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    Summary
    EudraCT Number:2021-000594-81
    Sponsor's Protocol Code Number:S65020
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-03-18
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2021-000594-81
    A.3Full title of the trial
    The effect of corticotropin release hormone on duodenal markers and gastric sensorimotor function in healthy volunteers
    Het effect van corticotropine-release hormone op duodenummarkers en gastrosensorimotorische functie bij gezonde vrijwilligers
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of stress hormone on duodenal mucosa and gastric function in healthy volunteers
    Het effect van het stresshormoon op het slijmvlies van de twaalfvingerige darm en de maagfunctie bij gezonde vrijwilligers
    A.3.2Name or abbreviated title of the trial where available
    Effect of CRH on duodenal markers and gastric sensorimotor function
    Effect van CRH op duodenummarkers en gastrische sensorimotorische functie
    A.4.1Sponsor's protocol code numberS65020
    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 SponsorUniversity Hospitals Leuven (UZ Leuven)
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportKU Leuven
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKU Leuven
    B.5.2Functional name of contact pointTARGID
    B.5.3 Address:
    B.5.3.1Street AddressHerestraat 49 - bus 701
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.4Telephone number3216345663
    B.5.6E-mailjolien.schol@kuleuven.be
    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 Yes
    D.2.1.1.1Trade name CRH Ferring
    D.2.1.1.2Name of the Marketing Authorisation holderFerring B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCorticorelin triflutate
    D.3.9.1CAS number 121249-14-7
    D.3.9.2Current sponsor codeCORTICORELIN TRIFLUTATE
    D.3.9.3Other descriptive nameCORTICORELIN TRIFLUTATE
    D.3.9.4EV Substance CodeSUB23368
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    To assess the effect of the CRH on duodenal mast cell count, eosinophil count, immune activation, mucosal permeability and gastric sensorimotor function and gastrointestinal symptoms.
    Het effect van CRH op het aantal mestcellen in het duodenum, het aantal eosinofielen, de immuunrespons, de mucosale permeabiliteit en de sensorimotorische maagfunctie en gastro-intestinale symptomen.
    E.1.1.1Medical condition in easily understood language
    To assess the effect of the stress hormone on duodenal inflammation cells and gastric motor function.
    Het effect van het stresshormoon op ontstekingscellen in de twaalfvingerige darm en maagmotiliteit.
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1
    ● The effect of corticotrophin release hormone (CRH) on duodenal mast cell count in healthy volunteers
    Part 2
    ● The effect of CRH on sensitivity to gastric distention in healthy volunteers
    Deel 1:
    * Het effect van het corticotropine release hormone (CRH) op duodenale mastcel telling bij gezonde vrijwilligers.

    Deel 2:
    * Het effect van het CRH op maaggevoeligheid bij gezonde vrijwilligers.
    E.2.2Secondary objectives of the trial
    Part 1
    ● The effect of CRH on duodenal eosinophilia in healthy volunteers
    ● The effect of CRH on markers of immune activation in healthy volunteers
    ● The effect of CRH on duodenal mucosal permeability in healthy volunteers

    Part 2
    ● The effect of CRH on gastric accommodation in healthy volunteers
    ● The effect of CRH on gastroduodenal symptoms in healthy volunteers
    ● The effect of CRH on gastric emptying time in healthy volunteers
    ● The effect of CRH on salivary cortisol level in healthy volunteers
    Deel 1
    ● Het effect van CRH op duodenale eosinofilie bij gezonde vrijwilligers.
    ● Het effect van CRH op markers van immuunactivatie bij gezonde vrijwilligers.
    ● Het effect van CRH op de permeabiliteit van de mucosa van het duodenum bij gezonde vrijwilligers.


    Deel 2
    ● Het effect van CRH op maagaccommodatie bij gezonde vrijwilligers.
    ● The effect of CRH op gastroduodenale symptomen bij gezonde vrijwilligers.
    ● The effect of CRH op de maaglediging bij gezonde vrijwilligers.
    ● The effect of CRH op speeksel cortisol levels bij gezonde vrijwilligers.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Voluntary written informed consent of the participant has been obtained prior to any screening procedures
    2. Women of child-bearing potential agree to apply a highly effective methods of birth control;
    3. Healthy volunteers
    4. Subjects aged 18-70 years old (70y included).
    5. Male or female subjects.
    6. Subjects who are capable to understand the study and the questionnaires, and to comply with the study requirements.
    1. Vrijwillige schriftelijke geïnformeerde toestemming van de deelnemer is verkregen voorafgaand aan screeningprocedures
    2. Vrouwen die zwanger kunnen worden, stemmen ermee in om zeer effectieve anticonceptiemethoden toe te passen; g
    3. Gezonde vrijwilligers
    4. Vrijwilligers tussen 18-70 jaar oud (inclusief 70 jaar).
    5. Mannelijke of vrouwelijke proefpersonen.
    6. Proefpersonen die in staat zijn de studie en de vragenlijsten te begrijpen en te voldoen aan de studie-eisen.
    E.4Principal exclusion criteria
    1. Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol
    2. Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial
    3. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive
    4. Presence of a history of gastrointestinal surgery other than appendectomy
    5. Presence of organic or functional gastrointestinal disease
    6. Presence of gastro-intestinal symptoms
    7. Major psychiatric disorder such as major depression
    8. Presence of any disease affecting the gastrointestinal tract or hepatobiliary system.
    9. History of allergic reaction to CRH
    10. Use of drugs included in this list:
    a. Opioids (unless short intake for acute pain and > 1month ago)
    b. Amitriptyline or mirtazapine; other antidepressants are allowed if the HV is on a stable dose and the drug is not combined with other antidepressants.
    c. Corticosteroids
    d. Antihistaminic drugs (last 2 weeks)
    e. Proton pump inhibitors (last 2 weeks)
    f. Disodiumchromoglycate or other mast cell stabilizers (last 2 weeks)
    g. Leukotriene receptor antagonists (last 2 weeks)
    h. NSAIDs (last 2 weeks)
    i. Antibiotics (last 2 months)
    j. Probiotics (last 2 weeks)
    1. Elke stoornis die naar de mening van de onderzoeker de veiligheid van de deelnemer of de naleving van het protocol in gevaar kan brengen
    2. Elke eerdere of gelijktijdige behandeling (en) die de veiligheid van de deelnemer in gevaar kunnen brengen of die de integriteit van het onderzoek in gevaar kunnen brengen
    3. Vrouwen die zwanger zijn, borstvoeding geven of van plan zijn zwanger te worden of een vruchtbare leeftijd hebben en geen geschikt, zeer effectief anticonceptiemiddel gebruiken
    4. Aanwezigheid van een voorgeschiedenis van gastro-intestinale chirurgie met uitzondering van een appendectomie
    5. Aanwezigheid van organische of functionele gastro-intestinale ziekte
    6. Aanwezigheid van gastro-intestinale symptomen
    7. Ernstige psychiatrische stoornis, zoals ernstige depressie
    8. Aanwezigheid van een ziekte die het maagdarmkanaal of het hepatobiliaire systeem aantast.
    9. Voorgeschiedenis van allergische reactie op CRH
    10. Gebruik van medicatie op deze lijst:
    a. Opioïden (tenzij korte inname voor acute pijn en> 1 maand geleden)
    b. Amitriptyline of mirtazapine; andere antidepressiva zijn toegestaan ​​als de HV een stabiele dosis heeft en het medicijn niet wordt gecombineerd met andere antidepressiva.
    c. Corticosteroïden
    d. Antihistaminica (laatste 2 weken)
    e. Protonpompremmers (laatste 2 weken)
    f. Dinatriumchromoglycaat of andere mestcelstabilisatoren (laatste 2 weken)
    g. Leukotriene receptorantagonisten (laatste 2 weken)
    h. NSAID's (afgelopen 2 weken)
    ik. Antibiotica (laatste 2 maanden)
    j. Probiotica (laatste 2 weken)
    E.5 End points
    E.5.1Primary end point(s)
    Part 1
    To determine duodenal mast cell count after administration of CRH vs. placebo

    Part 2
    To determine sensitivity to gastric distention after administration of CRH vs. placebo
    Deel 1
    Nagaan of het aantal duodenale mestcellen verandert na toediening van CRH vs placebo

    Deel 2
    Nagaan of de maaggevoeligheid verandert na toediening van CRH vs placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1
    2 hours after IMP/Placebo administration

    Part 2
    Evaluation will start during MP/Placebo administration
    Deel 1
    2 uur na toediening van IMP / Placebo

    Deel 2
    De evaluatie zal starten tijdens toediening van IMP / Placebo
    E.5.2Secondary end point(s)
    Part 1:
    ● The effect of CRH (vs placebo) on duodenal eosinophilia.
    ● The effect of CRH (vs placebo) on markers of immune activation.
    ● The effect of CRH (vs placebo) on duodenal mucosal permeability
    Part 2:
    ● The effect of CRH (vs placebo) on gastric emptying time
    ● The effect of CRH (vs placebo) on gastric accommodation
    ● The effect of CRH (vs placebo) on gastroduodenal symptoms.
    ● The effect of CRH (vs placebo) on salivary cortisol level
    Deel 1:
    ● Het effect van CRH (vs placebo) op duodenale eosinofilie.
    ● Het effect van CRH (vs placebo) op markers van immuunactivatie.
    ● Het effect van CRH (vs placebo) op de permeabiliteit van het slijmvlies van de twaalfvingerige darm

    Deel 2:
    ● Het effect van CRH (vs placebo) op maaglediging
    ● Het effect van CRH (vs placebo) op maagaccommodatie
    ● Het effect van CRH (vs placebo) op gastroduodenale symptomen.
    ● Het effect van CRH (vs placebo) op de cortisolspiegel in het speeksel
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part 1
    Before and 2 hours after IMP/Placebo administration

    Part 2
    Evaluation will start during MP/Placebo administration
    Deel 1
    voor, en 2 uur na toediening van IMP / Placebo

    Deel 2
    De evaluatie zal starten tijdens toediening van IMP / Placebo
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    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
    To unravel the process of increased duodenal mastcell count, duodenal eosinophil count, symptom perception, visceral sensitivity en gastrointestinal motility.
    Het bestuderen van de oorzaak van een verhoogd aantal mastcellen en eosinofielen duodenaal, symptoomperceptie, viscerale sensitiviteit en maagmotiliteit.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 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
    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 months
    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: 20
    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 Yes
    F.3.2Patients No
    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 No
    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
    (medical) students, hospital and laboratory personnel
    studenten, personeel van het ziekenhuis of laboratorium
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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
    geen
    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 Decision2021-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-07
    P. End of Trial
    P.End of Trial StatusOngoing
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