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    Summary
    EudraCT Number:2020-005513-41
    Sponsor's Protocol Code Number:TA799-012
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-08-30
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-005513-41
    A.3Full title of the trial
    An open-label extension trial to evaluate the long-term safety of apraglutide in short bowel syndrome
    Studio di estensione in aperto volto a valutare la sicurezza a lungo termine di apraglutide nella sindrome dell’intestino corto
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term safety of apraglutide in short bowel syndrome
    Sicurezza a lungo termine di apraglutide nella sindrome dell’intestino corto
    A.3.2Name or abbreviated title of the trial where available
    TA799-012
    TA799-012
    A.4.1Sponsor's protocol code numberTA799-012
    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.5.5Fax 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.3.9.3Other 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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    short bowel syndrome
    sindrome dell'intestino corto
    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 assess long-term safety and tolerability of apraglutide in subjects with SBS-IF
    Valutare la sicurezza e la tollerabilità a lungo termine di apraglutide in soggetti con SBS-IF
    E.2.2Secondary objectives of the trial
    To evaluate markers indicative of clinical effects of apraglutide
    Valutare i marcatori indicativi di effetti clinici di apraglutide
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females with a diagnosis of SBS-IF secondary to surgical resection of the small intestine, with CIC or stoma, who have completed parent trials TA799-007 or TA799-013 and:
    a. Did not meet any stopping criteria.
    b. Received a minimum of 70% of the planned doses in the trial (unless an AE precluded the subject from meeting this percentage; in this case, the Investigator will decide if the subject will benefit from enrolling in the trial).
    c. Complete the last two scheduled visits of the parent trial. Subjects who were forced to withdraw from TA799-007 for logistical reasons not related to the efficacy or safety of apraglutide (e.g., hospitalization for a car accident, COVID-19 pandemic, or emergency surgery) which resulted in several consecutive missed doses may be eligible to participate in this
    trial upon approval by the Medical Monitor.
    2. Able to give informed consent and agree to follow the details of participation as outlined in this protocol.
    3. Women of childbearing potential must agree to use a highly effective method of contraception during the trial and for 4 weeks after the end of trial (EOT) visit.
    4. Male subjects with a female partner of childbearing potential must commit to practice methods of contraception and abstain from sperm donation during the trial and for 2 weeks after the EOT Visit.
    1. Soggetti di ambo i sessi con diagnosi di SBS-IF secondaria a resezione chirurgica dell’intestino tenue, con CIC o stomia, che hanno completato lo studio originario TA799-007 o TA799-013 e:
    a. Non hanno soddisfatto i criteri di interruzione.
    b. Hanno ricevuto almeno il 70% delle dosi previste nello studio (eccetto laddove un AE abbia impedito al soggetto di soddisfare questa percentuale; in tal caso, lo sperimentatore deciderà se il soggetto trarrà beneficio dall’arruolamento nello studio).
    c. Si sono sottoposti alle ultime due visite programmate dello studio originario. I soggetti che sono stati costretti a ritirarsi dallo studio TA799-007 per motivi logistici non correlati all’efficacia o alla sicurezza di apraglutide (ad es. ricovero in ospedale per un incidente d’auto, a causa della pandemia da COVID-19 o per un intervento chirurgico d’emergenza) e che di conseguenza hanno saltato diverse dosi consecutive potranno essere ritenuti idonei alla partecipazione allo studio su autorizzazione del Medical Monitor.
    2. Soggetti in grado di rilasciare il consenso informato e che acconsentono a rispettare le specifiche della partecipazione riportate nel presente protocollo.
    3. Le donne in età fertile dovranno acconsentire a usare un metodo contraccettivo altamente efficace durante la sperimentazione e per 4 settimane dopo la visita di fine studio (EOT).
    4. I soggetti di sesso maschile con una partner in età fertile dovranno impegnarsi a usare metodi contraccettivi e ad astenersi dalla donazione del seme durante la sperimentazione e per 2 settimane dopo la visita EOT.
    E.4Principal exclusion criteria
    1. Subject not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements.
    2. Any other reason judged not eligible by the Investigator.
    1. Soggetti che non sono in grado di comprendere o non vogliono rispettare il programma delle visite dello studio e altri requisiti del protocollo.
    2. Qualsiasi altro motivo per cui i soggetti siano ritenuti non idonei dallo sperimentatore.
    E.5 End points
    E.5.1Primary end point(s)
    - Adverse events (AE; system organ class, frequency and severity)
    - Occurrence of clinically relevant AEs of special interest (AESIs):
    o Injection site reactions
    o Gastrointestinal (GI) obstructions
    o Gallbladder, biliary and pancreatic disease
    o Fluid overload
    o Colorectal polyps
    o Malignancies
    - Clinical chemistry, hematology, hemostasis and urinalysis
    - Occurrence of clinically relevant changes in vital signs (systolic and diastolic blood pressure, heart rate)
    - Occurrence of clinically relevant changes in electrocardiogram (ECG; intervals and rhythm)
    - Eventi avversi (AE; classificazione per sistemi e organi, frequenza e severità)
    - Comparsa di AE di interesse particolare (AESI) clinicamente rilevanti:
    o Reazioni nella sede di iniezione
    o Ostruzioni gastrointestinali (GI)
    o Disturbi a carico della colecisti, biliari e pancreatici
    o Sovraccarico di liquidi
    o Polipi del colon-retto
    o Neoplasie maligne
    - Esami biochimici, esami ematologici, esami per la valutazione dell’emostasi e analisi delle urine
    - Comparsa di variazioni clinicamente rilevanti dei parametri vitali (pressione arteriosa sistolica e diastolica, frequenza cardiaca)
    - Comparsa di variazioni clinicamente rilevanti nell’elettrocardiogramma (ECG; intervalli e ritmo)
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 104
    settimana 104
    E.5.2Secondary end point(s)
    - Change from baseline in PS volume at Week 104
    - Change from baseline in PS frequency at Week 104
    - Change from baseline in PS composition at Week 104
    - Change from baseline in PS infusion time at Week 104
    - Percentage of subjects reaching enteral autonomy by Week 104
    - Change from baseline in body weight at Week 104
    - Change from baseline on QoL measures at Week 104
    - Variazione rispetto al basale del volume di PS alla Settimana 104
    - Variazione rispetto al basale della frequenza del PS alla Settimana 104
    - Variazione rispetto al basale della composizione del PS alla Settimana 104
    - Variazione rispetto al basale del tempo di infusione del PS alla Settimana 104
    - Percentuale di soggetti che raggiungono l’autonomia enterale entro la Settimana 104
    - Variazione rispetto al basale del peso corporeo alla Settimana 104
    - Variazione rispetto al basale dei punteggi sulle scale QoL alla Settimana 104
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 104
    settimana 104
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 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 EEA26
    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
    China
    Israel
    Japan
    Korea, Republic of
    Taiwan
    United States
    Belgium
    Denmark
    France
    Germany
    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 years3
    E.8.9.1In the Member State concerned months3
    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 months8
    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: 76
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 62
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 154
    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
    Nessuno
    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 Decision2021-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-16
    P. End of Trial
    P.End of Trial StatusOngoing
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