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    Summary
    EudraCT Number:2009-012059-47
    Sponsor's Protocol Code Number:IFN-K-001
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-04-15
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2009-012059-47
    A.3Full title of the trial
    A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNα-Kinoid in adult subjects with Systemic Lupus Erythematosus.
    Фаза I-II, рандомизирано, двойно-сляпо, плацебо-контролирано, дозо-покачващо клинично проучване на Неовакс Интерферон α- Киноид при възрастни пациенти със системен Лупус Еритематозис (СЛЕ).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNα-Kinoid in adult subjects with Systemic Lupus Erythematosus.
    Фаза I-II, рандомизирано, двойно-сляпо, плацебо-контролирано, дозо-покачващо клинично проучване на Неовакс Интерферон α- Киноид при възрастни пациенти със системен Лупус Еритематозис (СЛЕ).
    A.3.2Name or abbreviated title of the trial where available
    IFN-Kinoid in Systemic Lupus Erythematosus
    A.4.1Sponsor's protocol code numberIFN-K-001
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameIFN-α2b Kinoid
    D.3.2Product code IFN-K
    D.3.4Pharmaceutical form Emulsion for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 codeIFN-K DS
    D.3.9.3Other descriptive nameIFN-a 2b Kinoid Drug Substance
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number350 to 450
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Systemic Lupus Erythematosus (SLE)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    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 trial is to assess the safety and tolerability of three
    administrations of IFN-K adjuvanted with ISA-51 at four doses (30, 60, 120 or 240 mcg), given on SD0, SD7 and SD28 (+/- a fourth dose on SD84 [Month 3]) in adult subjects with SLE.
    E.2.2Secondary objectives of the trial
    The secondary objectives will be:
    - To evaluate the anti-IFNα antibody response induced by IFN-K.
    - To evaluate the neutralizing antibody response induced by IFN-K.
    - To evaluate the cellular immune response in vitro.
    - To assess the levels of serum auto-antibodies.
    - To evaluate changes in the expression of IFNa inducible genes in peripheral blood
    mononuclear cells (PBMCs) in all subjects and in subjects with a positive IFN
    signature at baseline.
    - To evaluate the levels of IFNα inducible serum chemokines.
    - To evaluate the clinical response by assessing:
    • Disease activity using:
    o The SLE Disease Activity Index (SLEDAI).
    o The British Isles Lupus Assessment Group (BILAG) index.
    o The Physician Global Assessment (PGA)
    o The SELENA-SLEDAI Flare Index
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Diagnosis of SLE according to current American College of Rheumatology (ACR) criteria (4 of 11 ACR criteria),
    2. SLEDAI ≥4 and ≤10,
    3. Positive Anti-nuclear Antibodies (ANA) and/or Positive anti-dsDNA antibodies at the time of screening,
    4. Male or female between 18 and 50 years of age included at the time of the first
    planned administration of the study drug,
    5. Current immunity to measles, mumps, rubella and varicella, as evidenced by
    positive IgG titers at the time of screening,
    6. For subjects recruited during local influenza season, current vaccination against seasonal influenza at least 7 days prior to randomiza7. Vaccination against H1N1 influenza at least 7 days prior to randomization, if judged indicated by the Investigator. The nasal spray form of the vaccine is not acceptable as it is a live attenuated vaccine,
    8. For subjects with reproductive potential (males and females), use of a reliable
    means of contraception (e.g., hormonal contraceptive, patch, vaginal ring, intrauterine device, or other barrier method of contraception) throughout their
    participation in the study, (i.e. until study Day 168 (Month 6 study visit),
    unless additional extended follow up visits are needed in the presence of
    persisting anti-IFNα antibodies. In this case, contraception must be continued
    until anti-IFNα antibody levels are back to baseline and further follow visits
    are no longer required,
    9. According to the Investigator, able and willing to comply with the requirements of the study protocol (e.g., completion of the diary cards, return for follow-up visits),
    10. Written informed consent obtained from the subject.
    E.4Principal exclusion criteria
    1. Any serious manifestation of lupus at entry, that, in the opinion of the investigator is likely to require initiation of off-protocol medication changes during the course of the study and in particular no BILAG A score,
    2. Any non-SLE manifestation likely to require, in the investigator's judgment, treatment with highdose corticosteroids or the addition of an immunosuppressive
    regimen during the course of the trial,
    3. Received > 20 mg/day of prednisone, or equivalent, for > 7 days during the 30 days prior to screening,
    4. Currently receiving or having received pulse dose corticosteroids or intravenous immunoglobulin (IVIg) within 3 months prior to screening,
    5. Received cyclophosphamide within 3 months prior to screening,
    6. Received a monoclonal antibody during the 6 months prior to screening,
    7. Previously received an investigational treatment directed against IFN alpha ,
    8. Received B-cell depleting therapy (e.g. Rituximab) within 12 months prior to screening,
    9. Received IV antibiotics during the 30 days prior to screening,
    10. Significant electrocardiogram (ECG) abnormalities that are clinically relevant and
    preclude study entry according to the Investigator’s opinion,
    11. Evidence of any clinically significant abnormality on a chest X-ray which, in the opinion of the investigator could represent active infection, latent tuberculosis or treatable manifestation of lupus,
    12. Any laboratory abnormality that is clinically relevant and precludes study entry according to the Investigator’s opinion, in particular subjects with already impaired functions of central organs at screening (e.g. AST > 2.5 x upper limit of the norm (ULN), ALT > 2,5 x ULN, creatinine > 1,5 x ULN, serum potassium above
    or below the normal range, hemoglobin < 8g/dL, WBC < 1,800/mm3, neutrophils < 1,500/mm3, platelet count < 50,000/mm3, lupus with central manifestation) should be excluded from the study.
    13. History of malignancy except completely excised basal cell carcinoma,
    14. Congenital immune deficiency,
    15. Positive IgM antibody titers in the presence of negative IgG titers to Epstein-
    Barr virus (EBV) or cytomegalovirus (CMV),
    16. Frequent recurrences of oral or genital herpes simplex lesions (≥ 6 / year),
    17. Episode of shingles within one year of screening,
    18. Human Immunodeficiency Virus (HIV), hepatitis C virus (HCV) or HBV (HBsAg, anti-HBc ab) positive,
    19. Any current signs or symptoms of infection at entry,
    20. Administration of any live vaccine within the 3 months prior to study entry (e.g. oral poliomyelitis vaccine, measles-mumps-rubella vaccine, yellow fever vaccine, rotavirus vaccine, varicella vaccine, zoster vaccine, Bacillus Calmette-Guérin vaccine),
    21. Planned use of any investigational or non-registered product (drug or vaccine)
    other than the study product within 30 days preceding the first dose of study product, or during the study period,
    22. History of severe allergic or anaphylactic reactions to any component of the
    kinoid and/or seafood,
    23. Pregnancy or lactation,
    24. History of chronic alcohol consumption and/or drug abuse within 6 months of
    screening.
    E.5 End points
    E.5.1Primary end point(s)
    Safety endpoints:

    • Occurrence, intensity and relationship to IFN-K immunization of any solicited local and general signs and symptoms during a 7-day follow up period (i.e. Day of study drug administration and 6 subsequent days) after each IFN-K dose.
    • Occurrence, intensity and relationship to IFN-K immunization of unsolicited local and general signs and symptoms occurring throughout the study period.
    • Occurrence and relationship to IFN-K immunization of all serious adverse events (SAE) occurring throughout the study period.
    • Occurrence, intensity and relationship to IFN-K immunization of any abnormality in physical examination, vital signs, 12-lead ECG, clinical laboratory evaluations, and adverse events (AEs).
    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 No
    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) Yes
    E.7.1.1First administration to humans Yes
    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.8.3 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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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.1.3Elderly (>=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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 28
    F.4.2.2In the whole clinical trial 28
    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 Decision2010-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-06-27
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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