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    Summary
    EudraCT Number:2020-002765-34
    Sponsor's Protocol Code Number:MabionCD20-003RA
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-08-24
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2020-002765-34
    A.3Full title of the trial
    A Double-Blind, Randomized, Parallel-Group Study to Investigate the Pharmacokinetic and Clinical Similarity Between MabionCD20 (manufactured in commercial scale), EU-approved MabThera® and US-licensed Rituxan® in Patients with Moderate-to-Severe Rheumatoid Arthritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Comparing MabionCD20 (new Rituximab biosimilar) with MabThera (reference Rituximab from EU) and Rituxan (reference Rituximab from US) in Patients with Rheumatoid Arthritis
    A.3.2Name or abbreviated title of the trial where available
    MABRIDGE
    A.4.1Sponsor's protocol code numberMabionCD20-003RA
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04680962
    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 SponsorMabion S.A.
    B.1.3.4CountryPoland
    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 supportMabion S.A.
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMabion S.A.
    B.5.2Functional name of contact pointClinical Operation Team
    B.5.3 Address:
    B.5.3.1Street Addressgen. Mariana Langiewicza 60
    B.5.3.2Town/ cityKonstantynów Łódzki
    B.5.3.3Post code95-050
    B.5.3.4CountryPoland
    B.5.4Telephone number+4842290-82-12
    B.5.5Fax number+4842203-27-03
    B.5.6E-mailklinika@mabion.eu
    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 nameMabionCD20
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.2Current sponsor codeMabionCD20
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP 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 MabThera
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 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 Rituxan
    D.2.1.1.2Name of the Marketing Authorisation holderGenentech, Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate-to-severe rheumatoid arthritis
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis is a disease which causes joint inflammation and pain. The study is done in patients with rheumatoid arthritis of moderate to severe activity.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary study objective is to demonstrate a 3-way pharmacokinetic similarity between MabionCD20, EU-approved MabThera and US-licensed Rituxan following i.v. administration to patients with moderate-to-severe rheumatoid arthritis.
    E.2.2Secondary objectives of the trial
    Secondary study objectives are to comparatively assess secondary PK parameters, efficacy, pharmacodynamics, safety and immunogenicity following i.v. administration of MabionCD20, EU-approved MabThera and US-licensed Rituxan in patients with active, moderate-to-severe RA.
    The study will also investigate long-term safety, immunogenicity and efficacy outcomes following re-treatment with MabionCD20 (vs. re-treatment with MabThera); and safety and tolerability of switching the treatment from Rituxan to MabionCD20.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patients must be 18 to 80 years of age inclusive, at the time of signing the informed consent.
    2.Body Surface Area (BSA) between 1.5 and 2.2 m2, calculated according to the DuBois and DuBois formula: BSA in m2 = (weight (Kg)0.425 * height (cm) 0.725) * 0.007184).
    3.Patients with confirmed rheumatoid arthritis, diagnosed according to the revised (2010) ACR/EULAR classification criteria, with a disease duration minimum of 6 months prior to the Screening Visit.
    4.Patients with currently moderate to severe disease activity despite ongoing administration of an adequate methotrexate regimen. Moderate-to-severe activity is defined here as the presence of the following two
    criteria:
    a.Six or more swollen joints and ≥6 tender/painful joints (based on 66/68 joint count, not including distal interphalangeal joints), verified by a physician during screening and re-confirmed at baseline visit (Day 1).
    b.DAS28-ESR score ≥3.2 at screening.
    5.No history of treatment with TNF-α inhibitors (innovative or biosimilar, authorized or investigational) at any time before the screening i.e. patients naïve to TNF-α inhibitors.
    6. Male or female.
    7. Male patients must agree to use highly effective contraception, as detailed in Section 10.1. of this protocol, from the Screening Visit, during the intervention period, and for at least 12 months after the last dose of study intervention and refrain from donating sperm during this period.
    8.Female patients are eligible to participate if not pregnant, not breastfeeding, and at least one of the following
    conditions applies:
    •Not a woman of childbearing potential (WOCBP)
    •Patient is a WOCBP, but she and her partner agree to follow the contraceptive guidance outlined in Section 10.1 from the Screening Visit, during the intervention period, and for at least 12 months after the last dose of the study intervention.
    9.Able to provide written informed consent as described in Appendix 2: Regulatory, Ethical, and Study Oversight Considerations after receiving information about benefits and potential risks of the study, as well as details of the insurance covering the patients of the study.
    10. Patients receiving treatment with MTX 7.5–25 mg/week for at least 12 weeks, with the last 4 weeks at a stable dose, and willing to remain at this dose for the entire study duration.
    11. For WOCBP: negative serum and urine pregnancy test.
    12. Ability and willingness to comply with the requirements of the Clinical Study Protocol (CSP).
    E.4Principal exclusion criteria
    1.History of or current inflammatory joint disease other than RA.
    2.History of or a current systemic autoimmune disorder with the exception of the secondary Sjögren's syndrome. Patients with a history of or current autoimmune disease confined to a single organ (e.g. thyroiditis or vitiligo) can be considered for enrollment, provided that other eligibility criteria are met.
    3.American College for Rheumatology functional Class IV disease
    4.History of psychiatric disorder that would interfere with normal participation in this protocol
    5.Patient is positive for the current, clinically active or latent infection with human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus, as determined by the validated serologic, molecular or antigen testing methods and interpreted according to the international diagnostic guidelines
    6.History of or current active tuberculosis, with typical symptoms of M. tuberculosis infection confirmed by positive results of TB screening tests or documented diagnosis prior to screening.
    7.Latent tuberculosis, as documented in subject's medical records or shown by a positive or indeterminate QuantiFERON test performed at screening, in absence of the typical symptoms of tuberculosis. However, a patient with latent Mycobacterium tuberculosis infection may become eligible for the study, if the following safety criteria are met:
    •Patient completed a standard TB prophylaxis prior to the screening and had no active TB or contact with active TB case after completion of the most recent prophylactic regimen. OR
    •Patient received at least four weeks of standard TB prophylactic regimen prior to the screening visit and is capable and willing to continue on this regimen while participating in the study
    •Patient has no active TB at the time of screening, which must be confirmed through referral to a TB specialist if >1 year has passed since the completion of the last prophylaxis or if the prophylaxis is still being received by the time of screening
    •Patient had no positive findings on chest X-ray examination at screening and within three months prior to screening. Patient identified as latently infected with tuberculosis on the screening test may be later re-screened for the study if he/she receives appropriate anti-TB prophylaxis
    8.Serious AND/OR uncontrolled coexisting diseases which are recognized as: major contraindications to the administration of rituximab, MTX or any of the pre-medication components OR important risk factors for the development of severe or life-threatening SARS-CoV2 infection OR others, which in the Investigator's opinion, would
    preclude patient's participation
    9.Treatment with any of the authorized or investigational TNF-α inhibitors at any time before the screening.
    10.Recent use of biologic DMARDs or non-biologic DMARDs other than MTX within the washout periods specified in Table 6 2.
    11.Prior treatment with a B cell modulating or B cell depleting therapy such as, but not limited to, rituximab or other anti CD20 mAb (ocrelizumab, ofatumumab, obinutuzumab), belimumab, atacicept, tabalumab, epratuzumab and other experimental treatments.
    12.Use of systemic glucocorticoids at a dose higher than 10 mg prednisolone daily or equivalent, within 2 weeks prior to Screening OR between Screening and administration of the first IMP dose.
    13.Use of intraarticular hyaluronic acid injection within 28 days before the screening OR between Screening and administration of the first IMP dose.
    14.Recent vaccination with inactivated/non-live (<4 weeks prior to study intervention infusion on Day 1) or live (<6 weeks prior to study intervention infusion on Day 1) vaccine.
    15.Planned vaccination with live vaccine during the study follow-up.
    16.Chronic intake of narcotic analgesics (e.g. morphine, fentanyl, hydrocodone, oxycodone, codeine).
    17.Use of any drug or vaccine that has not received regulatory approval for any indication within 4 weeks or a minimum of 5 half lives, whichever is longer, prior to the Screening Visit or planned receipt of unauthorized
    drug or vaccine during the study
    18.Participation in a clinical study during the 2 months prior to enrolment in the study (exemption – previously failed screening procedures in MabionCD20 003RA study)
    19.Serious abnormal laboratory findings, specifically:
    a)White blood cell count <3,000/µL OR neutrophil count <1,500/µL
    b)Platelet count <75,000/µL
    c)Aspartate aminotransferase or alanine aminotransferase >2.5 times ULN.
    d)Hemoglobin <8.0 g/dL
    e)IgG below 5.0 mg/mL or IgM below 0.4 mg/mL
    f)Any other clinically significant laboratory abnormality, that in the opinion of Investigator could endanger the safety and well-being of participant OR affect the analysis and interpretation of study results.

    For other Exclusions please refer to Clinical Study Protocol v.2.0, Section 5.2
    E.5 End points
    E.5.1Primary end point(s)
    Co-primary PK endpoint 1:
    • AUC 0-inf (Day 1 to Week 24)
    Co-primary PK endpoint 2:
    • AUC 0-t (Day 1 to Day 15)
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Day 1, 2, 3, 7, 15, 16, 17, 22, 28, 56, 84, 112, 168
    • Day 1, 2, 3, 7, 15
    E.5.2Secondary end point(s)
    Secondary pharmacokinetic endpoints:
    • AUC0-t (Day 1 to Week 24)
    • AUC0-inf (Day 15 to Week 24)
    • Cmax (2nd dose), Cmax (1st dose)
    • Ctrough
    • Tmax (2nd dose), Tmax (2nd dose)
    • t1/2
    • Kel
    • Vd
    • CL
    Efficacy endpoints:
    • Mean change from baseline in DAS28-ESR score
    • Mean change from baseline in DAS28-CRP score
    • Percentage of patients with low disease activity (DAS28 <3.2)
    • Percentage of patients with disease remission (DAS28 <2.6)
    • Achievement of ACR 20%, 50% and 70% improvement from baseline (ACR20/50/70)
    • Percentage of patients with good or moderate response on the EULAR scale
    • Simplified Disease Activity Index (SDAI)
    • Clinical Disease Activity Index (CDAI)
    • Patient’s global assessment of disease activity
    • Physician’s global assessment of disease activity
    • Health Assessment Questionnaire Disability Index (HAQ DI)
    Safety endpoints:
    • Adverse events
    • Treatment-emergent AEs (any, related, serious, leading to discontinuation)
    • Adverse events of special interest [Infusion-related reactions (IRRs), Hypersensitivity and allergic reactions, Serious Infectious Events (SIEs), Infusion-associated cardiovascular events, SARS-CoV-2 infections, Progressive multifocal leukoencephalopathy (PML)]
    • Clinical laboratory data
    • Physical examinations
    • Vital signs
    • ECG abnormalities
    • Concomitant medication use
    Immunogenicity endpoints:
    • ADA positive response (Treatment-induced and treatment-boosted anti-drug antibodies)
    • Persistent ADA positive response
    • Transient ADA positive response
    • Neutralizing antibodies (NAb)
    • Median ADA titer
    Pharmacodynamic endpoints:
    • Absolute CD19+ B-cell counts by visit
    • Percentage of patients with undetectable levels of CD19+ B-cells
    E.5.2.1Timepoint(s) of evaluation of this end point
    Days 1,2,3,7,15,16,17,22,28,56,84,112,140,168,182,195,251,335
    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 Yes
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenecity
    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 No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Belgium
    Bulgaria
    Georgia
    Poland
    Serbia
    Ukraine
    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
    The end of the study will be defined as the date of the last visit of the last patient in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 184
    F.4.2.2In the whole clinical trial 280
    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)
    There are no plans for treatment or care after the subject has ended the participation in the trial
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-13
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
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    The status of studies in GB is no longer updated from 1.1.2021
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