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    Summary
    EudraCT Number:2017-002486-21
    Sponsor's Protocol Code Number:GLY-311-2017
    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:2017-11-24
    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 number2017-002486-21
    A.3Full title of the trial
    A once weekly, repeated dose, placebo controlled, double blind, randomised cross-over trial investigating safety, efficacy and pharmacodynamics of FE 203799 in patients with short bowel syndrome with intestinal failure requiring parenteral support followed by an additional treatment period in an open label regimen.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to investigate efficacy and safety of FE 203799 (GLP-2 analogue) or placebo administered as subcutaneous injections once weekly in two treatment periods followed by FE 203799 once weekly in one treatment period to patients with short bowel syndrome with intestinal failure.
    A.4.1Sponsor's protocol code numberGLY-311-2017
    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 SponsorGLyPharma Therapeutic, Inc. (a wholly owned subsidiary of VectivBio Holding AG)
    B.1.3.4CountrySwitzerland
    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 supportGLyPharma Therapeutic, Inc. (a wholly owned subsidiary of VectivBio Holding AG)
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGLyPharma Therapeutic, Inc. (a wholly owned subsidiary of VectivBio Holding AG)
    B.5.2Functional name of contact pointChristian Meyer
    B.5.3 Address:
    B.5.3.1Street AddressAeschenvorstadt 36
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4051
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0041796543455
    B.5.6E-mailchristian.meyer@vectivbio.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.3.2Product code FE 203799
    D.3.4Pharmaceutical form Powder and solution for 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 INNnone
    D.3.9.1CAS number 1295353-98-8
    D.3.9.2Current sponsor codeFE 203799
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 placeboPowder for concentrate for solution for injection/infusion
    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 (SBS)
    E.1.1.1Medical condition in easily understood language
    Patients with SBS with intestinal failure have a reduced absorption function in the intestines. Shortened intestines also lead to a changed hormone production.
    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 assess the safety and tolerability of FE 203799 in patients with SBS with intestinal.


    E.2.2Secondary objectives of the trial
    To assess the pharmacodynamics (PD) of FE 203799 in patients with SBS with intestinal failure
    To assess the trough concentration and the post dose plasma concentration of FE 203799 in patients with SBS with intestinal failure
    To evaluate markers indicative of a pharmacological effect
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Males and females with SBS secondary to surgical resection of the small intestine
    2.18-80 years of age
    3.Body Mass Index (BMI) between 16.0 and 32.0 (both inclusive)
    4.Patients with a jejuno- or ileostomy and a faecal wet weight excretion of at least 1500 g/day, as recorded within the last 18 months according to the patient’s medical record
    5.Parenteral support ≥3 times/week for ≥12 months according to the patient’s medical record
    6.At least 6 months since last surgical bowel resection
    7.Willing to adhere to a defined oral intake of fluids on certain days as required by the protocol (and based on the individual’s routine daily consumption)
    8.Women of childbearing potential must agree to use an adequate method of contraception during the trial and for 60 days after the end-of-trial visit. Adequate methods of contraception include intrauterine device or hormonal contraception (oral contraceptive pill, depot injections or implant, transdermal depot patch or vaginal ring). To be considered sterilised or infertile, females must have undergone surgical sterilisation (bilateral tubectomy, hysterectomy or bilateral ovariectomy) or be post-menopausal (defined as at least 12 months amenorrhoea may be confirmed with follicle-stimulating hormone [FSH] test) if there is doubt)
    9. Male subjects must commit to use barrier contraception (e.g. condom) during the trial and for 2 weeks after the end-of-trial visit.
    E.4Principal exclusion criteria
    1.Pregnancy or lactation
    2.Positive results on the human immunodeficiency virus (HIV), hepatitis B and/or C tests
    3.A history of clinically significant intestinal adhesions and/or chronic abdominal pain
    4.Require chronic systemic narcotics for treatment of pain that exceeds an amount corresponding to 80 mg of morphine per day
    5.History of cancer or clinically significant lymphoproliferative disease within ≤5 years, except for adequately treated basal cell skin cancer
    6.History of gallstone within the past 3 years. Gallstones with subsequent cholecystectomy to resolve the issues is acceptable
    7.Inflammatory bowel disease (IBD) patients who have not been on a stable drug treatment regimen for at least the past 4 weeks
    8.Evidence of active IBD in the past 12 weeks
    9.Visible blood in the stool within the last 3 months
    10.Catheter sepsis experienced within the last 3 months
    11.Decompensated heart failure (New York Heart Association [NYHA] class III-IV, see Appendix 12.2) and/or known coronary heart disease defined as unstable angina pectoris and/or myocardial infarction within the last 6 months prior to screening
    12.Radiation enteritis, scleroderma or other condition of intestinal dysmotility, coeliac disease, refractory or tropical sprue
    13.History of alcohol and/or drug abuse within the last 12 months
    14.Inadequate hepatic function as defined by: bilirubin >upper limit of normal (ULN), alanine transaminase (ALT) or aspartate transaminase (AST) >2.0 × ULN; alkaline phosphatase (ALP) >2.5 × ULN; or international normalised ratio (INR) >1.5 × ULN
    15.Inadequate renal function as defined by serum creatinine or blood urea nitrogen >2.5 × ULN
    16.Unplanned hospitalisation of >24 hours duration within 1 month before the screening visit
    17. Changes in systemic corticosteroids, methotrexate, cyclosporine, tacrolimus, sirolimus, infliximab or other biologic therapy/immune modifiers within 3 months of screening
    18.Any use of growth hormone, glutamine or growth factors such as native GLP 2 or GLP 2 analogue within the last 3 months
    19.Any use of antibiotics within the last 30 days
    20.Participation in another clinical trial within the last 3 months and during this trial
    21.Previously been randomised in this trial
    22.Loss of blood or donation of blood or plasma >500 mL within 3 months prior to screening
    23.Patient not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements
    24.For any other reason judged not eligible by the investigator
    E.5 End points
    E.5.1Primary end point(s)
    Adverse events (AEs; type, frequency and intensity), vital signs (systolic and diastolic blood pressure, heart rate), electrocardiogram (ECG; intervals, rhythm and morphology), clinical chemistry, haematology, haemostasis and urinalysis
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline run-in to End of trail visit, in total during 42 weeks
    E.5.2Secondary end point(s)
    •Change from baseline in urinary output over 48 hours at the end of the treatment period (Days 26-28)
    •Change from baseline in urinary output over 48 hours immediately after first dose in the treatment period (Days 1-3)
    •Change from baseline in urinary Na+ levels over 48 hours immediately after first dose (Days 1-3)
    •Change from baseline in urinary Na+ levels over 48 hours at the end of the treatment period (Days 26-28)
    •Change from baseline in PS volume during the treatment period (Days 21+22)
    •Change from baseline in oral fluid intake during the treatment period (Days 21+22)
    •Change from baseline in plasma citrulline levels on Day 8 and at the end of the treatment period (Day 29)
    •Change from baseline in lean body mass and other body composition parameters (bone mineral content and fat mass) using dual-energy X-ray absorptiometry (DEXA) scan at the end of the treatment period (Day 29)
    •Plasma concentration of FE 203799 at 72 hours (C72h) and trough concentration of FE 203799 (Ctrough)
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline run-in to End of trail visit, in total during 42 weeks
    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 No
    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 and changes in urine output, parenteral support and oral fluid intake
    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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    The above describes Part A. Part B will be a single arm open label design
    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 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 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 Yes
    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 is considered to have completed the trial if he or she has received all 4 IMP injections in treatment period 1 and at least 3 IMP injections in each treatment period 2 and 3, and if he or she has completed final safety assessments at the end-of-trial visit.
    The trial will be closed when all patients have completed Visit 29 (end-of-trial visit).

    LVFS 31Dec2019
    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 months8
    E.8.9.1In the Member State concerned days
    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: 8
    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 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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    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 Decision2018-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-11-21
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