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    Summary
    EudraCT Number:2004-004387-72
    Sponsor's Protocol Code Number:291-411
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-06-09
    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 ConcernedAustria - BASG
    A.2EudraCT number2004-004387-72
    A.3Full title of the trial
    A Phase IIa, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients with Crohn’s Disease.
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code number291-411
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorProtein Design Labs, Inc.
    B.1.3.4CountryUnited States
    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.2.5The 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 nameVisilizumab
    D.3.2Product code HuM291
    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.3.8INN - Proposed INNVisilizumab
    D.3.9.2Current sponsor codeHuM291
    D.3.9.3Other descriptive nameAnti-CD3 Monoclonal antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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
    Crohn’s disease (CD) in patients with at least one perianal fistula.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.1
    E.1.2Level LLT
    E.1.2Classification code 10011401
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the clinical activity of two consecutive daily doses of 10 mcg/kg visilizumab administered intravenously to patients with draining perianal fistulas associated with Crohn’s disease
    E.2.2Secondary objectives of the trial
    1) To evaluate the pharmacokinetics of two consecutive daily doses of 10 mcg/kg visilizumab administered intravenously in this patient population

    2) To determine the risk-benefit relationship of visilizumab in this patient population

    3) To assess immunogenicity of visilizumab in this patient population

    4) To evaluate the safety, tolerability, clinical activity, pharmacokinetics, and immunogenicity of retreatment (if warranted) of two consecutive daily doses of 10 mcg/kg visilizumab in patients with perianal fistulas associated with Crohn’s disease
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Eligible patients will be considered for inclusion in this study if they meet all of the following criteria:

    1) Male or female, 18 to 70 years of age

    2) A diagnosis of CD and at least one documented external, draining, perianal fistula

    3) Patients with reproductive potential who agree to use double-barrier methods of contraception during the study and for 3 months after receiving study drug

    4) Women of childbearing potential who have a negative serum pregnancy test at baseline screening

    5) Who have tested negative for Clostridium difficile within 3 weeks prior to treatment with study drug

    6) Who are capable of understanding the purpose and risks of the study and who provide signed and dated informed consent and an authorization to use protected health information (US sites only)

    7) Who have EBV DNA titers up to 30,000 copies/mL
    E.4Principal exclusion criteria
    Patients will be ineligible for this study if they meet any one of the following criteria:

    1) History of lymphoproliferative disorder or a prior malignancy within 5 years or current malignancies (excluding nonmelanoma skin cancers or carcinoma in situ of the cervix that has been adequately treated)

    2) Pregnant women or nursing mothers

    3) Any of the following hematologic abnormalities: WBC < 2500/mm3; platelets < 150,000/mm3; hemoglobin < 10 g/dL

    4) Serologic evidence of infection with human immunodeficiency virus (HIV) or hepatitis B or C virus (HBV, HCV)

    5) Presence of obstructive symptoms, confirmed by endoscopy showing an impassable stricture or computed tomography (CT) or barium studies showing stricture with prestenotic bowel dilation, within 6 months prior to receiving study drug

    6) Likely to require surgery in the next 6 months, such as those with clinically apparent abscesses or severely symptomatic stenoses (patients with fistula abscesses and/or setons at screen may be eligible for study entry if abscesses can be drained before patients receive study drug)

    7) Serious infections, particularly those of viral etiology, eg, known active CMV colitis, and who have history of opportunistic infections within the past year

    8) Active infections that require antibiotic therapy (not to include use of antibiotics to manage CD)

    9) Serious infections that required IV antibiotic therapy or hospitalization within 8 weeks prior to receiving study drug

    10) Started, or have had a dose change of, sulfasalazine; 5-aminosalicylic acid (5-ASA); or antibiotics, probiotics, or topical therapies for CD within 2 weeks prior to receiving study drug

    11) Had an increased dose in corticosteroid medication within 2 weeks prior to receiving study drug; is receiving IV steroids; or, is receiving a daily dose of > 40 mg prednisone, > 9 mg budesonide, or equivalent

    12) Received a live vaccine within 6 weeks prior to receiving study drug (patients may not receive a live vaccine during treatment or for 12 weeks after treatment with study drug)

    13) Received any monoclonal antibodies (including infliximab) or investigational agents or biologics within 3 months prior to receiving study drug

    14) Received cyclosporine or tacrolimus (FK506) within 4 weeks of receiving study drug

    15) Had a dose change of or discontinued from 6-mercaptopurine, azathioprine, or methotrexate within 4 weeks prior to receiving study drug

    16) Significant organ dysfunction, including cardiac, renal, liver, CNS, pulmonary, vascular, non-CD-related gastrointestinal, endocrine, or metabolic (eg, creatinine ≥1.6 mg/dL; ALT or AST ≥ twice the upper limit of normal (ULN); alkaline phosphatase ≥ 1.5 × ULN; history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to study entry).

    17) History of lymphoproliferative disorder

    18) History of tuberculosis (TB) or other mycobacteria infection, or chest x-ray positive for previous TB infection

    19) History of thrombophlebitis or pulmonary embolus

    20) Histories of immune deficiency or autoimmune disorders other than CD (not including joint, skin, hepatic, and ocular inflammatory conditions that may be components of CD)

    21) History of seizure with subtherapeutic blood levels of anticonvulsive medication (documented) within one week before study enrollment.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint, which is determined by clinical examination, is clinical response, defined as external closure of at least 50% of perianal fistulas identified at baseline and observed at two consecutive study visits at least 4 weeks apart by Study Day 89, without an accompanying increase in dose(s) of concomitant medication(s) or the addition of new medication(s) as therapy for CD, or CD-related surgery.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) 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 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) 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 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 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
    There are no predefined criteria for trial termination in this study. However, if PDL and/or the investigator(s) discover conditions during the course of the study that indicate it should be discontinued, an appropriate procedure for terminating the study will be instituted, including notification of the appropriate regulatory agencies and IRB or IEC at all study sites.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-06-09. Yes
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 16
    F.4.2.2In the whole clinical trial 18
    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)
    Should there be treatment failure, patients will receive appropriate rescue medications, and be followed for safety. There is a re-treatment option.
    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 Decision2005-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-10-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-05-04
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