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    Summary
    EudraCT Number:2017-003703-22
    Sponsor's Protocol Code Number:P2-IMU-838-UC
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-04-26
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2017-003703-22
    A.3Full title of the trial
    A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the efficacy and safety of IMU-838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1
    Wieloośrodkowe, randomizowane badanie fazy II mające na celu ustalenie dawki, prowadzone metodą podwójnie ślepej próby z grupą kontrolną otrzymującą placebo, oceniające skuteczność i bezpieczeństwo stosowania IMU-838 w leczeniu indukcyjnym i podtrzymującym u chorych z wrzodziejącym zapaleniem jelita grubego o nasileniu od umiarkowanego do ciężkiego (CALDOSE-1)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)
    Badanie fazy 2 mające na celu ustalenie dawki IMU-838 we wrzodziejącym zapaleniu jelita grubego (CALDOSE-1)
    A.4.1Sponsor's protocol code numberP2-IMU-838-UC
    A.5.4Other Identifiers
    Name:Clinical trial Gov.Number:NCT03341962
    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 Development S.A.
    B.5.2Functional name of contact pointJavier Floristan
    B.5.3 Address:
    B.5.3.1Street Addressc/Federico Mompou 5, Edeficio 1, planta 5
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28050
    B.5.3.4CountrySpain
    B.5.4Telephone number+34911149455
    B.5.6E-mailjavier.floristan@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 number5
    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 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: 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 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
    Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to determine the optimal dose of IMU-838 to induce symptomatic remission and endoscopic healing in patients with moderate-to-severe ulcerative colitis (UC)
    E.2.2Secondary objectives of the trial
    The secondary objective are:
    To determine the optimal dose of IMU-838 to maintain clinical benefits in patients with moderate-to-severe UC
    • To evaluate the effects of IMU-838 on clinical and endoscopic endpoints in patients with moderate-to-severe UC
    • To evaluate the time course of activity and effects of IMU-838
    • To evaluate the safety and tolerability of IMU-838 in patients with moderate-to-severe UC
    • To evaluate exploratory biomarkers, disease activity biomarkers, and pharmacodynamic (PD) effects of IMU-838
    • To evaluate population pharmacokinetics (PK) and plasma trough levels of IMU-838 throughout the induction period
    • To evaluate single dose PK at Week 50 for a subpopulation of patients with moderate-to-severe UC receiving 30 mg of IMU-838
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Induction phase 1)Male and female patients, aged 18 - 80 years
    2)UC diagnosed more than 3 months before Screening (Day-30) as documented in the medical chart 3)Previous treatment failure defined as a)Patient had an inadequate response with,lost response to or was intolerant to approved or experimental immunomodulators or biologics(no more than 2 treatment failures with biologic drugs i.e.anti-tumor necrosis factor α antibodies or b)Patient had an inadequate response to, was intolerant to, or is corticosteroid dependent(corticosteroid-dependent patients are defined as i)unable to reduce steroids below the equivalent of prednisolone 10 mg/day within 3 months of starting steroids, without recurrent active disease or ii) who have a relapse within 3 months of stopping steroids)
    4)Active disease defined as a)Mayo stool frequency score of ≥2 at Screening Visit 1 b)Mayo rectal bleeding score of ≥1 at Screening Visit 1 c)modified Mayo endoscopy subscore of ≥2 at the screening flexible sigmoidoscopy (endoscopy assessed by an independent central reader blinded to screening center and patient information) 5)Endoscopic appearance typical for UC and extending >15 cm from the anal verge as confirmed by an independent central reader (blinded to screening center and patient information) 6) Laboratory values: Neutrophil count >1500 cells/µL (>1.5x10^9/L), platelet count ≥100 000/mm3 (≥100 10^9/L), serum creatinine <1.5 x upper limit of normal (ULN), total bilirubin, alanine aminotransferase (ALT) and gamma-glutamyl transferase (GGT) <1.5 x ULN 7) Female patients must a)Be of non-child-bearing potential i.e.surgically sterilized(hysterectomy,bilateral salpingectomy,bilateral oophorectomy at least 6 weeks before Screening)or post-menopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause) or b) If of child-bearing potential,must have a negative pregnancy test at Screening (blood test) and before the first study drug administration (Day 0 urine test).They must agree not to attempt to become pregnant,must not donate ova,and must use a highly effective contraceptive method 2 months before Screening, during treatment with IMU-838 and at least 3 months after the last dose of study therapy Highly effective forms of birth control are those with a failure rate less than 1% per year and include: −oral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraceptives associated with inhibition of ovulation−oral, injectable or implantable progestogen-only hormonal contraceptives associated with inhibition of ovulation−intrauterine device or intrauterine hormone-releasing system-bilateral tubal occlusion−vasectomized partner −sexual abstinence (acceptable only if it is the patient’s usual form of birth control/lifestyle choice) 8) Male patients must agree not to father a child or to donate sperm starting at Screening and throughout the clinical trial and for 3 months after the last dose of study medication. Male patients must also either -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 IMU-838 and for at least 3 months after the last dose of study medication And o)if they have a female partner of childbearing potential,the partner should use a highly effective contraceptive method as outlined in inclusion criterion 7And if they have a pregnant partner they must use condoms while taking study medication to avoid exposure of the fetus to study medication
    9.Ability to understand and comply with study procedures and restrictions 10)The patient is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study’s provisions and has duly signed the informed consent form Maintenance phase 1)Symptomatic remission achieved at Week 10 or Week 22 of the induction phase
    Open-label treatment extension arm 1)Patient is in the induction phase, had received at least 6 weeks of blinded study treatment and completed the sigmoidoscopy regularly scheduled at Week 10/EoI, and has neither reached symptomatic remission nor symptomatic response Or Patient is in the extended induction phase, had completed all Week 10 assessments, and has not reached symptomatic remission during or at the end of the extended induction phase Or Patient is in the maintenance phase and discontinues from the maintenance phase due to symptomatic UC relapse or other reasons with a flexible sigmoidoscopy performed at discontinuation(if the previous sigmoidoscopy had been performed more than 4 weeks before discontinuation) Or Patient has completed the maintenance phase as scheduled (including all Week 50 assesments)
    E.4Principal exclusion criteria
    Gastrointestinal exclusion criteria:
    1. Diagnosis of Crohn’s disease, inflammatory bowel disease type unclassified, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis
    2. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
    3. History of colectomy with ileorectal anastomosis or ileal-pouch anal anastomosis or imminent need for colectomy (i.e. colectomy is being planned)
    4. Active therapeutically uncontrollable abscess or toxic megacolon
    5. Malabsorption or short bowel syndrome
    6. History of colorectal cancer or colorectal dysplasia (with the exception of dysplasia in polyps which have been removed)
    Infectious disease exclusion criteria
    7. Clostridium difficile (C. difficile) infection
    o Evidence of, or treatment for C. difficile infection within 30 days before first randomization
    o Positive C. difficile toxin B stool assay during the screening period
    8. Treatment for intestinal pathogens other than C. difficile within 30 days prior to first randomization
    9. Other chronic systemic infections
    o History of chronic systemic infections including but not limited to tuberculosis, human immunodeficiency virus (HIV), hepatitis B or C, within 6 months before Screening
    o Positive interferon-gamma release assay (IGRAs) for Mycobacterium tuberculosis at Screening
    o Positive HBsAg (hepatitis B virus surface antigen), HBcAb (hepatitis B core antibody), positive hepatitis C virus and/or HIV-antigen-antibody (HIV-Ag/Ab) test at Screening
    10. Any live vaccinations within 30 days prior to study drug administration except for the influenza vaccine
    Other medical history and concomitant disease exclusion criteria
    11. Known history of nephrolithiasis or underlying condition with a strong association of nephrolithiasis, including hereditary hyperoxaluria or hereditary hyperuricemia
    12. Diagnosis or suspected liver function impairment which may cause, as assessed by the investigator, a potential for fluctuating liver function tests during this trial
    13. Renal impairment i.e. estimated glomerular filtration rate ≤60 mL/min/1.73m²
    14. Serum uric acid levels at Screening >1.2 x ULN (for women >6.8 mg/dL, for men >8.4 mg/dL)
    15. History or clinical diagnosis of gout
    16. Known or suspected Gilbert syndrome
    17. Indirect (unconjucated) bilirubin ≥1.2 x ULN at Screening (i.e. ≥ 1.1 mg/dL)
    18. 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:
    19. Use of any investigational product within 8 weeks or 5 x the respective half-life before first randomization, whatever is longer
    20. Use of the following medications within 2 weeks before first 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 diproprionate (at >5 mg/day) and budesonide (multi-matrix [MMX] at >9 mg/day)
    f. Oral aminosalicylates (e.g. mesalazines) >4 g/day
    21. Use of the following medications within 4 weeks before first randomization:
    a. Use of intravenous corticosteroids
    b. Use of thiopurines including azathioprine, mercaptopurine and 6-thioguanine
    c. Use of any rectal and topical aminosalicylates and/or budesonide
    22. Use of oral systemic corticosteroids ≤20 mg/day prednisolone equivalent including beclomethasone diproprionate (at ≤5 mg/day) and budesonide (MMX at ≤9 mg/day) unless they have been used for at least 4 weeks before first randomization and at a stable dose for at least 2 weeks before first randomization
    23. Oral aminosalicylates (e.g. mesalazines) ≤4 g/day unless they have been used for at least 6 weeks and with a stable dose for at least 3 weeks before first randomization
    24. Use of biologics as follows:
    a. anti-tumor necrosis factor α antibodies (infliximab, adalimumab, golimumab, including their biosimilars) within 4 weeks before first randomization
    b. vedolizumab and ustekinumab within 8 weeks before first randomization
    25. Use of the DHODH inhibitors leflunomide or teriflunomide within 6 months before first randomization
    26. Any use of natalizumab (Tysabri™) within 12 months before first randomization
    27. Use of the following concomitant medications is prohibited at Screening and throughout the duration of the trial:
    o any medication known to significantly increase urinary elimination of uric acid, in particular lesinurad (Zurampic™) as well as uricosuric drugs such as probenecid
    o treatments for any malignancy, in particular irinotecan, paclitaxel, tretinoin, bosutinib, sorafinib, enasidenib, erlotinib, regorafenib, pazopanib and nilotinib .
    o any drug significantly restricting water diuresis, in particular vasopressin and vasopressin analogs
    criteria
    o Rosuvastatin at doses >10 mg/day
    Please refer Protocol, page 14 for additional information
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is:
    Efficacy
    Induction phase
    • Composite endpoint: Proportion of patients with both, symptomatic remission and endoscopic healing at Week 10
    All patients (both, Enrollment Period 1 and Enrollment Period 2 patients) who were randomized to 30 mg/day and 45 mg/day IMU-838 will be used for the assessment of the primary efficacy endpoint (see Section 16.4 of protocol for further information).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Proportion of patients with both, symptomatic remission and endoscopic healing at Week 10
    E.5.2Secondary end point(s)
    Secondary endpoint is:
    Efficacy
    Induction phase and extended induction phase
    • Proportion of patients with both symptomatic remission and endoscopic healing at Week 10 (all individual IMU-838 doses will be compared with one another and to placebo)
    • Proportion of patients achieving symptomatic remission during the induction phase (including extended induction phase)
    • Time to achieving symptomatic remission within the induction/extended induction phase
    • Proportion of patients with clinical response at Week 10
    • Proportion of patients with endoscopic healing at Week 10
    • Proportion of patients with symptomatic response during the induction phase (including extended induction phase)
    • Time course of Mayo scores (full score, partial score, PRO-2 score) over 10 or 22 weeks and changes from Baseline
    • Time course of disease activity biomarkers (fCP and CRP)
    Maintenance phase
    • Proportion of patients in symptomatic remission by visit up to Week 50
    • Proportion of patients in durable symptomatic remission up to Week 50
    • Time course of Mayo PRO-2 score until Week 50
    • Time to symptomatic UC relapse
    • Proportion of patients without symptomatic UC relapse until Week 50
    • Time course of disease activity biomarkers (fCP and CRP)
    • Proportion of patients with endoscopic healing at Week 50
    • Proportion of patients with microscopic healing at Week 50
    • Corticosteroid-free remission at Week 50 in patients receiving corticosteroids at Baseline Open-label treatment extension arm
    • Proportion of patients with symptom control
    • Time course of disease activity biomarkers (fCP and CRP)
    Safety
    • Incidence and severity of AEs
    • Physical examination, body weight, and vital signs*
    • Electrocardiogram (12-lead ECG)*
    • Safety laboratory: hematology, clinical chemistry including liver function, coagulation parameters, urinalysis
    • miR-122 expression (before first dose and 24 hours after first dose)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer Section 7.2 of protocol v3 dated 21 Nov 2017 page no. 44,45& 46
    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 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 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 concerned19
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA59
    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
    Belarus
    Belgium
    Bosnia and Herzegovina
    Bulgaria
    Croatia
    Czech Republic
    Germany
    Macedonia, the former Yugoslav Republic of
    Netherlands
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    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 years9
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years10
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 220
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 123
    F.4.2.2In the whole clinical trial 240
    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 who prematurely discontinue the study will be treated according to the investigator’s discretion and standard treatment guidelines, irrespective of the reason for withdrawal.
    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 Decision2018-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-25
    P. End of Trial
    P.End of Trial StatusOngoing
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