Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   38451   clinical trials with a EudraCT protocol, of which   6312   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-004788-30
    Sponsor's Protocol Code Number:4SC-202-3-2018
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-09-03
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2018-004788-30
    A.3Full title of the trial
    A phase II, open label study to investigate the efficacy and safety of domatinostat in combination with avelumab in patients with advanced unresectable/metastatic Merkel Cell Carcinoma progressing on anti-PD(L)1 antibody therapy – the MERKLIN 2 study
    Unverblindete Phase-II-Studie zur Untersuchung der Wirksamkeit und Sicherheit von Domatinostat in Kombination mit Avelumab bei Patienten mit fortgeschrittenem, nicht resezierbaren / metastasierten Merkelzellkarzinom, bei denen unter einer Anti-PD-(L)1-Antikörpertherapie eine Progression aufgetreten ist – Studie MERKLIN 2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of the research study is to determine if domatinostat in combination with avelumab will be able to delay or prevent worsening of the disease in patients with advanced unresectable/metastatic Merkel Cell Carcinoma that is continuing to grow after previous anti-PD-(L)1 antibody therapy. Furthermore, safety of the combination during the study conduct will be assessed.
    A.4.1Sponsor's protocol code number4SC-202-3-2018
    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 Sponsor4SC 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 support4SC AG
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportMerck KgAA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation4SC AG
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressFraunhoferstr. 22
    B.5.3.2Town/ cityPlanegg-Martinsried
    B.5.3.3Post code82152
    B.5.3.4CountryGermany
    B.5.4Telephone number0049897007630
    B.5.5Fax number00498970076329
    B.5.6E-mailMERKLIN2@4sc.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 nameDomatinostat, Formulation 01
    D.3.2Product code 4SC-202
    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 INNDomatinostat
    D.3.9.1CAS number 1186222-89-8
    D.3.9.2Current sponsor code4SC-202
    D.3.9.4EV Substance CodeSUB48521
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 nameAvelumab
    D.3.2Product code MSB0010718C
    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 INNAVELUMAB
    D.3.9.1CAS number 1537032-82-8
    D.3.9.2Current sponsor codeMSB0010718C
    D.3.9.3Other descriptive nameanti-PD-L1 antibody
    D.3.9.4EV Substance CodeSUB180078
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameDomatinostat, Formulation 02
    D.3.2Product code 4SC-202
    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 INNDomatinostat
    D.3.9.1CAS number 1186222-89-8
    D.3.9.2Current sponsor code4SC-202
    D.3.9.3Other descriptive name4SC-202
    D.3.9.4EV Substance CodeSUB48521
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    patients with advanced unresectable/metastatic Merkel Cell Carcinoma progressing on anti-PD(L)1 antibody therapy
    Patienten mit fortgeschrittenem, nicht resezierbaren / metastasierten Merkelzellkarzinom, bei denen unter einer Anti-PD-(L)1-Antikörpertherapie eine Progression aufgetreten ist
    E.1.1.1Medical condition in easily understood language
    Metastatic, unresectable Merkel Cell Carcinoma that continues to grow after trearment with anti-PD-(L)1 antibody therapy
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10064025
    E.1.2Term Merkel cell carcinoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to investigate the anti-tumor efficacy of domatinostat in combination with avelumab in advanced unresectable/metastatic MCC patients progressing on anti-PD-(L)1 antibody monotherapy.
    Untersuchung der gegen den Tumor gerichteten Wirksamkeit von Domatinostat in Kombination mit Avelumab bei Patienten mit fortgeschrittenem, nicht resezierbaren / metastasierten Merkelzellkarzinom (MZK), bei denen unter einer Anti-PD-(L)1-Antikörpertherapie eine Progression aufgetreten ist.
    E.2.2Secondary objectives of the trial
    to investigate safety, tolerability, pharmacokinetics, avelumab anti-drug antibodies (ADA) and health-related quality of life (HrQoL).
    Untersuchung der Sicherheit, der Verträglichkeit, der Pharmakokinetik, der gegen Avelumab gerichteten Anti-Medikamenten-Antikörper (ADA) und der gesundheitsbezogenen Lebensqualität (HrQoL).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years (at signature of ICF), mentally and physically able and willing to provide informed consent for study participation.

    2. Histologically confirmed Merkel Cell Carcinoma (MCC).

    3. ECOG performance status ≤ 1.

    4. MCC in an advanced, unresectable stage III or metastatic stage IV (includes patients who refused surgical resection or are not eligible for such surgical resection)

    5. RECIST v1.1 evaluable disease.

    6. Progressing on previous anti-PD-(L)1 antibody monotherapy within the last 12 weeks before planned first administration of study medication fulfilling at least one of the following criteria:
    • Radiology Criteria: - Detection of new lesion(s) or - At least a 20% increase in the sum of diameters; in addition, the sum must also demonstrate an absolute increase of at least 5 mm.
    • In case of unresectable locoregional tumor not measurable by scan, assessment with a caliper will be allowed: a single, unirradiated/ untreated lesion must have a diameter of > 10 mm, at least a 20% increase in the diameter and an absolute increase of at least 5 mm.
    • Biopsy of new lesion(s) and histological confirmation of PD in case of progression during adjuvant anti-PD-(L)1 treatment.

    7. Confirmation of PD not earlier than 4 weeks after initial assessment of PD on previous anti-PD-(L)1 monotherapy.

    8. Pretreatment with avelumab monotherapy or any antiPD-1 antibody monotherapy fulfilling the following minimum exposure criteria:
    • Anti-PD-(L)1 antibody given every 2 weeks Q2W: at least 6 administrations within the last 6 months, last dose within 3 months before planned first administration of study medication.
    • Anti-PD-(L)1 antibody given every 3 weeks Q3W: at least 4 administrations within the last 6 months, last dose within 3 months before planned first administration of study medication. • Anti-PD-(L)1 antibody given every 4 weeks Q4W: at least 3 administrations within the last 6 months, last dose within 3 months before planned first administration of study medication.

    9. Patients must have been treated with anti-PD-(L)1 antibody therapy as the most recent systemic anti-neoplastic therapy

    10. Patients must have been treated with approved doses and schedules of avelumab or anti-PD-1 antibodies. For investigational anti-PD-1 antibodies, patients must have been treated with the recommended phase 2 dose and schedule.

    11. Patients with brain or central nervous system metastases will be eligible, if asymptomatic, treated with surgery, whole brain or stereotactic radiotherapy, clinically stable (at least for a period of 2 months prior to signing ICF) and do not require continued steroid therapy.

    12. Locally advanced/unresectable MCC must not be eligible for radiation therapy due to prior cumulative radiation treatment, judgment of radiation oncologist that the tumor is unlikely to respond to therapy or because radiation treatment is contraindicated for other reasons (e.g. tumor location).

    13. Female patients of childbearing potential must have a negative urine or serum pregnancy test before receiving the first dose of study medication and they must comply with contraception methods as requested by the study protocol.
    E.4Principal exclusion criteria
    1. History of serious anti-PD-(L)1 therapy-related adverse reactions prohibiting further avelumab treatment:
    - Pneumonitis: Grade 3 or 4 or recurrent Grade 2
    - Hepatitis: AST or ALT more than 5 times the upper limit of normal or total bilirubin more than 3 times the upper limit of normal
    - Colitis/diarrhea: Grade 4 or recurrent Grade 3
    - Nephritis and renal dysfunction: serum creatinine more than 6 times the upper limit of normal
    - Any other immune-mediated adverse reactions which resulted in a life-threatening situation for the patient (excluding endocrinopathies) or infusion-related reactions Grade 3 or 4.

    2. More than one line of previous systemic anti-neoplastic therapy other than anti-PD-(L)1 antibody monotherapy.

    3. Palliative radiation therapy of single lesions within 2 weeks before planned administration of study medication.

    4. Patients currently participating or having participated in a clinical study in which the last administration of the investigational medicinal product was within 2 weeks before consenting to study participation (i.e. signing ICF).

    5. Not recovered adequately (≤ Grade 1) from toxicities and/or complications from surgical intervention or from previous anticancer therapies (excluding alopecia, fatigue or endocrine dysfunction on replacement therapy) as judged by the investigator.

    6. History or current evidence of clinically relevant allergies or hypersensitivity, which includes known or suspected intolerabilities attributed to domatinostat or avelumab or to constituents of the domatinostat tablets or avelumab infusion including known severe hypersensitivity reactions (Grade ≥ 3) to monoclonal antibodies.

    7. Inadequate organ function defined by the following laboratory parameters:
    • Absolute Neutrophil Count (ANC) < 1500/µl.
    • Hemoglobin (Hb) < 9 g/dl (< Hb 5.6 mmol/L), may have been transfused.
    • Platelet count < 100.000/µl.
    • Serum creatinine > 1.5 x ULN or eGFR < 60 mL/min (as per Cockroft-Gault formula).
    • ALT or AST > 1.5 x ULN.
    • Serum total bilirubin > 1.5 x ULN.

    8. Any medical condition requiring continuous systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications (e.g. methotrexate, azathioprine, interferons, mycophenolate, anti-TNF agents and other) within 2 weeks before consenting to study participation (i.e. signing ICF) except for the following: intranasal, inhaled, topical, local steroid applications/injection (e.g., intra-articular injection) or single doses of systemic corticosteroids as premedication/prevention for hypersensitivity reactions (e.g., CT scan premedication).

    9. Any active gastrointestinal disorder that could interfere with the absorption of domatinostat characterized by malabsorption or inability to swallow tablets as per judgment of the investigator.

    10. Any known or suspected, current or chronic infection, immunodeficiency disorder or autoimmune disease requiring systemic treatment and/or that might deteriorate when receiving an immunostimulatory agent (e.g. chronic lymphocytic leukemia (CLL) or allogeneic stem-cell transplantation).

    11. History of other hematologic or primary solid malignancies which received or require any form of active systemic anti-cancer treatment (such as, but not limited to, hormone anti-cancer therapy, immunotherapy or targeted therapy) during the last 12 months before consenting to study participation.

    12. Received a live vaccine within 30 days before consenting to study participation.

    13. Pregnant or breastfeeding.

    14. Conditions requiring systemic anti-arrhythmic therapy known to prolong QT/QTc interval, patients with QTcF interval >480 msec on at least 2 separate and consecutive ECGs at screening or a medical history of long-QT-Syndrome.

    15. Clinically significant (i.e. active) cardiovascular and/or thromboembolic diseases:
    • Cerebral vascular accident or stroke.
    • Uncontrolled hypertension.
    • Congestive heart failure (New York Heart Association (NYHA) Class III or IV).
    • Serious cardiac arrhythmia requiring medication (patients with status post pace maker and/or defibrillator implantation can be included).
    • Symptomatic ischemic or severe valvular heart disease.
    • Unstable angina pectoris or a myocardial infarction within 6 months prior to signing ICF. 1

    16. Patients with known HIV, acute or chronic active hepatitis B (defined as positive titers for HBsAg, anti-HBc-IgM or DNA) or Hepatitis C (HCV RNA if anti-HCV antibody screening test positive)

    17. Significant (current or chronic) diseases or other intercurrent illness, psychiatric illness or social situation that would limit compliance with study requirements or would pose an undue medical hazard, interfere with the conduct of the study or interfere with interpretation of the study results as judged by the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Objective Response Rate (ORR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Objective Response Rate (ORR), defined as the percentage of patients having a confirmed CR or PR according to RECIST v1.1 based on radiological imaging or for skin lesions not measurable by scan, measurements with a caliper will be allowed. Tumor assessment will be performed every 8 weeks for the first 6 months of study treatment and thereafter every 12 weeks until disease progression (RECIST-PD) or end of treatment period. For patients without confirmed RECIST-PD at the time of treatment discontinuation, tumor assessments should continue in the afore-mentioned intervals until confirmation of RECIST-PD disease progression or start of a new anticancer treatment, whichever occurs earlier.
    E.5.2Secondary end point(s)
    Secondary Endpoints:
    • Durable Response Rate (DRR), defined as the percentage of patients having a RECIST v1.1 response lasting ≥ 6 months.
    • Duration of Response (DoR), defined as the time from an initial objective response (CR or PR) according to RECIST v1.1 until disease progression or death due to any cause.
    • Disease Control Rate (DCR), defined as the proportion of patients with either an objective response (CR, PR) or stable disease (SD) according to RECIST v1.1.
    • Durable Disease Control Rate (dDCR), defined as the percentage of patients having a RECIST v1.1 disease control lasting ≥ 6 months.
    • Best Overall response (BOR), defined as the best response (PD, SD, PR, CR) according to RECIST v1.1 over the course of a patient’s participation in the study, assessed up to 2 years.
    • Progression Free Survival (PFS), defined as the time from first dosing (Day +1) to the date of PD or death from any cause (whichever comes first).
    • PFS Rate, defined as the percentage of patients without PD at 6 and 12 months after first administration of study drug.
    • Overall Survival (OS), defined as the time from the first administration of study medication until death due to any cause.
    • OS Rate, defined as the percentage of patients alive at 6 and at 12 months after first administration of study drug.
    • Safety and Tolerability of the study medication (determined by number, frequency, duration and severity of AEs using CTCAE v5.0, physical examination, laboratory tests, vital signs, and ECGs).
    • Health related Quality of Life (HrQoL).
    • Pharmacokinetics of domatinostat and avelumab.
    • Avelumab anti-drug antibodies (ADA).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy: for the first approximately 6 months imaging will be done every 8 weeks; thereafter the imaging interval will increase to every 12 weeks.
    Safety: During the regular study visits safety and tolerability assessments will be done.
    A full physical examination will be performed at screening, every 8 weeks until week 24 (i.e. weeks 8, 16, 24), every 12 weeks thereafter (i.e. weeks 36, 48, 60, 72, 84, 96) and at EOS Visit; brief physical examinations will be performed at all other visits.
    PK: Blood sampling for PK analysis will be performed on Day 1 and weeks 2, 4, 8, 16, 24, 36 and 48
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    France
    Germany
    Italy
    Netherlands
    Spain
    Switzerland
    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
    Last visit last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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: 10
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 40
    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)
    After a subject has completed the trial or has been discontinued early, the patient will receive treatment according to standard of care and generally accepted medical practice, depending on the subject’s individual medical needs.
    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 Decision2020-06-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-25
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA