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    Summary
    EudraCT Number:2017-001389-10
    Sponsor's Protocol Code Number:IASO
    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:2017-08-17
    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 number2017-001389-10
    A.3Full title of the trial
    A phase II randomised placebo controlled double blinded trial of Interleukin 1 blockade in Acute Severe Colitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomised Double Blind Clinical Trial in Acute Severe Colitis: The IASO trial
    A.3.2Name or abbreviated title of the trial where available
    IASO
    A.4.1Sponsor's protocol code numberIASO
    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 SponsorCambridge University Hospitals NHS Foundation Trust & University of Cambridge
    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 supportNIHR & MRC EME Programme
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCambridge Clinical Trials Unit
    B.5.2Functional name of contact pointCarrie Bayliss
    B.5.3 Address:
    B.5.3.1Street AddressAddenbrooke's Hospital, Coton House Flat 63
    B.5.3.2Town/ cityHills Road
    B.5.3.3Post codeCB2 0QQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01223 348158
    B.5.6E-mailcctu@addenbrookes.nhs.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 Anakinra
    D.2.1.1.2Name of the Marketing Authorisation holderSwedish Orphan Biovitrum
    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 nameAnakinra
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAnakinra
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboIntravenous bolus use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Severe Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    Severe ulcerative colitis flares that require admission to hospital for further treatment
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10066678
    E.1.2Term Acute ulcerative colitis
    E.1.2System Organ Class 100000016670
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this trial is to compare the clinical effects of anakinra with placebo when given in addition to current standard care in patients with acute severe ulcerative colitis.

    The primary measure of success will be any difference in the proportion of participants in the group receiving anakinra who needed escalation to more intensive medical or surgical therapy (known as rescue therapy) by 10 days after standard treatment was started, when compared with the group of participants receiving placebo.
    E.2.2Secondary objectives of the trial
    The trial will also compare the effects of anakinra with placebo when given in addition to current standard care in terms of:

    - Whether either treatment results in a difference in the number of cases of colectomy (surgical removal of the colon)
    - How safe both treatments are
    - The quality of life associated with both treatments, as reported by participants
    - The extent to which either treatment has an effect on the molecular mechanisms which can trigger ulcerative colitis
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: IASO Endoscopic Substudy
    Version: 1
    Date: 27/07/2017

    The main IASO study will assess whether anakinra can be used to help treat acute severe ulcerative colitis. To supplement this, the IASO substudy will collect additional information about inflammatory pathways in the colon to help understand more about how and why anakinra treatment may work and so refine drug selection and usage. To do this, participants in the substudy will be asked to consent to a flexible sigmoidoscopy (camera examination of the last part of the large bowel) approximately 3 days after starting treatment, to allow for visual assessment of bowel damage and collection of biopsy material from the bowel.
    E.3Principal inclusion criteria
    - Patients aged 16-80 inclusive
    - Have given written informed consent to participate
    - Hospitalised patients with clinically confirmed or suspected acute severe ulcerative colitis and a Modified Truelove Witts Severity Index score ≥11
    - Requirement for treatment with IV corticosteroids in the judgement of the treating clinician, with the possibility to receive a first dose of IMP within 36 hours of commencement of IV corticosteroids
    E.4Principal exclusion criteria
    - Pregnant or breast-feeding women
    - Oral corticosteroid dosing for a duration of 8 weeks or more immediately prior to commencement of IV corticosteroid dosing
    - History of severe hepatic impairment (e.g. Child-Pugh = Grade C)
    - Moderate or severe renal impairment (eGFR <50ml/minute)
    - Neutropenia (neutrophil count <1.5x109/l)
    - Previous treatment with anakinra for any indication
    - Evidence (from blood cultures etc) or clinical suspicion of systemic infection
    - Current or previous cytomegalovirus (CMV) infection requiring treatment with anti-viral agents
    - Current treatment with anti-TNF-α therapy or anti-TNF-α discontinuation within previous 16 weeks
    - A history of pulmonary TB infection
    - History of malignancy (with the exception of non-melanoma skin cancer) or colonic dysplasia
    - Receipt of another IMP as part of a CTIMP within the previous 16 weeks
    E.5 End points
    E.5.1Primary end point(s)
    The incidence of medical or surgical rescue therapy within 10 days following the commencement of intravenous corticosteroid therapy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    10 days after the commencement of intravenous corticosteroid therapy.
    E.5.2Secondary end point(s)
    1.Incidence of colectomy within 98 days following the commencement of IV corticosteroid therapy, assessed via review of medical records or by follow up telephone call.

    2.Burden of disease activity, measured by daily modified Truelove and Witts severity index (MTWSI) scores.

    3.Time to clinical response (defined as 2nd consecutive day with MTWSI <10).

    4.Time to medical or surgical rescue therapy, measured according to the time after the first dose of IV corticosteroids until the time that rescue therapy occurs.

    5.Incidence of serious adverese events (SAEs) assessed via review of medical records or by follow up telephone call.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.Incidence of Colectomy: 98 days after the commencement of IV corticosteroid therapy

    2.Burden of disease activity: Daily MTWSI scores at baseline and over Days 1-5 after initial IMP administration.

    3.Time to clinical response: During the inpatient stay, between Day 1-5 after initial IMP administration.

    4.Time to medical or surgical rescue therapy: Data will be captured up to 10 days after commencement of IV corticosteroids.

    5.Incidence of SAEs: Measured until Day 10 (+3) following administration of first IMP dose.
    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 No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 Yes
    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
    For regulatory notification purposes, the end of trial participation will be the earliest of:
    - The receipt of the final, returned 6 month quality of life questionnaires at the trial coordination centre
    - 6 months (+12 weeks) after the last participant entered the study

    However, participants will enter a period of long-term follow-up via HES data examination and the trial will remain open to the Ethics Committee until the last participant’s HES data has been captured.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 4
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 4
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state214
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 214
    F.4.2.2In the whole clinical trial 214
    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)
    Patients will return to their normal clinical management for their disease.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-09-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-21
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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