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    Summary
    EudraCT Number:2021-004420-15
    Sponsor's Protocol Code Number:M21IDB
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-07
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-004420-15
    A.3Full title of the trial
    A Phase 2 clinical study to assess efficacy of Induction ipilimumab/nivolumab to spare the Bladder in urothelial bladder cancer (Indi-Blade)
    Een fase 2 klinische studie naar de effectiviteit van inductie ipilimumab/nivolumab als blaassparende behandeling in blaaskanker (Indi-Blade)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunotherapy and chemoradiotherapy to spare the bladder in urothelial bladder cancer
    Immuuntherapie en chemoradiatie voor blaasbehoud bij blaaskanker
    A.3.2Name or abbreviated title of the trial where available
    Indi-Blade
    Indi-Blade
    A.4.1Sponsor's protocol code numberM21IDB
    A.5.4Other Identifiers
    Name:Indi-BladeNumber:Indi-Blade
    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 SponsorNKI-AVL
    B.1.3.4CountryNetherlands
    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 supportBristol Myer Squibb
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNKI-AVL
    B.5.2Functional name of contact pointMichiel van der Heijden
    B.5.3 Address:
    B.5.3.1Street AddressPlesmanlaan 121
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1066CX
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031205129111
    B.5.6E-mailms.vd.heijden@nki.nl
    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 Nivolumab (Opdivo)
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameNivolumab
    D.3.2Product code BMS-936558
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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.IMP: 2
    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 Ipilimumab (Yervoy)
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    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.3.1Product nameIpilimumab
    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.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Urothelial cell carcinoma of the bladder
    Urotheel cel carcinoom van de blaas
    E.1.1.1Medical condition in easily understood language
    Urothelial bladder cancer
    Blaaskanker
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    To establish efficacy of induction ipilimumab + nivolumab followed by chemoradiation by determining bladder-intact event-free survival (BI-EFS) for the intention-to-treat population. Events are defined as:
    - Death by any cause
    - Muscle-invasive bladder, upper urinary tract, nodal or distant recurrence
    - Cystectomy
    - Switch to cisplatin-based chemotherapy
    Effectiviteit van inductie met ipilimumab + nivolumab gevolg door chemoradiatie, gedefinieerd als overleving met blaasbehoud zonder events. De volgende gebeurtenissen worden beschouwd als een event:
    - Overlijden ongeacht de oorzaak
    - Terugkeer van ziekte: spierinvasie, tpv hogere urinewegen, lymfeklieren of metastasen op afstand
    - Cystectomie
    - Overstap naar chemotherapie met cisplatine
    E.2.2Secondary objectives of the trial
    - OS, defined as the time between the date of enrollment and the date of death.
    - RFS, defined as time from start of therapy until the following events: muscle-invasive bladder or upper urinary tract recurrence, locoregional or distant metastases, switch to cisplatin-based chemotherapy or death by any cause.
    - Rate of non muscle-invasive bladder cancer (NMIBC).
    - Feasibility to proceed to chemoradiation (CRT)
    - BI-EFS in the patient population proceeding to CRT
    - Safety of CRT, safety of ipi/nivo, and safety of chemoradiation + ipi/nivo: all grade AEs both treatment- and non-treatment related will be provided.
    - Tumor evaluation by mpMRI to identify nonresponding patients, to select for treatment switch
    - Biomarkers – PD-L1, TMB, molecular subtypes and imaging biomarkers (AI) will be assessed for correlation with outcome (recurrence and OS)
    - QoL and bladder function
    - Overleving: de tijd tussen de dag van inclusie en de dag van overlijden.
    - Progressie-vrije overleving: de tijd tussen start van behandeling tot een van de volgende gebeurtenissen: terugkeer van ziekte door spierinvasie, terugkeer tpv hogere urinewegen, lymfeklieren of metastasen op afstand, overstap naar chemotherapie met cisplatine of overlijden ongeacht de oorzaak.
    - De hoeveelheid niet spierinvasieve urotheel cel carcinomen van de blaas

    Veiligheid
    Haalbaarheid om door te gaan met chemoradiatie (CRT). Veiligheid
    - CRT
    - Ipilimumab/nivolumab
    - CRT i.c.m. ipilimumab/nivolumab.
    Bijwerkingen worden beoordeeld aan de hand van CTCAE 5.0.
    - De diagniostiche waarde van mpMRI
    - Translationele eindpunten: Biomarkers – PD-L1, TMB, moleculaire subtypes, ctDNA en kunstmatige intelligentie zal beoordeeld worden om te zien of er een correlatie bestaat met terugkeer van ziekte en overleving
    - Subjectieve eindpunten: kwaliteit van leven en blaasfunctie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Willing and able to provide informed consent
    2. Age ≥ 18 years
    3. cT2-4aN0-2 urothelial bladder cancer. Lymph nodes should be amenable for inclusion into the radiation field.
    4. World Health Organization (WHO) performance Status 0 or 1.
    5. Urothelial cancer is the dominant histology (>70%).
    6. Formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks from diagnostic TUR available.
    7. Screening laboratory values must meet the following criteria: WBC ≥ 2.0x109/L, Neutrophils ≥1.0x109/L, Platelets ≥100 x109/L, Hemoglobin ≥5.5 mmol/L, GFR>30 ml/min as per Cockcroft-Gault formula, AST ≤ 2.5 x ULN, ALT ≤2.5 x ULN, Bilirubin ≤1.5 X ULN
    8. Negative pregnancy test (βHCG in urine or blood) for female patients of childbearing potential within 2 weeks prior to day 1 of start immunotherapy.
    9. Highly effective contraception for both male and female subjects if the risk of conception exists. Female patients of childbearing potential must comply with contraception methods as requested by the study protocol
    1.Patient wilt deelnemen en is in staat om informed consent te geven
    2. Leeftijd ≥ 18 jaar
    3. cT2-4aN0-2 urotheel cel carcinoom van de blaas. Lymfeklieren moeten geschikt zijn om in het bestralingsveld te worden geincludeerd
    4. WHO performance status 0 of 1
    5. Urotheel cel carcinoom is de dominante histologie (>70%)
    6. FFPE tumor weefsel in paraffine blokken van de diagnostische TUR zijn beschikbaar
    7. Het screeningslab moet aan de volgende voorwaarden voldoen: leukocyten ≥ 2.0x109/L, Neutrofielen ≥1.0x109/L, bloedplaatjes ≥100 x109/L, Hemoglobine ≥5.5 mmol/L, GFR>30 ml/min volgens de Cockcroft-Gault formule, ASAT ≤ 2.5 x bovenste normaalwaarde, ALAT ≤2.5 x bovenste normaalwaarde, Bilirubine ≤1.5 X bovenste normaalwaarde
    8. Negatieve zwangerschapstest (βHCG in urine of bloed) binnen 2 weken voorafgaand aan start van immuuntherapie bij vrouwen in de vruchtbare leeftijd
    9. Het gebruik van effectieve anti-conceptie
    E.4Principal exclusion criteria
    1. Previous pelvic irradiation
    2. Upper tract urothelial cancer
    3. Extensive CIS of the bladder
    4. Bilateral hydronephrosis
    5. Previous intravenous chemotherapy for bladder cancer
    6. Contra-indication to one of the study treatment components, or mpMRI
    7. Subjects with active autoimmune disease in the past 2 years. Patients with diabetes mellitus, properly controlled hypothyroidism or hyperthyroidism, vitiligo, psoriasis or other mild skin disease can still be included
    8. Documented history of severe autoimmune disease (e.g. inflammatory bowel disease, myasthenia gravis)
    9. Prior CTLA-4 or PD-(L)1 -targeting immunotherapy
    10. Known history of Human Immunodeficiency Virus, active tuberculosis, or other active infection requiring therapy at the time of inclusion
    11. Positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA)
    12. Underlying medical conditions that, in the investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of adverse events
    13. Medical condition requiring the use of immunosuppressive medications, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) will be allowed
    14. Use of other investigational drugs four weeks or five half lifes before study drug administration
    15. Malignancy, other than urothelial cancer, in the previous 2 years, with a high chance of recurrence (estimated >10%). Patients with low risk prostate cancer (defined as Stage T1/T2a, Gleason score ≤ 6, and PSA ≤ 10 ng/mL) who are treatment-naive and undergoing active surveillance are eligible
    16. Pregnant and lactating female patients
    17. Major pelvic surgical procedure within 4 weeks prior to enrolment or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
    18. Severe infections within 2 weeks prior to enrolment in the study including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
    1. Eerder bestraling op het bekken
    2. Urotheel cel carcinoom tpv de hogere urinewegen
    3. Uitgebreid CIS in de blaas
    4. Beiderzijds hydronefrose
    5. Eerdere intraveneuze chemotherapie voor blaaskanker
    6. Een contra-indicatie voor een van de studie behandelingen of voor de mpMRI
    7. Patienten met een actieve auto-immuun ziekte in de afgelopen 2 jaar. Patienten met diabetes mellitus, goed ingestelde hypo- of hyperthyreoïdie, vitiligo, psoriasis of andere milde huidziekten kunnen wel worden geincludeerd
    8. Een voorgeschiedenis van een ernstige auto-immuun ziekte zoals IBD of myasthenia gravis
    9. Eerdere behandeling met immuuntherapie gericht tegen CTLA-4 of PD-(L)1
    10. Voorgeschiedenis met HIV, actieve TBC of een andere actieve infectie die behandeling behoeft ten tijde van inclusie
    11. Positieve test voor Hepatitis B oppervlakte antigeen of Hepatitis C RNA
    12. Onderliggende ziekte die de toediening van studie medicatie of de interpretatie van bijwerkingen bemoeilijkt volgens de onderzoeker
    13. Medische conditie waar het gebruik van immuunsuppressieve medicatie voor nodig is (uitgezonderd zijn intanasale- of inhalatie corticosteroïden of systemische corticosteroïden in fysiologische dosis die niet hoger zijn dan 10mg/dag prednison of equivalent. Steroïden als premedicatie voor overgevoeligheidsreacties zijn toegestaan)
    14. Gebruik van andere studie medicatie 4 weken of vijfmaal de halfwaarde tijd van het middel voorafgaand aan start studie medicatie
    15. Maligniteit in de afgelopen 2 jaar, anders dan urotheel cel carcinoom van de blaas, met een hoog risico op terugkeer (>10%). Patienten met een laag risico prostaat carcinoom (stadium T1/T2a, Gleason score ≤ 6 en PSA ≤ 10 ng/mL) die nog geen behandeling hebben ondergaan en actieve surveillance krijgen, zijn geschikt voor inclusie.
    16. Vrouwen die zwanger zijn of borstvoeding geven
    17. Grote pelviene operatie binnen 4 wegen voorafgaand aan inclusie, of de noodzaak tot een grote operatie tijdens de studie anders dan voor diagnostische doeleinden
    18. Ernstige infectie binnen 2 weken voorafgaand aan inclusie, inclusief maar niet beperkt tot opname voor complicaties van een infectie, bacteriemie of ernstige pneumonie.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy defined as bladder-intact event-free survival (BI-EFS)
    Primary endpoint readout will be BI-EFS. Events are defined as death by any cause, muscle-invasive, upper urinary tract, nodal or distant recurrence, cystectomy, or switch to cisplatin-based chemotherapy.
    Effectiviteit, gedefinieerd als overleving met blaasbehoud zonder events. De volgende gebeurtenissen worden beschouwd als een event:
    - Overlijden ongeacht de oorzaak
    - Terugkeer van ziekte: spierinvasie, tpv hogere urinewegen, lymfeklieren of metastasen op afstand
    - Cystectomie
    - Overstap naar chemotherapie met cisplatine
    E.5.1.1Timepoint(s) of evaluation of this end point
    BI-EFS will be determined starting from the initiation of the study drug by CT-imaging and cystoscopy. At the time of analysis, patients without an event will be censored at the time point of their last CT or cystoscopy assessment.
    Overleving met blaasbehoud zonder events zal worden bepaald vanaf de initiatie van studie medicatie middels een CT-scan en cystoscopie. Ten tijde van analyse zal bij een patient zonder event de laatste CT-scan of cystoscopie worden beoordeeld.
    E.5.2Secondary end point(s)
    Efficacy : other efficacy endpoints such as
    - Recurrence-free survival (RFS), defined as time from start of therapy until the following events: muscle-invasive bladder or upper urinary tract recurrence, locoregional or distant metastases, switch to cisplatin-based chemotherapy or death by any cause. A decision to switch to cystectomy is not an event, as RFS is meant to provide a measurement of induction therapy efficacy.
    - Overall survival (OS), defined as the time between the date of enrollment and the date of death. For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive.
    - The rate of NMIBC

    Safety
    Feasibility to proceed to CRT. Safety of CRT, safety of ipi/nivo, and safety of CRT as consolidative therapy after induction ipi/nivo: all grade AEs both treatment- and non-treatment related will be provided as measured according to CTCAE 5.0.

    Diagnostic value of mpMRI
    Tumor evaluation by AI based radiological assessment of pre- and on-treatment mpMRI will be established to identify nonresponding patients

    Translational
    Biomarkers – PD-L1, TMB, molecular subtypes, ctDNA and imaging biomarkers (AI) will be assessed for correlation with outcome (recurrence and OS)

    Subjective measures
    QoL and bladder function
    Effectiviteit : andere effectiviteits eindpunten zoals:
    - Progressie-vrije overleving, gedefinieerd als de tijd tussen start van behandeling tot een van de volgende gebeurtenissen: terugkeer van ziekte door spierinvasie, terugkeer tpv hogere urinewegen, lymfeklieren of metastasen op afstand, overstap naar chemotherapie met cisplatine of overlijden ongeacht de oorzaak. De beslissing om toch een cystectomie te verrichten wordt niet als een event beschouwd, aangezien progressie-vrije overleving bedoeld is als effectiviteitsmaat voor inductie behandeling.

    - Overleving, gedefinieerd als de tijd tussen de dag van inclusie en de dag van overlijden. Bij patienten waar niets is gedocumenteerd over overlijden zal overleving beoordeeld worden tot de laatste dag waarvan bekend is dat de patient nog in leven was.

    - De hoeveelheid niet spierinvasieve urotheel cel carcinomen van de blaas

    Veiligheid
    Haalbaarheid om door te gaan met chemoradiatie (CRT). Veiligheid van CRT, veiligheid van ipilimumab/nivolumab en veiligheid van CRT als consolidatieve behandeling na inductie met ipilimumab/nivolumab. Bijwerkingen van alle graderingen worden bijgehouden, ongeacht of ze gerelateerd zijn aan studie behandeling. Bijwerkingen worden beoordeeld aan de hand van CTCAE 5.0.

    De diagnostiche waarde van mpMRI
    Tumorevaluatie middels op kunstmatige intelligentie gebaseerde radiologische assessments zowel voorafgaand als tijdens behandeling zal worden gebruikt om nonresponders te kunnen identificeren.

    Translationele eindpunten
    Biomarkers – PD-L1, TMB, moleculaire subtypes, ctDNA en kunstmatige intelligentie zal beoordeeld worden om te zien of er een correlatie bestaat met terugkeer van ziekte en overleving

    Subjectieve eindpunten
    Kwaliteit van leven en blaasfunctie
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy
    - RFS will be evaluated during follow-up
    - OS will be evaluated during follow-up
    - The rate of NMIBC will be evaluated once the last patient has ended therapy within this trial

    Safety will be monitored from enrollment in the study and will be evaluated once the last patient has ended treatment in this trial

    Diagnostic value of mpMRI will be evaluated once the last patient has had the last mpMRI

    Translational endpoints will be evaluated once the last patient has ended therapy within this trial

    Quality of life and bladder function will be evaluated once the last patient has filled out the last questionnaire
    Effectiviteit
    - Progressie-vrije overleving zal geevalueerd worden tijdens follow-up
    - Overleving zal geevalueerd worden tijdens follow-up
    -De hoeveelheid niet spierinvasieve urotheel cel carcinomen van de blaas zal geevalueerd worden als de laatste patient behandeling binnen deze trial heeft afgerond

    Veiligheid zal gemonitord worden vanaf inclusie en zal geevalueerd worden als de laatste patient behandeling binnen deze trial heeft afgerond

    De diagnostiche waarde van mpMRI zal geevalueerd worden nadat de laatste mpMRI is gemaakt

    Translationele eindpunten zullen geevalueerd worden als de laatste patient behandeling binnen deze trial heeft afgerond

    Kwaliteit van leven en blaasfunctie zal geevalueerd worden als de laatste patient de laatste vragenlijst heeft ingevuld
    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 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 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 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 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
    Laatste visite van de laatste patient
    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 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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state50
    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 Decision2021-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-30
    P. End of Trial
    P.End of Trial StatusOngoing
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