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    Summary
    EudraCT Number:2005-002179-34
    Sponsor's Protocol Code Number:SLE01_ENK
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-08-31
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2005-002179-34
    A.3Full title of the trial
    SAFETY AND EFFICACY STUDY ON DEOXYSPERGUALIN (NKT-01) IN PATIENTS WITH UNCONTROLLED LUPUS NEPHRITIS RECEIVING ORAL CORTICOSTEROIDS AND PRIOR TREATMENT OF STANDARD IMMUNOSUPPRESSIVE THERAPY
    - a prospective open-labelled multi centre Phase I/II pilot study -
    A.3.2Name or abbreviated title of the trial where available
    Safety and Efficacy on Deoxyspergualin (NKT-01)
    A.4.1Sponsor's protocol code numberSLE01_ENK
    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 SponsorEuro Nippon Kayaku GmbH
    B.1.3.4CountryGermany
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Spanidin
    D.2.1.1.2Name of the Marketing Authorisation holderEuro Nippon Kayaku GmbH
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    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 nameDesoxspergualin
    D.3.2Product code NKT01
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGusperimus
    D.3.9.1CAS number 84937-45-1
    D.3.9.2Current sponsor codeNKT-01
    D.3.9.3Other descriptive nameNKT-01, gusperimus hydrochloride (JAN), 15-deoxyspergualin, DSG, BI61.051, BMY-42215-1, Spanidin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Systemic lupus erythrematosus (SLE) is an aggressive autoimmune disease. The chronic inflammatory processes involve many organs like the skin, lung, kidneys, central and peripheral nervous system, eyes, joints, bone marrow and blood cells, heart, and others. All organs can be affected. The diagnosis of SLE is based on the presence of composite clinical and serological markers. Nephritis is a major complication of SLE and is a strong determinant of morbidity and mortality.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.1
    E.1.2Level PT
    E.1.2Classification code 10025140
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This is a phase I/II pilot study in SLE patients with uncontrolled lupus nephritis with NKT-01 in addition to OCS (£ 1.0 mg/kg/day, a maximum dose of 80 mg/day). Its purpose is to establish that dose of NKT-01 which, in combination with OCS (LE 1.0 mg/kg/day) leads to complete response during a minimum of 6 cycles of treatment without causing WHO grade 3 leukopenia (WBC < 2x109/L).
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1) a diagnosis of SLE according to the ACR criteria (at least 4/11 ACR criteria to be fulfilled, see Appendix 2) , and
    2) signs of active SLE nephritis must be present:
    - increasing urinary protein excretion of 1g or more per 24 hours (if initially normal values) or an increase of >50% over the initially elevated values and/or
    - active urinary sediment and/or
    - impaired renal function due to SLE nephritis (elevated serum creatinine – if initially normal values – or >50% increase of serum creatinine levels if elevated before onset of renal flare), and/or
    Either the above-mentioned parameters of SLE nephritis must be present or

    - signs of active lupus nephritis in renal biopsy (any renal biopsy in the past 2 years within the scope of SLE disease)

    Signs must be sufficient to diagnose active lupus nephritis (i.e. active urinary sediment alone will not be sufficient);
    3) serum creatinine concentration of <=5.0 mg/dL;
    4) prior treatment with one or more immunosuppressive drugs (e.g. CYC, AZA, methotrexate, cyclosporin A, mycophenolate mofetil), or plasmapheresis. Conventional immunosuppressants must be stopped at least one week before NKT-01 treatment can be started. Concomitant use of these applications or immunosuppressants is excluded.
    5) daily dose of OCS of 1.0 mg/kg or less (a maximum daily dose of 80 mg)
    6) initial leukocyte count ³ 4000/µL (unless leukocytopenia is caused by SLE disease activity: leukocyte count ³ 2000/µL in these cases)
    7) written informed consent
    E.4Principal exclusion criteria
    1) chronic infection of HIV, Hepatitis B, Hepatitis C
    2) acute infection including fungal, viral, bacterial or protozoal diseases
    3) liver toxicity (CTC class 2 and higher). No adequate liver function (total bilirubin > 25 mmol/L =1.4 mg/dL unless explained otherwise (e.g. inherited, hemolysis), SGOT > 2.5 x N, SGPT > 2.5 x N)
    4) pregnant or lactating women
    5) female patients of child bearing age without safe method of contraception
    6) anemia (hemoglobulin < 8.0 g/dL), leukocytopenia (leukocytes < 4000/µL unless attributable to SLE: leukocytes < 2000/µL), thrombocytopenia (platelets < 50000/µL)
    7) neutrophils below 1000/µL
    8) hypogammaglobulinemia below 400 mg/dL of serum IgG
    9) any other condition that in the eyes of the investigator may render the patient unsuitable for participation into the study. This especially includes major and active SLE organ involvement other than the kidney. Patients with SLE involvement of the central nervous system must not be included into the study.
    10) history of malignancy
    11) Current participation in another trial or at least 6 months since participating in a similar trial
    E.5 End points
    E.5.1Primary end point(s)
    The response rate as the final outcome of the study is the primary endpoint of the study. It is a 4 point scale:
    (1) complete response
    (2) partial response
    (3) stable disease
    (4) treatment failure
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Pilot study Phase I / II
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    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) 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    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 months
    E.8.9.1In the Member State concerned days
    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 No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 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 30
    F.4.2.2In the whole clinical trial 30
    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 Decision2005-08-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-07-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-01-29
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