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    Summary
    EudraCT Number:2018-004701-11
    Sponsor's Protocol Code Number:MS200527_0073
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-01-09
    Trial results View 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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2018-004701-11
    A.3Full title of the trial
    A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with an Interferon Beta 1a (Avonex®), in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evobrutinib compared to Avonex in participants with Relapsing Multiple Sclerosis
    A.3.2Name or abbreviated title of the trial where available
    Phase III Study of Evobrutinib in RMS (EVOLUTION MS1)
    A.4.1Sponsor's protocol code numberMS200527_0073
    A.5.4Other Identifiers
    Name:AcronymNumber:EVOLUTION MS1
    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 SponsorMerck Healthcare KGaA
    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 supportMerck Healthcare KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Healthcare KGaA
    B.5.2Functional name of contact pointCommunication Center
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Str. 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 6151 72 5200
    B.5.5Fax number+49 6151 72 2000
    B.5.6E-mailservice@merckgroup.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 nameEvobrutinib 10mg
    D.3.2Product code M2951
    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 INNEVOBRUTINIB
    D.3.9.1CAS number 1415823-73-2
    D.3.9.2Current sponsor codeM2951
    D.3.9.3Other descriptive nameMSC2364447C
    D.3.9.4EV Substance CodeSUB188608
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 nameEvobrutinib 25mg
    D.3.2Product code M2951
    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 INNEVOBRUTINIB
    D.3.9.1CAS number 1415823-73-2
    D.3.9.2Current sponsor codeM2951
    D.3.9.3Other descriptive nameMSC2364447C
    D.3.9.4EV Substance CodeSUB188608
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 RoleComparator
    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 Avonex
    D.2.1.1.2Name of the Marketing Authorisation holderBiogen, Netherlands B.V.
    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 nameInterferon beta 1-a
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINTERFERON BETA-1A
    D.3.9.1CAS number 220581-49-7
    D.3.9.4EV Substance CodeSUB12440MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboIntramuscular use
    D.8 Placebo: 2
    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
    D.8 Placebo: 3
    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
    Relapsing Multiple Sclerosis
    E.1.1.1Medical condition in easily understood language
    Relapsing Multiple Sclerosis
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10048393
    E.1.2Term Multiple sclerosis relapse
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system 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 demonstrate superior efficacy with evobrutinib compared to Avonex in terms of Annualized Relapse Rate (ARR)
    E.2.2Secondary objectives of the trial
    a.To demonstrate the efficacy of evobrutinib relative to that of Avonex on disability progression
    b.To demonstrate the efficacy of evobrutinib relative to that of Avonex on patient reported symptoms and functional status
    c.To demonstrate the efficacy of evobrutinib relative to that of Avonex on magnetic resonance imaging (MRI) lesion parameters
    d.To characterize the safety and tolerability of evobrutinib.
    e. OLE period: To evaluate the long-term safety, efficacy, and HRQoL of evobrutinib for an additional up to 144 weeks.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetic (PK) and Pharmacodynamic (PD) substudies will be performed in selected sites.
    For the PK substudy, participants (N = 75) must meet the inclusion/exclusion criteria and must complete all safety and efficacy activities as described for other study participants. For the PK substudy participants, additional whole blood samples (37) of approximately 2 mL will be collected for measurement of plasma concentrations of evobrutinib. Participation in the substudy is mandatory at the selected sites.
    For PD substudy, participants (N = 75), blood samples will be collected for measurement of BTK Occupancy, cellular function, and cytokines (approximately 50 mL per visit) from participants at selected sites. Participation in the substudy is mandatory at the selected sites.
    E.3Principal inclusion criteria
    1.18 to 55 years of age at the time of signing the informed consent.
    2.Are diagnosed with RMS (relapsing-remitting multiple sclerosis [RRMS] or secondary progressive multiple sclerosis [SPMS] with relapses) in accordance with 2017 Revised McDonald criteria
    3.One or more documented relapses within the 2 years before Screening
    4. Have an EDSS score of 0 to 5.5 at Baseline
    5. Are neurologically stable for ≥ 30 days prior to both Screening and Baseline
    6. Are female or male
    a. Female participants are not pregnant or breastfeeding, and at least one of the following conditions
    applies:
    o Not a Woman of Child Bearing Potential OR
    o If a Woman of Child Bearing Potential, use a highly effective contraceptive method AND a barrier method
    7. Capable of giving signed informed consent
    8. Participants must be contactable by email or telephone throughout the study.
    E.4Principal exclusion criteria
    1.Participants diagnosed with Progressive MS, in accordance with the 2017 Revised McDonald criteria
    2.Disease duration > 10 years in participants with an EDSS ≤ 2.0 at Screening
    3.Immunologic disorder other than MS or any other condition requiring oral, intravenous, intramuscular, or intra-articular corticosteroid therapy, with the exception of well-controlled Type 2 diabetes mellitus or well controlled thyroid disease
    4.History or current diagnosis of other neurological disorders that may mimic MS
    5.History or current diagnosis of PML
    6.Active, clinically significant viral, bacterial, or fungal infection, or any major episode of infection
    7.History of or current diagnosis of active tuberculosis (TB) OR currently undergoing treatment for latent TB infection or untreated LTBI. TB skin test with purified protein derivative will not be performed at Screening
    8.Indeterminate QuantiFERON-TB test results may be repeated once. If results continue to be indeterminate, T-SPOT will be used. If T-SPOT.TB is not available, the Medical Monitor should be contacted
    9.Individuals with a diagnosis of hemochromatosis, Wilson’s disease, alpha-1-antitrypsin deficiency, or any other chronic liver disease including Gilbert’s disease
    10. Individuals with elevated transferrin saturation (> 50% transferrin saturation in males;
    and > 40% transferrin saturation in females) and/or with elevated ferritin levels > 500 μg/L
    11.Individuals with sickle cell anemia, thalassemia and/or any chronic blood disorder requiring blood transfusions
    12.History of splenectomy at any time, or any major surgery within 2 months prior to Screening
    13.History of myocardial infarction or cerebrovascular event within 6 months prior to Screening, or current active angina pectoris, history of or current congestive heart failure NYHA Class III or Class IV, uncontrolled seizures, prolonged untreated hypertension, active GI bleeding, others
    14.A history of attempted suicide within 6 months prior to Screening or a positive response to items 4 or 5 of the Columbia-Suicide Severity Rating Scale at Screening
    15.An episode of major depression within the last 6 months prior to Screening
    16.History of cancer with the exceptions per protocol
    17.Clinically significant abnormality on screening ECG
    18.An active infective process or any other clinically significant abnormality on Screening Chest X-ray
    19.Contraindication to Avonex or incompatibility with Avonex use
    20.IV or oral glucocorticoids within 4 weeks prior to randomization
    21.Treatment with monthly IV methylprednisolone
    22.Treatment with beta-interferons or glatiramer acetate within 4 weeks prior to randomization
    23.Treatment with dimethyl fumarate within 4 weeks prior to randomization
    24.Treatment with teriflunomide within 12 weeks or after the accelerated elimination procedure 12 days prior to randomization
    25.Use of lymphocyte trafficking blockers within 48 weeks prior to randomization
    26.Use of IV Ig or plasmapheresis within 12 weeks prior to randomization
    27. Treatment with rituximab and/or ocrelizumab
    28. Treatment with any other B cell depleting therapy, BTK inhibitors (including evobrutinib), mitoxantrone, or lymphocyte-depleting therapies (e.g., alemtuzumab, antiCD4, cladribine, cyclophosphamide, total body irradiation, bone marrow transplantation).
    29. Concomitant treatment with medications commonly used for symptom management of MS
    30. Treatment with medical marijuana for MS symptoms, unless it is consistent with local guidelines and local regulations
    31. On anticoagulation, or antiplatelet therapy other than daily aspirin for cardioprotection. Use of fish oil supplements within 4 weeks prior to randomization.
    32. Participants currently receiving potent inducers of cytochrome P450 3A (CYP3A) medications or herbal supplements known to be potent (strong to moderate) inhibitors of CYP3A or drugs mainly metabolized by CYP3A with a narrow therapeutic index
    33. Participation in any investigational drug study within 6 months or 5 half-lives of the investigational drug, whichever is longest, prior to Screening
    34. Any of the following:
    a. History of or positive for human immunodeficiency virus
    b. History of or positive for hepatitis C virus (HCV)
    c. Positive for hepatitis B surface antigen (HBsAg)
    35. Estimated glomerular filtration rate by the 4-variable Modification of Diet in Renal Disease equation of < 60 mL/min/1.73 m2 or any renal condition that would preclude the administration of gadolinium
    36. ALT, AST, amylase, or lipase > 2 × upper limit of normal (ULN) of laboratory reference range, total bilirubin > 1.5 × ULN
    37. Significant cytopenia
    38. Any allergy, contraindication, or inability to tolerate Avonex or evobrutinib or any of their excipients.
    39. Inability to comply with MRI scanning
    40. Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening
    41. Regular alcohol consumption within 6 months prior to the study
    E.5 End points
    E.5.1Primary end point(s)
    ARR based on qualified relapses at Week 96 in participants with RMS
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 96
    E.5.2Secondary end point(s)
    a. Time to first occurrence of 12-week confirmed Expanded Disability Status Scale (EDSS) progression over 96 weeks
    b.Time to first occurrence of 24-week confirmed EDSS progression over 96 weeks
    c.Change from Baseline (CFB) in Patient Reported Outcomes Measurement Information System [PROMIS] PF score at 96 weeks
    d.CFB in PROMIS Fatigue score at 96 weeks
    e.Total number of T1 Gd+ lesions based on assessments at Week 24, Week 48, and Week 96.
    f. Total number of new or enlarging T2 lesions based on assessments at Week 24, Week 48, and Week 96
    g.Safety as assessed by the nature, severity, and occurrence of adverse events (AEs) and adverse events of special interest (AESIs); vital signs; electrocardiograms (ECGs); absolute concentrations and change from Baseline in immunoglobulin (Ig) levels; and clinical laboratory safety parameters up to Week 108
    h. OLE period:
    •Efficacy and HRQoL endpoints at Weeks 48, 96, and 144
    oARR, based on protocol-defined qualified relapses
    oChange from Baseline in PROMIS PF score
    oChange from Baseline in PROMIS fatigue score
    oChange from Baseline in Medical Outcomes Study 36 Item Short Form Health Survey (SF-36v2)
    •Efficacy and HRQoL endpoints over 144 weeks
    oTime to first occurrence of 12-week confirmed EDSS progression over 144 weeks
    oTime to first occurrence of 24-week confirmed EDSS progression over 144 weeks
    oTime to first occurrence of 12-week confirmed PF deterioration compared to Baseline over 144 weeks
    •Efficacy endpoints at Weeks 24, 48, 96, and 144
    oTotal number of new or enlarging T2 lesions
    oTotal number of T1 Gd+ lesions
    •Safety as assessed by the nature, severity, and occurrence of AEs and AESIs; vital signs; ECGs; absolute concentrations and change from Baseline in Ig levels; clinical laboratory safety parameters up to Week 144
    E.5.2.1Timepoint(s) of evaluation of this end point
    a. 12 week over 96 weeks
    b. 24-week over 96 weeks
    c, d: 96 weeks
    e, f: Week 24, Week 48, and Week 96.
    g. Week 108
    h. OLE period timepoints described in E.5.2
    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 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) No
    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 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA87
    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
    Argentina
    Austria
    Belgium
    Bosnia and Herzegovina
    Bulgaria
    Canada
    Croatia
    Czech Republic
    Estonia
    France
    Georgia
    Germany
    Hungary
    Israel
    Italy
    Korea, Republic of
    Mexico
    Montenegro
    Poland
    Russian Federation
    Serbia
    Spain
    Taiwan
    Ukraine
    United Kingdom
    United States
    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
    A participant has completed the study if he/she has completed all study parts, including the
    Treatment Period and the last visit (Safety Follow-up Visit).
    The end of the study is defined as the date of the last visit of the last participant.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months2
    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: 950
    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 state72
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 261
    F.4.2.2In the whole clinical trial 950
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-02-18
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    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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