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    Summary
    EudraCT Number:2018-001429-26
    Sponsor's Protocol Code Number:ZP1848-17127
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-03-14
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2018-001429-26
    A.3Full title of the trial
    A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients with Short Bowel Syndrome (SBS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Extension trial to evaluate long-term
    efficacy and safety of glepaglutide in patients with short bowel syndrome
    A.3.2Name or abbreviated title of the trial where available
    EaseSBS 2 - Efficacy And Safety Evaluation of Glepaglutide in treatment of SBS
    A.4.1Sponsor's protocol code numberZP1848-17127
    A.5.4Other Identifiers
    Name:INDNumber:133151
    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 organisationZealand Pharma A/S
    B.5.2Functional name of contact pointTina Egegaard CT Manager
    B.5.3 Address:
    B.5.3.1Street AddressSydmarken 11
    B.5.3.2Town/ citySøborg
    B.5.3.3Post codeDK-2860
    B.5.3.4CountryDenmark
    B.5.4Telephone number+45 8877 3600
    B.5.6E-mailTEgegaard@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 nameGlepaglutide
    D.3.2Product code ZP1848
    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.3.8INN - Proposed INNGLEPAGLUTIDE
    D.3.9.1CAS number 914009-86-2
    D.3.9.2Current sponsor codeZP1848
    D.3.9.4EV Substance CodeSUB192388
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Short bowel syndrome
    E.1.1.1Medical condition in easily understood language
    Short gut
    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 20.1
    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
    To evaluate the long-term safety of glepaglutide treatment in short bowel syndrome (SBS) patients
    E.2.2Secondary objectives of the trial
    - To evaluate the long-term efficacy of glepaglutide treatment in SBS patients
    - To evaluate the long-term immunogenicity of glepaglutide and its impact on pharmacokinetics (PK), efficacy, and safety in SBS patients
    - To evaluate quality of life for SBS patients treated with glepaglutide
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetics Profile Sub-Study
    At Visit 7 (i.e. after 12 weeks of trial drug treatment), approximately 45 patients will be included in more extensive PK sampling. This is done to provide sufficient information about the PK-profile of glepaglutide and its primary active metabolites in SBS patients. The week prior to the PK sampling the patients must have been compliant to the planned dosing. The patients are planned to be from the lead-in trial from selected sites. The aim is to include about 15 patients allocated to twice weekly and about 30 patients allocated to once weekly. The PK profile sub-study is optional and patients can participate in the main trial without participating in the sub-study. As each PK sample contains 2 mL of blood, this is resulting in additional 14 mL blood drawn for PK-profile purposes. The PK profile sub-study must start on a day of trial drug administration, and the vial must be taken after the first PK sampling (0 hour).
    E.3Principal inclusion criteria
    Patients rolling over from the lead-in trial:
    The patient must meet all of the following inclusion criteria:
    1. Signed informed consent
    2. Either of the following:
    a) Completed the full Treatment phase of the lead-in trial (ZP1848-17111), regardless of treatment adherence.
    OR
    b) Eligible based on the same inclusion/exclusion criteria as in the lead-in
    trial (patients may be
    directly screened into this trial)
    Patients screened directly to the Extension Trial
    The patient must meet all of the following inclusion criteria:
    1. Informed consent obtained before any trial-related activity.
    2. Age ≥ 18 years and ≤ 90 years at Screening.
    3. Diagnosis of SBS defined as remaining small bowel in continuity of
    estimated less than 200 cm [equal to 79 inches] and with the latest
    intestinal resection being at least 6 months prior to Screening and
    considered stable with regard to PS need. No restorative surgery
    planned in the trial period.
    4. Requiring PS at least 3 days per week.
    5. Willing to adhere to an individual pre-defined drinking menu during
    48-hours measuring intervals.
    6. Willing to maintain a stable weight (± 5%) for the duration of the
    trial (24 weeks).
    7. Having:
    a. A stoma Or
    b. Colon-in-Continuity (CiC) with documented colonoscopy performed
    during Screening and which does not give rise to any safety concerns.
    Note: A colonoscopy performed within 6 months prior to Screening and
    not giving rise to any safety concerns is acceptable. For patients with a
    remnant colon, which is not connected to the passage of foods and is
    thereby dormant, a computerized tomography (CT) scan or magnetic
    resonance imaging (MRI) (if standard of care at site) will suffice at the
    discretion of the Investigator.
    8. Having:
    a) a stoma Or
    b) colon-in-continuity (CiC) and able to separate stool and urine during
    the 48 hours measuring intervals.
    E.4Principal exclusion criteria
    Patients rolling over from the lead-in trial:
    The patient must be excluded from this trial if any of the following criteria are met:
    1. Withdrew consent from lead-in trial.
    2. Any condition, disease, or circumstance that in the Investigator's
    opinion would put the patient at any undue risk, prevent completion of
    the trial, or confounds planned assessments of the trial.
    3. Use of GLP-1, GLP-2, human growth hormone (HGH), dipeptidyl
    peptidase-4 (DPP-4) inhibitors, citrulline, somatostatin, or analogs
    thereof within 3 months. Note: Prior glepaglutide trial drug is allowed.
    4. Females of childbearing potential, who are pregnant, breast-feeding,
    intend to become pregnant, or are not using highly effective
    contraceptive methods. Highly effective contraception methods and
    definition of child-bearing potential are described in Section 11.4.4.
    5. Committed to an institution by virtue of an order issued either by the
    judicial or the administrative authorities.
    6. An employee of the sponsor or Investigator or otherwise dependent
    on them.
    Patients screened directly to the Extension Trial
    The patient must be excluded from the trial if he or she meets any of the
    following criteria:
    1. More than 2 SBS-related or PS-related hospitalizations (e.g., catheter
    related bacteremia/sepsis, bowel obstruction, severe water-electrolytes
    disturbances, etc.) within 6 months prior to Screening.
    2. Poorly controlled inflammatory bowel disease (IBD) that is
    moderately or severely active or fistula interfering with measurements
    or examinations required in the trial.
    3. Bowel obstruction.
    4. Known radiation enteritis or significant villous atrophy, e.g., due to
    active celiac disease.
    5.Cardiac disease defined as: decompensated heart failure (New York
    Heart Association [NYHA] Class III-IV), unstable angina pectoris, and.
    6. Clinically significant abnormal ECG as judged by the Investigator.
    7. Repeated (2 or more consecutive measurements separated by at
    least 15 minutes) systolic blood pressure measurements > 180 mm Hg.
    8. Human immunodeficiency virus (HIV) positive, acute liver disease, or
    unstable chronic liver disease.
    9. Any history of colon cancer. History of any other cancers (except
    margin-free resected cutaneous basal or squamous cell carcinoma or
    adequately treated in situ cervical cancer) unless disease-free state for
    at least 5 years.
    10. Estimated creatinine clearance (CrCL; by the Cockcroft-Gault
    formula) < 30 mL/min.
    11. Hepatic impairment defined as:
    a. Total bilirubin ≥ 2 × the upper limit of normal (ULN), or
    b. Aspartate aminotransferase (AST) ≥ 5 × ULN, or
    c. Alanine aminotransferase (ALT) ≥ 5× ULN
    12. Use of GLP-1, GLP-2, HGH, somatostatin, or analogs thereof, within
    3 months prior to Screening.
    13. Use of DPP-4 inhibitors within 3 months prior to Screening.
    14. Systemic immunosuppressive therapy that has been introduced or
    has been unstable within 3 months prior to Screening.
    15. Unstable biological therapy (e.g. anti-tumor necrosis factor alpha
    [TNF-α], natalizumab, etc.) within 6 months prior to Screening, including
    significant changes in doses or switch of drug.
    16. Females of childbearing potential, who are pregnant, breastfeeding,
    intend to become pregnant or are not using highly effective
    contraceptive methods. Highly effective contraception methods and
    definition of child-bearing potential are described in Section 11.4.4.
    17. Known or suspected hypersensitivity to glepaglutide or related
    products.
    18. Previous exposure to glepaglutide.
    19. Previous participation (randomization) in this trial.
    20. Current, or within 30 days prior to Screening, participation in
    another interventional clinical trial that includes administration of an
    active compound.
    21. Mental incapacity or language barriers which preclude adequate
    understanding or cooperation, or unwillingness to comply with trial
    requirements.
    22. Any condition or disease or circumstance that in the Investigator's
    opinion would put the patient at any undue risk, prevent completion of
    the trial, or interfere with the analysis of the trial results.
    23. Committed to an institution by virtue of an order issued either by
    the judicial or the administrative authorities.
    24. An employee of the Sponsor or Investigator or otherwise dependent
    on them.
    E.5 End points
    E.5.1Primary end point(s)
    Safety Endpoints
    - Incidence and type of AEs (primary endpoint)
    - Incidence and type of serious adverse events (SAEs) and AESIs
    - Changes from baseline in:
    Vital signs
    Electrocardiogram (ECG)
    - Changes from baseline in:
    o Hematology
    o Biochemistry
    o Urinalysis
    o Standard bone markers (for patients screened directly only)
    o Immunogenicity
    Efficacy Endpoints:
    - Reduction in weekly PS volume from baseline
    - Reduction of at least 20% in weekly PS volume from baseline
    - Reduction in days on PS ≥ 1 day/week from baseline
    - Reduction in weekly PS volume of 100% (weaned off)
    The PS-related endpoints are based on actual PS, i.e. as reported by the patient.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint, AEs will be analysed using summary statistics
    (number of events, number of subjects with event, exposure and rate of
    event). An overall summary table will present the number and percent of
    subjects with any treatment emergent AE (TEAE), with serious TEAEs,
    with severe TEAEs, with related TEAEs, with AESIs and which lead to
    early discontinuation. For each AESI, a time to event analysis will be
    performed.
    For patients randomized in the lead-in trial, changes from baseline in the
    extension trial will be relative to their baseline assessment in the lead-in
    trial. For patients screened directly, baseline will be Visit 1 of this trial,
    prior to first dosing of trial drug.
    The timepoints of evaluation are provided in section E.5.1
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    - Change in fluid composite effect (FCE) from baseline
    - Reduction in calculated energy content of parenteral macronutrients from baseline
    - Reduction in number of days on PS per week from baseline
    - Reduction of at least 40% in weekly PS volume from baseline
    - Change in weight from Baseline
    Other efficacy endpoints are:
    - Reduction in days on PS ≥ 2 days/week from baseline
    - Reduction in days on PS ≥ 3 days/week from baseline
    - Reduction in duration of PS infusions per week from -baseline
    -Concentration trough levels of glepaglutide and metabolites
    - Change in plasma citrulline level from baseline
    - Change in weekly need for parenteral micronutrients (sodium, potassium, magnesium, and calcium) from baseline
    - Change in patient-reported outcomes (SBS-I and EQ-5D-5L) from baseline
    - Reduction in bowel movements or stoma bags emptying from baseline

    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint of evaluation of relevant end point are provided under section 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    Different dosage of the same product
    E.8.2.4Number of treatment arms in the trial2
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    Canada
    United Kingdom
    United States
    Belgium
    Denmark
    France
    Germany
    Italy
    Netherlands
    Poland
    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
    A patient will be considered as having completed the trial when:
    • Patient completed EOT visit and exit interview, if consented (Danish,
    French, German, United Kingdom [UK] and United States [US], sites
    only) may continue participation in ZP1848-20110 Trial.
    • Patient completed Follow-up/Final Visit and exit interview, if
    consented (Danish, French, German, UK, and US, sites only) and will
    not enter the extension trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months3
    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: 99
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 145
    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 completing the Treatment Phase, all patients will be offered to
    enter an extension to the extension trial (ZP1848-20110) and continue
    to receive glepaglutide, if approved by each country.
    For patients not entering the extension to the extension trial, a Followup
    Visit will be conducted 4 weeks after completion of the Treatment
    Phase. Any post-treatment Follow-up Visit will be considered
    redundant if the patient is enrolled in ZP1848-20110 at the time of the Follow-up Visit.
    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 Decision2019-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-22
    P. End of Trial
    P.End of Trial StatusOngoing
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