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    Summary
    EudraCT Number:2013-000366-11
    Sponsor's Protocol Code Number:TP0503
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-07-05
    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 ConcernedFinland - Fimea
    A.2EudraCT number2013-000366-11
    A.3Full title of the trial
    A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05.
    A.4.1Sponsor's protocol code numberTP0503
    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 SponsorTillotts Pharma AG
    B.1.3.4CountrySwitzerland
    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 supportTillotts Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRobarts Clinical Trials Inc.
    B.5.2Functional name of contact pointSenior Clinical Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressPietersbergweg 17, Trinity Building C
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 BM
    B.5.3.4CountryNetherlands
    B.5.6E-mailTanja.vanviegen@robartsinc.com
    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 TP05
    D.3.4Pharmaceutical form Gastro-resistant tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMESALAZINE
    D.3.9.1CAS number 89-57-6
    D.3.9.2Current sponsor codeTP05
    D.3.9.4EV Substance CodeSUB08782MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number4.8
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Asacol
    D.2.1.1.2Name of the Marketing Authorisation holderTillotts Pharma
    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.3.4Pharmaceutical form Gastro-resistant tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMESALAZINE
    D.3.9.1CAS number 89-57-6
    D.3.9.2Current sponsor codeAsacol
    D.3.9.4EV Substance CodeSUB08782MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number4.8
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative colitis
    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 17.0
    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
    Induction:
    The primary objective of the Induction phase is to determine if 8 weeks of treatment with 3.2 g/day of TP05 is not inferior to 3.2 g/day of Asacol™ in inducing clinical and endoscopic remission (a
    score ≤ 2 points on the Mayo scoring scale with no individual sub-score > 1 point) in subjects with active mild to moderate Ulcerative Colitis (UC).

    Open Label Extension (OLE):
    The primary objective of the OLE is to assess the safety and tolerability of TP05 over a 26-week period in subjects achieving endoscopic and clinical remission or exhibiting a response during the initial phase of TP0503. Maintenance of clinical remission by TP05 will also be assessed by determining the proportion of patients in clinical remission at the final visit.
    E.2.2Secondary objectives of the trial
    Induction:
    Proportion of subjects achieving:
    - endoscopic remission at Week 8
    - clinical remission at Week 8 or 12
    - a rectal bleeding sub-score of 0 at Week 8 or 12
    - clinical remission at both Week 8 and 12
    - a clinical and endoscopic response at Week 8
    - a clinical response at Week 12
    - a clinical response at Week 8 and 12
    Also:
    - change in Mayo scores and PMCS at Week 8 and 12
    - change in rectal bleeding and stool frequency at Week 8 and 12

    OLE:
    To assess whether a dose escalation to 4.8 g/day of TP05 is effective in inducing remission in subjects who fail to respond to either Asacol™ or TP05 during induction.
    Quality of life will also be assessed using the SF-36, EQ-5D, WPAI-UC, subject and physician global ratings.
    Exploratory analyses of potential associations between patient characteristics and clinical remission as well as AEs or SAEs will be conducted as well as the relationship between faecal calprotectin
    levels and UC disease severity.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Induction:
    (1) Male or non-pregnant, non-lactating females, 18 years of age or older. Females of child bearing potential must have a negative serum pregnancy test prior to randomisation, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout the study. Females unable to bear children must have documentation of such in the source records (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]).
    (2) Documented diagnosis of UC: the diagnosis of UC is based on the site investigator's assessment and should be available at randomisation.
    (3) Active UC defined by:
    a. Mayo score of > 5
    b. Sigmoidoscopy component score ≥ 2 confirmed by central review and
    c. Rectal bleeding component score ≥ 1
    (4) Ability of the subject to participate fully in all aspects of this clinical trial.
    (5) Written informed consent must be obtained and documented.

    OLE:
    (1) Attendance at the Week 8 visit and completion of disease activity assessments prior to enrolment in OLE at Week 12 (responders or remitters) or Week 8 (non-responders).
    (2) At least 75% compliance with study medication in the induction phase.
    E.4Principal exclusion criteria
    Induction:
    (1) Severe UC defined by the following criteria:
    ≥ 6 bloody stools daily with one or more of the following:
    a. oral temperature > 37.8°C or > 100.0°F
    b. pulse > 90 beats/min
    c. haemoglobin < 10 g/dL
    (2) Proctitis: distal disease involving the rectum only i.e. disease extending less than 15 cm from the anal verge.
    (3) Treatment with oral mesalamine at a dose of > 2.5 g/day within 4 weeks prior to randomisation. Pre-study mesalamine therapy at a dose of 2.5g/day or less must be stopped at Visit 2.
    (4) Treatment with rectal mesalamine within 2 weeks prior to randomisation.
    (5) Treatment with systemic or rectal steroids within 4 weeks prior to randomisation.
    (6) Treatment with immunosuppressants within 6 weeks prior to randomisation.
    (7) Treatment with infliximab or other biologics within 3 months prior to randomisation.
    (8) Treatment with antibiotics within 7 days prior to randomisation.
    (9) Treatment with anti-diarrhoeals within 7 days prior to randomisation
    (10) Treatment with nicotine patch within 7 days prior to randomisation.
    (11) Received any investigational drug within 30 days prior to randomisation.
    (12) History of colectomy or partial colectomy.
    (13) History of definite dysplasia in colonic biopsies.
    (14) Crohn’s disease.
    (15) Immediate or significant risk of toxic megacolon.
    (16) Known bleeding disorders.
    (17) Hypersensitivity to salicylates, aspirin, sulfasalazine or 5-ASA.
    (18) Serum creatinine > 1.5 times the upper limit of the normal range.
    (19) Aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin or alkaline phosphatase > 2 times the upper limit of the normal range.
    (20) Serious underlying disease other than UC which in the opinion of the investigator may interfere with the subject’s ability to fully participate in the study.
    (21) History of alcohol or drug abuse which in the opinion of the investigator may interfere with the subject’s ability to comply with the study procedures.
    (22) Stools positive for Clostridium difficile toxin.
    (23) Pregnant or lactating women.
    (24) Prior enrolment in the study.

    OLE:
    (1) Withdrawal from the induction phase prior to the Week 8 visit.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the proportion of subjects in clinical and endoscopic remission after 8 weeks of treatment, defined as achieving a Mayo score of ≤ 2 points, with no individual sub-score > 1 point at the Week 8 visit.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 8.
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints based on changes in the Mayo score and the PMCS include:
    - the proportion of subjects achieving endoscopic remission (endoscopic sub-score of 0) at Week 8
    - the proportion of subjects achieving clinical remission at Week 8
    - the proportion of subjects achieving a rectal bleeding sub-score of 0 at Week 8
    - the proportion of subjects achieving clinical remission at Week 12
    - the proportion of patients achieving a rectal bleeding sub-score of 0 at Week 12
    - the proportion of subjects achieving clinical remission at both Week 8 and Week 12
    - the proportion of subjects achieving a clinical and endoscopic response at Week 8
    - the proportion of subjects achieving a clinical response at Week 12
    - the proportion of subjects achieving a clinical response at both Week 8 and Week 12
    - the changes in Mayo scores and PMCS at Week 8 and Week 12, respectively
    - the changes in rectal bleeding and stool frequency at both Week 8 and Week 12
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 8 and 12.
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability, Non-inferiority
    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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Double-blind parallel phase, followed by open label extension phase
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA106
    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
    Belarus
    Belgium
    Bulgaria
    Canada
    Czech Republic
    Denmark
    Finland
    France
    Hungary
    Ireland
    Latvia
    Lithuania
    Norway
    Poland
    Russian Federation
    Slovakia
    Spain
    Sweden
    Ukraine
    United Kingdom
    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
    All subjects will be contacted via telephone for a post-treatment follow-up 4 weeks after the last dose of study drug. Any SAEs will be recorded.

    The end of the trial is defined as the date of the last patient contacted by telephone 4 weeks after the last dose of study drug.
    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 months10
    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 months10
    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: 752
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 635
    F.4.2.2In the whole clinical trial 800
    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)
    After a patient has completed/terminated their study participations, long term care for the participant will remain the responsibility of their primary treating physicians.
    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 Decision2013-08-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-17
    P. End of Trial
    P.End of Trial StatusCompleted
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