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    Summary
    EudraCT Number:2018-004321-86
    Sponsor's Protocol Code Number:RN5609C00
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-10-10
    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 number2018-004321-86
    A.3Full title of the trial
    First-in-human, dose titration and expansion trial to evaluate safety, immunogenicity and preliminary efficacy of W_pro1 (BNT112) monotherapy
    and in combination with cemiplimab in patients with prostate cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    First in human evaluation of the BNT112 cancer vaccine in patients that have been diagnosed with metastatic prostate cancer that is resistant to androgen depletion therapy, and in patients with newly diagnosed localized prostate cancer (LPC) before the surgical removal of the prostate. LPC patients will additionally be treated with hormonal treatment (Goserelin Acetate). All patients will be treated with either BNT112 alone or with BNT112 and an immune system modulating agent (Cemiplimab).
    A.3.2Name or abbreviated title of the trial where available
    PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy)
    A.4.1Sponsor's protocol code numberRN5609C00
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04382898
    A.5.4Other Identifiers
    Name:INDNumber:26912
    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 SponsorBioNTech SE
    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 supportBioNTech SE
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBioNTech SE
    B.5.2Functional name of contact pointClinical Study Manager
    B.5.3 Address:
    B.5.3.1Street AddressAn der Goldgrube 12
    B.5.3.2Town/ cityMainz
    B.5.3.3Post code55131
    B.5.3.4CountryGermany
    B.5.4Telephone number0049613190840
    B.5.5Fax number004961319084392010
    B.5.6E-mailPRO-MERIT@biontech.de
    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 nameBNT112 / W_pro1
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRBL038.1
    D.3.9.2Current sponsor codeRBL038.1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.22 to 0.28
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRBL039.1
    D.3.9.2Current sponsor codeRBL039.1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.22 to 0.28
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRBL040.1
    D.3.9.2Current sponsor codeRBL040.1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.22 to 0.28
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRBL041.1
    D.3.9.2Current sponsor codeRBL041.1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.22 to 0.28
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRBL045.1
    D.3.9.2Current sponsor codeRBL045.1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.22 to 0.28
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    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) Yes
    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 Yes
    D.2.1.1.1Trade name LIBTAYO
    D.2.1.1.2Name of the Marketing Authorisation holderRegeneron Pharmaceuticals, Inc.
    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 nameCemiplimab
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCEMIPLIMAB
    D.3.9.1CAS number 1801342-60-8
    D.3.9.3Other descriptive nameLIBTAYO, Cemiplimab-rwlc, REGN2810, NDC 61755-008-01
    D.3.9.4EV Substance CodeSUB189482
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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
    Male adults with prostate cancer, both mCRPC (Arms 1A & 1B) and LPC (ARms 2&3) patients, will be treated with BNT112 alone or in combination with cemiplimab. LPC patients will also receive neo-adjuvant goserelin acetate therapy addition to BNT112 with or without Cemiplimab.
    E.1.1.1Medical condition in easily understood language
    Prostate cancer (PC) spread beyond the prostate gland and is resistant to hormone therapy and newly diagnosed high-risk localised prostate cancer (LPC) which has not spread beyond the gland.
    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 PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10007113
    E.1.2Term Cancer of prostate
    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
    PRIMARY OBJECTIVE
    For Part 1 and Part 2: Assess safety and tolerability profile of BNT112 monotherapy or in combination with cemiplimab

    For Part 2 Arms 1A and 1B: Evaluate preliminary antitumor activity of BNT112 monotherapy and in combination with cemiplimab in patients with metastatic castration-resistant prostate cancer (mCRPC) based on ORR

    E.2.2Secondary objectives of the trial
    Evaluate anti-tumor activity based on levels of prostate specific antigen (PSA)

    (Part 1) Evaluate preliminary anti-tumor activity of BNT112 monotherapy in patients with mCRPC based on ORR.

    Evaluate preliminary anti-tumor activity of BNT112 monotherapy or in combination with cemiplimab in patients with newly diagnosed localised prostate cancer (LPC)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Main INCLUSION criteria for ALL patients
    • Patient must be male and aged ≥ 18 years
    • Patient must have histologically confirmed prostate adenocarcinoma.
    • Patients or their legally authorized representative (if applicable) must sign an informed consent form (ICF) indicating that they understand the purpose of the procedures required for the trial and are willing to participate.
    • Patient must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
    • Patient must have adequate organ and bone marrow function.
    • Patients who are sexually active with a woman of childbearing potential must agree to use a condom with spermicidal foam/gel/film/cream/suppository in addition to at least one form of highly effective contraception used by the patient or their partner (for details, see Section 10.4) during the trial starting after signing the ICF and for 90 days after receiving the last dose of BNT112 OR for 6 months after receiving the last dose of cemiplimab.
    • Patients should not donate sperm during the trial starting after signing the ICF and for 90 days after receiving the last dose of BNT112 OR for 6 months after receiving the last dose of cemiplimab.

    Main SPECIFIC INCLUSION criteria for mCRPC patients (Part 1 and Part 2 Arms 1A and 1B)
    • Patients must have histologically confirmed mCRPC and have progressed after at least 2 but no more than 3 lines of life-prolonging systemic therapy (e.g., abiraterone or enzalutamide, docetaxel, cabazitaxel) or cannot tolerate or have refused any of these therapies. These lines of therapy include life-prolonging therapies administered in the metastatic hormone-sensitive setting.
    • Prior surgical or chemical castration with a serum testosterone < 1.7 nmol/L (50 ng/dL).
    • Patients must have documented mCRPC progression within 6 months prior to screening (assuming no subsequent change in treatments), as determined by the investigator, by means of 1 or more of the following:
    - PSA progression as defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each assessment where the PSA value at screening should be > 2 ng/mL.
    - Two rises out of 3 PSA sequential tests separated by at least 1 week also satisfies the criteria for baseline progression providing a new nadir is not established (i.e., upward trend)
    - Radiographic disease progression in soft tissue based on modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) with or without PSA progression.
    - Radiographic disease progression in soft tissue based on modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) with or without PSA progression.
    - Radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression.
    • Patients must have adequate liver function
    • Patients must agree to provide an archival pre-treatment formalin-fixed, paraffin-embedded tumor sample if available.

    Main SPECIFIC INCLUSION criteria for newly diagnosed LPC patients (Part 2 Arms 2 and 3)
    • Treatment-naïve patients with LPC (i.e., N0, M0). According to risk levels of the European Association of Urology Guidelines on Prostate Cancer (2018)24 and in line with the U.S. National Comprehensive Cancer Network (NCCN 2020), patients must have at least one of the following:
    - PSA > 20 ng/mL or
    - Gleason Score > 7 or
    - Localized stage ≥cT2c, N0, M0 according to tumor, node, metastasis (TNM) classification
    • Patients who intend to have and are suitable for a radical prostatectomy.
    • Patients must have adequate liver function
    • Patients must agree to provide tumor sample(s) from pre-treatment diagnostic biopsy and planned post-treatment surgery.
    • Patients must be eligible for up to 6 months of ADT treatment before prostatectomy.
    E.4Principal exclusion criteria
    Main exclusion criteria for ALL patients
    • Patient has uncontrolled intercurrent illness, including but not limited to:
    - Ongoing or active infection which requires systemic treatment with antibiotics or corticoid therapy within 14 days before the first dose of IMP.
    - Symptomatic congestive heart failure (NYHA Grade III or IV), myocardial infarction within 3 months before screening, unstable angina pectoris, or cardiac arrhythmia.
    - Known recent history (in the past 5 years) or presence of significant pulmonary conditions.
    - Uncontrolled hypertension defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg, despite optimal medical management.
    - Known primary immunodeficiencies, either cellular or combined T- and B-cell immunodeficiencies.
    - Ongoing or recent evidence (within the past year) of significant autoimmune disease that required treatment with systemic immunosuppressive treatments which may suggest risk for immune-related AEs.
    - Non-healing wound, skin ulcer (of any grade), or bone fracture.
    - Patients with prior allogeneic stem cell or solid organ transplantation.
    - Patients with the risk factors for bowel perforation.
    - Patients with uncontrolled Type 1 diabetes mellitus.
    - Patients with uncontrolled adrenal insufficiency.
    - Any other disease, metabolic dysfunction, physical examination finding and/or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or may render the patient at high-risk for treatment of complications.
    • Patients with a known history or current malignancy other than the inclusion diagnosis.
    • Patients who have had a splenectomy.
    • Patients who have had a major surgery (e.g., requiring general anesthesia) within 4 weeks before screening, or have not have fully recovered from surgery, or have a surgery planned during the time of trial participation, except for the radical prostatectomy planned for patients in Part 2 Arms 2 and 3.
    •Patients with a known history of any of the following:
    a. HIV 1 or 2
    b. Hepatitis B
    c. Hepatitis C
    • Patients with a known allergy, hypersensitivity, or intolerance to BNT112 or its excipients (all patients in Parts 1 and 2), cemiplimab or its excipients (patients in Part 2 Arm 1A, Arm 1B switch-over patients, and Arm 2 only), or to ADT (e.g., goserelin)or its excipients (patients in Part 2 Arms 2 and 3 only).
    • Patients with any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments.
    • In situations where trial patients are not legally competent to provide consent (e.g. mentally incapacitated), these patients are not allowed to enter the trial.

    Prior/Concomitant Therapy
    •Patients who have received or currently receive the following therapy/treatment:
    a. Chronic systemic immunosuppressive corticosteroid treatment (prednisone >5 mg daily PO or IV, or equivalent) during the trial.
    b. Prior treatment with other immune modulating agents under conditions set in the Protocol.
    c. Prior treatment with live attenuated vaccines within 4 weeks before the first dose of IMP and during treatment with IMP.
    d. Prior treatment with an investigational drug within 4 weeks or 5 half-lives of the agent (whichever is longer) before the planned first dose of IMP.
    e. Therapeutic PO or IV antibiotics within 14 days prior to enrollment.
    f. Concurrent use of herbal products that may decrease PSA levels
    • Patients who have previously been enrolled in this trial.
    • Patients affiliated with the investigational site
    Specific exclusion criteria for mCRPC patients (Part 1 and Part 2 Arm 1A and 1B)
    • Patients with toxicities from previous anti-cancer therapies that have not resolved to baseline levels or to Grade ≤1 according to NCI CTCAE v5.0 with the exception of alopecia, anorexia, vitiligo, fatigue, hyperthyroidism, hypothyroidism, and peripheral neuropathy. Anorexia, hyperthyroidism, hypothyroidism, and peripheral neuropathy must have recovered to Grade ≤2.
    • Patients with clinically active brain metastases.
    • Patients who have received or currently receive the following anti-cancer therapy/agent:
    a. Prior radiation therapy with curative intent within 14 days before the first dose of IMP.
    b. Prior treatment with an anti-cancer agent (within 4 weeks or for systemic therapies after at least 5 half-lives of the drug (whichever is longer) before the first dose of IMP.
    c. Prior treatment with anti-cancer immunomodulating agents, such as blockers of PD-1, PD-L1, TNRSF9, 4-1BB, CD137, OX-40, therapeutic vaccines, cytokine treatments or any investigational agent within 4 weeks or 5 half-lives (whichever is longer) before the first dose of IMP

    Specific exclusion criteria for LPC patients (Part 2 Arms 2 and 3)
    • Patients who are expected to be unable to undergo an mpMRI or MRI.
    E.5 End points
    E.5.1Primary end point(s)
    For Part 1 and Part 2:
    • Occurrence of dose-limiting toxicities (DLTs)
    • Occurrence of TEAEs reported by relationship, grade, and seriousness according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

    For Part 2 Arms 1A and 1B:
    • ORR, defined as the number of patients with a complete response (CR) or partial response (PR) per Prostate Cancer Working Group 3 (PCWG3) as determined by the investigator as best objective response divided by the number of patients in the analysis set.
    E.5.1.1Timepoint(s) of evaluation of this end point
    • DLTs of BNT112 will be continuously monitored during the first treatment cycle (21 days [28 days]) in the Dose Titration Part of Part 1 Arm 1 (mCRPC), and
    • AEs will be continuously monitored from the moment that patient signs the general informed consent form for trial participation up to the end of the safety follow-up period (30 days for Arm 1A&1B + Arm 3, 90 days for Arm 2).
    E.5.2Secondary end point(s)
    • PSA decline of 0 to 25%, >25% to 50%, and >50% compared to baseline.
    • PSA doubling time (PSADT) post-treatment on C4D1 and D1 of every fourth subsequent cycle (e.g., C8D1, C12D1, etc.) in Part 1 and Part 2 Arm 1A and 1B, or on C4D1, C8D1, and EoT in Part 2 Arms 2 and 3 compared to baseline.
    • PSA decline of ≥50% (according to the PCWG3).
    • ORR, defined as the number of patients with a CR or PR per PCWG329 as determined by the investigator as best objective response divided by the number of patients in the analysis set.
    • Tumor response post-treatment compared to baseline.
    E.5.2.1Timepoint(s) of evaluation of this end point
    See description of endpoints
    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 No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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 Yes
    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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    United Kingdom
    United States
    Germany
    Hungary
    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
    LPLV
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 115
    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)
    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 Decision2020-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2024-01-23
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