs’ TNF-Kinoid in Adult Subjects with Active Rheumatoid Arthritis despite Methotrexate Therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to test the efficacy of a new product (TNF-Kinoid) in patients with Rheumatoid Arthritis in whom treatment with methotrexate is not working anymore
    A.3.2Name or abbreviated title of the trial where available
    Phase II study of TNF-K in Rheumatoid Arthritis
    A.4.1Sponsor's protocol code numberTNF-K-006
    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 SponsorNeovacs SA
    B.1.3.4CountryFrance
    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 supportNeovacs SA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNeovacs SA
    B.5.2Functional name of contact pointChief Medical Officer
    B.5.3 Address:
    B.5.3.1Street Address3-5 impasse Reille
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75014
    B.5.3.4CountryFrance
    B.5.4Telephone number33153 10 26 40
    B.5.5Fax number33153 10 93 03
    B.5.6E-mailpvandepapeliere@neovacs.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 nameTNF-Kinoid
    D.3.2Product code TNF-K
    D.3.4Pharmaceutical form Emulsion for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot assigned yet
    D.3.9.2Current sponsor codeTNF-K
    D.3.9.3Other descriptive nameTNF-Kinoid
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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) Yes
    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 placeboEmulsion for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active 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 16.1
    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
    The primary objective of this study is to demonstrate superior clinical efficacy of TNF-K compared to placebo.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    •To evaluate the clinical response by assessing disease activity scores and inflammatory markers
    •To evaluate immune response parameters (anti-TNFα and anti-KLH antibody titers and anti-TNFα neutralizing capacities)
    •To identify correlates between clinical efficacy and immune response parameters
    •To assess the safety and reactogenicity of TNF-K
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A patient who meets all of the following criteria will be eligible to participate in this study:
    1.Be a male or female of between 18 and 75 years of age at the time of randomization.
    2.Has had a diagnosis of RA according to the revised ACR criteria (Aletaha et al., 2010) for at least 6 months.
    3.Has been treated with and tolerated MTX at a dose of at least 10 mg/week for at least 3 months prior to the first administration of study product, with a MTX dose of ≥ 10 mg/week and ≤20 mg/week that has been stable for at least 4 weeks prior to first administration of study product. (Note: patients who weigh ≤ 40 kg will be allowed a minimum MTX dose of 7.5 mg/week.)
    4.Has at least four swollen joints/66 and/or four tender joints/68, at screening and baseline (SD1).
    5.Has CRP≥10mg/L at screening. Note: patients may be retested in 7–14 days only if their initial screening value is < 10 mg/L but ≥ 8mg/L.
    6.Is positive for rheumatoid factor (RF) or anti-cyclic citrullinated peptides (CCP) antibodies at screening.
    7.If using NSAIDs or other analgesics for RA, the patient must have been on stable dose for at least 2 weeks prior to first administration of study product.
    8.If using hydroxychloroquine for RA, the patient must have been on stable dose for at least 12 weeks prior to first administration of study product.
    9.If using oral corticosteroids, the patient must have been on stable dose equivalent to ≤10 mg of prednisone/day for at least 2 weeks prior to first administration of study product.
    10.If the patient is female, she must be of non-childbearing potential(i.e., either surgically sterilized or 1 year post-menopausal); or, if of childbearing potential, she is using adequate contraception (e.g., intra-uterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam). The patient must also have a negative serum pregnancy test at screening and must agree to continue to use adequate contraception during her participation in the study and for 6 months after completion of the vaccination series (i.e., SD71).
    11.Can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits),in the opinion of the Investigator.
    12.Has provided written informed consent.
    E.4Principal exclusion criteria
    A patient who meets any of the following criteria will not be enrolled in the study:
    1.Has inflammatory rheumatic disease other than RA, including but not limited to, psoriatic arthritis, ankylosingspondyl arthritis, systemic lupus erythematosus, or Lyme disease, that might confound the evaluation of the benefit of study therapy.
    2.Has been treated with non-biological DMARDs/systemic immunosuppressives(e.g., D-penicillamine, sulfasalazine, azathioprine, cyclosporine, mycophenolatemofetil) other than MTX or hydroxychloroquine within 4 weeks prior to the first administration of study product.
    3.Has been treated with leflunomide within 12 weeks prior to first administration of study product.
    4.Has received intra-articular, IM, or intravenous (IV) corticosteroids, including adrenocorticotropic hormone, within 4 weeks prior to first administration of study product.
    5.Has received infliximab, etanercept, adalimumab, certolizumab, golimumab; another TNFα antagonist; or rituximab prior to the study.
    7.Has been treated with any other biological DMARDs (e.g., tocilizumab, abatacept, anakinra) or with a Janus-activated kinase (JAK) inhibitor within 6 months prior to first study product administration.
    8.Has had a non-tuberculous mycobacterial infection or opportunistic infection (e.g., Pneumocystis carinii, aspergillosis) within 6 months prior to first administration of study product.
    9.Has received any live virus or bacterial vaccination within 3 months prior to the first administration of study product.
    10.Has a serious infection (e.g., hepatitis, pneumonia, pyelonephritis, or sepsis), has been hospitalized for an infection, or has been treated with IV antibiotics for an infection within 2 months prior to the first administration of study product. Less serious infections (e.g., acute upper respiratory tract infection, simple urinary tract infection) may not be considered exclusionary at the discretion of the Investigator.
    11.Has ongoing, chronic, or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection (e.g., bronchiectasis); recurrent urinary tract infection (e.g., recurrent pyelonephritis, chronic non remitting cystitis); or an open, draining, or infected skin wound or ulcer.
    12.Has a history of or current congestive heart failure, even if well controlled.
    13.Has known history of TB.
    14.Has positive IFNγ TB diagnostic test (Quantiferon Gold) at screening.
    15.The Investigator suspects TB based on a chest X-ray conducted at screening or within 3 months prior to first administration of study product.
    16.Is human immunodeficiency virus (HIV) antibody-positive, hepatitis C (HCV) antibody-positive, or hepatitis B surface antigen(HBsAg)-positive at screening.
    17.Has used any investigational or non-registered drug within 30 days or five half-lives, whichever is longer; or any investigational or non-registered vaccine within 30 days preceding the first dose of study product.
    18.Is pregnant or breastfeeding.
    19.Has a history of malignant cancer, with the exception of the following cancers, if they have been adequately treated: cervical carcinoma in situ, basal cell carcinoma, localized bladder cancer, or dermatological squamous cell carcinoma.
    20.Has a history of allergic disease or reactions likely to be exacerbated by any component of the study product.
    21.Has a history of or active lymphoproliferative disease, including lymphoma, or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location, or clinically significant splenomegaly.
    22.Has abnormal laboratory values, including the following:
    a.Hemoglobin <8g/dL.
    b.White blood cell (WBC) count < 3x10exp9/L or >15x10exp9/L.
    c.Platelet count < 75x10exp9/L.
    d.Serum creatinine level >1.5×upper limit of normal (ULN).
    e.Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST)> 2.5×ULN.
    f.Alkaline phosphatase >2.5 ×ULN.
    g.Any other clinically relevant abnormal value per the Investigator’s opinion.
    23.Has a history of a substance abuse (drug or alcohol) problem within the previous 3 years.
    24.Is unwilling or unable to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins.
    E.5 End points
    E.5.1Primary end point(s)
    Change in DAS28-CRP between SD169 and baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at study day (SD) 169
    E.5.2Secondary end point(s)
    •ACR20, ACR50, ACR70 response at SD85, SD113 and SD169 versus baseline.
    •Clinical response as defined by a ≥ 1.2 decrease in DAS28-CRP score at SD71, SD85, SD113 and SD169 versus baseline.
    •Geometric mean titers (GMTs) of anti-TNFα antibodies at SD1, SD29, SD50, SD71, SD85, SD113, and SD169.
    •Positive anti-TNFα neutralizing activity at SD85, SD113 and SD169.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at study days (SD): 1, 29, 50, 71, 85, 113, 169
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    Belgium
    Czech Republic
    Georgia
    Hungary
    Lebanon
    Macedonia, the former Yugoslav Republic of
    Moldova, Republic of
    Poland
    Russian Federation
    Serbia
    Ukraine
    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
    Last Patient Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months12
    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: 112
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 28
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 140
    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)
    Normal standard therapy for this condition
    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 Decision2013-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-07
    P. End of Trial
    P.End of Trial StatusCompleted
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