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    The EU Clinical Trials Register currently displays   42312   clinical trials with a EudraCT protocol, of which   6968   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2021-004588-29
    Sponsor's Protocol Code Number:TA799-101
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-04
    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 number2021-004588-29
    A.3Full title of the trial
    A randomized, double-blind trial to evaluate the safety and efficacy of apraglutide in subjects with Grade II to IV (MAGIC) steroid refractory gastrointestinal (GI) acute graft versus host disease on best available therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of apraglutide in steroid refractory gastrointestinal acute graft versus host disease
    A.3.2Name or abbreviated title of the trial where available
    Proof-of-concept trial of apraglutide in GVHD
    A.4.1Sponsor's protocol code numberTA799-101
    A.5.4Other Identifiers
    Name:INDNumber:156438
    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 number+41615513030
    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 No
    D.2.5.1Orphan drug designation number
    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
    Acute graft versus host disease (GVHD)
    E.1.1.1Medical condition in easily understood language
    inflammatory disorder
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10075160
    E.1.2Term Graft versus host disease in gastrointestinal tract
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10075161
    E.1.2Term Graft versus host disease in GI tract
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10066264
    E.1.2Term Acute graft versus host disease in intestine
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10066260
    E.1.2Term Acute graft versus host disease
    E.1.2System Organ Class 10021428 - Immune system 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 assess safety and tolerability of apraglutide in subjects with SR GI-aGVHD of the mid-lower GI tract who are treated with SS and with RUX for 0–3 days
    Key Efficacy Objective:
    To evaluate the SR GI-aGVHD response rate at Day 56 in subjects with SR GI-aGVHD Grade II to IV (Mount Sinai aGVHD International Consortium [MAGIC]; Harris 2016) treated with apraglutide, SS, and RUX compared with SS and RUX alone (BAT)
    E.2.2Secondary objectives of the trial
    Key Secondary Objectives:
    •Evaluate the SR GI-aGVHD response rate at Days 14,28,90,120,150, & 180 in subjects with GI-aGVHD treated with apraglutide and BAT compared with BAT
    •Estimate overall GVHD response rate at Days 14,28,56,90,120,150, & 180
    •Estimate duration of response from Day 56
    Secondary Efficacy Objectives:
    •Assess durability of GI response:
    -Assess time to complete GI-GVHD response and FFS
    -Assess individual course of GI-GVHD response and overall GVHD response at Days 14, 28, 56, 90, 120, 150, and 180
    -GI-GVHD response in subjects retreated due to GI-GVHD flare up to Day 180 post initial apraglutide dose
    •Incidence of GI-GVHD flare up to Day 180 following earlier cessation due to complete response
    •Assess duration of response from Day 29, non relapse mortality, overall survival, individual time courses, doses of BAT up to Day 90 post-initial apraglutide dose and nutrition status
    •Measure incidence of infections,sepsis,malignancy relapse, secondary malignancies
    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. A signed assent form will also be required for any subjects under the age of 18 years
    2. Male or female subjects aged 12 years or above at the time of consent and who weigh a minimum of 40 kg. Only subjects of 18 years and above will be included in Germany.
    3. Have undergone alloSCT from any donor source (matched unrelated donor, sibling, haplo-identical) using bone marrow, peripheral blood stem cells, or cord blood. Recipients of non-myeloablative, myeloablative, and reduced intensity conditioning are eligible
    4. Evident myeloid and platelet engraftment (confirmed prior to trial medication start):
    a) Absolute neutrophil count >1000/mm3
    AND
    b) Platelets ≥20,000/mm3
    Use of growth factor supplementation (granulocyte-colony stimulating factor and granulocyte-macrophage-colony stimulating factor) and transfusion support is allowed
    5. Histologically diagnosed GI-aGVHD at screening (with clinically confirmed SR GI-aGVHD at RUX start and prior to apraglutide start) defined as subjects administered SS, given alone or combined with calcineurin inhibitors (CNI) and either:
    a) Disease progression based on organ assessment after 3 days
    OR
    b) Did not improve after 7 days of treatment with MP 2mg/kg/day equivalent,
    OR
    c) Progressed to a new organ after treatment with MP 2 mg/kg/day equivalent for skin and upper GI-aGVHD,
    OR
    d) Recurred during or after a steroid taper
    All subjects must have Stage 1–4 lower GI-aGVHD at enrollment
    6. Treated with SS plus RUX (RUX at the recommended dose twice daily for 0–3 days). CNI are allowed as co-medication, if needed
    7. Women of childbearing potential must agree 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 (intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation injectable, implantable); intrauterine device; intrauterine hormone-releasing
    system; bilateral tubal occlusion; vasectomized partner. Oral methods of hormonal contraception are to be combined with another accepted method for contraception. 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
    without an alternative medical cause, may be confirmed with follicle-stimulating hormone test in case of doubt). Women who do not engage in heterosexual intercourse 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
    8. 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.
    Nevertheless, if their partners are women of childbearing potential, they must agree to practice contraception and 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; bilateral tubal occlusion
    E.4Principal exclusion criteria
    1. Treatment with any systemic GVHD therapy other than SS and RUX including methotrexate and mycophenolate mofetil. For subjects on GVHD prophylaxis (ciclosporin A, tacrolimus, sirolimus, everolimus, or anti-thymocyte globulin) this medication can be continued
    2. Concomitant treatment with Janus kinase inhibitor therapy for any other indication after initiation of current alloSCT conditioning
    3. Presence of any systemic corticosteroid therapy for indications other than aGVHD within 7 days prior to screening. Low doses of prednisolone/hydrocortisone for adrenal suppression are allowed
    4. Failed alloSCT within the past 6 months before randomization
    5. Presence of SR GI-aGVHD occurring after non-scheduled donor lymphocyte infusion administered for pre-emptive treatment of malignancy recurrence
    6. Previous administration of any investigational treatment agent within 30 days prior to screening or within five half-lives of the trial medication, whichever is greater. Subjects who have received placebo in a previous study during this period may be included.
    7. Known or suspected hypersensitivity to GLP-1 or GLP-2 analogs or apraglutide excipients
    8.Any use of enteral glutamine or growth factors such as native GLP-2, GLP-1 or GLP-2 and GLP-1 analogs within 6 months prior to randomization
    9.Inability to understand or adhere to the trial visit schedules and other protocol requirements, including subjects not willing to comply due to drug/alcohol abuse or any condition that would interfere with full participation in the trial, including administration of trial medication and attending required trial visits; pose a significant risk to the subject; or interfere with interpretation of trial data
    10. Less than 2 weeks anticipated survival at screening
    11.Known significant respiratory disease including subjects who are on mechanical ventilation or who have known resting O2 saturation <90% by pulse-oximetry on room air
    12.Presence of severely impaired renal function requiring dialysis, or has an estimated creatinine clearance <29 mL/min/1.73m2 measured or calculated by the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI; confirmed within 48 hours prior to randomization)
    13.Presence of decompensated liver cirrhosis Child-Pugh Class B and C
    14.Clinically significant or uncontrolled cardiac disease including acute myocardial infarction within 6 months prior to randomization, uncontrolled hypertension, New York Heart Association Class III or IV congestive heart failure, unstable angina within last 6 months prior to screening, or presence of severe arrhythmia
    15.Requirement for vasopressor or inotropic support (within 30 days to randomization)
    16.Presence of uncontrolled cholestatic disorders or unresolved sinusoidal obstructive syndrome/veno-occlusive disease of the liver
    17.Presence of relapsed primary malignancy, or treatment for relapse after the alloSCT, or requirement for rapid immune suppression withdrawal as pre-emergent treatment of early malignancy relapse
    18.Presence of newly diagnosed malignancies (intestinal- or liver malignancies) or history of chronic gall bladder or bile duct inflammation or biliary obstruction unless cholecystectomy was performed prior to screening
    19.Presence of GI tumors or colonic polyps that are not removed
    20.Presence of an active uncontrolled infection such as active viral infection (confirmed by peripheral blood viral load) including Epstein Barr virus, SARS-COV-2 virus, human immunodeficiency virus, hepatitis B virus, or hepatitis C virus. Cytomegalovirus reactivation is permitted as long as no evidence of pulmonary disease is present. Please refer to protocol.
    21.Known chronic GVHD
    22.Known active gut inflammation not related to GI-aGVHD
    23.History of progressive multifocal leuko-encephalopathy
    24.Known pregnant or nursing (lactating) women
    25.Known major abdominal surgery in the last 6 months prior to screening (surgical feeding tube placement or other minimally invasive surgery allowed)
    26.History of clinically significant intestinal adhesions increasing the risk of GI obstruction and/or GI contrast trial(s) suggesting subacute intestinal obstruction or stricture within 6 months prior to screening
    27.Presence of severe constipation (no stool in the past 48 hours prior to randomization) which is not managed by dietary recommendations, laxatives or cathartic medications
    28.History of intestinal pseudo-obstruction and refractory coeliac disease (within 6 months prior to screening)
    29.Any previous use of GLP-2 analogues or known ADA
    30.Liver enzyme deviation as described in the exclusion criterion #29 in the protocol
    E.5 End points
    E.5.1Primary end point(s)
    • Gastrointestinal-aGVHD response at Day 56 in subjects with GI-aGVHD treated with apraglutide, SS, and RUX compared with SS and RUX alone (BAT)
    E.5.1.1Timepoint(s) of evaluation of this end point
    After day 56 is completed for all subjects
    E.5.2Secondary end point(s)
    • Gastrointestinal-aGVHD response at Days 14, 28, 90, 120, 150, and 180 in subjects with GI-aGVHD treated with apraglutide, SS, and RUX compared
    with SS and RUX alone (BAT).
    • Overall response at Days 14, 28, 56, 90, 120, 150, and 180
    • Duration of response from Day 56
    E.5.2.1Timepoint(s) of evaluation of this end point
    When Days 14, 28, 56, 90, 120, 150, and 180 are completed by all subjects
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 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) Yes
    E.8.2.2Placebo No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Germany
    Portugal
    Spain
    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
    The end of the trial is defined as the last subject’s last visit.
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 4
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 4
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 28
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Elderly
    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 24
    F.4.2.2In the whole clinical trial 34
    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)
    All subjects are expected to return to standard of care
    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 Decision2021-12-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-01
    P. End of Trial
    P.End of Trial StatusOngoing
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