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    Summary
    EudraCT Number:2009-014339-19
    Sponsor's Protocol Code Number:ONO-4641POU006
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-01-29
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-014339-19
    A.3Full title of the trial
    A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS
    A.4.1Sponsor's protocol code numberONO-4641POU006
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01081782
    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 SponsorONO Pharmaceutical Co., Ltd.
    B.1.3.4CountryJapan
    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 supportOno Pharmaceutical Co. Ltd.
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOno Pharma UK, Ltd. (United Kingdom Subsidiary)
    B.5.2Functional name of contact pointGeneral European Contact Point
    B.5.3 Address:
    B.5.3.1Street Address11th Floor, Marble Arch Tower
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW1H 7AA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+442072585300
    B.5.5Fax number+442077235812
    B.5.6E-mailOPUK-Clinical@ono-uk.co.uk
    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 nameONO-4641
    D.3.2Product code ONO-4641
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeONO-4641
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.05
    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) 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.IMP: 2
    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 nameONO-4641
    D.3.2Product code ONO-4641
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeONO-4641
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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) 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.IMP: 3
    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 nameONO-4641
    D.3.2Product code ONO-4641
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeONO-4641
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.15
    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) 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
    Relapsing-remitting Multiple Sclerosis
    E.1.1.1Medical condition in easily understood language
    Multiple sclerosis is the result of damage to myelin a protective sheath surrounding nerve fibres of the central nervous system. This interferes with messages between the brain and rest of the body.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of the study is to evaluate the safety and efficacy of ONO-4641 at potentially therapeutic doses in patients with RRMS over a 26-week treatment period.
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients will be eligible to participate in this study if they meet all of the following criteria:
    1. Male and female patients aged 18 to 55 years (inclusive) at screening (Visit 1)
    2. Patients who have a definite diagnosis of relapsing remitting MS according to the 2005
    revised McDonald criteria (Appendix 19.2); AND who meet at least one of the following criteria:
    a. At least 2 documented relapses within previous 2 years prior to screening; OR
    b. At least 1 documented relapse within the year prior to screening; OR
    c. At least 1 Gd-enhanced lesion detected on locally-read MRI within 3 months prior to randomization (Visit 2);
    3. Patients with a stable neurological condition who have no evidence of relapse for at least 1 month prior to screening and during the screening period and at baseline (Visit 1 and reconfirm at Visit 2);
    4. Expanded Disability Status Scale (EDSS) score between 0 and 5.5 at Visits 1 and 2;
    5. duration of the study, male and female subjects of childbearing potential (ie, nonsterilized, premenopausal females) who are sexually active must use adequate contraception from 1 month prior to the first dose until 2 months after the last dose of study medication. An acceptable method of contraception is defined as one that has no failure rate or a <1% failure rate. It is recommended to combine a hormonal method (PEARL index < 1) with a barrier method.
    The following contraception methods are especially reliable according to the guidelines of the German Association of Gynaecology and Obstetrics:
    • Oral contraceptive pill with estrogen and gestagen (no micro pill)
    • Vaginal ring (i.e.. NuvaRing®)
    • Contraception plaster (i.e. EVRA®)
    • Estrogen-free ovulation inhibitor (i.e. Cerazette®)
    • Intradermal contraception sticks with progesteron (i.e. Implanon®)
    • Injection of gestagen every 3 months
    • Contraceptive coil with Progesteron (i.e. Minera®)
    Contraception with double barrier method (condom, contraceptive sponge, diaphragm, or vaginal ring with spermicidal gel or foam) Male subjects and women of child bearing potential will be provided with information on acceptable methods of contraception as part of the subject informed consent process, and will be advised of the requirements for avoidance of pregnancy from 1 month prior to the first dose until 2 months after the last dose of study medication. Subjects will receive continued guidance with respect to the avoidance of pregnancy as part of the study procedures. In addition to a negative serum hCG pregnancy test throughout the study period including screening, subjects also must have a negative urine hCG pregnancy test on the day of the first dose of study medication, prior to receiving any dose of study drug.
    6. Positive antibody enyzyme-linked immunosorbent assay (ELISA) for varicella zoster virus (chicken pox);
    7. Able and willing to provide signed, written, Informed Consent;
    E.4Principal exclusion criteria
    Patients will not be eligible to participate in this study if any of the following criteria apply:
    1. MS course other than RRMS;
    2. Patients who experienced their first documented MS symptom more than 12 years before the screening visit;
    3. Patients who have 10 or more Gd-enhanced lesions on locally-read MRI obtained during either Visits 1 or 2;
    4. Diagnosis of neuromyelitis optica (NMO);
    5. History of significant cardiac (e.g. coronary heart disease, myocarditis, cardiomyopathy, heart failure NYHA IIIV), hepatic, pulmonary, gastrointestinal or renal disease, immune deficiency, or any other medical conditions that would, in the investigator’s opinion, preclude therapy with ONO-4641
    6. Diagnosis of diabetes mellitus (type I or type II);
    7. History of severe respiratory disease, pulmonary fibrosis or asthma requiring chronic therapy (resolved childhood asthma is permitted);
    8. History of malignancy (including basal cell carcinoma);
    9. History of idiopathic CD4+ T-cell lymphopenia;
    10. History of clinically significant chronic disease of the immune system (other than MS);
    11. History of bone marrow transplant or total lymphoid irradiation;
    12. History of macular edema or macular dystrophy;
    13. Active systemic bacterial, viral or fungal infections, or positive for hepatitis B (HBsAg) antigen, hepatitis C (HCV) antibody or human immunodeficiency virus (HIV-1 and HIV-2) antibody at screening;
    14. Inability to undergo Gd-enhanced MRI scans;
    15. Prior treatment with:
    a. Alemtuzumab, rituximab, cladribine, cyclophosphamide or mitoxantrone at any time;
    b. Immunosuppressive medications (including, but not limited to, azathioprine, methotrexate, mycophenolate mofetil) within 6 months prior to randomization (Visit 1 and reconfirm at Visit 2);
    c. Immunoglobulins or monoclonal antibodies (including natalizumab) within 6 months prior to randomization (Visit 1 and reconfirm at Visit 2);
    d. Interferon beta or glatiramer acetate within 3 months prior to randomization (Visit 1 and reconfirm at Visit 2);
    e. Systemic or inhaled corticosteroids or adrenocorticotropic hormones (ACTH) within 1 month prior to screening;
    f. Plasmapheresis therapy within 1 month prior to screening;
    g. CYP3A4 inhibitors/inducers (except for rifampin) within 1 week prior to screening;
    h. Rifampin within 1 month prior to screening;
    i. Live vaccine within 1 month prior to randomization.
    16. Any of the following abnormal laboratory values:
    a. WBC < 3,500 cell/μL at screening;
    b. Lymphocyte count < 800 cell/μL at screening;
    c. ALT or aspartate aminotransferase (AST) > 2 × ULN at screening;
    d. Creatinine >1.5 mg/dL or estimated glomerular fitration rate (EGFR)
    ≤30 mL/min/1.73 m2 at screening.
    17. Any of the following cardiovascular conditions:
    a. History of symptomatic bradycardia, sick sinus syndrome, sino-atrial block, second (Mobitz type II) or third degree AV block, sustained VT, atrial fibrillation;
    b. History of myocardial infarction within 6 months at screening;
    c. Current unstable angina pectoris, history of angina pectoris due to coronary spasm, Raynaud’s syndrome (secondary Raynaud’s), or cardiac arrest;
    d. Resting heart rate <55 beat/min based on ECG at screening or history of any cardiac conditions that might increase the risk of a significant reduction in heart rate (e.g. any delay in the cardiac stimulus conduction on ECG);
    e. QTcB interval > 450 msec on 12-lead ECG at screening;
    f. Arrhythmia requiring current treatment;
    g. Hypertension uncontrolled by medication;
    18. Forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) < 75% of the predicted values at screening;
    19. Positive for the substance abuse screen conducted at screening (not if prescribed by a physician [e.g. opioids for chronic pain]);
    20. History of substance abuse or dependence (except nicotine or caffeine) within 6 months as judged by the Investigator at screening;
    21. History of alcohol abuse or dependence within 6 months as judged by the Investigator at screening;
    22. Received any investigational drug within 6 months (except S1P receptor agonists including ONO-4641 within 3 months) prior to randomization;
    23. In the opinion of the Investigator, a patient who may not be able to cooperate fully with the study staff, may have difficulty in some study requirements, or is otherwise not
    qualified for the study;
    24. Patients who may not have the ability to provide a valid, signed written informed consent.
    25. Any medical condition that poses a significant risk of predisposing a patient to induction of cardiac arrhythmias (e.g. status post catheter ablation, hyperkalemia [defined as 2 consecutive measures of K+ above 6.0 mEq/L])
    26. History of syncope
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the cumulative number of T1-weighted Gd-enhanced lesions obtained with MRI at Visits 5 to 9 (Weeks 10, 14, 18, 22 and 26).

    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 10, 14, 18, 22 and 26
    E.5.2Secondary end point(s)
    The secondary endpoints include:
    - the total number of T1-weighted Gd-enhanced lesions obtained with MRI at 4-week intervals for 26 weeks,
    - the cumulative volume of Gd-enhanced lesions,
    - the total number of new or enlarging T2 lesions,
    - change in T2 lesion volume,
    - change in brain volume,
    - the proportion of patients with Gd-enhanced lesions,
    - the number of patients remaining free of relapse,
    - annualized relapse rate,
    - the time to the first relapse,
    - and the change from baseline in EDSS scores.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 10, 14, 18, 22 and 26
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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) 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.8.2.4Number of treatment arms in the trial4
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Japan
    Russian Federation
    Ukraine
    United States
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 376
    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 state87
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 376
    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)
    At Visit 8, patients will be assigned to the extension study ONO-4641POU007. The ONO-POU007 study is a 122-week, dose-blinded, randomized, safety and efficacy multicenter extension trial in patients with RRMS. For further details please refer to the protocol of ONO-4641POU007, EudraCT #: 2010-018705-11.
    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 Decision2010-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-11-29
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