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    Summary
    EudraCT Number:2020-000505-80
    Sponsor's Protocol Code Number:BT-001.01
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-08-05
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2020-000505-80
    A.3Full title of the trial
    A phase I/IIa study of intra-tumoral BT-001 (TG6030) administered alone and in combination with pembrolizumab in patients with cutaneous or, subcutaneous lesions or easily injectable lymph nodes of metastatic/advanced solid tumors.
    Etude clinique de phase I/IIa évaluant des administrations intra-tumorales (IT) répétées de BT-001 (TG6030) seul ou en combinaison avec le pembrolizumab chez des patients présentant des lésions tumorales cutanées ou sous-cutanées ou des ganglions lymphatiques facilement injectables de tumeurs solides avancées ou métastatiques.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase I/IIa clinical study of BT-001 in the treatment of patients with
    metastatic or advanced solid cancer.
    Etude clinique de Phase I/IIa évaluant BT-001 chez des patients présentant des tumeurs solides avancées ou métastatiques.
    A.4.1Sponsor's protocol code numberBT-001.01
    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 SponsorTRANSGENE
    B.1.3.4CountryFrance
    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 supportTRANSGENE
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportBioInvent International AB (publ)
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTRANSGENE
    B.5.2Functional name of contact pointJulien ROMANETTO
    B.5.3 Address:
    B.5.3.1Street Address400, Boulevard Gonthier d'Andernach, CS80166
    B.5.3.2Town/ cityIllkirch Graffenstaden Cedex
    B.5.3.3Post code67405
    B.5.3.4CountryFrance
    B.5.4Telephone number+33388279218
    B.5.5Fax number+33388279241
    B.5.6E-mailromanetto@transgene.fr
    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 BT-001
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntratumoral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot yet defined
    D.3.9.2Current sponsor codeBT-001
    D.3.9.3Other descriptive nameInfectious particle containing sequences coding for the human GM-CSF cytokine and for 4-E03 human anti CTLA-4 monoclonal antibody
    D.3.10 Strength
    D.3.10.1Concentration unit PFU/ml plaque forming unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100000000
    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) 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) 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 Yes
    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 Keytruda (pembrolizumab)
    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 namePembrolizumab
    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 namePembrolizumab
    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
    Phase I: Advanced or metastatic Soft Tissue Sarcoma, Merkel Cell Carcinoma, Melanoma, Triple Negative Breast Cancer, Non Smal Cell Lung Cancer
    Phase IIa: Soft Tissue Sarcoma, Merkel Cell Carcinoma, Melanoma, Triple Negative Breast Cancer, Non Smal Cell Lung Cancer
    Phase I: Tumeurs solides avancées ou métastatiques incluant les sarcomes des tissus mous, carcinome à cellules de Merkel, mélanome, cancer du sein triple négatif ou cancer du poumon non à petites cellules
    Phase IIa: Sarcomes des tissus mous, carcinome à cellules de Merkel, mélanome, cancer du sein triple négatif ou cancer du poumon non à petites cellules
    E.1.1.1Medical condition in easily understood language
    Advanced or metastatic solid tumors
    Tumeurs solides avancées ou métastatiques
    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 10065252
    E.1.2Term Solid tumor
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    _ Phase I PartA: Assess the local and systemic safety and tolerability of BT-001 as a single agent in repeated IT administrations of 1 to 4 mL at 1x10E+06 to 1x10E+08 PFU/mL, determine the Maximum Tolerated Dose (MTD), if any, within this dose range, and determine the Maximum Feasible Dose (MFD) in patients with metastatic/advanced solid tumors.
    _ Phase I Part B: Assess the local and systemic safety and tolerability of BT-001 in repeated IT administrations at the Recommended Dose for Part B (RDPB) of 1 to 4 mL in combination with IV infusions of pembrolizumab in patients with metastatic/advanced solid tumors.
    _ Phase IIa: Evaluate the antitumor activity of BT-001 in repeated IT administrations in combination with IV infusions of pembrolizumab in patients with metastatic/advanced Soft Tissue Sarcoma (STS), Merkel Cell Carcinoma (MCC), Melanoma, Non Small Cell Lung Cancer (NSCLC) or Triple negative Breast Cancer (TNBC) using iRECIST
    _ Phase I, Partie A: Evaluer la sécurité d’emploi et la tolérance, locale et systémique, d’administrations IT répétées, de 1 à 4 mL de BT-001, à des doses de 1×10E6 à 1×10E8 UFP/mL, en monothérapie ; déterminer la Dose Maximale Tolérée (DMT), le cas échéant, dans cet intervalle de dose et déterminer la dose maximale atteignable chez des patients porteurs de tumeurs solides avancées ou métastatiques.
    _ Phase I, Partie B: Evaluer la sécurité d’emploi et la tolérance, locale et systémique, d’administrations IT répétées, de 1 à 4 mL de BT-001, à la DRPB, en combinaison avec des perfusions IV de pembrolizumab chez des patients porteurs de tumeurs solides avancées ou métastatiques.
    _ Phase IIa: Evaluer l’activité antitumorale d’administrations IT répétées de BT-001 en combinaison avec des perfusions IV de pembrolizumab chez des patients porteurs de STM, de CCM, de mélanome, de cancer du sein triple négatif ou de CPNPC avancés ou métastatiques en utilisant iRECIST.
    E.2.2Secondary objectives of the trial
    _ Evaluate tumor response of injected and non-injected lesions using RECIST version 1.1 [applicable to Phase I and Phase IIa] and iRECIST [applicable to Phase I only] (including clinical evaluation for superficial lesions);
    _ Assess the local and systemic safety and tolerability of BT-001 in repeated IT administrations in combination with IV infusions of pembrolizumab [only applicable to Phase IIa]
    _ Assess BT-001 blood pharmacokinetics;
    _ Monitor GM-CSF and anti-CTLA-4 mAb (4-E03 mAb) concentrations in the blood and in injected lesions;
    _ Assess immunogenicity by detecting anti-Vaccinia NAbs and antibodies anti-CTLA-4 mAb (anti-4-E03 mAb) in the blood;
    _ Assess immune changes in the tumor microenvironment for injected and, whenever possible, non-injected lesions;
    _ Perform BT-001 viral shedding analyses.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    I1. Signed informed consent in accordance to ICH-GCP and national/local regulation
    I2. Male or female patient aged ≥ 18 years
    I3. At least 1 injectable measurable cutaneous, subcutaneous or nodal lesion measuring between 25 and 50mm in longest diameter and whenever possible 1 distant non-injected measurable lesion
    I4. Expected survival of at least 3 months
    I5. Knowledge of his/her anti-variola vaccine status
    I6. Provide a fresh tumor sample at baseline and be willing to supply new tumor samples from a biopsy during treatment.
    I7. ECOG performance status of 0 or 1
    I8. Interval of at least 3 weeks between first study drug injection and exposure to prior chemotherapy; 4 weeks for immunotherapy and antibody-based therapy and 2 weeks for palliative radiotherapy
    I9. Adequate hematological, hepatic and renal functions:
    ­ Haemoglobin ≥ 9 g/dL (without packed red blood cell transfusion within the prior 2 weeks)
    ­ Neutrophils ≥ 1 x10E+9/L
    ­ Lymphocytes ≥ 0.750 x 10E+9/L
    ­ ­Platelets ≥ 100 x10E+9/L
    ­ Alanine aminotransferase (ALT) and aspartate aminotransferase [AST]) ≤ 3 x ULN; total bilirubin ≤ 1.5 x ULN except for patients with Gilbert’s syndrome who may be included if total bilirubin ≤ 2.5 x ULN
    ­ Lactate deshydrogenase ≤ 3 x ULN
    ­ Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60 mL/min according to Cockroft & Gault formula
    ­ International normalized ratio (INR) ≤ 1.5
    I10. Appropriate precaution against pregnancy whilst on study:
    - Women of childbearing potential (WOCBP) potential must have a negative pregnancy test prior to study entry.
    - Both men and WOCBP must be using a highly effective contraception method combined with a barrier method (e.g. condom) during BT-001 treatment period and for a minimum of 4 months following the last administration of BT-001

    For patients included in Phase I (parts A and B):
    IA-1 Have histologically confirmed, advanced/metastatic sarcoma (soft tissue and bone), MCC, melanoma, TNBC or NSCLC, with cutaneous or, palpable subcutaneous lesions or easily injectable lymph nodes
    IB-1 Patients who have failed and/or are intolerant to standard therapeutic options.

    For patient included in Phase IIa:
    IC- Soft Tissue Sarcoma (STS) Cohort:
    IC-1 Have a histologically confirmed metastatic and/or locally advanced inoperable undifferentiated pleomorphic sarcoma/myxofibrosarcoma, cutaneous angiosarcoma, dedifferentiated liposarcoma or leiomyosarcoma.
    IC-2 Have at least 1 injectable cutaneous or, palpable subcutaneous soft tissue or nodal lesion ≥ 20 mm in longest diameter.
    IC-3 Have at least one prior line of systemic therapy. A naive patient may be enrolled if they have refused standard systemic treatment. Prior adjuvant therapy will not count if it was completed more than 6 months previously.
    ID- Merkel Cell Carcinoma (MCC):
    ID-1 Have histologically confirmed stage IV MCC.
    ID-2 Have received at least 1 line of treatment for metastatic MCC and have progressed after the most recent line of treatment.
    IE- Melanoma:
    IE-1. Have pathologically confirmed metastatic or unresectable stage IIIb/c of IV melanoma with at least one cutaneous or, subcutaneous tumor or palpable lymph node amenable to IT injection.
    IE-2. Have had prior treatment with anti-PD-1 or anti-PD-L1 agents and have documented disease progression on these agents prior to registration; patient who have progressed after adjuvant anti-PD1/L1 agents are eligible.
    IE-3. Have failed and/or are intolerant to anti-CTLA-4 in combination with anti-PD-1, or anti-PD-L1, and have received therapy targeting BRAF or MEK when appropriate.
    IE-4. Do not have disease that is suitable for local therapy with curative intent.
    IE-5. Have not received previous treatment with talimogene laherparepvec in combination with pembrolizumab.
    IF- Triple Negative Breast Cancer (TNBC):
    IF-1 Have metastatic or locally advanced, histologically confirmed TNBC characterized by absence of human epidermal growth factor 2, estrogen receptor, and progesterone receptor expression.
    IF-2. Have at least one systemic treatment for metastatic breast cancer; prior treatment must include an anthracycline and a taxane in the neoadjuvant, adjuvant, or metastatic setting.
    IF-3. Have documented disease progression on or after the most recent therapy.
    IG- Non-Small Cell Lung Cancer (NSCLC):
    IG-1. Have histologically confirmed NSCLC, stage IIIb-IV or delayed relapse of any stage not amenable to surgery or RT with curative intent.
    IG-2. Have had prior treatment with anti-PD-1 or anti-PD-L1 agents and have documented disease progression on these agents prior to registration and one prior systemic treatment including chemotherapy; patients who have progressed after receiving anti-PD1 / L1 in a previous line are eligible.
    IG-3. Must have no EGFR, ALK or BRAF positive tumor mutations or ROS1 reaarangement.
    E.4Principal exclusion criteria
    E1 Have a tumor adjacent to the trachea or a major blood vessel for planned injection.
    E2 Have had major surgery within 4 weeks of first study drug administration.
    E3 Have received prior treatment with a vaccinia oncolytic virus.
    E4 Have known significant immunodeficiency due to underlying illness (e.g., HIV/AIDS) and/or immune-suppressive medication including systemic corticosteroids.
    E5 Have received antiviral therapy active on vaccinia virus (VV), e.g., ribavirin, interferon/pegylated interferon.
    E6 Have a history of severe exfoliative skin conditions (e.g., eczema or atopic dermatitis) requiring systemic therapy for more than 4 weeks within 2 years prior to BT-001 initiation.
    E7 Have uncontrolled intercurrent illness including but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social circumstances that could limit compliance with study requirements.
    E8 Have had a Grade ≥ 3 auto-immune manifestations of previous ICIs (e.g., anti-PD-1, anti-PDL1, anti-CTLA-4, or another immune checkpoint targeting agent under investigation).
    E9 Have received treatment with another investigational agent within 21 days before the inclusion.
    E10 Taken an anticoagulant medication that cannot be interrupted prior to IT injections.
    E11 Have active brain metastasis (stable and treated metastasis are accepted).
    E12 Have had any organ transplantation, including allogenic stem cell or bone marrow transplantation.
    E13 Have known hypersensitivity to egg or to any excipients of BT-001.
    E14 Have had any positive test for hepatitis C virus (HCV) or hepatitis B virus (HBV) indicating acute or chronic infection.
    E15 Are pregnant or a breastfeeding woman, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 10 mIU/mL).
    E16 Have any medical, familial, sociological or psychiatric condition that in the opinion of the investigator would prohibit inclusion in the trial.
    E17 Patients who have received or receiving any live vaccine during the period of 28 days before IMP(s) administration, during IMP’s administrations and 28 days after the last IMP’s administration.
    E18 Have a history of myocarditis or congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), uncontrolled infection, or myocardial infarction 6 months prior to clinical trial entry.
    E19 Have an active interstitial lung disease (ILD)/pneumonitis or a history of ILD/pneumonitis requiring treatment with systemic steroids

    For patients included in Phase I, Part B and IIa only:
    EB-1. Patient with an active known or suspected auto-immune disease. Patient with type I diabetes or hypothyroidism only requiring hormone replacement are permitted to enroll.
    EB-2. Have known hypersensitivity to the active substance or to any of the excipients of pembrolizumab.
    E.5 End points
    E.5.1Primary end point(s)
    Phase I:
    Safety and tolerability: Overall incidence of AEs (including SAEs), patients discontinuing study due to AEs, DLTs, changes in standard laboratory parameters and vital signs evaluated according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0.

    Phase IIa:
    Overall Response Rate (ORR) for injected and non-injected lesions according to Immune RECIST (iRECIST
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase I:
    Safety and tolerability assessment at baseline visit and visits on days 1, 2, 3, 8, 15, 22, 29, 36, 43, 64, 71; 85, then every 8 weeks, at end of study visit and at safety follow-up visit.

    Phase IIa:
    Clinical response assessment for ORR will be evaluated by clinical exam at visits on days 1, 8, 15, 22, 29, 43, 64, 85 and then every 8 weeks and by imaging exams at visits on days 1, 43, 85 and then every 8 weeks
    E.5.2Secondary end point(s)
    _ Tumor response: Overall Response Rate (ORR) injected and non-injected lesions using RECIST 1.1 [applicable to Phase I and Phase IIa] and iRECIST [applicable to Phase I only];
    _ Safety and tolerability : Overall incidence of AEs (including SAEs), evaluated according to NCI-CTCAE version 5.0 [only applicable to Phase IIa]
    _ Pharmacokinetics: Virus, GM-CSF and anti-CTLA-4 mAb concentrations over time in the blood and in injected lesions
    _ Immunogenicity: Anti-Vaccinia NAbs and antibodies anti-CTLA-4 mAb titers over time in injected lesions
    _ Viral shedding: Virus concentration in skin swabs, saliva, urine and feces samples
    E.5.2.1Timepoint(s) of evaluation of this end point
    _ Safety and tolerability: Same timepoints as in section E.5.1.1
    _ Clinical response assessment for ORR: Same timepoints as in section E.5.1.1
    _ PK and PD parameters through serial peripheral blood assays at baseline visit and visits on days 1, 2, 3, 5, 8, 15, 22, 29, 36, 43, 44, 45, 64 and through biopsies analysis collected at baseline visit and visits on days 5, 22 in Phase I, part A or at baseline visit and visits on day 64 / end of study visit in Phase I, Part B and Phase IIa
    _ Neutralizing antibodies titers assayed at baseline visit and visits on Days 8, 22, 36, 64.
    _ Tumor microenvironment immune changes: Tumor biopsies collected at baseline visit and visits on days 5, 22
    _ Virus concentrations in samples collected (skin swabs, saliva, urine and feces) on days 2, 8, 15, 43, 64.
    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 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) 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 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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    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 months3
    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 months3
    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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state39
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 258
    F.4.2.2In the whole clinical trial 258
    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)
    No specific plan out of expected normal treatment care for participating patient after the subject has ended the participation in the trial.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-03
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
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