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    Summary
    EudraCT Number:2011-003130-14
    Sponsor's Protocol Code Number:CSUC-01/10
    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:2011-08-11
    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 number2011-003130-14
    A.3Full title of the trial
    A placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatment
    A.4.1Sponsor's protocol code numberCSUC-01/10
    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 SponsorInDex Pharmaceuticals AB
    B.1.3.4CountrySweden
    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 supportInDex Pharmaceuticals AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInDex Pharmaceuticals AB
    B.5.2Functional name of contact pointInDex Pharmaceuticals AB
    B.5.3 Address:
    B.5.3.1Street AddressScheeles väg 2
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code171 77
    B.5.3.4CountrySweden
    B.5.4Telephone number+46 (0)850884730
    B.5.5Fax number+46 (0)8 50884739
    B.5.6E-mailinfo@indexpharmab.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/02/106
    D.3 Description of the IMP
    D.3.1Product nameKappaproct
    D.3.4Pharmaceutical form Rectal solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRectal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeDIMS0150
    D.3.9.3Other descriptive nameDIMS0150
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15.6
    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 placeboRectal capsule
    D.8.4Route of administration of the placeboRectal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic active treatment refractory 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 14.1
    E.1.2Level PT
    E.1.2Classification code 10009900
    E.1.2Term Colitis ulcerative
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the induction of clinical remission with Kappaproct given as an add-on treatment
    in two doses of 30 mg each compared to placebo.
    E.2.2Secondary objectives of the trial
    • To evaluate the rate of colectomy with Kappaproct given as an add-on treatment in
    two doses of 30 mg each compared to placebo.
    • To evaluate the induction and maintenance of steroid-free remission.
    • To evaluate safety and tolerability.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female ≥ 18 years of age.
    2. Well established diagnosis of moderate to moderately severe chronic active UC with a CAI score ≥9, an endoscopic score ≥2, not responding adequately to currently available
    therapies and potential candidates for colectomy. Previously tried therapies should
    include:
    • At least one treatment course with mesalazine; at least 2.4 g/day for at least 4 weeks,
    or at least one treatment course with similar drugs in this class.
    • At least one treatment course of corticosteroids (which can be the
    treatment of a recent relapse), with up to 0.75 mg/kg as starting dose
    or highest dose according to local clinical practice.
    • At least one treatment course of azathioprine or mercaptopurine of at least 3 months
    duration and/or at least one adequate treatment course of an anti-TNF alpha.
    • Any unsuccessful combination treatment of the above.
    • May have tried treatment with cyclosporine and/or tacrolimus or any other
    immunosuppressant/immunomodulating agent.
    • Intolerance to any of the above medications corresponds to inadequate response.
    3. Patients shall at study enrolment be on an accumulated stable tolerable GCS dose
    equivalent to at least 140 mg of prednisolone/prednisone (by any route of administration)
    for the last two weeks. Patients may also be on concomitant therapies such as, but not
    restricted to, 5-ASA, azathioprine and sulphasalazine.
    4. Ability to understand the treatment, willingness to comply with all study requirements,
    and ability to provide informed consent.
    E.4Principal exclusion criteria
    1. Patients with suspicion of Crohn’s enterocolitis, ischaemic colitis, radiation colitis, diverticular disease associated colitis, as well as microscopic colitis should be excluded. Patients with disease limited to the rectum (ulcerative proctitis) should also be excluded.
    2. History or presence of a clinically significant cardiovascular, hepatic, renal,
    haematological, endocrine, neurological, psychiatric disease, or immune compromised
    state as judged relevant by the investigator.
    3. Patients with acute fulminant UC and/or signs of systemic toxicity to an extent that
    requires immediate surgical action.
    4. History or presence of any colonic malignancy and/or dysplasia.
    5. Concomitant treatment with cyclosporine, tacrolimus, anti-TNFs or similar
    immunosuppressants/immunomodulators is not allowed and should have been
    discontinued 4 weeks before enrolment. Patients who fail the wash-out criteria can
    undergo wash-out and be re-screened at a later time point.
    6. Treatment with antibiotics or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) within
    two weeks before enrolment.
    7. An active ongoing infection.
    8. Positive Clostridium difficile stool assay.
    9. Currently receiving parenteral nutrition or blood transfusions.
    10. Pregnancy or breast-feeding.
    11. Women of childbearing potential not using reliable contraceptive methods (reliable
    methods are barrier protection, hormonal contraception, intra-uterine device or
    abstinence) throughout the duration of the trial (52 weeks)
    12. Concurrent participation in another clinical study with investigational therapy or previous
    use of investigational therapy within 30 days before enrolment. Patients who fail the
    wash-out criteria can undergo wash-out and be re-screened at a later time point.
    E.5 End points
    E.5.1Primary end point(s)
    The induction of clinical remission at week 12, defined as a CAI score of ≤4.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Refer to E.5.1
    E.5.2Secondary end point(s)
    - The time to colectomy.
    - The rate of colectomy at 3, 5 and 12 months.
    - Steroid free remission at 5 and 12 months.
    - The induction of clinical remission at week 12, defined as a CAI score of ≤4, with
    subscores of blood in stool and number of stools weekly not exceeding 0 and 0 or 1,
    respectively.
    - The induction of symptomatic remission at week 1, 4, 8 and 12, and the
    maintenance of this remission at 5 and 12 months, defined as subscores of blood in stool and number of stools weekly not exceeding 0 and 0 or 1, respectively.
    - The induction of registration remission at week 4 and 12, and the maintenance of this
    remission at 5 and 12 months, defined as a CAI score of ≤4 and an endoscopic score
    of 0 or 1.
    - The induction of clinical remission at week 1, 4, 8 and the maintenance of this
    remission at 5 and 12 months, defined as a CAI score of ≤4.
    - The induction of clinical response at week 1, 4, 8 and 12, defined as a decrease in CAI
    score of ≥5 from baseline.
    - Health related quality of life evaluation using an inflammatory bowel disease
    questionnaire (IBDQ) and a short-form health survey with 36 questions (SF-36) at
    week 12 and at 12 months, compared to baseline.
    - The induction of mucosal healing defined as an endoscopic score of 0 or 1 at week 4
    • The histopathological response/remission at week 4 and 12. Histopathological
    response is defined as an improvement in the histopathological score of ≥3 from
    baseline, i.e. a histopathological response could go from 5 to 2 or from 4 to 1.
    Histopathological remission is defined as an improvement from baseline to a histopathological score of 0.
    • Frequency of and time to UC relapses, defined as an increase of CAI ≥5 from the previous study visit.
    • Safety and tolerability.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Refer to E.5.2
    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) 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 Yes
    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 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 No
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    When the last patient in has completed the 12-month follow-up visit.
    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.1.1Number of subjects for this age range: 0
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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)
    Not different from normal treatment
    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 Decision2011-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-03-25
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