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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   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).

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    Summary
    EudraCT Number:2018-003959-37
    Sponsor's Protocol Code Number:NC-6004-009
    National Competent Authority:Croatia - MIZ
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-12-11
    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 ConcernedCroatia - MIZ
    A.2EudraCT number2018-003959-37
    A.3Full title of the trial
    Phase IIa/IIb Clinical Trial of NC-6004 in Combination with Pembrolizumab in Subjects with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Who Have Failed Platinum or a Platinum-containing Regimen
    Kliničko ispitivanje Faze IIa/IIb sa NC-6004 u kombinaciji sa pembrolizumabom kod ispitanika sa rekurentnim ili metastatskim karcinomom skvamoznih stanica glave i vrata koji nisu reagirali na platinu ili terapiju koja sadrži platinu
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial for patients with serious head and neck cancer
    A.4.1Sponsor's protocol code numberNC-6004-009
    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 SponsorNanoCarrier Co, Ltd.
    B.1.3.4CountryJapan
    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 supportNanoCarrier Co, Ltd
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNanoCarrier Co, Ltd.
    B.5.2Functional name of contact pointStudy Director
    B.5.3 Address:
    B.5.3.1Street Address144-15 Chuo Gaiku, 226-39 Wakashiba
    B.5.3.2Town/ cityKashiwa, Chiba
    B.5.3.3Post code277-0871
    B.5.3.4CountryJapan
    B.5.4Telephone number+813-3241-0551
    B.5.5Fax number+813-3241-0554
    B.5.6E-mailosada@nanocarrier.co.jp
    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 NC-6004
    D.3.4Pharmaceutical form 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 INNCISPLATIN
    D.3.9.1CAS number 1009838-50-9
    D.3.9.2Current sponsor codeNC-6004
    D.3.9.3Other descriptive nameCisplatin-PEG-pGlu
    D.3.9.4EV Substance CodeSUB07483MIG
    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 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 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 KEYTRUDA
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme 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 nameKEYTRUDA
    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 INNPembrolizumab
    D.3.9.3Other descriptive nameNot applicable
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 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 KEYTRUDA
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme 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 nameKEYTRUDA
    D.3.4Pharmaceutical form Powder for 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 INNPembrolizumab
    D.3.9.3Other descriptive nameNot applicable
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.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
    Head and neck squamous cell carcinoma (HNSCC)
    E.1.1.1Medical condition in easily understood language
    Head and neck cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10060121
    E.1.2Term Squamous cell carcinoma of head and neck
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1(Phase IIa):
    To assess dose-limiting toxicities (DLTs), and to determine the optimal dose in order to establish the recommended Phase IIb (RPIIb) dose for the combination of NC-6004 plus pembrolizumab.

    Part 2 (Phase IIb):
    To compare progression-free survival (PFS) between NC-6004 plus pembrolizumab and pembrolizumab alone.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of NC-6004 when combined with pembrolizumab.
    To compare OS between NC-6004 plus pembrolizumab and pembrolizumab alone.
    To compare tumor response between NC-6004 plus pembrolizumab and pembrolizumab alone.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each subject must meet all of the following criteria to be enrolled in this study:
    1. Be willing and able to provide written informed consent for the trial.
    2. Males or females aged ≥18 years at screening.
    3. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
    4. Have histologically- or cytologically-confirmed HNSCC.
    5. Have recurrent disease not amenable to curative treatment with local or systemic therapy, or metastatic (disseminated) HNSCC of the oral cavity, oropharynx, hypopharynx, or larynx that is considered incurable by local therapies.
    6. Must have received ≥150 mg/m2 of a total dose of cisplatin or 2 cycles of carboplatin AUC5 (maximum carboplatin dose per cycle 750mg).
    7. Prior platinum failure as defined by:
    a. Disease progression confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) scans using RECIST 1.1 criteria at any time during or after treatment with a platinum agent or a platinum-containing regimen for recurrent/metastatic disease.
    b. Recurrence/progression confirmed by CT or MRI imaging scans using RECIST 1.1 criteria <6 months of prior modal therapy using a platinum agent or a platinum-containing regimen for locally advanced setting.
    c. Recurrence/progression ≥6 months of prior modal therapy in locally advanced HNSCC can be accepted only if subjects have received a further platinum-containing regimen for recurrent and metastatic stage of disease and have progressed during or after this regimen.
    8. Have a life expectancy of >3 months.
    9. Have radiographically measurable disease based on RECIST 1.1.
    10. Have adequate bone marrow reserve, defined as:
    a. Absolute neutrophil count ≥ 1.5 × 109/L;
    b. Platelet count ≥100 × 109/L; and
    c. Hemoglobin ≥10 g/dL (transfusion is allowed to achieve ≥10 g/dL).
    11. Have adequate liver function, defined as:
    a. Total serum bilirubin ≤1.5 × the upper limit of normal (ULN) or ≤2 × ULN in the cases of subjects with documented hepatic metastasis;
    b. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.0 × ULN or <5.0 × ULN in the cases of subjects with documented hepatic metastasis;
    c. Serum albumin ≥3.5 g/dL.
    12. Have prothrombin time within normal limits.
    13. Have adequate renal function, using the Cockcroft method: Glomerular filtration rate ≥ 60 mL/min.
    14. Have results from central laboratory testing of HPV (defined as p16 IHC testing using CINtec p16 Histology assay and a 70% cutoff point).
    Note: HPV stratification will be performed in subjects with oropharynx cancer. Oral cavity, hypopharynx, and larynx cancer are not required to undergo HPV testing by the central laboratory.
    15. Have provided tissue for PD-L1 biomarker analysis from a newly obtained core, excisional biopsy or an archived specimen. Repeat samples may be required if adequate tissue is not provided or for indeterminate results.
    Note: If emerging data indicate a high concordance in PD-L1 expression scores between newly obtained and archival samples, archived samples may be acceptable.
    16. Female subjects of childbearing potential should have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication. A urine test can be considered if a serum test is not appropriate.
    17. Female subjects of childbearing potential must be willing to use 2 methods of birth control or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study therapy according to local standard of care.
    Note: Abstinence is acceptable if this is the established and preferred contraception for the subject.
    18. Male subjects must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy according to local standard of care.
    Note: Abstinence is acceptable if this is the established and preferred contraception for the subject.
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria will be excluded from the study:
    1. Subjects with carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary origination, squamous cell carcinoma that originates from the skin and salivary gland or paranasal sinus, non-squamous histology.
    2. Have disease that is suitable for locoregional treatment administered with curative intent or refuses curative intent.
    3. Have more than 15% body weight loss due to the underlying condition in the last 3 months from signing of informed consent in Part 1 of the study and from randomization in to Part 2.
    4. Are currently participating in or have participated in a study of an investigational agent or are using an investigational device within 4 weeks prior to the first dose of trial treatment.
    5. Have entered the follow-up phase of an investigational study may participate as long as it has been at least 4 weeks since the last dose of trial treatment with the previous investigational agent or device.
    6. Were previously treated with 3 or more lines of systemic therapies administered for recurrent and/or metastatic disease.
    7. Were diagnosed and/or treated additional malignancy within 5 years of randomization, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin, and/or curatively-resected in situ cervical and/or breast carcinoma.
    8. Have a diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
    9. Subjects with a condition requiring systematic treatment with corticosteroids (>10 mg daily prednisone equivalents) within 14 days prior to the first dose of study treatment.
    10. Have had prior anti-cancer treatment or radiation therapy within 4 weeks prior to study Day 1 or who have not recovered (i.e., ≤Grade 1 or at baseline) from AEs due to previously administered treatment more than 4 weeks earlier (i.e., monoclonal antibody [mAb], cetuximab, or any other cytotoxic drugs). (Subjects with ≤Grade 2 alopecia are an exception to this criterion and may qualify for the study.)
    11. Had a prior allogenic organ or tissue transplant.
    12. Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
    13. Have peripheral sensory neuropathies (including hearing loss) and motor neuropathies ≥Grade 2, in the opinion of the Investigator.
    14. Have uncontrolled hypertension, defined as systolic blood pressure >180 mmHg and/or diastolic blood pressure >130 mmHg under resting conditions.
    15. Have experienced any of the following within the 6-month period prior to screening: unstable angina pectoris, cerebrovascular accident, transient ischemic attack, uncontrolled congestive heart failure (New York Heart Association >Class II) (Appendix 8) cardiac failure with known ejection fraction less than 40%, or cardiac arrhythmia (subjects with well-controlled cardiac arrhythmia on stable doses of medication are permitted).
    16. Have an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo, diabetes Type I, or resolved childhood asthma/atopy would be an exception to this rule. Subjects who require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study. Subjects with hypothyroidism that is stable on hormone replacement or Sjøgren’s syndrome will not be excluded from the study.
    17. Have active, non-infectious pneumonitis or prior pneumonitis requiring systemic corticosteroid therapy or an interstitial disease.
    18. Have hypersensitivity to the active substances (of either NC-6004 or pembrolizumab) or any of the excipients (e.g. L-histidine, polysorbate 80) or have a history of allergic reaction to prior platinum therapy.
    19. Have a history of severe hypersensitivity to another monoclonal antibody.
    20. Have a history of anaphylaxis as assessed by the Investigator.
    21. Have uncontrolled chronic obstructive pulmonary disease (COPD) or asthma.
    22. Have an active infection requiring systemic therapy.
    E.5 End points
    E.5.1Primary end point(s)
    - To establish the RPIIb dose.
    - To determine the PFS by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) in eligible subjects after treatment with NC-6004 plus pembrolizumab and pembrolizumab alone.
    E.5.1.1Timepoint(s) of evaluation of this end point
    RP2D will be determined in March 2019. PFS in PIIb portion will be available in March 2022.
    E.5.2Secondary end point(s)
    • Overall response rate (ORR)
    • Complete response (CR)/ Partial response (PR)
    • Stable disease (SD)
    • Duration of response (DOR)
    • Time to response (TTR)
    Pharmacokinetics endpoints:
    • Cmax (maximum concentration)
    • Tmax (time to maximum concentration)
    • AUC0-τ (area under the concentration-time curve from time zero to the end of the dosing interval)
    • AUC0-∞ (area under the concentration-time curve from time zero to infinity)
    • Rac (Accumulation Ratio)
    • λz (terminal elimination phase rate constant)
    • T½ (terminal half-life)
    • CL (clearance)
    • Vz (volume of distribution)
    • Vss (volume of distribution at steady-state)
    E.5.2.1Timepoint(s) of evaluation of this end point
    ORR will be assessed by performing study imaging every 6 weeks after the first dose of study treatment.
    Safety data as well as PK data of PIIa portion will be available in March 2019. OS or other efficacy data of PIIb will be available in March 2022.
    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 No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Croatia
    Czechia
    Hungary
    Poland
    Russian Federation
    Serbia
    Taiwan
    Ukraine
    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
    The end of the study is defined as 12 months following the start of treatment for the last subject in the study. A follow-up period for overall survival (OS) will continue for all remaining subjects for an additional 12 months.
    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 months4
    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 months4
    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: 41
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 95
    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 46
    F.4.2.2In the whole clinical trial 136
    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)
    Subjects will be treated as per local standard of care.
    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 Decision2020-12-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-06-30
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