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    Summary
    EudraCT Number:2018-001429-26
    Sponsor's Protocol Code Number:ZP1848-17127
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-02-25
    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 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
    The patient must meet all of the following inclusion criteria:
    - Signed informed consent
    Either of the following:
    - Completed the full treatment period of the lead-in trial (ZP1848-17111), regardless of treatment adherence.
    OR
    - Completed the Phase 2 trial (ZP1848-15073).
    E.4Principal exclusion criteria
    The patient must be excluded from this trial if any of the following criteria are met:
    - Withdrew consent from lead-in or Phase 2 trial.
    - 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.
    - 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.
    - 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 of there Study Protocol.
    - Committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
    - An employee of the sponsor or the 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:
    Hematology
    Biochemistry
    Urinalysis
    Immunogenicity
    Efficacy Endpoints:
    - Reduction in weekly PS volume from baseline
    - Having at least 20% reduction 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 will be analyzed using the incidence of AEs occurring in each 3-month period for the first year; subsequent years will have longer periods assigned for analysis. All efficacy endpoints will be analyzed using average weekly results over the 3-month period between visits.
    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
    Per week from baseline
    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 No
    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 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 EEA27
    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
    Belgium
    Canada
    Denmark
    France
    Germany
    Italy
    Netherlands
    Poland
    United Kingdom
    United States
    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 and Follow-up (FU)/Final Visit and patient interview, if consented (US, UK, DK, FR, DE sites only).
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months11
    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 state20
    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)
    Patients will be treated in Extension study for 2 years. Afterwards, they may be treated with the approved drug.
    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 Decision2019-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-08
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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