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    Summary
    EudraCT Number:2020-001202-32
    Sponsor's Protocol Code Number:TA799-007
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-05-24
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-001202-32
    A.3Full title of the trial
    A multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of apraglutide in adult subjects with short bowel syndrome and intestinal failure (SBS-IF)
    Studio multicentrico, randomizzato, in doppio cieco, controllato con placebo per valutare l’efficacia e la sicurezza di apraglutide in pazienti adulti con sindrome dell’intestino corto e insufficienza intestinale (SBS-IF)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of apraglutide in short bowel syndrome and intestinal failure
    Efficacia e sicurezza di apraglutide nella sindrome dell’intestino corto e insufficienza intestinale
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and Safety of apraglutide in SBS-IF
    Efficacia e sicurezza di apraglutide nella SBS-IF
    A.4.1Sponsor's protocol code numberTA799-007
    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/ cityBasilea
    B.5.3.3Post code4051
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41446606590
    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.3.9.4EV 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 solution 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 and intestinal failure
    sindrome dell’intestino corto e insufficienza intestinale
    E.1.1.1Medical condition in easily understood language
    short gut
    intestino corto
    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 weekly SC apraglutide in reducing parenteral support dependency
    Valutare l’efficacia della somministrazione SC settimanale di apraglutide nel ridurre la dipendenza da PS
    E.2.2Secondary objectives of the trial
    • To evaluate selected parameters indicative of clinical efficacy
    • To evaluate the safety and tolerability of apraglutide compared with
    placebo
    • To assess the PK of apraglutide
    - Valutare alcuni parametri selezionati indicativi di efficacia clinica
    - Valutare la sicurezza e la tollerabilità di apraglutide rispetto a placebo
    - Definire la farmacocinetica (PK) di apraglutide
    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, receiving parenteral support (PS), secondary to surgical resection of the small intestine with either stoma or colon-in-continuity (CIC).
    3. Subject must require PS at least 3 days per week and be considered stable.
    4. No restorative surgery intended to change PS requirements in the trial period.
    5. Age =18 years at screening.
    1. Consenso informato firmato per questa sperimentazione prima di qualunque valutazione specifica per la sperimentazione.
    2. Soggetti di ambo i sessi con SBS-IF sottoposti a PS a seguito di resezione chirurgica dell’intestino tenue con stomia o colon in continuità
    3. Soggetti che necessitano di nutrizione parenterale di supporto per almeno 3 giorni a settimana e che possono essere considerati stabili
    4. Nessun intervento chirurgico di ripristino allo scopo di modificare il fabbisogno di PS pianificato nel periodo della sperimentazione
    5. Età =18 anni allo screening
    E.4Principal exclusion criteria
    1. Pregnancy or lactation.
    2. Major abdominal surgery in the last 6 months prior to screening.
    3. History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within =5 years, except for adequately treated basal cell skin cancer.
    4. Evidence of active inflammatory GI conditions in the previous 6 months.
    5. Evidence of decompensated heart failure.
    6. Evidence of severe renal or hepatic impairment.
    7. Any previous use of growth factors such as growth hormone (GH), native GLP-2, GLP-1, or GLP-2 or GLP-1 analogues should be discussed with the Investigator.
    1. Gravidanza o allattamento
    2. Intervento di chirurgia addominale maggiore negli ultimi 6 mesi che precedono lo screening
    3. Storia di neoplasia maligna (incluso carcinoma del colon) o di malattia linfoproliferativa clinicamente rilevante entro =5 anni, a eccezione di carcinoma cutaneo basocellulare adeguatamente trattato.
    4. Evidenze di malattia infiammatoria intestinale attiva nei 6 mesi precedent
    5. Evidenze di scompenso cardiaco
    6. Evidenze di grave insufficienza renale o epatica
    7. Qualunque uso precedente di fattori di crescita quali l’ormone della crescita (GH), GLP-2 o GLP1 nativo oppure analoghi del GLP-2 o del GLP-1 dovrà essere discusso con lo Sperimentatore
    E.5 End points
    E.5.1Primary end point(s)
    Relative change from baseline in actual weekly PS volume at Week 24
    Variazione relativa rispetto al basale del volume settimanale effettivo della PS alla Settimana 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    Settimana 24
    E.5.2Secondary end point(s)
    • Subjects who achieve a reduction of at least 1 day per week of PS from baseline at Weeks 24 / 48.
    • Relative change from baseline in actual weekly PS volume at Weeks 12 / 24 / 48.
    • SBS-IF patients reaching enteral autonomy at Weeks 24 / 48.
    • At least 20% reduction of PS volume from baseline at Weeks 20 / 24.
    • Calorie reduction in the PN at Weeks 24.
    • Change from baseline on QoL measures at Weeks 24 / 48.
    • Apraglutide PK parameters (baseline through Week 48).
    - Soggetti che ottengono una riduzione di almeno 1 giorno a settimana della PS dal basale alle Settimane 24 / 48
    - Variazione relativa rispetto al basale del volume settimanale effettivo della PS alle Settimane 12 / 24 / 48
    - Soggetti con SBS-IF che raggiungono l’autonomia enterale alle Settimane 24 / 48
    - Riduzione di almeno il 20% del volume della PS rispetto al basale alle Settimane 20 / 24
    - Riduzione dell’apporto calorico fornito dalla nutrizione parenterale (NP) alla Settimana 24
    - Variazione rispetto al basale dei punteggi dei questionari QoL alle Settimane 24 / 48
    - Parametri PK di apraglutide (dal basale fino alla Settimana 48)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Specified at point E.5.2
    Specificati al punto 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 Yes
    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) 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 No
    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 EEA42
    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 Information not present in EudraCT
    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
    China
    Israel
    Japan
    Korea, Republic of
    Taiwan
    Ukraine
    United States
    Belgium
    Denmark
    France
    Germany
    Hungary
    Italy
    Norway
    Poland
    Spain
    Sweden
    United Kingdom
    Czechia
    Argentina
    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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days16
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 144
    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)
    Continuous treatment in a Long-term Safety and Clinical Outcomes Extension Trial (LTE) may be offered to subjects at the final planned dosing visit in this trial, allowing subjects in the placebo arm to also have the option of receiving apraglutide. The open-label LTE trial will be described in a separate protocol.
    In occasione della visita finale programmata del periodo di somministrazione di questa sperimentazione, potrà essere proposto ai soggetti di proseguire il trattamento in uno studio di estensione a lungo termine (LTE) per la valutazione della sicurezza e degli outcome clinici. Lo studio di estensione a lungo termine per la valutazione della sicurezza sarà descritto in un protocollo separato.
    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 Decision2020-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-22
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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