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    Summary
    EudraCT Number:2007-004223-38
    Sponsor's Protocol Code Number:GEN414/OMS115102
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-11-26
    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 ConcernedUK - MHRA
    A.2EudraCT number2007-004223-38
    A.3Full title of the trial
    A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients
    A.3.2Name or abbreviated title of the trial where available
    Ofatumumab dose-finding in RRMS patients
    A.4.1Sponsor's protocol code numberGEN414/OMS115102
    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 SponsorGlaxoSmithKline UK
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationi3 Research
    B.5.2Functional name of contact pointAnn Spratley
    B.5.3 Address:
    B.5.3.1Street AddressSygnus Court, 22-32 Market Street
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 8AD
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 01708853742
    B.5.5Fax number+4401628408401
    B.5.6E-mailann.spratley@i3research.com
    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 nameOfatumumab
    D.3.2Product code HuMax-CD20
    D.3.4Pharmaceutical form Concentrate for 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 INNOfatumumab
    D.3.9.1CAS number 679818-59-8
    D.3.9.2Current sponsor codeHuMax-CD20
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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 Yes
    D.3.11.13.1Other medicinal product typeHuman monoclonal antibody
    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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    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 (RRMS)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A: Evaluate the safety of three doses of ofatumumab in patients with relapsing remitting multiple sclerosis (RRMS).
    E.2.2Secondary objectives of the trial
    Part A: Evaluate the pharmacokinetic (PK) profile of ofatumumab in patients with RRMS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with definite diagnosis of relapsing-remitting MS according to McDonald criteria
    2. Patients with:
    • At least two confirmed relapses within the last 24 months or
    • At least one confirmed relapse within the last 12 months or
    • One confirmed relapse between 12 and 24 months prior to screening, and at least one documented T1 Gd-enhancing lesion on an MRI performed within 12 months prior to screening.
    3. Patients with disability equivalent to Expanded Disability Status Scale (EDSS) score of 0-5.0 (both included) at screening
    4. Neurologically stable patients with no evidence of relapse for at least 30 days prior to start of Screening and during the Screening Phase
    5. Age 18-55 years
    6. Female patients must be either post-menopausal, surgically incapable of bearing children or practicing an acceptable method of birth control e.g. hormonal contraceptives, intrauterine device, spermicide and barrier as long as they are on trial medication and for a period of 1 year following the last infusion of trial drug. Females of childbearing potential must have a negative pregnancy test at screening visit prior to entry into the treatment period
    7. Following receipt of verbal and written information about the trial, the patient must provide signed informed consent before any trial related activity is carried out.
    E.4Principal exclusion criteria
    Please refer to protocol for full list of exclusion criteria
    1. Diagnosis of SPMS, PPMS or PRMS or Neuromyelitis optica
    2. Neurological findings consistent with PML
    3. Findings on brain MRI scan indicating any other clinically significant brain abnormality other than MS
    4. Patients unable to undergo MRI scans
    5. Patients who have had the following treatments:
    • Lymphocyte-depleting therapies (e.g. alemtuzumab (Campath®), anti-CD4, cladribine, total body irradiation, bone marrow transplantation), mitoxantrone or cyclophosphamide • Anti-CD20 treatments or any monoclonal antibodies
    • Immunoglobulin, azathioprine, cyclosporine, tacrolimus or other immunosuppressive agents, immunomodulatory agents or plasma exchange within six months prior to randomization in the trial apart from Glatiramer Acetate and IFN-beta
    • Glatiramer Acetate or IFN-beta within three months prior to the randomization
    • Glucocorticoids or ACTH within one month prior to the screening
    • Receipt of a live vaccine within one month prior to screening
    • Plasmapheresis for treatment of relapses within 2 months prior to randomization
    • Initiation of therapy with Statins or hormone replacement treatment within one month or less prior to screening
    • Patients who have received other disease modifying therapies for MS may be allowed on a case to case basis
    6. Past or current history of medically significant adverse effects (including allergic reactions) from:• Cetirizine • Prednisolone• Paracetamol/acetaminophen• Plasma proteins or a known hypersensitivity to components of the investigational product.
    7. Past or current malignancy, except for • Cervical carcinoma Stage 1B or less • Non-invasive basal cell and squamous cell skin carcinoma • Cancer diagnoses with a complete response of a duration of > 5 years. Patients with a prior history of hematological malignancies are excluded regardless of response
    8. Clinically significant cardiac disease, including acute myocardial infarction within six months from screening, unstable angina, congestive heart failure, previous venous or arterial thrombosis or arrhythmia requiring therapy.
    9. Electrocardiogram (ECG) showing significant abnormality
    10. Significant concurrent, uncontrolled medical condition
    11. History of severe, clinically significant CNS trauma
    12. Chronic or ongoing active infectious disease requiring systemic treatment
    13. Female patients who are pregnant or nursing.
    14. Use of an investigational drug or other experimental therapy for a condition other than MS within 4 weeks prior to screening. Any prior use of an investigational drug or other experimental therapy for MS at any time should be discussed
    15. Current participation in any other interventional clinical study
    16. Serum vitamin B12 below lower limit of normal
    17. Positive PCR screening for JC Virus as measured by qualitative plasma and/or white blood cell JCV DNA
    18. Serologic evidence of Hepatitis B (HB) infection based on the results of testing for HBsAg, anti-HBc and anti-HBs antibodies with eligibility based on the results as follows:
    1. Patients positive for HBsAg are excluded
    2. Patients negative for HBsAg but positive for both anti-HBc and anti-HBs antibodies (indicating past infection) are eligible
    3. Patients negative for HBsAg and anti-HBc antibody but positive for anti-HB
    antibody (indicating past vaccination) are eligible
    4. Patients negative for HBsAg and anti-HBs antibody but positive for anti-HBc antibody will require clarification of their status by testing for HB DNA, which if positive will exclude the patient from participation
    Patient with documented vaccination against Hepatitis B (primary and secondary immunization and booster) will be considered eligible for the trial.
    19. Positive serology for HIV
    20. Screening laboratory values:• WBC < 3.0 x 109/L • Neutrophils < 2 x 109/L • Platelets < 100 x 109/L • Circulating IgG level < lower limit of normal • S-ALAT > 2.5 times the upper limit of normal • S-AP > 2.0 times the upper limit of normal • ASAT >3.0 times the upper limit of normal • Bilirubin > 1.5 times the upper limit of normal
    • S-creatinine > the upper limit of normal • CD4 count <500 cells/mm3, CD4:CD8 <0.9
    22. Positive test for Hepatitis C antibody confirmed with a Hepatitis C real time (RT) PCR assay. Patients who are positive for Hepatitis C antibody and negative when the Hepatitis C RT PCR assay is performed will be eligible for the study. Patients who are positive for Hepatitis C antibody and have a positive or indeterminate result when the Hepatitis C RT PCR assay is performed will not be eligible for the study.
    23. Positive test results for tuberculosis using the QuantiFERON test and/or Chest X-ray findings suggestive of tuberculosis. For patients who have had a Chest X-ray performed within the past 6 months without any findings indicative of TB, QuantiFERON test alone may be performed.
    E.5 End points
    E.5.1Primary end point(s)
    Cumulative number of new Gd-enhancing lesions on T1-weighted MRI from week 8 to week 24.
    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 No
    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 Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Part A: Dose Escalation
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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 visit for individualized follow up
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 57
    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 Decision2007-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-10-26
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