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    Summary
    EudraCT Number:2018-000022-66
    Sponsor's Protocol Code Number:16-HMedIdeS-12
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-12-09
    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 ConcernedGermany - BfArM
    A.2EudraCT number2018-000022-66
    A.3Full title of the trial
    A Randomized, Open-Label, Multi-Centre, Active Control Study Investigating the Efficacy and Safety of Imlifidase in Eliminating Donor Specific Anti-HLA Antibodies in the Treatment of Active Antibody-Mediated Rejection in Kidney Transplant Patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study investigating the efficacy and safety of imlifidase in eliminating donor specific antibodies in the treatment of antibody-mediated rejection in kidney Transplant patients
    A.4.1Sponsor's protocol code number16-HMedIdeS-12
    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
    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
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHansa Biopharma
    B.5.2Functional name of contact pointClinical contact information
    B.5.3 Address:
    B.5.3.1Street AddressScheelevägen 22
    B.5.3.2Town/ cityLund
    B.5.3.3Post code223 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 Yes
    D.2.1.1.1Trade name Idefirix
    D.2.1.1.2Name of the Marketing Authorisation holderHansa Biopharma AB
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1826
    D.3 Description of the IMP
    D.3.1Product nameImlifidase
    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 milligram(s)
    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
    Antibody-mediated rejection in kidney transplant patients
    E.1.1.1Medical condition in easily understood language
    Rejection caused by antibodies in kidney transplant patients
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10023439
    E.1.2Term Kidney transplant rejection
    E.1.2System Organ Class 10021428 - Immune 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
    Investigate the efficacy of imlifidase compared with PE in removal of DSA in patients who are experiencing an active AMR episode after kidney transplantation
    E.2.2Secondary objectives of the trial
    • Evaluate DSA levels up to 180 days after treatment
    • Evaluate HLA-antibodies levels up to 180 days after treatment
    • Evaluate the overall kidney function up to 180 days after treatment
    • Investigate the occurrence of AMR up to 180 days after treatment
    • Investigate the safety and tolerability of imlifidase compared to PE in patients experiencing active AMR episodes
    • Evaluate the number of PE-sessions needed
    • Evaluate the pharmacokinetics, pharmacodynamics and immunogenicity of imlifidase
    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 and/or female donor kidney recipients age ≥18 years at the time of screening
    4. Presence of DSA(s)
    5. Meet the Banff 2017 criteria for active or chronic active AMR
    6. At least 25% rise in serum creatinine compared to last individual value taken prior to the AMR. Patients with delayed graft function and AMR within 10 days after transplant (confirmed by kidney biopsy) can be included regardless of serum creatinine level
    7. Women of child-bearing potential willing or able to use at least one highly effective contraceptive method throughout the study. 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 such as:
    • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, intravaginal, transdermal
    • progestogen-only hormonal contraception associated with inhibition of ovulation; oral, injectable, implantable
    • intrauterine device (IUD)
    • intrauterine hormone-releasing system (IUS)
    • bilateral tubal occlusion
    • vasectomised partner
    • true abstinence: When this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (such as calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception]
    8. Men willing to use double-barrier contraception from the first day of treatment until at least 2 months after the dose of imlifidase, if not abstinent. In addition, the female partner should be recommended to use a highly effective contraceptive method (as defined under inclusion criteria 7)
    E.4Principal exclusion criteria
    1. Previous treatment with imlifidase
    2. Previous high dose IVIg treatment (2 g/kg) within 28 days prior to inclusion
    3. Lactating or pregnant females
    4. Serum lab screening results for total bilirubin >2x the upper limit of normal (ULN) and/or alanine aminotransferase and/or aspartate aminotransferase >2,5x ULN and/or any other significantly abnormal general serum screening lab results judged inappropriate for inclusion in the study by the investigator
    5. Intake of other investigational drugs within 5 half-lives (or similar) of the product prior to inclusion
    6. Clinically relevant active infection(s) as judged by the investigator
    7. Any condition that in the opinion of the investigator could increase the subject’s risk by participating in the study such as severe immune deficiency and severe cardiac insufficiency (New York Heart Association (NYHA) Class IV) or severe uncontrolled heart disease
    8. Known allergy/sensitivity to imlifidase, IVIg and/or rituximab and the respective excipients
    9. Patient unable to tolerate treatment with plasmapheresis or immunoadsorption, as judged by the investigator
    10. Unsuitable to participate in the study for any reason e.g., individuals who have been placed in an institution on the basis of an official or court order, or subjects who are dependent on the Sponsor, investigator or the study site, or any other reasons as judged by the investigator
    11. Positive PCR test for SARS-CoV-2 virus infection
    12. Current diagnosis or history of thrombotic thrombocytopenic purpura (TTP), or known familial history of TTP
    E.5 End points
    E.5.1Primary end point(s)
    Maximum reduction in mean DSA level at any time point during the 5 days following the start of treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    • DSA levels will be evaluated pre-dose, at 2, 6, 24, 48, 72, and 96 hours
    E.5.2Secondary end point(s)
    • DSA levels up to 180 days after treatment
    • HLA-antibodies levels up to 180 days after treatment
    • Kidney function change from baseline (at screening) as evaluated by eGFR, P creatinine and albumin/creatinine ratio in urine up to 180 days after treatment
    • Proportion of subjects with graft loss within 180 days of treatment
    • Signs of transplant glomerulopathy 180 days post treatment
    • Change from baseline (at screening) in histopathology per Banff Criteria at 29 and 180 days
    • Change from baseline (at screening) in mRNA levels in kidney biopsies evaluated by MMDx at 29 and 180 days from baseline. If kidney biopsy is performed before screening, mRNA levels will be evaluated on day 29 and day 180 (no baseline will be available)
    • Safety parameters (AEs, safety laboratory tests, vital signs and ECG)
    • Type, frequency and intensity of adverse events
    • Number of sessions with PE
    • Total Serum IgG levels over time
    • Presence of intact IgG on SDS-page/Western blot until start of IVIg treatment
    • DSA functionality determined by C1q or C3d analysis pre- and post-treatment
    • PK profile of imlifidase (Cmax, Tmax, t½, AUC, CL, V)
    • Presence of ADA (anti-imlifidase IgG)
    E.5.2.1Timepoint(s) of evaluation of this end point
    • DSA levels will be evaluated on day 6, 8, 11, 15, 22, 29, 64, 90, and 180
    • Kidney function will be measured predose, at 24, 48, 72, and 96 hours, and at day 6, 8, 11, 22, 29, 64, 90 and 180
    • Kidney biopsies will be performed pre-dose and on day 29 and 180
    • Safety parameters pre-dose, at 24, 48, 72, and 96 hours, and at day 6, 8, 11, 15, 22, 29, 64 and 90
    • DSA functionality (C1q or C3d) will be evaluated at multiple timepoint up to day 180
    • Pharmacodynamic profile will be measured up to 180 days after start of treatment
    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 Yes
    E.8.1.1Randomised Yes
    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 Yes
    E.8.2.3.1Comparator description
    plasma exchange
    E.8.2.4Number of treatment arms in the trial2
    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 EEA7
    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
    United States
    Austria
    France
    Germany
    Sweden
    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 years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 18
    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)
    None
    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 Decision2021-02-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-11-16
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