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    Summary
    EudraCT Number:2016-000137-52
    Sponsor's Protocol Code Number:IFN-K-005-DM
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-06-06
    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 number2016-000137-52
    A.3Full title of the trial
    A Phase IIa, Single Blind, Randomized, Study to Evaluate the Safety, the Immunogenicity, and the Clinical and Biological Efficacy of IFNα-Kinoid (IFN-K) in Adult Subjects with Dermatomyositis.
    Eine einfach verblindete, randomisierte Phase-IIa-Studie zur Bewertung der Sicherheit, Immunogenität und klinischen und biologischen Wirksamkeit von IFNα-Kinoid (IFN-K) bei erwachsenen Patienten mit Dermatomyositis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase IIa exploratory study to assess the safety and effect of IFNα-Kinoid (IFN-K) in adult patients with Dermatomyositis
    A.4.1Sponsor's protocol code numberIFN-K-005-DM
    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 pointRegulatory Affairs
    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 number33153109300
    B.5.5Fax number33155109303
    B.5.6E-mailnpujol@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 nameIFNα-Kinoid
    D.3.2Product code IFN-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 yet assigned
    D.3.9.2Current sponsor codeIFN-K DS
    D.3.9.3Other descriptive nameIFN-Kinoid Drug Substance
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number380
    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
    Dermatomyositis
    E.1.1.1Medical condition in easily understood language
    Dermatomyositis
    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 19.1
    E.1.2Level PT
    E.1.2Classification code 10012503
    E.1.2Term Dermatomyositis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Cohort 1: the primary objective of this cohort is to evaluate the immune response induced by IFN-K as measured by the production of anti-IFNα neutralizing antibody at Week 16.
    Cohort 2: the primary objectives of this cohort are to evaluate the down regulation of IFN-induced gene following IFN-K treatment at Week 48, taking into account the IFN-gene signature at baseline.
    E.2.2Secondary objectives of the trial
    •To assess the safety of IFN-K emulsified with ISA 51 VG
    •To assess the immune response (anti-IFNα neutralizing antibody at Week 24 & W48))
    •To assess the biological efficacy (change from baseline of the expression of IFN induced genes at W24 & W48)
    •To assess the clinical response as measured by the clinical disease activity at W24 & W48:
    -Manual Muscle Testing MMT 8 and MMT 5
    -Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)
    -Physician’s Global Activity
    -Patient Global Activity
    -Accelerometer to measure patients activity levels
    -Quality of Life Questionnaires (HAQ and DLQI)
    -Changes in DM therapy
    •To evaluate the immune response:
    -Anti-IFNα antibody
    -Anti-KLH antibody

    Exploratory Objectives
    •To assess biological parameters:
    -Neutralizing capacity against IFNα subtypes
    -Anti-IFNα and anti-KLH antibody isotyping
    -IFNβ cross-neutralization
    •IFN gene signature in muscle and skin biopsies
    •Histopathological features of muscle and skin biopsies
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Has provided written informed consent
    2. Patient newly diagnosed or relapsing with “definite” or “probable” dermatomyositis based on ENMC criteria (2004)
    3. Patient with an MMT-8 ≤120 and/or an MMT-5 ≤22
    4. Patient:
    •requiring corticosteroids (CS) at a dose of 1 mg/Kg or ≤ 70 mg of prednisone equivalent/day
    •or currently receiving CS at a dose of 1 mg/Kg or ≤ 70 mg of prednisone equivalent/day for less than 2 weeks at the time of screening visit
    5. Must have a muscle biopsy if not performed within 1 month at the time of screening visit
    6. Is a male or female, aged between 18 and 65 years, inclusive, at the time of the screening visit
    7. Study patient and his/her partner has to use effective method of contraception for the duration of the study including the Extended Follow-up period
    Note: If of child-bearing potential, effective contraception methods include:
    i. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 6 weeks prior to the first planned administration of the study product. In case of oophorectomy alone, the reproductive status of the woman must be confirmed by follow-up hormone level assessment.
    ii. Male sterilization (at least 6 months prior to Screening).
    iii. Combination of the following:
    •Oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception
    •Or Placement of an intrauterine device (IUD) or intrauterine system (IUS)
    •AND Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps)
    A combination of the use of condoms and the use of oil and grease containing chemical contraceptives (vaginal suppositories, tablets, gel) is not recommended, as the grease and oil might affect the condom and cause it to leak, and therefore reduces the contraception safety (pearl index not below 1%).
    Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago prior screening visit. In the case of oophorectomy alone, women are considered not of child bearing potential only when their reproductive status have been confirmed by follow-up hormone level assessment.
    8. Is able and willing to comply with the requirements of the study protocol (e.g. completion of the diary cards, return for follow-up visits), in the opinion of the investigator.
    E.4Principal exclusion criteria
    1. Is high-risk human papilloma virus (HPV) positive by reverse transcription polymerase chain reaction (RT-qPCR) on a cervical swab at Screening or within 3 months prior to the first planned study product administration
    2. Has cytological abnormalities ≥ HSIL on a cervical swab at Screening or within 3 months prior to the first planned study product administration
    3. Is positive for autoantibodies anti-NXP2, TIF1ɤ, MDA5 or anti-synthetase antibodies
    4. Is positive for any malignancy documented at the time of screening visit, i.e. by biological markers, images*, biopsies* or endoscopies*
    *note: please refer to study flow chart for acceptable window period for previous exams
    5. Has a history of any malignancy except than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix within five years prior to study entry
    6. Has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
    7. Has preexisting severe cardiac or pulmonary conditions
    8. Has received IV pulse dose CS (≥ 250 mg prednisone equivalent/day) within 3 months prior to the first planned administration of the study product
    9. Has received intravenous immunoglobulin (IVIg) within 4 months before the first administration of the study product
    10. Has received potent immunosuppressive drugs such as cyclophosphamide, methotrexate, azathioprine, mycophenolate, cyclosporine A, oral tacrolimus within 12 months prior to the first planned administration of the study product
    11. Has received abatacept, anifrolumab, belimumab, TNF antagonists or another registered or investigational biological therapy within 12 months prior to the first planned administration of the study product
    12. Has received anti-B-cell therapy (e.g. rituximab, epratuzumab) within 12 months prior to the first planned administration of the study product
    13. Has received any live vaccine within 3 months prior to the first planned administration of the study product (e.g. nasal flu vaccine, oral poliomyelitis vaccine, measles-mumps-rubella vaccine, yellow fever vaccine, Japanese encephalitis vaccine, dengue vaccine, rotavirus vaccine, varicella vaccine, zoster vaccine, Bacillus Calmette-Guérin [BCG] vaccine, oral typhoid vaccine)
    14. Has used any investigational or non-registered product within 30 days or 5 half-lives, whichever is longer, or any investigational or non-registered vaccine within 30 days prior to the first planned administration of the study product
    15. Has significant electrocardiogram (ECG) abnormalities other that consistent with dermatomyositis that are clinically relevant and preclude study eligibility in the investigator’s opinion
    16. Has inflammatory joint or skin disease other than dermatomyositis that may interfere with study assessments
    17. Has frequent recurrences of oral or genital herpes simplex lesions
    (≥ 6 occurrences during the 12 months prior to first study product administration)
    18. Has had an episode of shingles during the 12 months prior to the first planned administration of the study product
    19. Has no IgG against herpes simplex virus (HSV-1 and HSV-2), varicella zoster virus (VZV), cytomegalovirus (CMV) or Epstein-Barr virus (EBV)
    20. Is positive for HTLV 1-2 antibodies, HIV antibodies, Hepatitis C (HCV) antibodies, or Hepatitis B surface antigen (HBsAg), HBc antibody
    21. Is at high risk of significant infection and/or has any current signs or symptoms of infection at entry or has received intravenous antibiotics within 2 months prior to the first planned administration of the study product
    22. Has a history of chronic alcohol and/or product abuse within 6 months prior to the first planned administration of the study product
    23. Is breastfeeding, pregnant, or planning to become pregnant during the study period
    24. Has known hypersensitivity to any component of the study product.
    25. Patient who was interned in an institution due to official or judicial orders
    26. Patient dependent on the examiner /sponsor or testing laboratory
    E.5 End points
    E.5.1Primary end point(s)
    Cohort 1: production of anti-IFNα neutralizing antibody at Week 16.
    Cohort 2: change from baseline in the expression of IFN-induced genes at Week 48 in blood.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cohort 1: at Week 16.
    Cohort 2: at Week 48.
    E.5.2Secondary end point(s)
    Safety Endpoints
    • Occurrence, intensity and relationship of any solicited local and systemic AEs during a 7-day follow-up period (i.e. day of study product administration and 6 subsequent days) after each IFN-K or placebo dose
    • Occurrence, intensity and relationship of unsolicited local and systemic AEs occurring throughout the study period
    • Occurrence and relationship of all SAEs occurring throughout the study period
    • Occurrence and intensity of solicited injection site reactions 1 hour post study product administration
    • Occurrence and intensity of solicited systemic reactions 1 hour post study product administration
    • Hematological and biochemical results within or outside the normal ranges and percent change from baseline at each visit
    • Occurrence, intensity and relationship of any abnormality in physical examination, vital signs, 12-lead ECG, clinical laboratory evaluations
    • Rate and severity of viral infections
    • Occurrence of cancers

    Biological secondary End point
    • Production of anti-IFNα neutralizing antibody at W24 and W48
    • Change from baseline in the expression of IFN-induced genes at W24 and W48 in blood

    Clinical secondary Endpoints
    • Response to treatment with IFN-K, as measured by Muscle Strength Testing-MMT 5 and MMT 8 at W0, W12, W24, W36 and W48
    • Response to treatment with IFN-K, as measured by Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) at W0, W12, W24, W36 and W48
    • Evaluation of clinical response by assessing disease activity using: Patient Global Activity
    • Evaluation of clinical response by assessing disease activity using: Physician Global Activity
    • Response to treatment with IFN-K as measured by an accelerometer at W0, W12, W24, W36 and W48.
    • Changes from baseline in the HAQ-DI score at W0, W12, W24, W36 and W48
    • Changes from baseline in the DLQI score at W0, W12, W24, W36 and W48
    • Scores and incidence of patient requiring change in DM therapy (intensification and/or addition of drugs)

    Immunogenicity secondary Endpoints
    At timepoints specified on the flow chart, Geometric Mean Titers (GMT) and seroconversion rates for:
    • Anti-IFNα binding antibody titers
    • Anti-IFNα neutralizing antibody titers
    • Anti-KLH binding antibody titers

    Exploratory Endpoints
    • Evaluation of biological response by assessing:
    -Neutralizing Anti-IFNα antibodies towards IFNα subtypes
    -Anti-IFNα and anti-KLH antibody isotyping
    -IFNβ cross neutralization
    • IFN gene signature in muscle and skin biopsies
    • Histopathological features of muscle and skin biopsies.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety Endpoints: throughout the study period
    Biological secondary End point: at Week 24 and Week 48
    Clinical secondary Endpoints: at Week 0, Week 12, Week 24, Week 36 and Week 48
    Immunogenicity secondary Endpoints: At timepoints specified on the flow chart
    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 No
    E.6.12Pharmacoeconomic Yes
    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 Yes
    E.8.1.4Double blind No
    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 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 EEA9
    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
    France
    Germany
    Italy
    Switzerland
    United Kingdom
    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 years6
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    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: 30
    F.1.3Elderly (>=65 years) No
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 28
    F.4.2.2In the whole clinical trial 30
    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)
    If patients remain positive for anti-IFNα neutralizing antibodies after the study Extended Follow-up Period, they will be proposed to be enrolled in another 4-year follow up study to confirm the favorable safety profile of IFN-K.
    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 Decision2016-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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