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    Summary
    EudraCT Number:2020-005129-99
    Sponsor's Protocol Code Number:TA799-013
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-12-24
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-005129-99
    A.3Full title of the trial
    A multicenter, open-label, metabolic balance study to evaluate the effects of apraglutide on intestinal absorption in adult subjects with short bowel syndrome, intestinal failure (SBS-IF), and colon-in-continuity (CIC)
    Étude de l’équilibre métabolique multicentrique en ouvert visant à évaluer les effets de l’apraglutide sur l’absorption intestinale chez des patients adultes présentant un syndrome du grêle court avec une insuffisance intestinale (SGC-II) et un côlon en continuité (CEC).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to evaluate the effects of apraglutide on intestinal absorption.
    Effets de l’apraglutide sur l’absorption intestinale dans le SGC-II avec CEC
    A.4.1Sponsor's protocol code numberTA799-013
    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 SponsorVectivBio 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 supportVectivBio AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVectivBio AG
    B.5.2Functional name of contact pointClinical Trial Information Desk
    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 numberNANANA
    B.5.5Fax number+41 44 660 6590
    B.5.6E-mailclinicaltrial.enquiries@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 Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2102
    D.3 Description of the IMP
    D.3.1Product nameapraglutide
    D.3.2Product code TA799
    D.3.4Pharmaceutical form Powder 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 INNAPRAGLUTIDE
    D.3.9.1CAS number 1295353-98-8
    D.3.9.2Current sponsor codeTA799; FE 203799
    D.3.9.3Other descriptive nameapraglutide
    D.3.9.4EV Substance CodeSUB193006
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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, intestinal failure (SBS-IF), colon-in-continuity (CIC)
    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 efficacy of apraglutide in increasing intestinal energy absorption assessed by bomb calorimetry in relation to metabolic balance assessments.
    E.2.2Secondary objectives of the trial
    • To evaluate fluid, electrolytes and macronutrients absorption indicative of clinical efficacy
    • To evaluate the efficacy of apraglutide in reducing the administered volume per week of PS from baseline
    • To evaluate the safety and tolerability of apraglutide
    • To assess apraglutide plasma concentrations to inform the population pharmacokinetic (PopPK) model
    • To evaluate citrulline plasma concentrations to inform the PopPK / pharmacodynamic (PD) analysis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent for this trial prior to any trial specific assessment
    2. Male and female subjects with SBS-IF and CIC (at least 28% [Cummings, 1973] and no colostomy), receiving PS, secondary to surgical resection of the small intestine with <200 cm from duodeno-jejunal flexure, based on available medical/surgical records and with the latest intestinal resection being at least 12 months prior to Screening
    3. Subject considered stable with regards to PS and weight. Stability is defined as a subject meeting all the following criteria in the 3 months preceding screening:
    a) Weight change ≤ 5%
    b) PS volume change not exceeding 10-25%
    c) PS energy content change not exceeding 10-25%
    d) Actual PS usage in terms of volume and content matches prescribed PS (±10%)
    4. Average fecal wet weight excretion of ≥500 g/day during the baseline metabolic balance study
    5. Urine volume is ≥0.8 L and ≤2.5 L per day during baseline metabolic balance study
    6. Parenteral support requirement of at least 2 days perweek as assessed at Screening
    7. Willingness to remain in clinic for metabolic study on three occasions for 5 days, adhere to an individual pre-defined drinking menu and urine measurements during the 48-hour fluid balance periods
    8. No restorative surgery intended to change PS requirements planned during the trial period
    9. Age ≥18 years at screening
    10. Women of childbearing potential must agree to practice effective contraception and to use a highly effective method of contraception during the trial and for 4 weeks after the End of Trial (EOT) visit. Such methods include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner. To be considered sterilized or infertile, females must have undergone surgical sterilization (bilateral tubectomy, hysterectomy or bilateral ovariectomy) or be post-menopausal (defined as at least 12 months amenorrhea may be confirmed with follicle-stimulating hormone test if there is doubt). Women who do not engage in heterosexual intercourse, during the trial and 4 weeks after the EoT Visit, will be allowed to join the trial without contraception following a thorough discussion with the Investigator to determine if this is feasible for the subject. The following methods are not considered acceptable methods of contraception: calendar, ovulation, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method (LAM)
    11. Male subjects with a female partner of childbearing potential must commit to practice highly effective methods of contraception (e.g., condom, vasectomy, etc.) and abstain from sperm donation during the trial and for 2 weeks after the EOT Visit. Their partners, if they are women of childbearing potential, must agree to practice effective contraception and to use a highly effective method of contraception during the trial and for 4 weeks after the EOT visit. Such methods include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device, intrauterine hormone-releasing system
    E.4Principal exclusion criteria
    1. Pregnancy or lactation
    2. Body mass index equal or higher than 30 kg/m2 at Screening
    3. Major abdominal surgery (more than 10% intestinal resection or surgery that changes anatomy group) in the last 6 months prior to screening. Surgery for feeding tube placement allowed
    4. A history of clinically significant intestinal adhesions which have not been treated surgically, increasing the risk of GI obstruction
    5. Severe constipation which is not managed by dietary recommendations or laxatives
    6. Enterocutaneous fistula
    7. History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within ≤5 years, except for adequately treated basal cell skin cancer
    8. History of cholecystitis or biliary obstruction, unless cholecystectomy was performed prior to screening and resolved the issues
    9. Evidence of active IBD in the previous 6 months prior to Screening
    10. Central venous catheter sepsis experienced within the previous 8 weeks, prior to screening or use of systemic antibiotics within the last 30 days, prior to screening, due to catheter infection
    11. Decompensated heart failure (New York Heart Association class III–IV) [NYHA] and/or known coronary heart disease defined as unstable angina pectoris and/or myocardial infarction within the previous 6 months prior to Screening
    12. Radiation enteritis, scleroderma or other condition of severe intestinal dysmotility unrelated to SBS, coeliac disease, refractory or tropical sprue
    13. History of alcohol and/or drug abuse within the previous 12 months prior to Screening
    14. Child-Pugh score Class C
    15. Inadequate renal function as defined by estimated glomerular filtration rate (eGFR) using the Chronic Kidney Disease Epidemiology (CKD-EPI) formula at screening visit <30 mL/min/1.73m2
    16. Unplanned hospitalization of >24 hours duration within 30 days prior to Screening
    17. More than two changes in systemic corticosteroids, methotrexate, cyclosporine, tacrolimus, sirolimus, infliximab, or other biologic therapy/immunomodulators within 30 days of Screening
    18. Use of glutamine, or growth factors such as growth hormone (GH), somatostatin analogs, native GLP-1, GLP-2, or GLP-1 or GLP-2 analogs in the previous 6ºmonths prior to Screening
    19. Known or suspected hypersensitivity to GLP-1 or GLP-2 analogs or apraglutide excipients
    20. Known neutralizing antibodies (nAb) against GLP-1 or GLP-2 analogs
    21. Participation in another clinical trial within 12 weeks prior to Screening and during this trial (studies with catheter locks, COVID-19 vaccines and observational trials, which are not a burden on the subject and do not interfere with the participation in this trial, are allowed)
    22. Donation of blood or plasma >500 mL within 12ºweeks prior to Screening
    23. Positive results for human immunodeficiency virus, hepatitis A, B and/or C tests*
    24. Subject not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements
    25. Judged not eligible by the Investigator for any other reason
    *Subjects recovered from hepatitis A, B or C can be enrolled; i.e., they have markers of the infection, but the viral load for hepatitis B and/or C is equal to zero. Subjects with evidence of an acute or chronically active hepatitis B or C infection should be excluded. Subjects experiencing acute hepatitis A are excluded.
    E.5 End points
    E.5.1Primary end point(s)
    Change in absolute energy absorption over metabolic balance periods from baseline to end of treatment at Week 48
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 48
    E.5.2Secondary end point(s)
    Efficacy endpoints related to PS volume
    • Relative change from baseline in actual weekly PS volume at Weeks 24 and 52
    • Absolute change from baseline in actual weekly PS volume at Weeks 24 and 52
    • Subjects who achieve a reduction of at least 1 day per week of PS from baseline at Weeks 24 and 52
    • Clinical responders (20% reduction of PS volume from baseline) at Weeks 24 and 52
    • Subjects reaching enteral autonomy at Weeks 24 and 52
    • Energy reduction in the PN from baseline at Weeks 24 and 52
    Efficacy endpoint related to nutritional, fluid (wet weight) and electrolyte absorption
    • Relative change in absorption of energy, over metabolic balance periods from baseline at Week 48
    • Change in absorption of macronutrients, over metabolic balance periods from baseline at Week 48
    • Change in absolute absorption of energy over metabolic balance periods from baseline at Week 4
    • Change in absorption of macronutrients, over metabolic balance periods from baseline at Week 4
    • Changes in urine output and urinary electrolytes (sodium, potassium, calcium and magnesium) over metabolic balance periods, from baseline at Week 4 and at Week 48
    Patient reported outcomes
    • Changes from baseline in Pittsburgh Sleep Quality Inventory (PSQI) at Weeks 24 and 52
    • Patient Global Impression of Change (PGIC) at Weeks 24 and 52
    • Changes from baseline in Patient Global Impression of Severity (PGIS) at Weeks 24 and 52
    PK/PD related endpoints
    • Trough plasma concentration (Ctrough)
    • Plasma citrulline levels
    Safety endpoints
    • Adverse events of special interest (AESIs)
    • Clinical chemistry, hematology, hemostasis, anti-drug antibodies (ADA) and urine analysis
    • Adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    As per information provided in E.5.2.

    PK/PD related endpoints and Safety endpoints are being evaluated on an ongoing basis as per the study schedule given in the protocol.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 EEA3
    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
    LVLS
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    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: 10
    F.1.3Elderly (>=65 years) No
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 10
    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 Decision2021-02-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-06-06
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