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    Summary
    EudraCT Number:2021-002162-40
    Sponsor's Protocol Code Number:2021-004
    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:2022-02-05
    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 number2021-002162-40
    A.3Full title of the trial
    IBIS: A single-centre, phase II study to evaluate the safety, tolerability and pharmacokinetics of 2-IminoBiotin in acute Ischemic Stroke due to large vessel occlusion
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    IBIS: 2-iminobiotin for ischemic stroke
    A.3.2Name or abbreviated title of the trial where available
    IBIS
    A.4.1Sponsor's protocol code number2021-004
    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 SponsorHaaglanden Medisch Centrum
    B.1.3.4CountryNetherlands
    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 supportJacobus Stichting
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportNeurophyxia BV
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHaaglanden Medisch Centrum
    B.5.2Functional name of contact pointNeurology department
    B.5.3 Address:
    B.5.3.1Street AddressLijnbaan 32
    B.5.3.2Town/ cityDen Haag
    B.5.3.3Post code2512 VA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+310889797900
    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 name2-Iminobiotin
    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 INN2-iminobiotin
    D.3.9.3Other descriptive name2-IMINOBIOTIN
    D.3.9.4EV Substance CodeSUB193823
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.75
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 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
    Acute ischemic stroke due to proximal large vessel occlusion
    E.1.1.1Medical condition in easily understood language
    Stroke
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This study will be a prospective, Phase 2, randomised controlled, single centre study with the primary objective to evaluate the safety and tolerability of 2-Iminobiotin when administered to patients with acute ischemic stroke due to large vessel occlusion, treated with intravenous thrombolysis and/or endovascular therapy.
    E.2.2Secondary objectives of the trial
    The secondary objective will be to study preliminary efficacy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Adults (age > 18 years for males and age >49 years for females)
    • A clinical diagnosis of AIS
    • Disabling stroke defined as a baseline NIH stroke scale score  5
    • Alberta Stroke Program Early CT score (ASPECTS) > 4 on CT (or MRI)
    • Presence of an intracranial LVO of the anterior circulation (distal ICA, M1 or proximal M2 segment of the MCA) on CTA, MRA or DSA
    • Start of EVT (arterial access puncture) possible within the first 6 hours after stroke onset or last seen well
    • EVT with declared first endovascular approach as either stent retriever, aspiration device or a combined approach
    • Pre-stroke independent functional status in activities of daily living (mRS ≤2)
    E.4Principal exclusion criteria
    • Contraindication to EVT or EVT > 6 hours after symptom onset (or last seen well)
    • No informed consent
    • Evidence of a large core of established infarction defined as ASPECTS 0-4.
    • Evidence of absence/poor collateral circulation on CTA (Tan collateral score of 0 or 1)26.
    • Known co-morbidity with a life expectancy of <6 months prior to acute ischemic stroke
    • Women aged 49 or less or known pregnancy*
    • Cognitive impairment (documented dementia) known prior to ischemic stroke
    • Pre-stroke disability which interferes with the assessment of functional outcome at 90 days, i.e. mRS >2
    • Intent to use any endovascular device other than a stent retriever or clot aspiration device or intra-arterial medications as the initial thrombectomy approach.
    • History of life threatening allergy (more than rash) to contrast medium
    • Evidence of acute hemorrhage on CT, MRI
    · Significant mass effect with midline shift.
    · Subjects with occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation)
    · Severe known renal impairment defined as requiring dialysis (hemo- or peritoneal) or if known a eGFR < 20 mL/min.

    *As 2-IB has not been tested yet for embryonic toxicity and limited pre- and postnatal development studies have been performed, women who can be pregnant must not be included be in this study.
    E.5 End points
    E.5.1Primary end point(s)
    The main study parameters used for evaluating the short-term safety and tolerability will be vital signs (heart frequency, blood pressure and oxygen saturation) before and during 24 hours after administration of the study drug and the need for clinical intervention. Furthermore, the occurrence of (serious) adverse events until 7 days will be recorded on the neurology department or until discharge from the neurology department, whichever occurs earlier. For evaluation of the pharmacokinetics profile of 2-IB, 4 plasma samples will be analysed at different intervals (4 hours, 24 hours, 25 hours, and 28 hours after study medication) Pharmacokinetic parameters to be determined will include Cmax, AUC, Tmax, T1/2, clearance (Cl), and volume of distribution (Vd)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Vital signs: during 24 hours of treatment
    Adverse events: 7 days
    Pharmacokinetics: during 24 hours of treatment and 4 hours after treatment
    E.5.2Secondary end point(s)
    1. Stroke Severity measured with the NIH stroke scale (NIHSS) at 24 hours and at discharge or at 7 days, whichever occurs earlier.
    2. Infarct volume measured with MRI at 24-48 hours. In case of contraindication(s) for MRI, CT/CTA will be performed at day 5 or discharge.
    3. Embolization in new territory on angiography during EVT or infarction in new territory on 24-48h MRI (or CT)
    4. Vessel recanalization at 24 hours with MRA (or CTA in case of contraindications for MRI)
    5. Any postintervention intracranial haemorrhage on neuroimaging within 48 hours.
    6. Blood investigation (CBC, electrolytes, serum creatinine, serum glucose) at 24 hours
    7. Blood investigation, biomarker neurofilament light at 24 hours and at 7 days or discharge from hospital, whichever occurs earlier and and neuron specific enolase at 24hr and 48 hr.
    8. Cognitive assessment using the Cognitive Assessment scale for Stroke Patients (CASP) at 7 days or at discharge from hospital, whichever occurs earlier
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Stroke Severity (NIHSS) at 24 hours and at discharge or at 7 days, whichever occurs earlier.
    2. Infarct volume at 24-48 hours.
    3. Embolization in new territory on angiography or at 24-48h MRI
    4. Vessel recanalization at 24 hours with MRA
    5. Any postintervention intracranial haemorrhage on neuroimaging within 48 hours.
    6. Blood investigation at 24 hours
    7. biomarker neurofilament light at 24 hours and at 7 days and neuron specific enolase at 24 hours and 48 hours
    8. Cognitive assessment at 7 days or at discharge from hospital, whichever occurs earlier
    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 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.8.2.4Number 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 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 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 last patient’s last visit. The sponsor will notify the medical ethics committee (METC) immediately of a temporary hold of the study, including the reason of such an action. In case the study is ended prematurely, the sponsor will notify the accredited METC and the competent authority within 15 days, including the reasons for the premature termination.
    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
    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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Most patients with severe cortical ischemic stroke eligible for endovascular therapy have neurological deficits interfering with their decision-making capacity.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state36
    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 Decision2022-02-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-21
    P. End of Trial
    P.End of Trial StatusOngoing
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