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    Summary
    EudraCT Number:2013-000228-33
    Sponsor's Protocol Code Number:GN12NE462
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-10-01
    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 number2013-000228-33
    A.3Full title of the trial
    Inhibition of complement activation (eculizumab®) in Guillain-Barré Syndrome study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ICA-GBS
    A.3.2Name or abbreviated title of the trial where available
    ICA-GBS
    A.4.1Sponsor's protocol code numberGN12NE462
    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 SponsorNHS Greater Glasgow & Clyde
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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
    B.Sponsor: 2
    B.1.1Name of SponsorThe University of Glasgow
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAlexion Pharmaceuticals
    B.4.2CountryUnited States
    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 Yes
    D.2.1.1.1Trade name Soliris
    D.2.1.1.2Name of the Marketing Authorisation holderAlexion Europe SAS
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameEculizumab
    D.3.2Product code N/A
    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 INNEculizumab
    D.3.9.1CAS number 219685-50-4
    D.3.9.2Current sponsor codeN/A
    D.3.9.4EV Substance CodeAS1
    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 Yes
    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 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
    Guillain-Barré Syndrome
    E.1.1.1Medical condition in easily understood language
    Acute inflammatory process causing rapidly progressive muscle weakness, with risks of respiratory failure and death.
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10018766
    E.1.2Term Guillain Barre syndrome
    E.1.2System Organ Class 100000004852
    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 safety and tolerability, of eculizumab in patients with GBS.
    E.2.2Secondary objectives of the trial
    To determine whether more GBS patients improve in functional outcome (GBS disability scale) after treatment with eculizumab and IVIg compared to placebo controls, 4 weeks after randomisation.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients aged ≥18 years diagnosed with GBS according to NINDS diagnostic criteria
    • Onset of weakness due to GBS is less than 2 weeks ago
    • Patients who are unable to walk unaided for >10 meters
    (grade ≥ 3 on GBS disability scale)
    • Patients who are being considered for or already on IVIg treatment
    • First dose of eculizumab must be started within 2 weeks from onset of weakness and any
    time during the IVIg treatment period
    • Signed informed consent
    E.4Principal exclusion criteria
    • Age<18 years

    • Patients who are being considered for, or already on, plasma exchange

    • Pregnancy or lactation

    • Patient shows clear clinical evidence of a polyneuropathy caused by e.g. diabetes mellitus
    (except mild sensory), alcoholism, severe vitamin deficiency, and porphyria

    • Patient received immunosuppressive treatment (e.g. azathioprine, cyclosporine, mycofenolatemofetil,
    tacrolimus, sirolimus or > 20 mg prednisolone daily) during the last month

    • Patient known to have a severe concurrent disease, like malignancy, severe cardiovascular disease, AIDS,
    severe COPD, TB

    • Inability to comply with study related procedures or appointments during 6 months

    • Any condition that in the opinion of the investigator could increase the patient’s risk by participating in the
    study or confound the outcome of the study

    • Related to the administration of eculizumab:

    ➢ Unresolved Neisseria meningitidis infection or history of meningococcal infection
    ➢ Unsuitable for antibiotic prophylaxis (e.g. due to allergy)
    ➢ Known hypersensitivity to eculizumab, murine proteins or to any of the excipients
    ➢ Known or suspected hereditary complement deficiencies
    ➢ Women of child-bearing potential who are unwilling to use effective contraception during treatment and for 5
    months after treatment is completed.
    E.5 End points
    E.5.1Primary end point(s)
    Primary safety endpoint
    To determine the incidence of AE/SAEs after treatment with eculizumab and IVIg compared to placebo controls

    Primary Efficacy Endpoint
    Improvement of one or more grade in functional outcome (on the 6 point GBS disability scale) at 4 weeks.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary Safety endpoint timepoint will be at close of study.

    Primary Efficacy Endpoint will be evaluated by the research team at 4 weeks.
    E.5.2Secondary end point(s)
    • Ability to walk unaided (GBS disability score 2) at 8 weeks.
    • Time taken to improve by at least one grade (on the GBS disability scale).
    • Time taken to walk independently.
    • Difference in GBS disability score at maximum disability compared with 6 months.
    • Percentage of patients with a clinically relevant improvement in R-ODS score defined as an increase from Baseline in R-ODS score by at least 6 points on the centile metric score at 4 weeks and 6 months.
    • Percentage of patients with a clinically relevant improvement in ONLS defined as an increase from Baseline in ONLS score by at least 1 point at 4 weeks and 6 months.
    • Requirement for ventilatory support (GBS disability score 5).
    • Duration of ventilatory support.
    • Occurrence of relapse.
    • Death within the first 6 months.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary end points will be evaluated at each clinical encounter.
    Significant time points are:
    Improvements in RODS/ONLS at 4 weeks and 6 months
    Mobility at 8 weeks.
    GBS disability score at 6 months
    Fatality at 6 months (attributable to GBS)
    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 No
    E.6.7Pharmacodynamic No
    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 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) 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 concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    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 months6
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days1
    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: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state30
    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)
    Not applicable. GBS is a monophasic illness and thus will not require any long term therapeutic intervetion. At the end of the study patients will revert back to standard care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-11-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-08-10
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