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    Summary
    EudraCT Number:2011-002462-20
    Sponsor's Protocol Code Number:KPT4-01/2011
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-09-22
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2011-002462-20
    A.3Full title of the trial
    Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis
    A.3.2Name or abbreviated title of the trial where available
    K(D)PT in ulcerative colitis: proof of concept study
    A.4.1Sponsor's protocol code numberKPT4-01/2011
    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 SponsorDr August Wolff GmbH & Co KG Arzneimittel
    B.1.3.4CountryGermany
    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 supportDr August Wolff GmbH & Co KG Arzneimittel
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr August Wolff GmbH & Co KG Arzneimittel
    B.5.2Functional name of contact pointClinical trial information
    B.5.3 Address:
    B.5.3.1Street AddressSudbrackstrasse 56
    B.5.3.2Town/ cityBielefeld
    B.5.3.3Post codeD-33611
    B.5.3.4CountryGermany
    B.5.4Telephone number+495218808437
    B.5.5Fax number+495218808474
    B.5.6E-mailinfo@wolff-arzneimittel.de
    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 nameKdPT
    D.3.2Product code 20 mg
    D.3.4Pharmaceutical form Powder for oral solution
    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.3.9.2Current sponsor codeK(D)PT Acetate
    D.3.9.3Other descriptive nameL-Lysyl-D-Prolyl-L-Threonine Acetate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Yes
    D.3.11.13.1Other medicinal product typeIMP will be reconstitutued with 20 g solvent for oral solution before use.
    D.IMP: 2
    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 nameKdPT
    D.3.2Product code 50 mg
    D.3.4Pharmaceutical form Powder for oral solution
    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.3.9.2Current sponsor codeK(D)PT Acetate
    D.3.9.3Other descriptive nameL-Lysyl-D-Prolyl-L-Threonine Acetate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    D.3.11.13.1Other medicinal product typeIMP will be reconstitutued with 20 g solvent for oral solution before use.
    D.IMP: 3
    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 nameKdPT
    D.3.2Product code 100 mg
    D.3.4Pharmaceutical form Powder for oral solution
    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.3.9.2Current sponsor codeK(D)PT Acetate
    D.3.9.3Other descriptive nameL-Lysyl-D-Prolyl-L-Threonine Acetate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 Yes
    D.3.11.13.1Other medicinal product typeIMP will be reconstitutued with 20 g solvent for oral solution before use.
    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 placeboPowder for oral solution
    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
    Acute mild to moderate ulcerative colitis.
    E.1.1.1Medical condition in easily understood language
    Acute mild to moderate 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 LLT
    E.1.2Classification code 10066678
    E.1.2Term Acute ulcerative colitis
    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 proof of concept placebo-controlled study to determine the efficacy and safety of 3 dose groups of K(D)PT in patients with acute mild to moderate ulcerative colitis.
    The primary objective is to determine the time to response to K(D)PT, defined as the time from Day 0 to the earliest treatment visit at which a sustained improvement in CAI of ≥50% is determined (CAI scored according to Rachmilewitz, 1989). The improvement in CAI must be ≥50% at week 8 (Visit 7) irrespective of any interim decline, for the improvement to be classified as sustained.
    E.2.2Secondary objectives of the trial
    To determine:
    • remission at Weeks 4, 8 and 12, defined as CAI ≤3
    • response at Weeks 4, 8 and 12, defined as an improvement in CAI of ≥50% from Day 0
    • improvement in CAI during the (total) treatment period defined as the area under the curve of CAI values from Day 1 until Week 8.
    • response at Week 8, defined as a decrease from baseline in Disease Activity Index (DAI) of 30% or more
    • response at Week 8, defined as a change from baseline in endoscopy index (EI) of >1.5
    • endoscopic remission, defined as flexible proctosigmoidoscopy score of 0 to 1 at Week 8.
    • the improvement in faecal calprotectin concentration from baseline to Weeks 4, 8, and 12.
    • the improvement in C-reactive protein (CRP) from baseline to Weeks 4, 8, and 12.
    • the improvement in the score for Inflammatory Bowel Disease Questionnaire (IBDQ) from baseline to Weeks 8 and 12.
    • the incidence of adverse events (AEs) throughout the study.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provide written informed consent, i.e. they must be willing and able to comply with the study procedures.
    2. Adult males or females, aged 18 to 70 years (inclusive).
    3. Females of childbearing potential must have a negative urine pregnancy test at screening and must agree to use adequate contraception (e.g. oral, depot or implanted hormonal contraception, intrauterine device, surgical sterilisation or partner vasectomy, or doble barrier method) from screening visit until at least 4 weeks after last dose of study medication (Week 12). A double barrier method means condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam, gel, cream of suppository.A female condom and a male condom should not be used together as friction between the two can result in either product failing.
    4. Females of non-child bearing potential should be postmenopausal for >1 year or permanently sterilised (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy).
    5. Male patients must agree to use adequate contraception (e.g. vasectomy or adequate partner contraception).
    6. Body mass index (BMI) ≥19 and ≤30 kg/m2.
    7. Mild to moderately active UC proven by endoscopy and criteria according to European Crohn's and Colitis Organisation (ECCO) guidelines and defined as a CAI of 6 to 12.
    8. Pre-treatment of active ulcerative colitis with any of the following:
    - a stable dose of oral mesalazine, sulphasalazine or olsalazine for >4 weeks (oral), and/or
    - a stable dose of azathioprine or 6-mercaptopurin for >3 months, and/or
    - a stable dose of oral corticosteroids of ≤20 mg oral prednisolone or equivalent for >2 weeks before baseline (Visit 2).
    E.4Principal exclusion criteria
    1. Pregnant, planning to become pregnant during the study, or breast feeding females.
    2. Previous participation in any clinical study with K(D)PT.
    3. Crohn’s disease.
    4. Treatment-naive.
    5. Infectious diarrhoea within the screening period (up to 14 days prior the randomization visit (Visit 2)), after randomization or during the treatment period.
    6. Indeterminate colitis.
    7. Significantly impaired liver, renal, pulmonary or cardiovascular function.
    8. Use of systemic or topical gastrointestinal antibiotics within 4 weeks before or during the treatment period(day 1).
    9.Use of E. coli Nissle within 4 weeks before or during the treatment period.
    10. Previous use of cyclosporine, anti-TNF therapy (e.g. infliximab) or tacrolimus at any time.
    11. Any rectal therapy four weeks before or during the treatment period.
    12. Use of corticosteroids >20 mg oral prednisolone or equivalent.
    13. Use of methotrexate within 3 months before or during the treatment period.
    14. Use of anti-diarrhoeal drugs within 2 weeks before or during the treatment period.
    15. Effective anti-coagulation therapy (e.g. Marcumar) or severe grade coagulation defects.
    16. Any clinically relevant abnormal findings at screening, vital signs or ECG which, in the opinion of the investigator, may put the patient at risk because of his or her participation in the study. Patients must have undergone colonoscopy for dysplasia screening according to local guidelines before randomization.
    17. History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or could influence the results, or the patient’s ability to participate in the study.
    18. History of or current alcohol or drug abuse, as judged by the investigator.
    19. Participation in another investigational drug study within 3 months before first administration of study medication.
    20. Donation of blood within 3 months, or donation of plasma within 2 weeks, before the first administration of study medication. Planned donation of blood, plasma or sperm at any time during the study (from the start of screening until follow up visit).
    21. Proctitis (≤5 cm).
    22. QTcF >450 ms or <350 ms or QT >500 ms or other relevant ECG abnormality as judged by the investigator.
    23. History of pathological skin condition or melanoma within the previous 5 years.
    24. Known intolerance to methylparaben or propylparaben.
    25. Known intolerance to any other excipient of the investigational medicinal product (IMP).
    26. Positive history of hepatitis B and/or C and/or history of human immunodeficiency virus (HIV).
    27. Planned surgery or hospitalisation during the study.
    28. Patients who, in the opinion of the investigator, should not participate in the study.
    29. Patients unable to understand informed consent.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the time to sustained response to study medication, where response is defined as an improvement in CAI of ≥50% from Day 0 (CAI scored according to Rachmilewitz, 1989). The improvement in CAI must be ≥50% at week 8 (visit 7), irrespective of any interim decline, for the improvement to be classified as sustained.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 2, week 4, week 6, week 8 and week 12
    E.5.2Secondary end point(s)
    • Frequency of remission, defined as CAI ≤3 (CAI scored according to Rachmilewitz, 1989), at Weeks 4, 8 and 12.
    • Response to study medication at Weeks 4, 8 and 12, where response is defined as an improvement in CAI of ≥50% (CAI scored according to Rachmilewitz, 1989).
    • Area under the curve for the change from baseline in CAI scores during the (total) treatment period from Day 1 until Week 8
    • Frequency of response rates at Week 8 with response defined as decrease from baseline in DAI of 30% or more
    • Frequency of response rates at Week 8 with response defined as change from baseline in EI of >1.5
    • Frequency of patients with endoscopic remission
    • Change from baseline to Weeks 4, 8, and 12 in faecal calprotectin concentrations.
    • Change from baseline to Weeks 4, 8, and 12 in CRP concentrations.
    • Change from baseline to Week 8 and 12 in IBDQ scores.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Varies between day 1 to week 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 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 trial4
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    LVLS
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    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 end of the trial, the patient will be treated with the medical standard according to patient’s need.
    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 Decision2011-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-04-03
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