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    Summary
    EudraCT Number:2019-000328-16
    Sponsor's Protocol Code Number:20170588
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-11
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2019-000328-16
    A.3Full title of the trial
    A Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy
    A.3.2Name or abbreviated title of the trial where available
    Safety and Efficacy of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)
    A.4.1Sponsor's protocol code number20170588
    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 SponsorAmgen Inc
    B.1.3.4CountryUnited States
    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 supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen GmbH
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressRiesstr. 24
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code80992
    B.5.3.4CountryGermany
    B.5.4Telephone number+498002643644
    B.5.6E-maileudemedinf@amgen.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.3.2Product code AMG 570
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMG 570
    D.3.9.3Other descriptive nameAMG 570
    D.3.9.4EV Substance CodeSUB186902
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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 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.3.2Product code AMG 570
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMG 570
    D.3.9.3Other descriptive nameAMG 570
    D.3.9.4EV Substance CodeSUB186902
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number280
    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 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.3.2Product code AMG 570
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMG 570
    D.3.9.3Other descriptive nameAMG 570
    D.3.9.4EV Substance CodeSUB186902
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number420
    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
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active Systemic Lupus Erythematosus
    E.1.1.1Medical condition in easily understood language
    Active Systemic Lupus Erythematosus
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    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
    To evaluate the efficacy of AMG 570 at week 24 as measured by the Systemic Lupus Erythematosus Responder Index (SRI-4) in subjects with SLE with inadequate response to SOC therapy
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of AMG 570 with oral corticosteroid (OCS)-tapering in subjects with SLE with inadequate response to SOC therapy (key secondary).
    - To evaluate the effect of AMG 570 on the efficacy response after 52 weeks of treatment (key secondary).
    - To evaluate the effect of AMG 570 on additional SLE efficacy endpoints.
    - To describe the effect of treatment with AMG 570 using patient reported outcome.
    - To characterize the safety of AMG 570.
    - To characterize the pharmacokinetics (PK) of AMG 570.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
    - Age ≥ 18 years to ≤ 75 years at visit 1.
    - Fulfills classification criteria for SLE according to the SLICC criteria or by at least 4 of the 11 criteria of the 1997 modification of the ACR classification criteria for SLE, with at least 1 of the following being present at screening: Antinuclear antibody ≥ 1:80; or Elevated anti-dsDNA antibodies by the Farr assay.
    - SLEDAI-2K score ≥ 6 points with "Clinical" SLEDAI-2K score ≥ 4 points. The "Clinical" SLEDAI-2K is the SLEDAI-2K assessment score without the inclusion of points attributable to any urine or laboratory results including immunologic measures. For a subject whose clinical SLEDAI-2K score requires any of the following components, the subject must meet the following additional criteria:
    o Arthritis: If a subject qualifies for the study by scoring for arthritis on the SLEDAI-2K form, they must have ≥3 swollen and/or tender joints in the hands or wrists, and the distribution should not involve the ankles, elbows, shoulders, or hips.
    o Alopecia: Subjects scoring for alopecia on the SLEDAI-2K should have patchy hair loss without scarring; subjects should neither have alopecia areata nor androgenic alopecia.
    o Oral ulcers: Subjects scoring for oral ulcers on the SLEDAI-2K should have physician documented location and appearance.
    o Rash: To contribute to the minimally required clinical SLEDAI-2K score, rash must have been present for a minimum of 1 week, must cover at least 5% of the body surface area if discoid and 10% of the body surface area if any other type of lupus rash. Rash must have physician documented location and appearance.
    - Must be taking at least 1 but not more than 2 of the following SLE treatments: mycophenolate mofetil, azathioprine, methotrexate, hydroxychloroquine, chloroquine, dapsone, or quinacrine. Treatment should be taken for ≥12 weeks prior to screening and must be a stable dose for ≥ 8 weeks prior to screening. Patients cannot be taking two immunosuppresants (ie, mycophenolate mofetil, azathioprine, or methotrexate) simultaneously.
    - For subjects taking OCS, dose must be ≤ 20 mg/day of prednisone or OCS equivalent, and the dose must be stable ≥ 4 weeks prior to screening.
    E.4Principal exclusion criteria
    - History of lupus nephritis requiring induction therapy within 1 year or active lupus nephritis (defined as any of the following: clean catch, spot urine protein creatinine ratio > 3000 mg/g at screening or active urinary sediment attributable to SLE).
    - History of CNS lupus within 1 year prior to screening or active CNS lupus including, but not limited to, aseptic meningitis, ataxia, CNS vasculitis, cranial neuropathy, demyelinating syndrome, optic neuritis, psychosis, seizures, or transverse myelitis.
    - Currently present or within 1 year prior to screening a diagnosis of any inflammatory joint or skin disease other than SLE (confirmed accurate by the PI) which would interfere with SLE disease assessment based on investigator judgement.
    - History of any disease other than SLE that has required treatment with oral or parenteral corticosteroids for > 2 weeks within 6 months prior to screening.
    - Active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to day 1 OR presence of serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to day 1.
    - Known history of active tuberculosis.
    - Positive test for tuberculosis during screening defined as either positive or indeterminate QuantiFERON®-TB or T-spot test OR positive purified protein derivative (PPD) (≥ 5 mm of induration at 48 to 72 hours after test is placed).
    - Positive for hepatitis B surface antigen, hepatitis B core antibody (confirmed by hepatitis B DNA polymerase chain reaction [PCR] test) or detectable hepatitis C virus RNA by PCR (screening is generally done by hepatitis C antibody [HepCAb], followed by hepatitis C virus RNA by PCR if HepCAb is positive). A history of hepatitis B vaccination without history of hepatitis B is allowed.
    - Known history of HIV or positive serology for HIV antibodies at screening.
    - Presence of 1 or more significant concurrent medical conditions per investigator judgment, including but not limited to the following:
    o poorly controlled diabetes or hypertension (ie, systolic blood pressure > 170 mmHg and/or diastolic blood pressure > 100 mmHg)
    o symptomatic heart failure (New York Heart Association class III or IV)
    o myocardial infarction or unstable angina pectoris within the past 12 months prior to randomization
    o severe chronic pulmonary disease (eg, requiring oxygen therapy)
    o multiple sclerosis or any other demyelinating disease
    o major chronic inflammatory disease or connective tissue disease other than SLE (eg, RA, mixed connective tissue disease [MCTD], antiphospholipid antibody syndrome)
    - Currently receiving or had treatment with: cyclophosphamide, chlorambucil, nitrogen mustard, or any other alkylating agent ≤ 6 months prior to day 1 OR oral calcineurin inhibitors (eg, cyclosporine, tacrolimus, sirolimus, voclosporin) ≤ 4 weeks prior to day 1.
    - Currently receiving or had treatment with a JAK inhibitor or oral, targeted investigational agent (eg, Bruton’s tyrosine kinase inhibitor) < 3 months or 5 half-lives (whichever is longer) prior to day 1.
    - Prior treatment with an immune checkpoint inhibitor (eg, PD-1 inhibitor, PD-L1 inhibitor, CTLA-4 inhibitor).
    - Current or previous treatment for SLE with a biologic agent as follows: rituximab < 6 months prior to day 1 and undetectable B cell count; belimumab or anifrolumab < 6 months prior to day 1; abatacept < 6 months prior to day 1; or any other biologics < 5 half-lives prior to day 1.
    - Subjects who have received intra-articular or systemic corticosteroid injections within 6 weeks prior to day 1.
    - Currently receiving treatment in another investigational device or drug study.
    - Ending a treatment or another investigation device or drug study(ies) less than 5 have-lives from the last dose of the investigational drug or 42 calendar days (whichever is longer) at day 1.
    - Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 16 weeks after the last dose of investigational product.
    - Female subjects of childbearing potential or female partners of male subjects unwilling to use 1 highly effective method of contraception during treatment and for an additional 16 weeks after the last dose of investigational product.
    - Female subjects of childbearing potential with a positive pregnancy test (assessed by a serum pregnancy test at screening and a urine pregnancy test at baseline).
    - Subject has known sensitivity to any of the products to be administered during dosing.
    - Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the subject and investigator’s knowledge.
    E.5 End points
    E.5.1Primary end point(s)
    - SRI-4 response at week 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Week 24
    E.5.2Secondary end point(s)
    - SRI-4 at week 52 with reduction of OCS to ≤ 7.5 mg/day by week 44 and sustained through week 52 in subjects with a baseline OCS dose ≥ 10 mg/day (key secondary).
    - SRI-4 response at week 52 (key secondary).
    - Tender and swollen joint count ≥ 50% improvement from baseline at week 12, 24, 36, and 52 in subjects with ≥ 6 tender and ≥ 6 swollen joints at baseline.
    - Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) activity score ≥ 50% improvement from baseline at week 12, 24, 36, and 52 in subjects with a CLASI score ≥ 10 at baseline.
    - Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score and change from baseline at week 12, 24, 36, 44, and 52.
    - Medical Outcomes Short Form 36 version 2 Questionnaire (SF36v2) score and change from baseline at week 12, 24, 36, 44, and 52.
    - Modified Lupus QoL score and change from baseline at week 12, 24, 36, 44, and 52.
    - Patient Global Assessment (PtGA) score and change from baseline at week 12, 24, 36, 44, and 52.
    - Adverse events, Serious adverse events and Significant changes in laboratory values and vital signs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Weeks 52 and 44
    - Week 52
    - Weeks 12, 24, 36 and 52
    - Weeks 12, 24, 36 and 52
    - Weeks 12, 24, 36, 44 and 52
    - Weeks 12, 24, 36, 44 and 52
    - Weeks 12, 24, 36, 44 and 52
    - Weeks 12, 24, 36, 44 and 52
    - Duration of the study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response 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 Yes
    E.8.1.7.1Other trial design description
    Adaptive design
    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 trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Bulgaria
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Japan
    Korea, Republic of
    Mexico
    Poland
    Portugal
    Russian Federation
    Switzerland
    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
    End of Study: LVLS

    Primary Completion: The primary completion date is defined as the date when the last subject is assessed or receives an intervention for the final collection of data for the primary endpoint(s), for the purposes of conducting the primary analysis, whether the study concluded as planned in the protocol or was terminated early.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 280
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 141
    F.4.2.2In the whole clinical trial 300
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-17
    P. End of Trial
    P.End of Trial StatusOngoing
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