Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44237   clinical trials with a EudraCT protocol, of which   7338   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-005019-30
    Sponsor's Protocol Code Number:IM047-023
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2023-01-11
    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 number2021-005019-30
    A.3Full title of the trial
    A Phase 2/3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Participants with Moderately to Severely Active Crohn’s Disease with an Inadequate Response to Conventional Therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Oral Ozanimod in Pediatric Participants with Moderately to Severely Active Crohn’s Disease with an Inadequate Response to Conventional Therapy
    A.4.1Sponsor's protocol code numberIM047-023
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1275-2700
    A.5.4Other Identifiers
    Name:INDNumber:126740
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/131/2022
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCelgene International II Sarl
    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 supportCelgene Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb Company
    B.5.2Functional name of contact pointGSN-CT
    B.5.3 Address:
    B.5.3.1Street AddressParc de L'Alliance - Avenue de Finlande 4
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.6E-mailclinical.trials@bms.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 nameOzanimod HCL
    D.3.2Product code RPC1063
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOzanimod HCL
    D.3.9.1CAS number 1618636-37-5
    D.3.9.3Other descriptive nameRPC1063
    D.3.9.4EV Substance CodeSUB175614
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.92
    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.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 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 nameOzanimod HCL
    D.3.2Product code RPC1063
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOzanimod HCL
    D.3.9.1CAS number 1618636-37-5
    D.3.9.3Other descriptive nameRPC1063
    D.3.9.4EV Substance CodeSUB175614
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.46
    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.IMP: 3
    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 nameOzanimod HCL
    D.3.2Product code RPC1063
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOzanimod HCL
    D.3.9.1CAS number 1618636-37-5
    D.3.9.3Other descriptive nameRPC1063
    D.3.9.4EV Substance CodeSUB175614
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.23
    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
    Moderately to Severely Active Crohn’s Disease
    E.1.1.1Medical condition in easily understood language
    Moderately to Severely Active Crohn’s Disease
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To evaluate the efficacy of ozanimod once daily in pediatric participants with moderately to severely active CD: clinical remission by PCDAI at Week 64
    - To evaluate endoscopic remission at Week 64 by SES-CD
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of ozanimod once daily in pediatric participants with moderately to severely active CD: clinical remission by PCDAI at Week 12
    - To evaluate endoscopic response by SES-CD
    - To evaluate clinical response by PCDAI
    - To evaluate symptomatic remission (adolescents only)
    - To evaluate change in CD symptoms over time
    - To evaluate clinical response by CDAI (adolescents only)
    - To evaluate corticosteroid-free remission
    - To evaluate endoscopic remission at Week 12
    - To characterize the PK of 2 doses of oral ozanimod and its major active metabolites in pediatric participants with moderately to severely active CD
    - To evaluate the PD effects of 2 dose levels of ozanimod (eg, effects on ALC) in pediatric participants with moderately to severely active CD
    - To evaluate the safety and tolerability of 2 dose levels of oral ozanimod once daily in pediatric participants with moderately to severely active CD
    For exploratory objectives, please refer to protocol
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all of the following criteria apply:
    1) Signed Written Informed Consent
    2)Type of Participant and Target Disease Characteristics
    a) Participant is willing and able to adhere to the study visit schedule and other protocol requirements including is willing and able to swallow a capsule until a sprinkle formulation of ozanimod is available.
    b) Participant has been diagnosed with CD ≥ 3 months prior to the Screening Visit. The diagnosis should be confirmed by clinical and endoscopic evidence and corroborated by a histopathology report (Note: Histopathology may be performed during endoscopy at Screening if no prior report is readily available).
    c) Participant has met each of the following 2 criteria:
    i) A PCDAI score ≥ 30.
    ii) Participant has a SES-CD score ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease).
    d) Participant has an inadequate response, intolerance, or loss of response to at least 1 of the following treatments for CD.
    i) corticosteroids (eg, oral prednisone, budesonide MMX, IV corticosteroids).
    ii) immunomodulators (eg, AZA, 6-MP, cyclosporine, MTX).
    iii) biologic therapy (eg, ustekinumab, abatacept, infliximab, etanercept, adalimumab, anakinra, rituximab, vedolizumab).
    iv) other systemic immunomodulatory therapies for CD.
    e) If the participant is taking the following background therapies for CD, a stable dose must be maintained as indicated below (dosage regimen can be adjusted to accommodate mg/kg/day dosing as appropriate):
    i) Oral aminosalicylates (eg, mesalamine, sulfasalazine, olsalazine, balsalazide), the dose must have been stable starting 3 weeks prior to Screening endoscopy.
    ii) Prednisone (≤ 0.5 mg/kg/day up to 20 mg/day), the dose must have been stable starting 2 weeks prior to Screening endoscopy and must remain stable through the first 5 weeks of treatment.
    iii) Budesonide therapy (doses ≤ 9 mg per day) or beclomethasone (doses ≤ 5 mg per day), the dose must have been stable starting 3 weeks prior to Screening endoscopy and must remain stable through the first 5 weeks of treatment
    f) Participant must have documentation of vaccinations per standard immunization schedule including complete varicella vaccination at least 30 days prior to randomization
    3) Age of Participant
    a) Participant must be age 2 to 17 years, inclusive (for the assigned cohort) at the time of informed consent/assent.

    Please refer to Protocol for detailed list of Inclusion criteria
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    1) Medical Conditions
    a) Participant has clinically relevant cardiovascular, hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the participant at risk by participating in the study.
    i) Clinically relevant pulmonary conditions include, but are not limited to, history of severe or chronic lung disease, bronchopulmonary dysplasia,
    cystic fibrosis, or severe asthma (ie, that interferes with normal activities of daily living).
    b) Participant is likely to require, in the physician's judgment, bowel resection within 12 weeks of entry into the study.
    c) Participant has a diagnosis of UC, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation,
    requiring procedural intervention, or with obstructive symptoms. In addition, participants with colonic or ileal strictures that are not
    passable with an age-appropriate colonoscope that the endoscopist normally uses in clinical practice, or strictures in the ileum or ileocecal
    valve that are fibrotic in nature, will be excluded.
    d) Participant has current stoma, ileal-anal pouch anastomosis, fistula that is likely to require, in the physician's judgment, surgical or medical intervention within 12 weeks of entry into the study or need for ileostomy or colostomy.
    e) Participant has extensive small bowel resection (> 100 cm) or known diagnosis of short bowel syndrome or participant requires total parenteral nutrition.
    f) Participant has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated.
    g) Participant has documentation of positive test for toxigenic Clostridioides difficile (formerly Clostridium difficile [C difficile]) by polymerase chain reaction examination of the stool during Screening. If positive, participants may be rescreened after appropriate treatment and negative retest no earlier than 7 days after completion of treatment.
    h) Participant has documentation of positive examination for pathogens (ova, parasites, and bacteria). If positive, participants may be treated
    and rescreened.
    i) Participant requires or is expected to undergo apheresis (eg,
    Adacolumn apheresis) within 2 weeks of randomization.
    j) Participant is pregnant, lactating, or has a positive serum β-subunit human chorionic gonadotropin measured during Screening.
    k) Participant has a history or presence of the following clinically relevant cardiovascular conditions:
    i) Structural cardiac disease (eg, hypertrophic obstructive cardiomyopathy, unrepaired congenital heart defects). Participants with repaired congenital heart defects should be discussed with the Clinical Trial Physician or designee prior to enrollment.
    ii) Cardiac events (eg, myocardial infarction) or diseases that predispose to cardiac complications.
    iii) History of stroke, heart failure, or symptomatic bradycardia defined as <5th percentile of normal sinus rhythm HR for age.29
    iv) Second degree (Mobitz type II) AV block or higher, sick sinus syndrome, or sino-atrial block.
    v) Prolonged QT interval corrected for HR using Fridericia's formula > 450 msec for both males and females (at either Screening or Day 1 Predose assessment), or is at additional risk for QT interval prolongation (eg, hypokalemia, hypomagnesemia, congenital long-QT syndrome).
    vi) During either Screening or Day 1 pre-dose assessment, resting HR < 55 beats per minute (bpm) in participants 12 to 17 years old, resting HR
    < 65 bpm in participants 6 to 11 years old, or resting HR < 75 bpm in participants 2 to 5 years old (one retest is allowed).
    vii) Severe untreated sleep apnea.
    l) Participant has a history of diabetes mellitus (DM) type 1, or uncontrolled DM type 2 (hemoglobin A1c [HbA1c] > 9%) or is a diabetic participant with significant comorbid conditions such as retinopathy or nephropathy.
    m) Participant has a history of uveitis within the last year prior to Screening, or history or evidence of retinal disease (eg, macular edema).
    n) Participant has any known active bacterial, viral, fungal (excluding fungal infection of nail beds, minor upper respiratory tract infections,
    and minor skin infections), mycobacterial infection (including tuberculosis [TB] or atypical mycobacterial disease), or any other infection that required hospitalization or treatment with IV antibiotics within 30 days of Screening or oral antibiotics within 14 days of Screening.
    Please refer to Protocol for detailed list of exclusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    -Proportion of participants who achieve PCDAI < 10 at Week 64
    - Proportion of participants achieving SES-CD ≤ 2 or SES-CD ≤ 4 points with no SES-CD subscore > 1 point at Week 64
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Week 64
    - Week 64
    E.5.2Secondary end point(s)
    - Proportion of participants who achieve PCDAI < 10 at Week 12
    - Proportion of participants who achieve SES-CD decrease from Baseline of ≥ 50% (ER-50) at Week 64; Week 12
    - Proportion of participants who achieve reduction in PCDAI score ≥ 12.5 and a total PCDAI score of < 30 points at Week 64; Week 12
    - Proportion of adolescents who achieve an average daily abdominal pain score ≤ 1 point and an average daily stool frequency ≤ 3 points with abdominal pain and stool frequency no worse than Baseline at Week 64; Week 12
    - Change from Baseline in stool frequency score over time
    - Change from Baseline in abdominal pain over time
    - Proportion of adolescents who achieve CDAI score < 150 at Week 64; Week 12
    - Proportion of adolescents who achieve CDAI reduction from Baseline of ≥ 100 points or CDAI score < 150 at Week 64; Week 12
    - Proportion of participants who achieve a PCDAI score < 10 at Week 64 while remaining corticosteroid free in the prior 12 weeks
    - Proportion of participants who achieve a CDAI score < 150 at Week 64 while remaining corticosteroid free in the prior 12 weeks (adolescents only)
    - Proportion of participants achieving SES-CD ≤ 2 or SES-CD ≤ 4 points with no SES-CD subscore > 1 point at Week 12
    - Steady state systemic exposures of ozanimod and CC112273 at Week 20 and throughout the study
    - Absolute and percent change from Baseline in ALC at Week 64, Week 12, and throughout the study
    - Number and proportion of participants experiencing AEs, SAEs, AEs leading to discontinuation from treatment, and AESIs throughout the study
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Week 12
    - Week 12
    - Week 12
    - Week 12
    - Change from Baseline in stool frequency score over time
    - Change from Baseline in abdominal pain over time
    - Week 12
    - Week 12
    - Week 64 while remaining corticosteroid free in the prior 12 weeks
    - Week 64 while remaining corticosteroid free in the prior 12 weeks (adolescents only)
    - Week 12
    - Week 20 and throughout the study
    - Week 12, and throughout the study
    - throughout the study
    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) Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    Different dosage of the same IMP
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Australia
    Canada
    Israel
    United Kingdom
    United States
    Belgium
    France
    Germany
    Hungary
    Italy
    Poland
    Spain
    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
    End of trial is defined as the last participant last visit or the date of receipt of the last data point from the last participant that is required for primary, secondary, and/or exploratory analysis, as pre-specified in the protocol, whichever is the later date.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days19
    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: 120
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 48
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 72
    F.1.2Adults (18-64 years) No
    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 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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 120
    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)
    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 Decision2023-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-09-27
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
    For support, Contact us.
    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.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA