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    Summary
    EudraCT Number:2016-003725-42
    Sponsor's Protocol Code Number:R121178
    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:2018-06-21
    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 number2016-003725-42
    A.3Full title of the trial
    Does Interleukin-1 Receptor Antagonist Improve Outcome following aneurysmal Subarachnoid Haemorrhage (aSAH)? A Phase III trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Does reducing inflammation after subarachnoid brain haemorrhage with Kineret improve levels of disability at 6 months?
    A.3.2Name or abbreviated title of the trial where available
    SC IL-1Ra in SAH - phase III trial
    A.4.1Sponsor's protocol code numberR121178
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN12961797
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03249207
    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 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
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportSwedish Orphan Biovitrum
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSalford Royal NHS Foundation Trust
    B.5.2Functional name of contact pointKing
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Neurosurgery
    B.5.3.2Town/ citySalford Royal NHS Foundation Trust
    B.5.3.3Post codeM6 8HD
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01612060631
    B.5.5Fax number01612064606
    B.5.6E-mailandrew.king@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 milligram(s)
    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
    subarachnoid haemorrhage
    E.1.1.1Medical condition in easily understood language
    Bleed from a ruptured aneurysm (abnormal bulge) in a blood vessel on the surface of 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 20.1
    E.1.2Level PT
    E.1.2Classification code 10042316
    E.1.2Term Subarachnoid haemorrhage
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Does reducing levels of inflammation after subarachnoid brain haemorrhage (SAH) lead to an improvement in level of disability (measured using modified Rankin Score) at 6 months?
    E.2.2Secondary objectives of the trial
    Does reducing inflammation after SAH:
    1. Improve mood (measured as levels of anxiety and depression) at 6 months?
    2. Improve levels of fatigue at 6 months?
    3. Improve the quality of life at 6 months?

    Does any effect of this treatment on clinical outcome correlate with its effect on plasma IL-6 concentration?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patients with confirmed spontaneous SAH admitted to a participating neurosurgical centre where consent can be obtained and study drug / placebo administered within 72 hours of ictus.
    2.No concomitant health problems that, in the opinion of the PI or designee, would interfere with participation, administration of study drug / placebo or assessment of outcomes including safety, for example, pre-existing active malignancy.
    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 / placebo and undergo all study assessments.
    4.Aged 18 years or above.
    E.4Principal exclusion criteria
    1. Unconfirmed or uncertain diagnosis of spontaneous SAH.
    2. Known active tuberculosis or active hepatitis.
    3. Known active malignancy.
    4. Neutropenia (ANC <1.5 x 109/L ).
    5. Abnormal renal function (creatinine clearance or estimated Glomerular Filtration Rate (eGFR) < 30 ml/minute) documented in the last 3 months prior to this SAH.
    6. Live vaccinations within the last 10 days of this SAH.
    7. Previous or concurrent treatment with IL-1Ra known at the time of trial entry or previous participation in this trial.
    8. Previous or current treatment with medication suspected of interacting with IL-1Ra, listed in the drug SmPC (please see section 8.1.4 for the prohibited medication).
    9. Known to have participated in a clinical trial of an investigational agent or device in the previous 30 days or 5 half-lives of enrolment (whichever is longer) of ictus, or for the period determined by the protocol of the trial / study the patient has taken part in.
    10. Known to be pregnant or breast feeding or inability to reliably confirm that the patient is not pregnant.
    11. Clinically significant serious concurrent medical condition, pre morbid illnesses, or concurrent serious infection, at the PI’s (or designee’s) discretion, which could affect the safety or tolerability of the intervention.
    12. Known allergy to IL-1Ra or any of the excipients listed in the drug SmPC.
    13. 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)
    Ordinal shift in modified Rankin Scale (mRS) at 6months from randomisation
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months from date of randomisation
    E.5.2Secondary end point(s)
    1. Mood (Hospital Anxiety and Depression Score)
    2. Fatigue (GM-SAT question and Fatigue Severity Score)
    3. Quality of Life (ED-5D-5L)
    4. Correlation of effect of treatment on clinical outcome with effect of treatment on plasma IL-6 concentration.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-3 assessed by telephone at 6 months after date of randomisation. Blood samples for assessment of plasma IL-6 concentration taken at baseline and between 3-5 days after randomisation.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 concerned20
    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
    Final outcome assessment for last recruited participant.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months1
    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.1.1Number 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: 700
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 state1000
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1000
    F.4.2.2In the whole clinical trial 1000
    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 III double-blind, randomised, placebo-controlled trial and there are no plans to continue provision of the intervention to participants once the research has finished.

    Results of this study will provide evidence of the efficacy of IL-1Ra in SAH and may change treatment in the future. 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 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 Decision2018-03-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-03
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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