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    Summary
    EudraCT Number:2015-002826-38
    Sponsor's Protocol Code Number:ZP1848-15073
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-10-29
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2015-002826-38
    A.3Full title of the trial
    A phase 2 trial testing ZP1848 in patients with SBS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A proof-of-concept, dose finding, controlled, single-senter, randomized, cross-over, double-blind, fixed dose phase 2 trial with ZP1848 in patients with Short Bowel Syndrome
    A.4.1Sponsor's protocol code numberZP1848-15073
    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 SponsorZealand Pharma A/S
    B.1.3.4CountryDenmark
    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 supportZealand Pharma A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegulatory Affairs/ Zealand Pharma A/S
    B.5.2Functional name of contact pointVicky Lüth Bjerre
    B.5.3 Address:
    B.5.3.1Street AddressSmedeland 36
    B.5.3.2Town/ cityGlostrup
    B.5.3.3Post code2600
    B.5.3.4CountryDenmark
    B.5.4Telephone number004588 77 36 00
    B.5.5Fax number004588 77 38 98
    B.5.6E-mailvlb@zealandpharma.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.3.1Product nameZP1848
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number None
    D.3.9.2Current sponsor codeZP1848
    D.3.9.3Other descriptive nameZP1848
    D.3.9.4EV Substance CodeSUB180965
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Short Bowel Syndrome (SBS)
    E.1.1.1Medical condition in easily understood language
    Patients with SBS suffer from accelerated gastrointestinal motility, gastric and intestinal hypersecretion, disturbed immunological/barrier functions, and impaired mucosal repair and blood flow.
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10049416
    E.1.2Term Short-bowel syndrome
    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
    The primary objective is to evaluate the effect of three different doses of ZP1848 on intestinal
    absorption in SBS patients after three week treatment periods.
    E.2.2Secondary objectives of the trial
    Secondary Objectives
    • To evaluate the efficacy of three different doses of ZP1848 on other functional
    parameters than those covered in the primary objective after three week treatment
    periods.
    • To describe safety and tolerability of three different doses of ZP1848 during and after
    three week treatment periods.
    • To describe the pharmacokinetics of three different doses of ZP1848 during and after
    three week treatment periods.
    • To describe the pharmacodynamics of three different doses of ZP1848 during and after
    three week treatment periods.
    • To describe the immunogenicity of ZP1848.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Following receipt of verbal and written information about the trial, the patient must
    provide signed informed consent before any trial related activity is carried out.
    2. Age 18 years and 90 years
    3. Stable SBS patients with intestinal insufficiency or failure, where the last surgical
    resection of gut tissue was performed at least 1 year ago
    4. A stable PS volume ( < 25% change in volume or energy content) for four weeks prior to
    randomization for patients requiring PS
    5. Wet weight of fecal excretion 1500 g/day demonstrated during a hospital stay prior to
    screening or during at least one day of the first baseline balance study.
    6. Stable body weight (<5% weight deviance in the three months prior to screening)
    E.4Principal exclusion criteria
    8. Patients with known or suspected intestinal strictures of clinical relevance as judged by
    the Investigator
    11. Active inflammatory bowel disease (IBD) or fistula during the screening period as judged
    by conventional means of the Investigator.
    12. Crohn’s disease patients not being in clinical remission for the last 12 weeks prior to
    randomization
    13. Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and/or
    diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months prior to screening
    15. History of cancer (except resected cutaneous basal or squamous cell carcinoma and
    except in situ cervical cancer) unless it can be documented that the patient has been in a
    disease-free state for at least 5 years (except colon cancer: patients with a history of colon
    cancer generally have to be excluded)
    20. eGFR (by the MDRD formula) <30 mL/min/1.73 m2
    21. Clinically meaningful renal disease as judged by the Investigator
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the absolute change from baseline to the end of three week treatment periods of wet weight of ostomy output or diarrhea measured separately over each of the two treatment periods, where:
    •The baseline values are measured as the average of the 72h baseline balance studies before each treatment period, and
    •The end of three week treatment period values are measured as the average of the 72h treatment balance studies at the end of each treatment period
    Each patient is therefore planned to deliver two values for the primary endpoint; one value for each of the two planned treatment periods.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline balance study to end of 3 weeks treatment period
    E.5.2Secondary end point(s)
    Secondary Endpoints Efficacy
    1.Relative change from baseline to the end of treatment of wet weight of ostomy output or diarrhea measured separately over each of the two treatment periods
    2.Absolute and relative change from baseline to the end of treatment of urine weight measured separately over each of the two treatment periods
    3.Absolute and relative change from baseline to the end of treatment of wet weight absorption (measured by oral intake minus fecal excretion) measured separately over each of the two treatment periods
    4.Absolute and relative change from baseline to end of treatment of urine weight minus oral intake, measured separately over each of the two treatment periods
    5.Absolute and relative change from baseline to the end of treatment of the intestinal absorption (oral intake minus fecal excretion) of electrolytes measured separately over each of the two treatment periods
    -Sodium
    -Magnesium
    -Calcium
    -Potassium
    6.Absolute and relative change from baseline to the end of treatment of the intestinal absorption (oral intake minus fecal excretion) of macronutrients measured separately over each of the two treatment periods
    -Energy assessed by bomb calorimetry
    -Lipids
    -Nitrogen
    -Carbohydrates
    7.Change in patient reported outcomes (SF-36, SBS-QoL, VAS scales)
    8.Incidence of adverse events
    9. Incidence of anti-drug antibodies
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-7 From baseline balance study to end of three weeks treatment period.
    8-9 Up to day 109
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Local tolerability, immunogenicity, patient reported outcomes
    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 Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Another dose of the IMP, ZP1848
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS is 31-12-2016
    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 months0
    E.8.9.1In the Member State concerned 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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 No
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    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 Decision2015-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-05-04
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