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    Summary
    EudraCT Number:2018-002109-70
    Sponsor's Protocol Code Number:E6011-ET2
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-12-27
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2018-002109-70
    A.3Full title of the trial
    Early phase 2 clinical trial of E6011 in patients with active Crohn’s disease
    Klinické hodnocení časné fáze 2 přípravku E6011 u pacientů s aktivní Crohnovou chorobou.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research aimed study to test the efficacy and safety of a new medical product, called E6011, in treating Crohn’s disease, which is a type of inflammatory bowel disease
    A.3.2Name or abbreviated title of the trial where available
    Not applicable
    A.4.1Sponsor's protocol code numberE6011-ET2
    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 SponsorEA Pharma Co., Ltd.
    B.1.3.4CountryJapan
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEA Pharma Co., Ltd.
    B.4.2CountryJapan
    B.4.1Name of organisation providing supportJapan Agency for Medical Research and Development (AMED)
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEA Pharma Co., Ltd.
    B.5.2Functional name of contact pointGroup 3, Clinical Development Dept.
    B.5.3 Address:
    B.5.3.1Street Address2-1-1 Irifune, Chuo-ku,
    B.5.3.2Town/ cityTokyo
    B.5.3.3Post code104-0042
    B.5.3.4CountryJapan
    B.5.4Telephone number8136280 9735
    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.3.2Product code E6011
    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 INNUndetermined
    D.3.9.2Current sponsor codeE6011
    D.3.9.3Other descriptive nameIGG2 ANTIBODIES
    D.3.9.4EV Substance CodeSUB180771
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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
    Active Crohn’s disease
    E.1.1.1Medical condition in easily understood language
    Presence of a type of inflammatory bowel disease, called Crohn’s disease
    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 PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's 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
    To examine the efficacy and safety of E6011 at 12 weeks after administration by means of double-blind placebo-controlled trial
    E.2.2Secondary objectives of the trial
    To examine the efficacy and safety of a long-term administration of E6011.
    To evaluate the pharmacokinetics and immunogenicity of E6011.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects who meet all of the following criteria are eligible to participate in this clinical trial.
    (1) Crohn’s disease patients aged 18 or over and under 65 on the date of consent.
    (2) Patients diagnosed on basis of clinical findings, endoscopic findings, etc. with small intestine-type, small and large intestine-type, or large intestine-type Crohn's disease at least 12 weeks before giving consent.
    (3) Patients with a baseline (at Week 0 before the start of IMP administration) disease severity ranging from moderate to severe. CDAI score between 220 and 450, and a PRO2 score between 14 and 34.
    (4) Patients with a Simple Endoscopic Score for Crohn’s Disease (SES-CD) ≥ 7 (or for patients with isolated ileal disease, ≥ 4 in ileum segment) in the screening period, with one or more ulcers (in SES-CD score, ulcer presence subscore ≥ 1 in any segment) assessed by colonoscopy and confirmed by a centralised review.
    (5) Patients who received adrenocorticosteroids or immunomodulators in the past, but showed no therapeutic response (insufficient response) or the drugs were not tolerated (intolerance). Alternatively, patients who cannot taper adrenocorticosteroids (dependence). Alternatively, patients who showed no therapeutic response after administering biologic(s) (primary nonresponse), patients who initially showed therapeutic response but it lessened or disappeared afterwards (secondary nonresponse), or patients who did not tolerate the drug (intolerance). (Detailed criteria are described in Attachment 7 and Attachment 8).
    (6) If the patients are taking 1,200 kcal/day or less enteral nutrition, the dosage and administration have not changed for at least 4 weeks prior to the start of the IMP administration.
    (7) If the patients are taking aminosalicylic acid (5-ASA), salazosulfapyridine, or antibiotics for the treatment of Crohn's disease (metronidazole, ciprofloxacin, etc.), the dosage and administration have not changed for at least 4 weeks prior to the start of the IMP administration.
    (8) If the patients are taking under 30 mg/day of oral prednisolone (or equivalent adrenocorticosteroid) or 9 mg/day or less of oral budesonide, the dosage and administration have not changed for at least 4 weeks prior to the start of the IMP administration.
    (9) If the patients are taking azathioprine (AZP), 6-mercaptopurine (6-MP) or methotrexate (MTX), the dosage and administration have not changed for at least 8 weeks prior to the start of the IMP administration.
    (10) Patients who have received a sufficient explanation about the compliance rules of this clinical trial, who are willing to comply with them, and who are able to do so.
    (11) Patients who voluntarily gave a written consent to participate in this clinical trial.
    E.4Principal exclusion criteria
    Patients diagnosed with ulcerative colitis or indeterminate colitis
    Patients diagnosed with gastrointestinal epithelial dysplasia
    Patients who have an abscess or are suspected to have one
    Patients with an artificial anus, ileo-anal pouch or fistula
    Patients with symptomatic or high-grade gastrointestinal stenosis
    Patients who, after undergoing small bowel resection, have been diagnosed with a short bowel syndrome, which makes maintaining caloric intake difficult
    Patients who have newly started seton drainage treatment within 12 weeks prior to the start of the IMP
    Patients who have undergone bowel resection or a gastrointestinal surgery within 24 weeks prior to the start of the IMP administration
    Patients who tested positive for C. difficile toxin test in the screening
    Patients who tested positive for HIV, hepatitis B surface antigen, hepatitis B surface antibody, hepatitis B core antibody, hepatitis B virus DNA, hepatitis C virus antibody, or human T cell leukemia virus type 1 antibody in the screening
    Patients with positive or repeated indeterminate results on the TB test
    Patients with findings showing a history of tuberculosis on a chest X-ray test in the screening period
    Patients with findings of neurological symptoms such as motor impairment, cognitive disorder, language disorder or dysphagia in the evaluations during the screening period
    Patients with a WBC count of less than 3,000/μL or blood CD4+ cell count under 200/μL in the screening tests
    Patients with a medical history of clinically significant vasculitis
    Acute myocardial infarction, unstable angina pectoris, cerebral infarction, and symptomatic cerebral haemorrhage patients
    Patients whose AST or ALT was more than three times the UNL in the screening period tests or patients whose serum creatinine level was more than 1.5 times the UNL in the screening tests
    Patients with a QTcF exceeding 450 ms repeatedly in standard 12-lead ECG tests in the screening period tests
    Patients who have undergone cytoapheresis (granulocytapheresis) within 2 weeks prior to the start of the IMP
    Hospitalisation within 4 weeks prior to the start of IMP, intravenous treatment of antibiotics, antiviral drugs within 4 weeks prior to the start of IMP or oral treatment of antibiotics, antiviral drugs within 2 weeks prior to the start of IMP. COVID-19: patients required hospitalization within 4 weeks prior to the start of the IMP, any intravenous treatment within 4 weeks prior to the start of the IMP or any oral treatment within 2 weeks prior to the start of IMP
    Patients who received total parenteral nutrition, peripheral parenteral nutrition, or enteral nutrition exceeding 1200 kcal/day within 4 weeks prior to the start of the IMP
    Patients who received ≥30 mg/day of oral prednisolone (or an equivalent adrenocorticosteroid), adrenocorticosteroid injection, enema or suppository within 4 weeks prior to the start of the IMP
    Patients who received cyclosporine, mycophenolate mofetil, or tacrolimus within 8 weeks prior to the start of the IMP
    Patients who received adalimumab, infliximab, certolizumab pegol, vedolizumab or ustekinumab within 8 weeks prior to the start of the IMP
    Patients vaccinated with live vaccines within 12 weeks prior to the start of the IMP
    Patients who received an immunoglobulin preparation or a blood product within 24 weeks prior to the start of the IMP administration
    Patients who have received natalizumab or E6011 in the past
    Patients with a history of a malignant tumour, lymphoma, leukemia, or lymphoproliferative disorders, or with complications thereof
    Patients with immunodeficiency or a history of HIV infection
    Patients with a history of severe allergy
    Patients currently taking part in another clinical trial (including the post-observation period), or patients who were participating in another trial using an IMP or investigational medical device within 28 days (or within five times the length of the half-life period of the IMP, whichever is longer) prior to giving consent
    Patients who received a faecal microbiota transplant, mesenchymal stem cell, etc. within 24 weeks prior to giving consent
    Female patients of childbearing potential who had a positive result on the pregnancy test at screening or baseline, as well as lactating patients
    Female patients of childbearing potential who:
    have not been on a highly effective method of contraception within 28 days prior to the start of IMP administration
    Potential male patients with female partners of childbearing potential:
    that have not undergone proper vasectomy
    patients whose female partner is pregnant and do not agree to use latex or synthetic condoms during the clinical trial and for 70 days after the last administration of the IMP
    the patients must not donate sperm during the clinical trial and for 70 days after the last administration of the IMP
    Patients who were judged to be unsuitable for participation in this clinical trial by the investigator
    E.5 End points
    E.5.1Primary end point(s)
    CR100 (CDAI reductions of at least 100 points) response rate
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    • CR70 response rate, CR100 response rate (excluding Week 12) and CDAI remission rate (proportion of subjects with below 150 points) at each evaluation time
    •proportion of subjects with at least 5-point reduction in PRO2 from baseline (PRO2-CR5 response rate), proportion of subjects with at least 8-point reduction from baseline (PRO2-CR8 response rate), and proportion of subjects with below 8 points (PRO2-resmission rate) at each evaluation time
    • Proportion of subjects with at least 50% improvement in SES-CD score from prior to IMP administration (endoscopic response rate) and proportion of subjects with 2 or less in SES-CD score (endoscopic remission rate) at Week 12
    • Change and percent change in CDAI score from baseline at each evaluation time
    • Change and percent change in PRO2 from baseline at each evaluation time
    • Change and percent change in SES-CD score from baseline at Week 12
    • In subjects who were concomintantly taking adrenocorticosteroid, proportion of subjects who achieved steroid-free maintenance (steroid-free remission rate, steroid-free improvement rate) through steroid dose reduction and clinical remission (CDAI remission or PRO2 remission) or clinical improvement (CR70 response, CR100 response, PRO2-CR5 response or PRO2-CR8 response)
    • In subjects who were concomintantly taking adrenocorticosteroid, dosage, change and percent change of adrenocorticosteroid from baseline
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week2, Week4, Week8, Week12, Responders: Week16, Week 20, Week24, Week28, Week32, Week36, Week40, Week44, Week48, Week 52, Non-responders: Week14, Week16, Week20, Week24, Week28, Week32, Week36, Week40, Week44, Week48, Week 52, Week56, Week60, Week64, or at discontinuation in any period
    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 Yes
    E.6.11Pharmacogenomic Yes
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Japan
    Russian Federation
    Hungary
    Poland
    Czechia
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months8
    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: 40
    F.1.3Elderly (>=65 years) No
    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 Yes
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 40
    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 Decision2019-08-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-13
    P. End of Trial
    P.End of Trial StatusOngoing
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