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    Summary
    EudraCT Number:2012-004768-23
    Sponsor's Protocol Code Number:SIC002
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-02-06
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-004768-23
    A.3Full title of the trial
    A Phase 2a Trial of STNM01 by a Single Submucosal Injection to Investigate the Mucosal Healing Efficacy in Patients with Ulcerative Colitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2a Trial of STNM01 by a Single Submucosal Injection to Investigate the Mucosal Healing Efficacy in Patients with Ulcerative Colitis
    A.4.1Sponsor's protocol code numberSIC002
    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 SponsorSTELIC INSTITUTE & CO.
    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 supportSTELIC INSTITUTE & CO.
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSTELIC INSTITUTE & CO.
    B.5.2Functional name of contact pointHiroyuki Yoneyama, MD, PhD
    B.5.3 Address:
    B.5.3.1Street Address1-9-15, Higashi Azabu 1, Minato-city
    B.5.3.2Town/ cityTokyo
    B.5.3.3Post code106-0044
    B.5.3.4CountryJapan
    B.5.4Telephone number+81335602621
    B.5.5Fax number+81335602620
    B.5.6E-mailyoneyama@stelic.co.jp
    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.3.1Product nameSTNM01 1.84 mg
    D.3.2Product code STNM01
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubmucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSTNM01
    D.3.9.2Current sponsor codeSTNM01
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.84
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubmucosal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative Colitis with active endoscopic lesion(s), ranging in severity from moderate to severe in endoscopic score not responding sufficiently to conventional treatment
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to investigate the efficacy and safety of a single dose of STNM01 when concomitantly administered with conventional treatment in patients with Ulcerative colitis who have active endoscopic lesion(s) and do not respond sufficiently to the conventional treatment.
    E.2.2Secondary objectives of the trial
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject eligibility is determined according to the following criteria:
    1) Male/female
    2) The subject is a patient with Ulcerative colitis with active lesion(s).
    3) The subject has been treated for more than 2 months before the screening
    tests by conventional drug(s) generally used to treat Ulcerative colitis [e.g.,
    5-aminosalicylic acid agent, steroid, immunoregulating agent, biological
    agent (e.g. anti-TNF-α antibody or Vedolizumab need a wash out period of 4
    weeks)]. In the opinion of his primary doctor, the subject has experienced an
    insufficient response or resistance to one of the current conventional
    treatment options. The subject’s insufficient response or resistance to the
    current treatment is also confirmed by the principal investigator of this
    study, based on the screening tests including endoscopic examination,
    clinical examination and laboratory tests.
    The subject’s experiencing an “insufficient response or resistance” can be
    assessed at the primary doctor’s and principal investigator’s discretion;
    however, use of one prescribed medication and insufficient therapeutic
    effect by the medication(s) at present should be documented in the subject’s
    medical record.
    4) The subject has little difficulty with the introduction of an endoscope, e.g., he has little stenosis or, if any, the diameter of the narrowed lesion is 14 mm or more.
    5) Endoscopic Mayo score at Screening has to be 1 or above 1.
    6) The subject’s age is 18 or older and under 65 at the time of informed consent.
    7) The subject signs and dates a written informed consent to participate in the study.
    E.4Principal exclusion criteria
    Any subject who meets any of the following criteria will not qualify for entry into the study:
    1) The subject has or has a history of serious cardiac, hematological or pulmonary disease, and is unsuitable, in the investigator’s opinion, to participate in the study.
    2) The subject has a history of complete colon resection surgery for Ulcerative colitis.
    3) The subject has a complication of Ulcerative colitis such as severe bleeding or intestinal adhesions to other organs, and is unsuitable, in the investigator’s opinion, to participate in the study.
    4) The subject has an anal stenosis that affects defecation frequency, or perianal abscess with fever. However, the subject is eligible if his bowel movement has been improved by Seton method.
    5) The subject has an obviously reduced general condition.
    6) The subject in whom large parts of the colon are affected (pancolitis).
    7) The subjects who are expected to evince an indication for colectomy during the study participation.
    8) The subject is currently receiving total parenteral nutrition.
    9) The subject has a hepatic impairment or renal disorder, and is unsuitable, in the investigator’s opinion, to participate in the study.
    10) The subject has or has a history of malignant tumor within the past 5 years.
    11) The subject has or has a history of abdominal phthisis.
    12) The subject has a complication of serious infection that requires hospitalization.
    13) The subject should be excluded if he is currently treated with biological agents (e.g. anti-TNF-alpha antibody or Vedolizumab).
    14) The subject should be excluded if he is treated with concomitant medication [e.g., 5-aminosalicylic acid agent, steroid, immunoregulating agent] by local administration.
    15) The subject has a history of clinically serious allergic symptom. “Serious” means an allergic symptom causing generalized hives, anaphylaxis or shock requiring hospitalization, when exposed to a specific antigen or drug.
    16) The subject has a history of HBV, HCV and/or HIV infection.
    17) The person has alcohol or drug dependency.
    18) The subject’s conventional treatment for Ulcerative colitis has been changed in its ‘quality’ (medication class) of therapy regimen or added with a new treatment: No introduction of thiopurines the previous 3 months, no Change of dosing 5-ASA or corticosteroids within 14 days prior to the study drug administration.
    19) The subject is currently participating or plans to participate in another clinical study during the course of this study.
    20) The subject received administration of any other investigational product within 6 months prior to the informed consent for this study.
    21) The subject has any psychiatric or neurological disorder, and is unsuitable, in the investigator’s opinion, to participate in the study.
    22) The subject is incapable of or restricted to the protocol-directed examinations or procedures.
    23) The subject is considered by the investigator, for any other reason, to be unsuitable for participating in this study.
    24) Not willing and able to use a reliable and acceptable contraceptive method (Pearl Index < 1). The subjects or their sexual partners, respectively, must use at least one of these reliable methods from 6 weeks before until 3 weeks after the administration of the study medication.
    25) For females: pregnancy or lactation
    26) Co-worker, student, relative or spouse of the investigator
    E.5 End points
    E.5.1Primary end point(s)
    Assessment of efficacy:
    Improvement of endoscopic lesions with respect to Mucosal healing by Mayo Endoscopic Subscore
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 14 (Day 28)
    E.5.2Secondary end point(s)
    Assessment of efficacy:
    Clinical response, change in Mayo Clinical Subscores
    Change in Ulcerative Colonoscopic Index of Severity (UCCIS)
    Histological response, change in Geboes Index
    Assessment of safety:
    Adverse events and adverse drug reactions
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 14; Day 28
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 trial3
    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 concerned6
    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 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
    Last Visit Last Subject (LVLS)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1In 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: 24
    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 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 state24
    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)
    Once a patient completes the study treatment the patient will be treated according to standard clinical practice at the site.
    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 Decision2013-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-07-13
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