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    Summary
    EudraCT Number:2006-002204-33
    Sponsor's Protocol Code Number:C32322
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-03-26
    Trial results View 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 ConcernedFrance - ANSM
    A.2EudraCT number2006-002204-33
    A.3Full title of the trial
    Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks.
    A.4.1Sponsor's protocol code numberC32322
    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 SponsorUCB Pharma S.A.
    B.1.3.4CountryBelgium
    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 nameCDP323
    D.3.2Product code CDP323
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 455264-30-9
    D.3.9.2Current sponsor codeCDP323
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsing forms of multiple slerosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10048393
    E.1.2Term Multiple sclerosis relapse
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare the effects of 500 mg CDP323 twice daily on MS-related imaging parameters in subjects with relapsing MS (RMS) with the effects seen under placebo treatment in that population over a period of 24 weeks
    E.2.2Secondary objectives of the trial
    - Compare CDP323's tolerability and safety in RMS subjects with placebo treatment in that population over a period of 24 weeks;
    - Compare the effects of CDP323 on the occurrence of relapses in RMS subjects with the effects seen under placebo treatment in that population over a period of 24 weeks;
    - Compare the effects of twice daily dosing of CDP323 vs once daily dosing of CDP323 including the related time course of α4/VCAM-1 binding between the two dosing regimen and placebo;
    - Characterize the main pharmacokinetic parameters of CDP323 and its metabolites in subjects suffering from RMS;
    - Assess potential withdrawal effects after termination of treatment with CDP323.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The sub-study is included in this protocol. It's a pharmacodynamic sub-study with in addition an investigation of a kinetic-dynamic relationship.
    E.3Principal inclusion criteria
    • written informed consent;
    • being of legal capacity and able to understand the nature of the study and its potential risks;
    • willing to comply with the study's safety precautions and with the intended drug-free long-term follow-up over the telephone;
    • diagnosis of MS according to the revised McDonald criteria (Polman et al. Ann Neurol 2005;58:840-6);
    • relapsing form of MS, i.e., RRMS or SPMS (with superimposed relapses) according to Lublin and Reingold (Neurology 1996;46:907-11);
    • screening EDSS score of 0-5.5, inclusive;
    • female and male subjects aged 18-55 years inclusive at time of informed consent;
    • at least one clinical relapse in the 12 months before screening and documented in the subject's medical records;
    • active disease, defined by the presence of either,
    • at least nine lesions on the screening T2 scan or,
    • Gd enhancement on the screening T1 scan or,
    • Gd enhancement on an MRI scan during the past 12 months or,
    • at least two new T2 lesions during the past 12 months;
    • failed prior treatment with beta-interferons due to lack of efficacy or tolerability;
    • female subjects of childbearing potential must agree to practice one of the following contraception method:
    • double-barrier contraception (i.e., using a male or female condom with
    spermicide, or diaphragm or cervical cap with spermicide) or
    • any contraceptives containing estrogens plus one of the following:
    diaphragm or cervical cap with spermicide, male or female condom with
    spermicide or
    • intrauterine devices or
    • contraceptives containing progestins only, e.g., etonogestrel or
    levonorgestrel or medroxyprogesterone or norethindrone or
    • monogamous relationship with vasectomized partner or,
    • sexual abstinence.
    Note: Lack of childbearing potential will be considered under these
    circumstances:
    • post-menopausal for at least two years,
    • bilateral oophorectomy, ovariectomy, salpingectomy, or tubal ligation,
    • hysterectomy;
    • congenital sterility.
    • negative pregnancy tests at screening and at baseline for female subjects of
    childbearing potential;
    • full immunocompetency: CD4+ lymphocyte count within reference range;
    • JC viral DNA particles undetectable in blood at two separate measurements.
    E.4Principal exclusion criteria
    • type of MS other than relapsing;
    • any disease other than MS that could better explain the subject's signs and symptoms;
    • any conditions that could interfere with the contrast-enhanced MRI, including an estimated glomerular filtration rate (eGFR) <= 60ml/min or with any other evaluation in the study;
    • any clinically significant disease state or findings other than MS, in particular
    neoplastic disease or organ transplantation (in case of doubt, UCB's responsible
    medical officer will be consulted and a joint documented decision will be made
    between investigator and UCB's medical officer);
    • any clinically significant deviation from reference ranges in laboratory tests or any
    abnormal, clinically significant ECG findings, in particular any marked pre-study
    prolongation of the QTcB interval, i.e., if both, the Screening (V1) and the Baseline
    (V3) ECG demonstrate a QTcB interval >450 ms (in case of doubt, UCB's responsible
    medical officer will be consulted and a joint documented decision will be made
    between investigator and UCB's medical officer);
    • any significant deviation from reference ranges for hepatic function as defined by either SGOT, SGPT, GGT, or AP elevated 3-fold or higher beyond the upper limit of the
    reference range or total bilirubin elevated 2-fold or higher beyond the upper limit of the reference range;
    • signs of silent infections, including positive tests for HIV1, HIV2, or Hepatitis B or
    Hepatitis C, or tuberculosis;
    • any condition possibly interfering with drug absorption;
    • known allergy to gadolinium-DTPA, and/or ingredients of the study drug formulation;
    • history of severe AEs to any drug;
    • participation in any clinical drug trial within 30 days prior to screening;
    • concomitant treatment with the CYP1A substrates mexiletine, propafenone, theophylline, verapamil or warfarin or statins (e.g. atorvastatin), protease inhibitors(e.g. ketoconazole) for either their interference with transport protein systems or for their strong inhibition of the P450 cytochrome pathway, or these drugs known for their potential to interfere with cardiac repolarization: amiodarone, arsenic trioxide, bepredil, budipine, cisapride, chinidine (quinidine), chloroquine, chlorpromazine, clarithromycin, disopyramide, dofetilide, domperidone, droperidol, erythromycin, halofantrine, haloperidol, ibutilide, levomethadyl, mesoridazine, methadone, pentamidine, pimozide, procainamide, sotalol, sparfloxacin, thioridazine
    • pre-treatment with the following substances prior to screening within the following
    time frames:
    • at any time: natalizumab, rituximab, mitoxantrone or cyclophosphamide; total lymphoid
    irradiation; anti-lymphocyte monoclonal antibody treatment (e.g., anti-CD4,
    Campath-1H);
    • up to 30 days prior to screening: any interferons, glatiramer acetate,
    corticosteroids and ACTH, IvIg, cyclosporine A, human antibodies, any other
    immunomodulating or immunosuppressive drugs including recombinant
    cytokines, any other putative or experimental MS treatment; any inoculation with attenuated live vaccines;
    • six month prior to screening: azathioprine
    • pregnancy or lactation;
    • history of alcohol or drug abuse within the year before screening;
    • medical, psychiatric or other conditions that compromise the subject's ability to
    understand the subject information, to give informed consent, to comply with the trial
    protocol, or to complete the study;
    • any reason why, in the investigator's opinion, the subject should not participate.

    If a subject suffers a relapse during the screening phase, he/she may not be randomized on the planned SoT visit. He/she may be randomized 30 days ± 3 days after the end of the last relapse.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Variable
    Cumulative number of newly active lesions over 24 weeks as seen on standardized brain MRI
    scans. The following lesions are considered newly active:
    • new gadolinium (Gd) enhancement on T1-weighted images;
    • non-enhancing on T1-weighted images but new on T2-weighted images;
    • new enlargement on T2-weighted images but non-enhancing on T1-weighted images.

    Pharmacokinetic and Pharmacodynamic Variables
    • for all subjects, plasma concentrations of CDP323, CT7758, and CT533652-00 will be determined from samples taken during specified time points; a 'sparse' sampling
    schedule will be followed
    • population-kinetic methods may be used to describe derived pharmacokinetic
    parameters for CDP323, CT7758, and CT533652-00
    • in a subset of centers suitable to set up the logistics for pharmacodynamic tests markers, such markers including VCAM1 binding may be determined; in addition, subjects participating in this pharmacodynamic sub-study will be asked to also undergo a more intense pharmacokinetic sampling schedule to allow an investigation of a kineticdynamic relationship. Some pharmacokinetic parameters will be computed from this subgroup.

    Safety Variables
    Standard and disease-related safety variables:
    • adverse events (AEs)
    • vital sign parameters (heart rate, blood pressure, body temperature, body weight)
    • blood chemistry: sodium, potassium, chloride, calcium, magnesium, urea, creatinine,
    SGOT, SGPT, GGT, AP, uric acid, bilirubin (total, conjugated and unconjugated), total
    serum protein, albumin, total cholesterol and glucose
    • hematology: erythrocytes, leukocytesa, differential leukocyte count including immature formsa, thrombocytes, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC)
    • thyroid function tests: TSH
    • clotting tests: partial thromboplastin time and prothrombin time
    • urinalysis: pH, protein, glucose, erythrocytes, leukocytes
    • 12-lead ECG: centrally measured or calculated variables: heart rate, PQ time, QRS
    time, and QT time in lead II; QTcB (corrected QT time calculated according to Bazett's
    formula); QTcF (corrected QT time calculated according to Fridericia's formula);
    ∆QTcBV4-QTcB3, ∆QTcBV5-QTcBV3, ∆QTcFV4-QTcFV3, and ∆QTcFV5-QTcFV3 (i.e.,
    differences between QTcB/QTcF calculated at V4 and V5 to the respective values
    calculated for Baseline (V3); central overall assessment of normal/abnormal findings
    with/without clinical relevance
    • proportion of subjects who have worsened by 1.0 EDSS point between the
    measurements at 'Start of treatment' (SoT) and EoT (EDSS = Expanded Disability
    Status Scale)
    Class-related
    • pre-post status for markers for infectious diseases:
    • Tuberculosis
    • Toxoplasmosis (IgG antibody to Toxoplasma gondii)
    • time-course of lymphocyte phenotyping (CD3, CD4, CD8, CD19, and CD25)a
    • presence of JC virus DNA in serum and/or PBMCs
    • presence of potential signs of progressive multifocal leukencephalopathy (PML)in MRI
    • presence of potential clinical signs and/or symptoms of PML
    Safety variables related to study drug withdrawal:
    • cumulative number of newly active lesions on the two T1/T2 post-withdrawal scans
    • cumulative volume of Gd-enhancing lesions (new or persisting) on the two T1 postwithdrawal scans
    •volume of hyperintense lesions (BOD) on T2 at wk40 or 'End of Study' (EoS)
    • 'scan activity' on each post-withdrawal scan
    • proportion of 'active' post-withdrawal scans per subject
    • 'subject activity' throughout the drug-free follow-up period
    • variables related to MS relapses (all at wk40 or EoS)
    • total number of relapses
    • number of relapses confirmed by the investigator
    • number of relapses documented otherwise
    • number of relapses treated with steroids
    • need for hospitalization due to relapses
    • proportion of relapse-free subjects
    • proportion of subjects who have worsened by 1.0 EDSS point between the
    measurements at EoT and 'End of study' (EoS)
    • number of 'activity-free' subjects at wk40 or EoS
    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 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) 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 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 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) 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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 202
    F.4.2.2In the whole clinical trial 279
    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)
    All subjects having received study drug will be followed every 12 months in an open-end fashion. The first such follow-up will be done at the investigational site while later follow-ups will be done over the telephone. Subjects having received placebo during the study will be followed only until the study code is broken.
    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 Decision2007-07-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-07-28
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