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    Summary
    EudraCT Number:2018-001546-33
    Sponsor's Protocol Code Number:RHMMED1526
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-05-14
    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 number2018-001546-33
    A.3Full title of the trial
    IBD Biosimilar to Biosimilar Infliximab Switching Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effects of switching one drug, used to treat either Ulcerative Colitis (UC) or Crohn’s disease (CD) to another drug, also used to treat UC or Crohn’s disease
    A.3.2Name or abbreviated title of the trial where available
    iBiSS v1.0
    A.4.1Sponsor's protocol code numberRHMMED1526
    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 Southampton Hospital NHS Foundation Trust
    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 supportBiogen Idec Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Southampton Hospital NHS Trust
    B.5.2Functional name of contact pointDr Fraser Cummings
    B.5.3 Address:
    B.5.3.1Street AddressTremona Road
    B.5.3.2Town/ citySouthampton
    B.5.3.3Post codeSO16 6YD
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number023 8077 7222
    B.5.6E-mailFraser.Cummings@uhs.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 Flixabi
    D.2.1.1.2Name of the Marketing Authorisation holderSamsung Bioepis UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameFlixabi
    D.3.4Pharmaceutical form 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 INNInfliximab
    D.3.9.1CAS number 170277-31-3
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.11 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Inflammatory Bowel Disease in particular Crohn's Disease and Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    Crohn’s Disease: Inflammation of the digestive system or gut
    Ulcerative Colitis: Inflammation and ulceration of the large bowel
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10021972
    E.1.2Term Inflammatory bowel disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This is a research study looking at the effects of switching from one biosimilar drug (CT-P13), used to treat either Ulcerative Colitis (UC) or Crohn’s disease (CD) to another biosimilar drug (SB2), also used to treat UC or Crohn’s disease. CTP-13 (Inflectra, Remsima) and SB2 (Flixabi) are ‘biosimilars’ of Remicade, but work in the same way.
    The primary objective of this study is to evaluate the clinical outcome of switching a cohort of IBD patients from CT-P13 to SB2.
    Infliximab is a product originally produced and marketed by a single pharmaceutical company and given a brand name (Remicade). After a number of years, it is agreed that other companies can produce their own copies of Remicade. These copies are known as biosimilars and act in a similar way to the original product Remicade
    There are very tiny differences to the original product but we do not believe these affect how the drug works or it's safety and side effects.
    E.2.2Secondary objectives of the trial
    In addition the research will gather information to show the following:
    How UC or CD is managed after switching.
    How safe it is to switch from one Biosimilar drug to another
    How the immune system responds to this change
    Assess the quality of life after switching from CT-P13 (Inflectra, Remsima) to SB2 (Flixabi).
    Assess the patient life experiences after switching from CT-P13 (Inflectra, Remsima) to SB2 (Flixabi).

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The principal inclusion criteria are;
    • All patients with IBD (Crohn’s Disease and Ulcerative Colitis) treated with ≥1 dose of CT-P13 at time of enrolment
    • Aged ≥18 years at time of enrolment
    • Planned continuation of infliximab treatment for at least 3 months after enrolment
    • Capable of providing written informed consent
    E.4Principal exclusion criteria
    Patients with the following characteristics are ineligible for this study
    • Unable to provide written informed consent
    • Involved in another IMP trial
    • Age < 18 years at time of enrolment
    • Planned discontinuation of treatment at UHS within 3 months of enrolment
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is the clinical status as assessed by IBD control patient reported outcome measure, drug persistence laboratory measurements and appropriate validated disease activity scores.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Clinical status at week 30 or week 32 (depending on the infusion regime)
    E.5.2Secondary end point(s)
    1. Incidence of Adverse Events, Serious Adverse Events, Adverse Events of Special Interest causally related to SB2
    2. Immunogenicity as determined by presence of anti-drug antibodies (binding and /or circulating?)
    3. Change from baseline to Week 24 and over time in patient reported outcomes or IBD PROM
    4. Levels of laboratory inflammatory markers (faecal calprotectin,
    FBC, CRP and albumin) at baseline and over time during the study
    5. Semi Structured interviews analysed using thematic analysis
    E.5.2.1Timepoint(s) of evaluation of this end point
    Clinical status at week 30 or week 32 (depending on the infusion regime)
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    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
    CTP-13
    E.8.2.4Number of treatment arms in the trial1
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 trial will be defined as the last patient last visit at week 54 for participants on 6 weekly infusion cycle or week 56 for participants on 8 weekly infusion cycle
    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 months8
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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: 200
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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)
    Following the trial, patients will continue with their standard of care. This will include being treated with the infliximab in use at UHS at that time which may be SB2, but could also involve changing to a different infliximab including going back to CT-P13 or Remicade.
    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 Decision2018-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-02-20
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