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    Summary
    EudraCT Number:2018-001059-12
    Sponsor's Protocol Code Number:15-HMedIdeS-09
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-12-19
    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 ConcernedUK - MHRA
    A.2EudraCT number2018-001059-12
    A.3Full title of the trial
    An open-label, single arm, multi-centre, phase II study investigating safety, tolerability, efficacy, pharmacodynamics and pharmacokinetics of imlifidase (IdeS) in patients with Guillain-Barré Syndrome (GBS), in comparison with matched control patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study investigating the safety and effect of Imlifidase (IdeS) in patients with Guillain-Barré Syndrome (GBS)
    A.4.1Sponsor's protocol code number15-HMedIdeS-09
    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 SponsorHansa Biopharma AB
    B.1.3.4CountrySweden
    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 supportHansa Biopharma AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHansa Biopharma AB
    B.5.2Functional name of contact pointClinical Study Information
    B.5.3 Address:
    B.5.3.1Street AddressScheelevägen 22
    B.5.3.2Town/ cityLund
    B.5.3.3Post codeSE-223 63
    B.5.3.4CountrySweden
    B.5.6E-mailclinicalstudyinfo@hansabiopharma.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 nameImlifidase
    D.3.2Product code Imlifidase
    D.3.4Pharmaceutical form Powder for 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 INNImlifidase
    D.3.9.1CAS number 1947415-68-0
    D.3.9.3Other descriptive nameIMLIFIDASE
    D.3.9.4EV Substance CodeSUB191871
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Guillain-Barré Syndrome (GBS)
    E.1.1.1Medical condition in easily understood language
    Guillain-Barré Syndrome (GBS)
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess safety and tolerability of imlifidase in combination with standard IVIg treatment in GBS subjects
    E.2.2Secondary objectives of the trial
    • Evaluate pharmacokinetics of imlifidase
    • Evaluate pharmacodynamics profile of imlifidase
    • Evaluate efficacy of imlifidase in subjects with GBS
    • Compare the outcome of GBS subjects after a dose of imlifidase in combination with standard IVIg treatment with matched control subjects obtained as part of the IGOS study with respect to reduction in severity of symptoms and improved recovery time in terms of:
    • Evaluate time to improvement on the GBS DS
    • Evaluate time to walk independently (DS 2)
    • Evaluate proportion of subjects with a clinically relevant improvement in R-ODS score
    • Evaluate proportion of subjects requiring ventilator support (GBS DS 5)
    • Evaluate time on a ventilator
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed Informed Consent obtained before any study-related procedures.
    2. Willingness and ability to comply with the protocol.
    3. Male or female aged ≥18 years at the time of screening.
    4. GBS diagnosed according to National Institute of Neurological Disorders and Stroke (NINDS) diagnostic criteria (Asbury et al. 1990)
    5. Onset of weakness due to GBS is not more than 10 days prior to screening.
    6. Unable to walk unaided for >10 meters (grade ≥ 3 on GBS DS).
    7. IVIg treatment being considered.
    8. Women of child-bearing potential willing or able to use at least one highly effective contraceptive method from the day of treatment until at least 6 months after the dose of imlifidase if not abstinent. In the context of this study, an effective method is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.
    9. Men willing to use double-barrier contraception from the day of treatment until at least 2 months after the dose of imlifidase if not abstinent.
    E.4Principal exclusion criteria
    1. Previous treatment with imlifidase.
    2. Previous IVIg treatment within 28 days prior to imlifidase treatment.
    3. Subjects who are being considered for, or already on, PE.
    4. Women of childbearing potential who are not willing to use contraception from the screening visit until at least 180 days following imlifidase dosing.
    5. Breastfeeding or pregnancy
    6. Clinical evidence of a polyneuropathy of another cause e.g. diabetes mellitus (except mild sensory), alcoholism, vitamin deficiency, or porphyria.
    7. Known selective IgA deficiency.
    8. Hypersensitivity to IVIg or to any of the excipients.
    9. Immunosuppressive treatment (e.g. azathioprine, cyclosporine, mycofenolatemofetil, tacrolimus, sirolimus or > 20 mg prednisolone daily) during the last month.
    10. Subject known to have a severe concurrent disease, e.g. malignancy, severe cardiovascular disease and severe chronic obstructive pulmonary disease (COPD).
    11. Any condition that in the opinion of the investigator could increase the subject's risk by participating in the study or confound the outcome of the study.
    12. Known mental incapacity or language barriers precluding adequate understanding of the Informed Consent information and the study activities.
    13. Subjects with clinical signs of ongoing infectious diseases that requires treatment.
    14. Subjects who have received other investigational drugs within 5 halflives prior to imlifidase dosing.

    A subject will be withdrawn from the study if more than 12 days elapse between the onset of weakness and planned imlifidase administration, thus preventing that the administration of IVIg after imlifidase administration would be later than 14 days after onset of weakness.
    E.5 End points
    E.5.1Primary end point(s)
    Safety as measured by type, frequency and intensity of Adverse Event (AE) / Serious Adverse Event (SAE) and change from baseline in parameters of clinical laboratory tests, vital signs and Electrocardiograms (ECG).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study
    E.5.2Secondary end point(s)
    • Efficacy as assessed by the proportion of subjects with improvement of one or more grades in disability outcome (on the 6-point GBS DS)
    • Time to walk independently (DS 2).
    • Proportion of subjects with an increase from baseline in R-ODS score by at least 6 points on the centile metric score at 4, 8 and 26 weeks.
    • Proportion of subjects requiring ventilator support (GBS disability score 5).
    • Time on a ventilator (counted only if at least 12 hours/day).
    • Pharmacokinetics (PK) parameters Cmax, Area under the curve (AUC), tmax, t½, V, Clearance (CL), of imlifidase
    • Pharmacodynamics (PD) effect by means of time course of IgG following administration of imlifidase
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy: at 4 weeks
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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 EEA10
    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 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
    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 days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    A physically disabled patient may lack the capability to sign the ICF, in that case consent must be obtained using local regulations (eg next of kin or designated authorised person consenting on behalf of the patient, as applicable)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    Standard of care
    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 Decision2019-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-29
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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