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    Summary
    EudraCT Number:2013-005557-73
    Sponsor's Protocol Code Number:I10E-1302
    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:2014-08-15
    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 number2013-005557-73
    A.3Full title of the trial
    An international, multicentre, efficacy and safety study of I10E in
    initial and maintenance treatment of patients with Chronic
    Inflammatory Demyelinating Polyradiculoneuropathy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An international study on efficacy and safety of I10E in CIDP patients
    A.3.2Name or abbreviated title of the trial where available
    PRISM
    A.4.1Sponsor's protocol code numberI10E-1302
    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 SponsorLFB BIOTECHNOLOGIES
    B.1.3.4CountryFrance
    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 supportLFB BIOTECHNOLOGIES
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLFB BIOTECHNOLOGIES
    B.5.2Functional name of contact pointClinical trial information desk
    B.5.3 Address:
    B.5.3.1Street Address3, avenue des Tropiques, BP 40305 – LES ULIS
    B.5.3.2Town/ cityCOURTABOEUF CEDEX
    B.5.3.3Post code91958
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 1 69 82 70 10
    B.5.5Fax number+33 1 69 82 72 72
    B.5.6E-mailleonem@lfb.fr
    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 IQYMUNE
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoire Francais du Fractionnement et des Biotechnologies
    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 namehuman normal immunoglobulin for intravenous administration
    D.3.2Product code I10E
    D.3.4Pharmaceutical form 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 INNHUMAN NORMAL IMMUNOGLOBULIN (IV)
    D.3.9.2Current sponsor codeI10E
    D.3.9.3Other descriptive nameHUMAN NORMAL IMMUNOGLOBULIN (IV)
    D.3.9.4EV Substance CodeSUB12041MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    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
    Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
    E.1.1.1Medical condition in easily understood language
    Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an acquired paralytic illness affecting peripheral nerves and caused by a demyelinating process.
    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 PT
    E.1.2Classification code 10057645
    E.1.2Term Chronic inflammatory demyelinating polyradiculoneuropathy
    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 primary objective of this study is to assess the efficacy of I10E in improving the disability of patients with CIDP.

    E.2.2Secondary objectives of the trial
    The secondary objective is to assess the safety of I10E in patients with CIDP.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patient aged 18 years or more.
    2. - Definite or probable CIDP according to the European Federation of Neurological Societies (EFNS)/Peripheral Nerve Society (PNS) guidelines 2010 clinical and neurophysiological criteria.
    - Pure motor CIDP, provided that a diagnosis of multifocal motor neuropathy has been ruled out.
    - CIDP associated with monoclonal gammopathy of undetermined significance (MGUS), provided that anti-MAG antibodies titer is lower than the used technique's negativity threshold (1000 BTU for Bühlmann ELISA technique).
    - Lewis-Sumner syndrome.
    3. Score of at least 2 on the adjusted INCAT disability scale.
    4. Patient who either :
    a) has never been previously treated with Ig (Ig-naive patient)
    Or
    b) was previously treated with Ig but is in clinical relapse following treatment withdrawal. In the latter case, the last Ig course shall have been administered no less than 3 months prior to screening.
    5. Covered by national healthcare insurance system as required by local regulations.
    6. Written informed consent obtained prior to any study-related procedures.
    E.4Principal exclusion criteria
    1. History of severe allergic reaction or serious adverse reaction to any immunoglobulin (Ig).
    2. Clinically documented lack of response to previous Ig treatment.
    3. History of IgA deficiency (IgA ≤ 70 mg/L), unless the absence of anti-IgA antibodies has been documented.
    4. Known hypersensitivity to human Ig or to any of the excipients of I10E (glycine and polysorbate 80).
    5. History of cardiac insufficiency (New York Heart Association [NYHA] III/IV), uncontrolled cardiac arrhythmia, unstable ischemic heart disease, or uncontrolled
    hypertension.
    6. History of venous thrombo-embolic disease, myocardial infarction or, cerebrovascular accident.
    7. Risk factor for blood hyperviscosity such as cryoglobulinemia or haematologic malignancy with monoclonal gammopathy.
    8. History of personal or familial congenital thrombophilia or acquired thrombophilia.
    9. Factors contributing to venous stasis such as long-term bed confinement.
    10. Body mass Index (BMI) ≥40 kg/m².
    11. Protein-losing enteropathy characterised by total serum protein levels <60 g/L and serum albumin levels <30 g/L or nephrotic syndrome characterised by proteinuria ≥3.5 g/24hours, serum protein levels <60 g/L and serum albumin levels <30 g/L.
    12. History of kidney transplantation, nephrotic syndrome (defined as proteinuria > 3.5 g per 24 hours accompanied by hypoalbuminemia and edema), or any acute or chronic kidney disease that in the opinion of the investigator and/or nephrologist would preclude that the use of I10E and/or interfere with the assessment of the safety and efficacy of I10E.
    AND / OR
    *Chronic kidney disease (CKD) for more than 3 months as documented by at least one of the following:
    *Glomerular filtration rate <60 mL/min/1.73m² measured according to the Modified Diet in Renal Disease (MDRD) formula
    AND/OR
    *urine protein reagent strip: ≥ 2 crosses
    AND/OR
    *urine protein reagent strip: one cross with one of the following:
    *albumin excretion rate (AER) > 300 mg/24 hours or protein excretion rate (PER) > 500 mg/24 hours (24h-urine collection)
    OR
    *albumin to creatinine ration (ACR) >30mg/mmol or protein to creatinine ratio (PCR) > 50 mg/mmol (spot urine sample)
    13. Serum levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times upper limit of normal (ULN) range.
    14. Any other ongoing disease that may cause chronic peripheral neuropathy, such as toxin exposure, dietary deficiency, uncontrolled diabetes, hyperthyroidism, cancer, systemic lupus erythematosus or other connective tissue diseases, infection with HIV, HBV or HCV, Lyme disease, multiple myeloma, Waldenström's macroglobulinaemia, amyloid, and hereditary
    neuropathy.
    15. Woman with positive results on a urine pregnancy test or breastfeeding woman or woman of childbearing potential without an effective contraception.
    Effective contraceptive are injectables, patch or oral combinded o eston progestative or progestative contraceptives, Cooper T or levonorgest releasing intra-uterine devices, depot intramuscular medroxyprogesterone, subcutaneous progestative contraceptive implants, condoms or occulsive caps (diapgragm or cervical/ vault caps) with spermicide, true abstinence (when this is in line with the preferred and usual lifestyle of the patient).
    16. Any other serious medical condition that would interfere with the clinical assessment of CIDP or use of I10E or prevent the patient from complying with the protocol requirements.
    17. Increasing dosage or introduction of a systemic corticoids therapy, or corticosteroid therapy at a dose higher than 10 mg prednisolone per day or equivalent within the last 3 months prior to screening. Topical corticosteroids are permitted.
    18. Treatment within 12 months prior to screening with immunomodulatory or immunosuppressant agents (including but not limited to cyclophosphamide, cyclosporine, interferon-α, interferon-β1a, anti-CD20, alemtuzumab, aziathioprine, etanercept, mycophenolate mofetil, methotrexate and haemopoetic stem cell transplantation.)
    19. Plasma exchange, blood products or derivatives administered within the last 3 months prior to screening.
    20. Administration of another investigational product within the last month prior to screening.
    21. Drug or alcohol abuse.
    22. Anticipated poor compliance of patient with study procedures.
    E.5 End points
    E.5.1Primary end point(s)
    Responder rate at EOS visit.
    Responders are defined as patients with a decrease ≥1 point in the adjusted INCAT disability score between baseline and the EOS visit.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at baseline and the End Of Study visit.
    E.5.2Secondary end point(s)
    - Responder rate at 12 weeks.
    - Time to response.
    - Percentage of patients at 12 weeks and EOS visit with no change in
    CIDP treatment.
    - Changes from baseline to 12 weeks and EOS visit in the following
    scores:
    • Adjusted INCAT disability score;
    • Grip strength with the Martin vigorimeter in both hands;
    • Rasch-built Overall Disability Scale (R-ODS);
    • Patient and Investigator Clinical Global Impression (CGI);
    • Medical Research Council (MRC) 12 muscles sum score (0 to 5) and Rasch-modified MRC (0 to 3).

    Safety Endpoints:
    Safety will be evaluated by the assessement of AEs and TAAEs – including SAEs – from first IMP administration through EOS visit, as well as by assessment of clinically significant changes from baseline in vital signs and laboratory tests.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, at 12 weeks and End of study visit

    Safety endpoints will be assessed from first IMP administration through EOS visit, as well as by assessment of clinically significant changes from baseline in vital signs and laboratory tests.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Other exploratory objectives are to assess:
    - To assess a potential relationship between serum total serum IgG trough levels, biomarkers levels and clinical changes - as assessed by neurological scales – in patients with CIDP.
    - To assess a potential relationship between ultrasonography (USG) coupled to neurophysiology analysis of nerves and clinical response as assessed by neurological scales - in patients with CIDP (ancillary study in Italy).
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Single arm
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    France
    Italy
    Spain
    Tunisia
    Turkey
    United Kingdom
    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 years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 38
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 26
    F.4.2.2In the whole clinical trial 42
    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 the last visit patients will be switched to the normal 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 Decision2014-08-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-09-29
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