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    Summary
    EudraCT Number:2020-005502-25
    Sponsor's Protocol Code Number:ZP1848-20110
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-08-02
    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 ConcernedGermany - BfArM
    A.2EudraCT number2020-005502-25
    A.3Full title of the trial
    A 104-Week, Multicenter, Single-Arm, Long-Term, Phase 3 Extension Trial Investigating the Safety and Efficacy of Glepaglutide in Adult Patients with Short Bowel Syndrome (SBS) Completing the EASE SBS 2 Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-Term, Extension Trial Investigating the Safety and Efficacy of glepaglutide in patients with short bowel syndrome
    A.3.2Name or abbreviated title of the trial where available
    EASE SBS 3 (Efficacy and Safety Evaluation of Glepaglutide in Treatment of SBS)
    A.4.1Sponsor's protocol code numberZP1848-20110
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1261-3358
    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 point Ebru Ucar Kaarup Trial 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 3835
    B.5.6E-maileucar@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 in pre-filled injector
    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 Yes
    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
    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
    Primary Objective:
    • To evaluate the long-term safety of glepaglutide treatment in adult patients with SBS.
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    • To evaluate the maintenance of response with regards to efficacy endpoints with glepaglutide 10 mg once weekly (OW)
    • To assess the long-term immunogenicity of glepaglutide and its impact on pharmacokinetics (PK), safety, and efficacy maintenance
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The patient must meet both of the following inclusion criteria:
    1. Signed informed consent
    2. Completed the full treatment period of the extension trial EASE SBS 2
    E.4Principal exclusion criteria
    The patient must be excluded from this trial if any of the following criteria are met:
    1. 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 confound the planned assessments of the trial.
    2. Not having a colonoscopy performed at EOT in EASE SBS 2 (for patients with remnant colon).
    Note: The results of the colonoscopy must not give rise to any safety concerns. A colonoscopy performed within 6 months prior to EOT and not giving rise to any safety concerns is accepted. 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) will suffice at the discretion of the Investigator.
    3. Use of GLP-1, GLP-2, human growth hormone (HGH), dipeptidyl peptidase-4 (DPP-4) inhibitors, somatostatin, or analogs thereof within 3 months. Note: Prior use of 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.
    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.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the incidence and type of AEs, with onset or worsening following Visit 1 and will be presented by system organ class (SOC) and preferred term (PT) in total and by treatment sequence prior to the EASE SBS 3 trial.
    E.5.1.1Timepoint(s) of evaluation of this end point
    As described under point E 5.1.: With onset or worsening following Visit 1
    E.5.2Secondary end point(s)
    The following secondary safety endpoints will be summarized descriptively:
    • Incidence and type of serious adverse events (SAEs) and AEs of special interest (AESIs) with onset or worsening following Visit 1
    • Changes from baseline in:
    o Vital signs
    o ECG
    • Changes from baseline in:
    o Hematology
    o Biochemistry
    o Urinalysis
    • Immunogenicity (anti-glepaglutide antibodies, antibody reactivity to ZP18481-34, cross-reactivity to glucagon-like peptide-2 (GLP-2), glepaglutide neutralizing antibodies)
    The secondary efficacy endpoints are:
    • Reduction in weekly PS volume (prescribed) from baseline
    • Reduction of at least 20% in weekly PS volume (prescribed) from baseline
    • Reduction in days on PS ≥ 1 day/week from baseline
    • Reduction in weekly PS volume of 100% (weaned off)
    E.5.2.1Timepoint(s) of evaluation of this end point
    As specified under point E.5.2. Changes from baseline in this extension trial will be relative to the baseline assessment in the lead-in trial, EASE SBS 1, independent of receiving active or placebo treatment for the first 6 months.
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    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 (scheduled when the trial drug is either discontinued or completed) and Follow-up (FU)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months7
    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 months7
    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: 97
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    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 87
    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 could be treated with standard treatment of this condition or 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 Decision2021-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-07
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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