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    Summary
    EudraCT Number:2010-024152-29
    Sponsor's Protocol Code Number:
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-06-21
    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 number2010-024152-29
    A.3Full title of the trial
    Canakinumab for Behçet`s Disease Resistant to Standard Treatment
    (CanBeDisT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label study to evaluate efficacy and tolerability of Canakinumab in patients with Behçet Disease who do not respond to standard treatment (Eine offene Studie zur Wirksamkeit und Verträglichkeit von Canakinumab bei Patienten mit Morbus Behçet, die auf die übliche Behandlung nicht ansprechen)
    A.3.2Name or abbreviated title of the trial where available
    CanBeDisT
    A.4.1Sponsor's protocol code number
    A.5.4Other Identifiers
    Name:Active ingredientNumber:Canakinumab
    Name:Brand nameNumber:Ilaris
    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 SponsorUniversity Hospital of Tübingen
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovartis Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSTZ eyetrial
    B.5.2Functional name of contact point
    B.5.3 Address:
    B.5.3.1Street AddressSchleichstr. 12-16
    B.5.3.2Town/ cityTübingen
    B.5.3.3Post code72076
    B.5.3.4CountryGermany
    B.5.4Telephone number49 7071298 4898
    B.5.5Fax number49707129 50 21
    B.5.6E-mailbarbara.wilhelm@stz-eyetrial.de
    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 Yes
    D.2.1.1.1Trade name Ilaris
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameIlaris
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCANAKINUMAB
    D.3.9.1CAS number 914613-48-2
    D.3.9.4EV Substance CodeSUB30137
    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) No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Behçet`s Disease
    E.1.1.1Medical condition in easily understood language
    Behçet`s Disease is an inflammatory disease involving mainly blood vessels. Its main symptoms are oral and genital ulcerations, skin lesions and CNS manifestations.
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10004213
    E.1.2Term Behcet's syndrome
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this clinical pilot study is to evaluate the efficacy, safety and tolerability of canakinumab in treatment resistant Behçet`s disease.
    The primary endpoint is to evaluate the percentage of patients achieving Major Response according to BDCAFadapted (Behçet`s Disease Current Activity Form (adapted from observation period of 4 weeks in the past to one week in the past)), defined as improvement by >50%) and Uveitis Scoring system (defined as posterior uveitis score improving by > 50%)- the latter to be used in case of uveitis only. The primary endpoint will be determined at week 24 (close out)).
    E.2.2Secondary objectives of the trial
    Percentage of patients achieving remission according to BDCAFadapted (becoming <1)
    • Percentage of patients achieving remission according to Uveitis Scoring System (score becoming < 1)
    • Reduction in Birmingham Vasculitis Score (BVAS)
    • Reduction in visual analog scale for disease activity (patient/physician)
    • Reduction in number and size of oral and cutaneous lesions
    • Reduction of DAS44 (in case of arthritis)
    • Improvement of visual acuity (in case of ocular disease)
    • Quality of life as recorded by HAQ and FfbH, EuroQuol
    • Dose reduction of concomitant glucocorticosteroids (GC)
    • Time to remission/major response
    • Duration of remission/major response – time to relapse
    • Improvement of laboratory activity markers (ESR, CRP, IL-18, SAA, S100 A12 and A9)
    • reduction of gamma delta T cells
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with BD fulfilling the international study group criteria (ISBD) from 1990 with active disease defined as BDCAF >3 and/or posterior uveitis score >2
    • Treatment resistant to standard treatment according to EULAR guidelines (colchicine, azathioprine, methotrexate (plus glucocorticosteroids), in case of ocular disease also TNF-antagonists or interferon-alpha.
    • Age ≥ 18 years ≤ 65 years
    • Capable of understanding the purposes and risks of the study, able to give informed consent and to comply with the study requirements
    • Women of childbearing age must have a negative urine pregnancy test (UPT) within 48 hours prior to starting study drug and at the end of the trial and must not be lactating.
    • Female subjects of non-childbearing potential must meet at least one of the
    following criteria:
    Postmenopausal females, defined as:
    Females over the age of 60 years.
    Females who are 45 to 60 years of age must be amenorrhoic for at least 2 years.
    Females who had a hysterectomy and/or bilateral oophorectomy.
    Protocol: CanBeDisT Version 1.0 29.04.2011
    18
    • Subjects of both genders with reproductive potential who are sexually active
    agree to use contraception throughout the course of the study and for at least
    3 months after completion of their study participation.
    • Women of childbearing potential have to use a highly effective method of birth control defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, hormonal IUDs combined with barrier methods (e.g. condom, diaphragm or spermicide), sexual abstinence or vasectomised partner.
    • Negative PPD or Quantiferon test and uneventful chest X ray from last 12
    months (negative for tuberculosis)
    • Negative serology for HIV, hepatitis ABC
    • Prior Medication:
    Patients with non-ocular, non-severe disease (mucocutaneuous, arthritis,
    thrombophlebitis) must have had colchicine and/or azathioprine without
    sufficient efficacy before entering the study.
    Patients with ocular BD must have been treated at least with azathioprine,
    and/or cyclosporin A plus glucocorticosteroids without effect before entering
    the study. Interferon-alpha and TNF antagonists may have also been
    ineffective before entering the study.
    E.4Principal exclusion criteria
    Patients under 18 years
    • Severe, life threatening BD manifestations (pulmonary arterial aneurysms,
    CNS)
    • Female patients not willing to use contraceptives
    • Signs of tuberculosis in chest x-ray during the past 12 months before study
    entry
    • Hemoglobin < 8 g/dl, WBC < 3000/ul, platelet count < 100.000/ul, GFR/MDRD
    < 50 ml/min/1,73m2, AST/ALT > 2x upper normal limit, alkaline phosphatase >
    2x upper normal limit
    • Known HIV antibody, hepatitis B surface antigen, and/or hepatitis C antibody
    History of malignancy within 5 years prior to study entry other than carcinoma
    in situ of the cervix, or adequately treated, non-metastatic squamous or basal
    cell carcinoma of the skin
    • History of severe allergic reaction to humanized or murine monoclonal
    antibodies
    • Fever or infection requiring antibiotic treatment within 3 weeks prior to
    screening, history of recurrent infection or predisposition to infections
    • Immunodeficiency
    • Demyelinating disease
    • Known presence or suspicion of active or recurrent bacterial, fungal or viral
    infection at the time of enrollment, where an IL-1 blocker might have an impact
    on underlying severe immunocompromising diseases as e.g. evidence of
    Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C
    infections (based on history and/or clinical findings).
    • One of the risk factors for TB such as but not limited or exclusive to:
    a. History of any of the following: residence in a congregate setting (e.g.
    jail or prison, homeless shelter, or chronic care facility), substance
    abuse (e.g. injection or noninjection); health-care workers with
    unprotected exposure to patients who are at high risk of TB or patients
    with TB disease before the identification and correct airborne
    precautions of the patient, or
    b. Close contact (i.e. share the same air space in a household or other
    enclosed environment for a prolonged period (days or weeks, not
    minutes or hours)) with a person with active pulmonary TB disease
    within the last 12 months.
    History of ongoing, chronic or recurrent infectious disease or evidence of
    tuberculosis infection determined as defined by local guidelines/ local medical
    practice. If presence of tuberculosis is established then treatment (according
    to local guidelines) must have been completed prior to randomization.
    • Significant medical problems, including but not limited to the following:
    uncontrolled hypertension (= 200/105 mmHg), congestive heart failure [New
    York Heart Association Stage D], uncontrolled diabetes type I and II (recent
    blood glucose > 300 mg/dl), thyroid disease (unless the patient is taking a
    stable dose of thyroid hormone or anti-thyroid medications (hyperthyroidism)
    for at least 12 weeks), which in the opinion of the Investigator will exclude the
    patient from the study (can be discussed on a case by case basis with
    Novartis).
    • Life vaccine within 3 months prior to screening. Live seasonal flu /H1N1
    vaccines are permitted > 2 weeks prior to screening
    Major surgery within 4 weeks prior to week 1 (injection of canakinumab)
    • Participation in an investigational drug trial within 4 weeks prior to screening
    • Presence of absolute contraindications for canakinumab as mentioned in the
    product information (Appendix 1)
    • Presence of relative contraindications for canakinumab as mentioned in the
    product information (Appendix) if the disorder leading to the relative
    contraindication can not sufficiently managed by concomitant medication.
    • Subjects with medically significant co-morbid conditions that impair normal
    activities, require systemic corticosteroids or immunosuppressives, or any
    medical condition that would likely have an impact on the participant´s ability
    to comply with the study visit schedule
    • Any current or history of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication
    E.5 End points
    E.5.1Primary end point(s)
    The efficacy of the investigational drug will be assessed by established scoring systems for Behçet`s disease (Behçet`s disease current activity form, BDCAF) and the Uveitis scoring system (in case of ocular manifestation).
    The percentage of patients achieving Major Response according to BDCAFadapted (Behçet`s Disease Current Activity Form (adapted from observation period of 4 weeks in the past to one week in the past), defined as either improvement by >50%) and Uveitis Scoring system (defined as posterior uveitis score improving by > 50%) is to be evaluated.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 24 (close-out)
    E.5.2Secondary end point(s)
    Percentage of patients achieving remission according to BDCAFadapted (becoming <1)
    • Percentage of patients achieving remission according to Uveitis Scoring System (score becoming < 1)
    • Reduction in Birmingham Vasculitis Score (BVAS)
    • Reduction in visual analog scale for disease activity (patient/physician)
    • Reduction in number and size of oral and cutaneous lesions
    • Reduction of DAS44 (in case of arthritis)
    • Improvement of visual acuity (in case of ocular disease)
    • Quality of life as recorded by HAQ and FfbH, EuroQuol
    • Dose reduction of concomitant glucocorticosteroids (GC)
    • Time to remission/major response
    • Duration of remission/major response – time to relapse
    • Improvement of laboratory activity markers (ESR, CRP, IL-18, SAA, S100 A12 and A9)
    • reduction of gamma delta T cells
    E.5.2.1Timepoint(s) of evaluation of this end point
    At week 24 (close-out)
    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 No
    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) 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 No
    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 No
    E.8.7Trial has a data monitoring committee No
    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
    Premature termination of this clinical study may occur because of a regulatory authority decision, drug safety as well as at the discretion of the Sponsor or Novartis Pharma GmbH.
    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 months2
    E.8.9.1In the Member State concerned 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) 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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 10
    F.4.2.2In the whole clinical trial 10
    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)
    Treatment of subjects after the end of the study will be at the discretion of the investigator.
    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 Decision2011-09-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-30
    P. End of Trial
    P.End of Trial StatusOngoing
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