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    Summary
    EudraCT Number:2014-000253-36
    Sponsor's Protocol Code Number:CD-IA-MEDI-551-1155
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-04-16
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-000253-36
    A.3Full title of the trial
    A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders
    A.3.2Name or abbreviated title of the trial where available
    A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD
    A.4.1Sponsor's protocol code numberCD-IA-MEDI-551-1155
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02200770
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1159-8686
    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 SponsorMedImmune LLC
    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 supportMedImmune LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedImmune LLC
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressOne MedImmune Way
    B.5.3.2Town/ cityGaithersburg
    B.5.3.3Post codeMD 20878
    B.5.3.4CountryUnited States
    B.5.4Telephone number13013980000
    B.5.6E-mailinformationcenter@astrazeneca.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/17/1856 – EMA/OD/267/16
    D.3 Description of the IMP
    D.3.1Product nameMEDI-551
    D.3.2Product code MEDI-551
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNInebilizumab
    D.3.9.1CAS number 1299440-37-1
    D.3.9.2Current sponsor codeMEDI-551
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    D.3.11.13.1Other medicinal product typeMEDI-551 is a humanized, affinity-optimized, afucosylated immunoglobulin G1 kappa (IgG1κ) 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 placeboSolution 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
    Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD)
    E.1.1.1Medical condition in easily understood language
    Neuromyelitis optica (NMO) and NMO Spectrum Disorders, involve inflammation and damage of the optic nerve (optic neuritis), spinal cord (myelitis) and certain areas of the brain.
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10029322
    E.1.2Term Neuromyelitis optica
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of MEDI-551 versus placebo in reducing the risk of an NMO/NMOSD attack
    E.2.2Secondary objectives of the trial
    1. To compare the efficacy of MEDI-551 versus placebo on the reduction of EDSS worsening
    2. To compare the efficacy of MEDI-551 versus placebo on the change from baseline of low-contrast visual acuity score
    3. To compare the efficacy of MEDI-551 versus placebo in reducing the cumulative active MRI lesion count
    4. To compare the efficacy of MEDI-551 versus placebo in reducing NMO/NMOSD-related in-patient hospitalizations
    5. To characterize the long-term efficacy of MEDI-551 by means of annualized attack rate.
    6. To evaluate the safety and tolerability of a single course of MEDI-551 in randomised control phase and repeated doses of MEDI-551 in open label phase
    7. To characterize the pharmacokinetic (PK) profile and immunogenicity of MEDI-551
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Men and women 18 years or older with diagnosis of NMO/NMOSD.
    2) Confirmation of NMO/NMOSD status:
    a.) AQP4-IgG sero-positive NMO/NMOSD with at least one attack requiring rescue
    therapy in the last year or two attacks requiring rescue therapy in the last 2 years.
    b.) AQP4-IgG sero-negative NMO with at least one attack requiring rescue therapy in the
    last year or two attacks requiring rescue therapy in the last 2 years.
    3) Able and willing to give written informed consent and comply with the requirements of the study protocol.
    4) EDSS <= 7.5 (8 in special circumstances).
    5) Men and women of reproductive potential must agree to use a highly effective method of birth control from screening to 6 months after final dose of the investigational product.
    E.4Principal exclusion criteria
    1) Lactating and pregnant females.
    2) Treatment with any investigational agent within 4 weeks of screening.
    3) Known history of a severe allergy or reaction to any component of the investigational product formulation or history of anaphylaxis following any biologic therapy.
    4) Known active severe bacterial, viral, or other infection or any major episode of infection requiring hospitalization.
    5) History of of alcohol, drug, or chemical abuse, or a recent history of such abuse < 1 year prior to randomization.
    6) Receipt of the following at any time prior to randomization:
    a) Alemtuzumab
    b) Total lymphoid irradiation
    c) Bone marrow transplant
    d) T-cell vaccination therapy
    7) Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior screening and B-cells below the lower limit of normal.
    8) Receipt of IVIG within 1 month prior to randomization.
    9) Receipt of any of the following within 3 months prior to randomization:
    a) Natalizumab (Tysabri®)
    b) Cyclosporin
    c) Methotrexate
    d) Mitoxantrone
    e) Cyclophosphamide
    f) Tocilizumab
    g) Eculizumab
    10) History of Hepatitis B and/or Hepatitis C (Hep B/C at screening).
    11) Known history of a primary immunodeficiency (congenital or acquired) or an underlying condition such as human immunodeficiency virus (HIV) infection.
    12) History of malignancies, apart from squamous cell or basal cell carcinoma of the skin treated with documented success of curative therapy > 3 months prior to randomization.
    13) Any concomitant disease other than NMO/NMOSD that required treatment with oral or intravenous steroids at doses over 20 mg a day for over 21 days.
    E.5 End points
    E.5.1Primary end point(s)
    Time to an NMO/NMOSD attack determined by Adjudication Committee in randomized-control period
    E.5.1.1Timepoint(s) of evaluation of this end point
    on or before Day 197
    E.5.2Secondary end point(s)
    1. Worsening from baseline in EDSS at last visit during the RCP.
    2. Change from baseline in low-contrast visual acuity binocular score measured by low-contrast Landolt C Broken Rings Chart, at last visit during RCP.
    3. Cumulative total active MRI lesions (new Gd-enhancing or new/enlarging T2) during the RCP.
    4. Number of NMO/NMOSD-related in-patient hospitalizations. In-patient hospitalization is defined as more than an overnight stay.
    5. Annualized attack rate (total number of AC-determined NMO/NMOSD attacks normalized by person years) during any exposure to MEDI-551.
    6. Treatment-emergent adverse events (TEAEs), including treatment-emergent serious adverse events (TESAEs). Laboratory measurements as well as their changes or shift from baseline over time.
    7. Pharmacokinetic profile of MEDI-551.
    8. Incidence of anti-drug antibodies (ADAs) directed against MEDI-551 for the duration of the study, both predose and postdose for each subject.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of Randomized-controlled Period and End of Study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Open label extension
    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 trial2
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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
    Australia
    Bulgaria
    Canada
    China
    Colombia
    Czech Republic
    Estonia
    Germany
    Greece
    Hong Kong
    Hungary
    India
    Israel
    Japan
    Korea, Republic of
    Mexico
    Moldova, Republic of
    Netherlands
    New Zealand
    Peru
    Poland
    Russian Federation
    Serbia
    South Africa
    Spain
    Taiwan
    Thailand
    Turkey
    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
    The end of the study is defined as the date of the last protocol-specified visit/assessment (including telephone contact) for the last subject in the study. This will occur when the last subject completes the 52-week safety follow up.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    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 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.1.2.1Number of subjects for this age range: 240
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 92
    F.4.2.2In the whole clinical trial 252
    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)
    Revert to standard of care for the condition
    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 Decision2018-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-30
    P. End of Trial
    P.End of Trial StatusOngoing
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