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   43235   clinical trials with a EudraCT protocol, of which   7153   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:2018-001895-39
    Sponsor's Protocol Code Number:P2-IMU-838-CD
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-06-03
    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 number2018-001895-39
    A.3Full title of the trial
    A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s disease
    A.3.2Name or abbreviated title of the trial where available
    CALDOSE-2
    A.4.1Sponsor's protocol code numberP2-IMU-838-CD
    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 SponsorImmunic AG
    B.1.3.4CountryGermany
    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 supportImmunic AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCovance Clinical and Periapproval Services Limited
    B.5.2Functional name of contact pointGlobal Regulatory Submissions
    B.5.3 Address:
    B.5.3.1Street AddressOsprey House Maidenhead Office Park, Westacott Way
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 3QH
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailsubmissions@covance.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 namevidofludimus calcium
    D.3.2Product code IMU-838
    D.3.4Pharmaceutical form Tablet
    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 INNVidofludimus calcium
    D.3.9.2Current sponsor codeIMU-838
    D.3.9.3Other descriptive nameIM90838
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 namevidofludimus calcium
    D.3.2Product code IMU-838
    D.3.4Pharmaceutical form Tablet
    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 INNVidofludimus calcium
    D.3.9.2Current sponsor codeIMU-838
    D.3.9.3Other descriptive nameIM90838
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number22.5
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Crohn’s disease (CD)
    E.1.1.1Medical condition in easily understood language
    Crohn’s disease (CD)
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    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 determine the optimal dose of IMU-838 to induce symptomatic remission (based on stool frequency [SF] and abdominal pain [AP], as assessed in the Crohn’s Disease Activity Index [CDAI] patient-reported outcome [PRO]-2) in patients with active Crohn’s disease (CD)
    E.2.2Secondary objectives of the trial
    To determine the optimal dose of IMU-838 to induce endoscopic improvement in patients with active CD.
    Further secondary and exploratory objectives
    • To evaluate the potential of IMU-838 to induce clinical response and clinical remission
    • To evaluate the time course of IMU-838 activity
    • To evaluate the durability of response and remission
    • To explore the potential of IMU-838 to maintain remission as well as avoid CD relapse
    • To evaluate the safety and tolerability of IMU-838 in patients with active CD
    • To evaluate trough levels of IMU-838 in patients with active CD
    • To assess disease activity markers and biomarkers
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    INDUCTION TREATMENT PHASE
    1 Male or female patient, aged 18-80 years
    2 Confirmed diagnosis of active luminal CD, at least 3 months before Screening Visit S1
    3 SES-CD score of at least 6, or of at least 4 in patients with isolated ileitis (screening ileocolonoscopy and SES-CD score assessed by an in-dependent central reader blinded to center and patient information)
    4 At least one aphthous ulcerative lesion or more severe ulcer accessible by ileocolonoscopy (as confirmed by an independent central blinded reader from screening ileocolonoscopy)
    5 Full CDAI score ≥220 and ≤450 at Screening Visit S1
    6 Average daily very soft or liquid stool frequency score (based on the BSFS) ≥4.0 and/or AP-CDAI score ≥2.0 at Screening Visit S1 (according to retrospective data of the preceding 7 days)
    7 Previous treatment failure defined as:
    a Patient had an inadequate response with, lost response to, or was in-tolerant to approved or experimental immunomodulators or biologics. A maximum of 3 treatment failures with biologic drugs i.e. anti-tumor necrosis factor alpha antibodies, certolizumab pegol, vedolizumab, natalizumab, ustekinumab, or experimental antibodies, i.e. not approved for the use in CD or not approved but in development for CD, is allowed; or
    b Patient had an inadequate response to corticosteroids (a corticosteroidrefractory patient is defined as having active disease despite prednisolone up to 1 mg/kg/day for a period of 4 weeks), was intolerant to corticosteroids, or is corticosteroid dependent (a corticosteroid-dependent patient is defined as i) unable to reduce steroids below the equivalent of prednisolone 10 mg/day [or budesonide be-low 3 mg/day] within 3 months of starting steroids, without recurrent active disease, or ii) who has a relapse within 3 months of stopping steroids.
    8 Laboratory values: Neutrophil count >1500 cells/µL (>1.5 x 10^9 cells/L), platelet count
    ≥100 000/mm3 (≥100 x 10^9/L), serum creatinine <1.5 upper limit of normal (ULN), total bilirubin, alanine aminotransferase, and aspartate aminotransferase <1.5 ULN
    9 Female patients
    - must be of non-childbearing potential i.e. surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before Screening Visit S1) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause), or
    - if of childbearing potential, must have a negative pregnancy test at Screening Visit S1 (blood test) and at Day 0 before IMP administration (urine test). They must agree not to attempt to become pregnant, not to donate ova and to use a highly effective contraceptive method at the start of the trial (trial consent), during treatment with IMU 838, and for at least 30 days after the last intake of the IMP.
    10 Male patients must agree not to father a child or to donate sperm starting at Screening Visit S1, throughout the clinical trial and for 30 days after the last intake of the IMP. Male patients must also
    - abstain from sexual intercourse with a female partner (acceptable only if it is the patient’s usual form of birth control/lifestyle choice), or use adequate barrier contraception during treatment with the IMP and for at least 30 days after the last intake of the IMP, and
    - if they have a female partner of childbearing potential, ensure that the partner uses a highly effective contraceptive method as outlined in inclusion criterion 9
    - if they have a pregnant partner, use condoms while taking the IMP to avoid exposure of the fetus to the IMP
    11 Ability to understand and comply with trial procedures and restrictions
    12 Written informed consent

    EXTENDED TREATMENT PHASE
    1 At least symptomatic response at Week 14, defined as improvement in AP-CDAI or SF CDAI scores of at least 30%, and both scores not worse than at Baseline

    CRITERIA FOR SWITCHING FROM BLINDED TREATMENT TO OLE
    1 Completion of at least 10 weeks of blinded treatment
    2 Completion of a post-baseline ileocolonoscopy (either as EoI or EoBT ileocolonoscopy) in the last 14 weeks before switching to OLE
    a if discontinuing the induction treatment phase at Week 10 or be-tween Week 10 and Week 14, a complete EoI visit must be per-formed at the time of discontinuation, including EoI ileocolonos-copy, or
    b if discontinuing the extended treatment phase before Week 38, a complete EoBT examination must be performed; however, EoBT ileocolonoscopy will only be required if the EoI ileocolonoscopy was performed more than 14 weeks before the time of discontinuation
    3 At least 2 valid assessments of the full CDAI, SF-CDAI and AP-CDAI scores post Baseline:
    E.4Principal exclusion criteria
    GI CRITERIA
    1 Diagnosis of ulcerative colitis, inflammatory bowel disease type unclassified, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis
    2 High likelihood of requiring bowel surgery during the 38 weeks of the BT period
    3 Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
    4 Ileorectal anastomosis or ileal-pouch anal anastomosis
    5 Celiac disease
    6 Presence of intra-abdominal or perianal abscess that is undrained
    7 History of subtotal colectomy or imminent need for colectomy (i.e. colectomy is being planned)
    8 Malabsorption or short-bowel syndrome
    9 History of small bowel or colorectal cancer or gastrointestinal dysplasia (with the exception of dysplasia in polyps that have been removed)

    INFECTIOUS DISEASE
    10 Clostridium difficile (C. difficile) infection
    a Evidence of, or treatment for, C. difficile infection within 30 days before randomization
    b Positive C. difficile toxin B stool assay at Screening Visit S1
    11 Treatment for intestinal pathogens other than C. difficile within 30 days before randomization
    12 Other chronic systemic infections
    a History of chronic systemic infections including but not limited to tuberculosis, HIV, HBV, or HCV, within 6 months before Screening Visit S1
    b Positive interferon-gamma release assay for Mycobacterium tuberculosis at Screening Visit S1
    c Positive HBV surface antigen (HBsAg), hepatitis B core antibody (HBcAb), positive HCV and/or HIV-antigen-antibody (HIV-Ag/Ab) test at Screening Visit S1 (even without detectable virus load in blood)
    13 Any live vaccinations within 30 days before randomization except for the influenza vaccine

    OTHER MEDICAL HISTORY AND CONCOMITANT DISEASE EXCLUSION CRITERIA
    14 Known history of nephrolithiasis or underlying condition with a strong association o nephrolithiasis, including hereditary hyperoxaluria or hereditary hyperuricemia
    15 Diagnosis or suspected liver function impairment which may cause, as assessed by the investigator, a potential for fluctuating liver function tests during this trial
    16 Renal impairment i.e. eGFR >60 mL/min/1.73 m²
    17 Serum uric acid levels at Screening Visit S1 >1.2 x ULN (for women >6.8 mg/dL, for men >8.4 mg/dL)
    18 History or clinical diagnosis of gout
    19 Known or suspected Gilbert syndrome
    20 Indirect (unconjugated) bilirubin ≥1.2 x ULN (i.e. ≥1.1 mg/dL) at Screening Visit S1
    21 Concurrent malignancy or prior malignancy within the previous 10 years except for the following: adequately-treated non-melanoma skin cancer and adequately-treated cervical cancer

    THERAPY EXCLUSION CRITERIA
    22 Use of any IMP within 8 weeks or 5 x the respective half-life before randomization, whichever is longer
    23 Use of the following medications within 2 weeks before randomization:
    a Tofacitinib
    b Methotrexate,
    c Mycophenolate mofetil
    d Any calcineurin inhibitors (e.g. tacrolimus, cyclosporine, or pimecrolimus)
    e Oral systemic corticosteroids >20 mg/day prednisolone equivalent including beclomethasone dipropionate (at >5 mg/day) and budesonide (at >9 mg/day)
    f Oral aminosalicylates (e.g. mesalazines) >4 g/day
    24 Use of the following medications within 4 weeks before randomization:
    a Use of intravenous corticosteroids
    b Use of thiopurines including azathioprine, 6-mercaptopurine and 6-thioguanine
    c Use of any rectal or topical aminosalicylates and/or budesonide
    25 Use of oral systemic corticosteroids ≤20 mg/day prednisolone equivalent including beclomethasone dipropionate (at ≤5 mg/day) and budesonide (at ≤9 mg/day) unless they have been used at a stable dose for at least 2 weeks before randomization
    26 Oral aminosalicylates (e.g. mesalazines) ≤4 g/day unless they have been used at a stable dose for at least 3 weeks before randomization
    27 Use of biologics as follows:
    a anti-TNF╬▒ antibodies (infliximab, adalimumab, golimumab, certolizumab pegol, including their biosimilars, if available) within 4 weeks before randomization
    b vedolizumab and ustekinumab within 8 weeks before randomization
    28 Use of the DHODH inhibitors leflunomide or teriflunomide within 6 months before randomization
    29 Any use of natalizumab (Tysabri™) within 12 months before randomization
    30 Use of the following concomitant medications is prohibited at Screening Visit S1 and throughout the duration of the trial:
    a any medication known to significantly increase urinary elimination of uric acid, in particular lesinurad (Zurampic™) as well as uricosuric drugs such as probenecid
    b active treatments for any malignancy, in particular irinotecan, paclitaxel, tretinoin, bosutinib, sorafinib, enasidenib, erlotinib, regorafenib, pazopanib and nilotinib
    c any drug significantly restricting water diuresis, in particular vasopressin and vasopressin analogs
    d Rosuvastatin at doses >10 mg/day

    Please refer to protocol for information on general exclusion criteria and exclusion criteria during OLE period.
    E.5 End points
    E.5.1Primary end point(s)
    Induction treatment phase (BT period)
    • Proportion of patients with symptomatic remission at Week 14 i.e. fulfilling the following criteria:
    - Remission in AP-CDAI, defined as AP-CDAI score ≤1 and not worse than at Baseline,
    and
    - Remission in SF-CDAI, defined as SF-CDAI score ≤2.8 and not worse than at Baseline
    For the primary analysis, the 45 mg/day IMU-838 will be compared to placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    AP-CDAI and SF-CDAI: screening, pre-dose and week 14
    E.5.2Secondary end point(s)
    Induction treatment phase (BT period)
    • Proportion of patients achieving endoscopic improvement at Week 14:
    - Reduction of the SES-CD by ≥50% versus Baseline, or SES-CD score ≤4 (or in patients with isolated ileitis an SES-CD score ≤2), a reduction of ≥2 points from Baseline, and no ulcer sub-score >1 in any of the 5 segments (ileum, right/transverse/left colon, and rectum)
    BT period
    • Proportion of patients with endoscopic remission at Weeks 14 and 38
    • Change in AP-LPS score and SF-CDAI score from Baseline
    Proportion of patients with the primary and the key secondary endpoints for the following comparisons:
    - 30 mg/day IMU-838 versus placebo
    - 30 mg/day versus 45 mg/day IMU-838
    • Proportion of patients in clinical remission (full CDAI) at Weeks 14 and 38
    E.5.2.1Timepoint(s) of evaluation of this end point
    Induction treatment phase (BT period)
    • Proportion of patients achieving endoscopic improvement,
    SES-CD: baseline, w14
    BT period
    • Proportion of patients with endoscopic remission: w14, w38
    • AP-LPS score and SF-CDAI score: screening, pre-dose, w1, w2, w6, w10, w14 and w38
    • Proportion of patients in clinical remission (full CDAI): screening, pre-dose, w14 and w38
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 EEA58
    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
    Bulgaria
    Croatia
    Czech Republic
    Germany
    Netherlands
    Poland
    Romania
    Russian Federation
    Serbia
    Slovenia
    Spain
    Ukraine
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 240
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 114
    F.4.2.2In the whole clinical trial 258
    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)
    Patients will be treated according to the investigator's discretion and standard treatment guidelines.
    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 Decision2019-06-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    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 © 1995-2023 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA