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    Summary
    EudraCT Number:2018-000249-38
    Sponsor's Protocol Code Number:R118439
    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:2019-06-24
    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 number2018-000249-38
    A.3Full title of the trial
    Phase II trial of interleukin-1 receptor antagonist in intracerebral haemorrhage: BLOcking the Cytokine IL-1 in ICH
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    BLOC-ICH; Could a new treatment improve recovery for patients who have had an intracerebral haemorrhage
    A.3.2Name or abbreviated title of the trial where available
    BLOC-ICH - BLOcking the Cytokine IL-1 in ICH
    A.4.1Sponsor's protocol code numberR118439
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03737344
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Manchester
    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 supportNational Institute for Health Research (NIHR) Clinician Scientist Award
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportSwedish Orphan Biovitrum AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Manchester
    B.5.2Functional name of contact pointTimothy Lubinda
    B.5.3 Address:
    B.5.3.1Street AddressManchester Clinical Trials Unit
    B.5.3.2Town/ cityUniveristy of Manchester, Oxford Road
    B.5.3.3Post codeM13 9PL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0161 306 3195
    B.5.6E-mailBLOC-ICH@manchester.ac.uk
    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 Kineret (anakinra)
    D.2.1.1.2Name of the Marketing Authorisation holderSwedish Orphan Biovitrum AB, Sweden
    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 nameKineret (anakinra)
    D.3.2Product code EU/1/02/203/001-003
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAnakinra
    D.3.9.1CAS number 143090920
    D.3.9.3Other descriptive nameKineret
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    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 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 placeboSuspension for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    intracerebral haemorrhage
    E.1.1.1Medical condition in easily understood language
    Stroke caused by spontaneous bleeding in to the brain
    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 LLT
    E.1.2Classification code 10022753
    E.1.2Term Intracerebral haemorrhage
    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
    Does an anti-inflammatory drug (IL-1Ra) reduce inflammation after brain haemorrhage when given as an injection into the skin?
    E.2.2Secondary objectives of the trial
    1. If IL-1Ra reduces inflammation after brain haemorrhage, does this improve recovery?
    2. Is IL-1Ra given as an injection into the skin for 3 days after brain haemorrhage safe?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with spontaneous, primary, supratentorial ICH admitted to a participating centre within 8 hours of symptom onset.
    2. No concomitant health problems that, in the opinion of the PI or designee, would interfere with participation, administration of study drug or assessment of outcomes including safety.
    3. Willing and able to give informed consent or consent available from a patient
    representative for trial inclusion including agreement in principle to receive study drug and undergo all study assessments.
    4. Male or female aged 18 years or above (no upper age limit).
    E.4Principal exclusion criteria
    1. Severe ICH, unlikely to survive to 72 hours scan (defined as Glasgow Coma Scale score 6 at any time prior to consent);
    2. Confirmed or suspected structural abnormality as cause of ICH (including tumour, vascular malformation);
    3. Confirmed or suspected haemorrhagic transformation of an arterial or venous infarct;
    4. Acute neurosurgery planned within 72 hours of admission;
    5. Known active tuberculosis or active hepatitis;
    6. Known active malignancy;
    7. Neutropenia (neutrophil count (ANC) <1.5 x 10^9 );
    8. Abnormal renal function (previous eGFR<30 mL/min in 3 months prior to this ICH*
    9. Live vaccinations within the last 10 days prior to this ICH;
    10. Previous or concurrent treatment with IL-1Ra known at the time of trial entry or previous participation in this trial.
    11. Previous or current treatment with etanercept or any other TNF-α antagonist
    12. Known to have participated in a clinical trial of an investigational agent or device in the 30 days prior to symptom onset;
    13. Known to have participated in a clinical trial of an investigational agent or device within 5 half-lives (of the previous agent or device) prior to symptom onset;
    14. Known to be pregnant or breast-feeding or inability to reliably confirm that the patient is
    not pregnant (Please see further guidance on pregnancy prevention in section 7.2.1).
    15. Known diagnosis of Still’s disease;
    16. Clinically significant serious concurrent medical condition, premorbid illnesses, or
    concurrent serious infection, at the PI’s (or designee’s) discretion, which could affect the safety
    or tolerability of the intervention. Please see precaution of use section 8.1.5 for further
    guidance.
    17. Known allergy to IL-1Ra or any of the excipients listed in the drug SmPC (please
    section 8.1.4).
    18.Known allergy to other products that are produced by DNA technology using
    the micro-organism E. coli (e.g. E.coli derived protein).
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome for the trial will be perihaematomal oedema on CT scan at 72 hours as measured by the ‘oedema extension distance’ (OED), which equates to the average distance that oedema extends beyond the haematoma border.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months from date of randomisation
    E.5.2Secondary end point(s)
    1. Early haematoma growth: Haematoma volume will be measured by the central study team on the baseline clinical diagnostic CT brain scan and the 72 hours research CT brain scan using standard volumetric methods. Haematoma will be defined by tissue with a Hounsfield Unit (HU) range of 44-100. Significant haematoma expansion will be defined as a ≥33% and/or ≥6 ml increase in haematoma volume between baseline and 72 hours. The chosen definition for haematoma expansion is widely used and has been shown to have a high specificity and moderate sensitivity for a poor long term outcome
    2. Early Neurological Decline (END) between baseline and 72 hours: END defined as a decrease of ≥2 in the Glasgow Coma Scale (GCS) score or an increase in the National Institutes of Health Stroke Scale (NIHSS) score ≥ 4, lasting longer than 8 h, requiring surgical intervention, or resulting in death.
    3. Blood-brain barrier breakdown: Using a tracer kinetic model developed and established at the University of Manchester, maps of the blood-brain barrier transfer constant (Ktrans) will be generated. Mean values for Ktrans will be derived from within haematoma and perihaematomal oedema volume (as defined by co-registered FLAIR images) and the mean linear distance that increased Ktrans extends beyond the haematoma border will be derived, using a similar approach to that described for OED.
    4. Clinical outcomes: Exploratory clinical outcomes will be measured at 3 months and will include the mRS, SIS, FSS, EQ-5D-5L and HADS. Fatigue, depression and cognitive deficits are key unmet needs in stroke patients and may be influenced by inflammation via ‘cytokine-induced’ sickness behaviour, so will be measured alongside the mRS at 3 months.
    5. Area under the curve for inflammatory markers (CRP, IL-6) from baseline to day 4. Measuring inflammatory markers will allow assessment of the impact of IL-1Ra on systemic inflammation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Blood samples for research assessment after randomisation, a CT Scan within 72 hours. Adverse Event and survival check at 30 days and Quality of life assessments at 3 months after date of randomisation conducted by telephone
    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 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 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 concerned5
    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 definition of the end of the trial will be the final outcome assessment for the last recruited patient.
    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 months3
    E.8.9.1In the Member State concerned days5
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days5
    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: 27
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 53
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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)
    The trial is Phase II double-blinded, randomised, placebo-controlled trial and there are no plans to continue provision of the intervention to participants once the research has finished. This will be made clear to participants and/or representatives prior to consent.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation NIHR Clinical Research Network
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-25
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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