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    Summary
    EudraCT Number:2007-001857-24
    Sponsor's Protocol Code Number:NI-0401-02
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-07-31
    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 ConcernedUK - MHRA
    A.2EudraCT number2007-001857-24
    A.3Full title of the trial
    A Phase IIa, open-label, dose-titration, multicentre study to assess the safety and preliminary efficacy of NI-0401 in patients with acute cellular renal allograftt rejection
    A.4.1Sponsor's protocol code numberNI-0401-02
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovImmune S.A.
    B.1.3.4CountrySwitzerland
    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.3.2Product code NI-0401
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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) No
    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 Yes
    D.3.11.13.1Other medicinal product typeAnti-CD3 monoclonal antibody
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute cellular renal allograft rejection.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess safety and tolerability of NI-0401
    To determine whether NI-0401 can reverse BpACR
    E.2.2Secondary objectives of the trial
    To assess changes in renal function over time, as measured by serum creatinine.
    To establish NI-0401 pharmacokinetics in patients with BpACR.
    To assess pharmacodynamics of NI-0401.
    To quantify the level of recurrent rejections, their severity and response to treatment.
    To assess the incidence of anti-NI-0401 antibodies.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women ≥ 18 and ≤ 70 years of age.
    2. Recipient of a kidney graft (first or second) from a deceased or living donor (non-HLA-identical).
    3. Rise in SCr concentration by > 20% compared to baseline, defined as the most recent creatinine level measured prior to rejection but after transplantation.
    4. Allograft biopsy showing evidence of acute cellular rejection, according to Banff 97 criteria.
    5. Men and women of childbearing potential must use adequate birth control measures until 6 months after receiving study drug. Therefore, women of childbearing potential and their partners are required to use two forms of contraception. Men with partners of childbearing potential are required to use barrier contraception, in addition to their partners using another method. Acceptable forms of contraception are as follows:
    - Barrier methods: condoms, diaphragms, cervical caps;
    - Hormonal contraceptives: combination or progesterone only;
    Includes depot contraceptives;
    - Intrauterine methods: intrauterine devices or systems.
    6. The screening laboratory tests must meet the following criteria:
    a. Hb ³ 8.5 g/dL (4.5 mmol/L)
    b. WBC ³ 4 x 109/L
    c. Neutrophils ³ 1.5 x 109/L
    d. Platelets ³ 100 x 109/L
    e. The hepatic function tests (including transaminases and alkaline phosphatase) are in the normal ranges for the patient as evaluated by investigator..
    7. Patients must be able to adhere to the study visits and protocol requirements.
    8. Patients must be able to give written informed consent.
    E.4Principal exclusion criteria
    1. Patients who have received therapy for the current graft with anti-CD3 mAb (OKT3) or anti-lymphocytes polyclonal antibodies (ATG, Atgam) in the past.
    2. Patients with cardiac insufficiency or fluid overload (to be excluded by a chest X ray).
    3. Severe HLA sensitization (>50% panel reactive antibodies prior to transplantation).
    4. Evidence of delayed renal graft function.
    5. Have received or are planned to receive immunization with a live vaccine within 6 weeks prior to receiving study drug and 12 weeks after treatment cessation.
    6. Concomitant disease:
    a. Current signs or symptoms of severe, progressive or uncontrolled disease. Patients with cardiac (e.g. recent myocardial infarction or symptomatic ischemic heart disease); pulmonary (e.g. chronic obstructive pulmonary disease); or neurologic disease (e.g. seizure disorder or head trauma).
    b. Previous diagnosis of, or known, malignancies, except for completely excised basal cell carcinoma.
    c. Ongoing severe infections, such as hepatitis or pneumonia, or any active infection (requiring therapy).
    d. History of opportunistic infections such as herpes zoster within 2 months prior to screening. History of active tuberculosis (TB) or currently undergoing treatment for TB.
    e. Evidence of acute CMV (or D+/R-) or EBV infection.
    f. Serum anti HCV positive, serum HBsAg positive, serum anti-HIV positive.
    g. Patients with BK Virus nephropathy.
    7. Patients with any history of coagulopathy or medical condition requiring long-term anticoagulation after transplantation (low-dose of aspirin treatment is allowed).
    8. Female patients who are pregnant or breast feeding.
    9. A psychiatric, addictive, or any other disorder that compromises the ability to give truly informed written consent for participation in this study.
    10. Suspected hypersensitivity to any component of the drug product.
    11. Has undergone or is undergoing treatment with another investigational drug or approved therapy for investigational use within 3 months prior to entry in this study. Has previously participated in this study.
    12. Patients for whom pre-study assessment would lead to delay (as judged by the investigator) in initiating therapy with NI-0401.
    E.5 End points
    E.5.1Primary end point(s)
    Adverse events (nature, frequency, intensity, causality, seriousness, treatability and outcome).
    The percentage of patients demonstrating a complete normalization of SCr at study day 14. Complete normalization is defined as a return of the SCr concentration to < 120% of baseline value.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    All patients will be followed-up for a minimum of 6 weeks. Patients with SAEs and/or low peripheral T-cells count (≤ 200cells/ μL) will be followed-up till resolution.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Information not present in EudraCT
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    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 12
    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)
    The choice of immunosuppressant medication after resolution of rejection is left at the investigator’s discretion without study-specific limitations or guidance.
    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 Decision2007-08-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-12-03
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