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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7294   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:2018-003555-38
    Sponsor's Protocol Code Number:CP-MGC018-01
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-06-12
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2018-003555-38
    A.3Full title of the trial
    A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of MGC018 (Anti–B7-H3 Antibody Drug Conjugate) Alone and in Combination with MGA012 (Anti–PD-1 Antibody) in Patients with Advanced Solid Tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of MGC018 Alone and in Combination with MGA012 in Patients with Advanced Solid Tumors
    A.4.1Sponsor's protocol code numberCP-MGC018-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03729596
    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 SponsorMacroGenics, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMacroGenics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMacroGenics, Inc.
    B.5.2Functional name of contact pointPepi Pencheva
    B.5.3 Address:
    B.5.3.1Street Address9704 Medical Center Drive
    B.5.3.2Town/ cityRockville
    B.5.3.3Post codeMD 20850
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1240 5528088
    B.5.6E-mailpenchevap@macrogenics.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 nameMGC018
    D.3.2Product code NA
    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 INNNA
    D.3.9.2Current sponsor codeMGC018
    D.3.9.3Other descriptive nameMGC018
    D.3.9.4EV Substance CodeSUB197002
    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 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: 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 nameMGA012 (INCMGA00012)
    D.3.2Product code NA
    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 INNNA
    D.3.9.1CAS number 2079108-44-2
    D.3.9.2Current sponsor codeMGA012
    D.3.9.3Other descriptive nameINCMGA00012
    D.3.9.4EV Substance CodeSUB193740
    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.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
    Advanced Solid Tumors
    E.1.1.1Medical condition in easily understood language
    Advanced cancer disease
    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 10067821
    E.1.2Term Head and neck cancer
    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 10036921
    E.1.2Term Prostate carcinoma
    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 PT
    E.1.2Classification code 10075566
    E.1.2Term Triple negative breast cancer
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065147
    E.1.2Term Malignant solid tumor
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065252
    E.1.2Term Solid tumor
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    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 10040891
    E.1.2Term Skin melanoma
    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
    To characterize the safety, tolerability, dose-limiting toxicities (DLTs), and maximum tolerated dose (MTD) or maximum administered dose (MAD) (if no MTD is defined) for MGC018 administered as monotherapy or in combination with MGA012, each administered intravenously (IV), in participants who have relapsed/refractory, unresectable locally advanced or metastatic solid tumors.
    E.2.2Secondary objectives of the trial
    - To characterize the pharmacokinetics (PK) and immunogenicity of MGC018 alone and in combination with MGA012
    - To describe antitumor activity of MGC018 administered as monotherapy or in combination with MGA012 in participants with advanced solid tumors using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
    - To describe the radiographic progression free survival (rPFS) in mCRPC
    - To describe the prostate-specific antigen (PSA) response rate and best PSA percent change in mCRPC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability to provide informed consent and documentation of informed consent prior to initiation of any study-related tests or procedures that
    are not part of standard-of-care for the participant's disease. Participants must also be willing and able to comply with study procedures, including the acquisition of specified research specimens.
    2. Age ≥ 18 years old.
    3. Archival or FFPE tissue must be available for determination of B7-H3 (Module A) and B7-H3 and PD-L1 expression (Module B). Participants
    may undergo a fresh tumor biopsy to obtain a specimen for testing if a tumor sample is not available; mCRPC with bone only disease not amenable to fresh biopsy may be eligible in consultation with the sponsor.
    4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
    5. Life expectancy ≥ 12 weeks for Dose Escalation Phase and ≥ 24 weeks for Cohort Expansion Phase.
    6. Measurable disease as per RECIST v1.1 criteria. Participants with mCRPC without measurable disease may be enrolled. Cutaneous or
    subcutaneous lesions must be measurable by calipers. Note: Lesions to be used as measurable disease for the purpose of response assessment
    must not reside in a field that has been subjected to prior radiotherapy
    or.
    7. Tumor Histology Types
    Dose Escalation Phase of the Study:
    a) Participants with histologically proven, relapsed or refractory, unresectable locally advanced or metastatic solid tumors of any histology for whom no therapy with demonstrated clinical benefit is available.
    Cohort Expansion Module A:
    a) mCRPC that has progressed during or following one prior line of chemotherapy for metastatic disease, and if approved and available, no
    more than two prior lines of an anti-hormonal agent (e.g., abiraterone, enzalutamide) with a PSA value of at least 2 ng/mL and meeting at least
    one of the following:
    • Progression in measurable disease (RECIST v1.1).
    • Appearance of 2 or more new bone lesions according to Prostate Cancer Working Group 2 (PCWG2).
    • Rising PSA defined as at least two sequential rises in PSA (PSA obtained ≥ 1 week apart) over a reference value (the last PSA [PSA ≥ 2 ng/mL] measured before the first rise in PSA) (as defined by the PCWG2).
    b) NSCLC
    • Metastatic NSCLC who have failed standard cytotoxic, targeted, and biologic or checkpoint inhibitor therapy. No more than two prior lines of
    cytotoxic chemotherapy.
    c) TNBC
    • Locally advanced or metastatic TNBC that has progressed during or following at least one systemic therapy. American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines should be followed for establishing the diagnosis of TNBC.
    d) SCCHN that has progressed during or following at least one systemic therapy for metastatic or recurrent unresectable disease. No more than 2 prior lines of cytotoxic chemotherapy are allowed.
    e) Melanoma that has progressed during or following at least one systemic treatment for unresectable locally advanced or metastatic disease. Patients who are intolerant of or refused standard therapy are eligible.
    Cohort Expansion Module B:
    Participants with histologically proven, unresectable, locally advanced or metastatic solid tumors for whom no therapy with demonstrated clinical
    benefit is available as described below.
    a) SCCHN that has progressed following treatment with platinum-based chemotherapy for metastatic or recurrent disease, or progression of disease within 6 months of completing prior platinum therapy used as part of neoadjuvant, concurrent chemoradiation, or adjuvant therapy.
    - Participants with upper esophageal or salivary gland tumors will not be considered as SCCHN.
    - Participants who refuse radical resection for recurrent disease are eligible.
    b) mCRPC that has progressed during or following one prior line of chemotherapy for metastatic disease, and if approved and available, no
    more than two prior lines of anti-hormonal agent (e.g. abiraterone, enzalutamide) with a PSA value of at least 2 ng/mL and meeting at least one of the following:
    • Progression in measurable disease (RECIST v1.1).
    • Appearance of 2 or more new bone lesions according to Prostate Cancer Working Group 2 (PCWG2).
    • Rising PSA defined as at least two sequential rises in PSA (PSA obtained ≥ 1 week apart) over a reference value (the last PSA [PSA ≥ 2
    ng/mL] measured before the first rise in PSA) (as defined by the PCWG2).
    c) Tumor type TBD at a later date; cancer will be required to have progressed or recurred despite prior standard therapy for that specific tumor.
    8. Acceptable laboratory parameters.

    For additional inclusion criteria and further details, please refer to the study protocol.
    E.4Principal exclusion criteria
    1. Participants with history of prior central nervous system (CNS) metastasis must have been treated, must be asymptomatic, and must
    not have any of the following at the time of enrollment:
    - Concurrent treatment for the CNS disease (e.g., surgery, radiation, corticosteroids > 10 mg prednisone/day or equivalent)
    - Progression after primary treatment of CNS metastases on imaging with MRI, CT or positron emission tomography (PET)/CT within 6 months prior to screening.
    - History of leptomeningeal disease or spinal cord compression.
    2. Module B only: Participants with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment (within the past 2 years), and participants with a history of Grave’s disease that are now euthyroid clinically and by laboratory testing.
    3. Treatment with any, investigational therapy within the 4 weeks prior to the initiation of study drug administration.
    4. Module B only: Previous Checkpoint Inhibitor Therapy: Patients who experienced the following immune checkpoint inhibitor-related AEs make the patient ineligible despite the AE resolving to ≤ Grade 1 or baseline:
    o ≥ Grade 3 ocular AE
    o Changes in liver function tests that met the criteria for Hy's Law (> 3 × ULN of either ALT/AST with concurrent > 2 × ULN of total
    bilirubin and without alternate etiology)
    o ≥ Grade 3 neurologic toxicity
    o ≥ Grade 3 colitis
    o ≥ Grade 3 pneumonitis
    o ≥ Grade 3 renal toxicity
    o ≥ Grade 3 skin toxicity
    5. Prior treatment with MGD009, enoblituzumab, or other B7-H3 targeted agents for cancer.
    6. Treatment with any systemic anti-cancer therapy within the interval specified in the protocol
    7. Treatment with mediastinal or pelvic radiation therapy within 4 weeks prior to the minitiation of study drug administration. Palliative, limited
    field radiation for symptom control to soft tissues, or bone lesions within 2 weeks prior to the initiation of study drug administration.
    8. Module B only: Treatment with systemic corticosteroids (> 10 mg per day prednisone or equivalent) or other immune suppressive drugs within the 14 days prior to the initiation of study drug administration.
    9. Clinically significant cardiovascular diseases.
    10. Clinically significant pulmonary compromise, including pneumonia, pneumonitis, or a requirement for supplemental oxygen use to maintain adequate oxygenation or history of ≥ Grade 3 drug-induced or radiation pneumonitis.
    11. Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral antibiotic, antiviral, or antifungal treatment within 7 days prior to the initiation of study drug. Participants requiring any systemic antiviral, antifungal, or antibacterial therapy for active infection must have completed treatment no less than one week prior to the initiation of study drug.
    12. Known history of positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.
    13. Known history of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction.
    14. History of prior allogeneic bone marrow, stem-cell, or solid organ transplantation.
    15. Second primary invasive malignancy that has not been in remission for greater than
    2 years except non-melanoma skin cancer; cervical carcinoma in situ on biopsy; or squamous intraepithelial lesion on Pap smear; localized prostate cancer (Gleason score < 6); or resected melanoma in situ.
    16. Major Trauma or major surgery within 4 weeks prior to the initiation of study drug administration.
    17. Any serious underlying medical or psychiatric condition that would impair the ability of the participant to receive or tolerate the planned treatment at the study site.
    18. Known hypersensitivity to recombinant proteins, polysorbate 80, or any excipient contained in the drug formulation or custom vehicle.
    19. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed.
    20. Dementia or altered mental status that would preclude understanding and rendering
    of informed consent.
    21. Prisoners or other individuals who are involuntarily detained.
    22. Any investigative site personnel directly affiliated with this study.
    23. Any issue that in the opinion of the investigator would contraindicate the participant’s participation in the study or confound the results of the study.
    24. Clinically significant venous insufficiency.
    25. > Grade 1 peripheral neuropathy.
    26. Evidence of pleural effusion.
    27. Evidence of ascites.
    28. Serum testosterone >50 ng/dl or >1.7 nmol/L in mCRPC in Module A Cohort Expansion Phase and Module B Cohort Expansion Phase.
    29. Confirmed or presumed COVID-19/SARS-CoV-2 infection.
    For more details, please refer to study protocol.
    E.5 End points
    E.5.1Primary end point(s)
    1. Safety
    Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE
    Safety is based on evaluation of adverse events (AEs) and serious
    adverse events (SAEs) from the time of study drug administration
    through the End of Study Visit.
    2. Maximum Tolerated Dose
    Maximum tolerated or maximum administered dose of MGC018 alone and in combination with MGA012.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The time frame for evaluation of the endpoint is 24 months
    E.5.2Secondary end point(s)
    1. Pharmacokinetics and Immunogenicity
    Characterize the PK and immunogenicity of MGC018 alone and in combination with MGA012
    2. Efficacy
    Preliminary anti-tumor activity of of MGC018 administered as monotherapy or in combination with MGA012.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. For Pharmacokinetics and Immunogenicity endpoint the time frame is 24 months
    2. For Efficacy end point the time frame is 48 months
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability and immunogenicity
    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 Yes
    E.8.1.7.1Other trial design description
    dose escalation and cohort expansion
    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 trial8
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    United States
    Poland
    Spain
    United Kingdom
    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
    Patient is lost to follow-up (LTFU) or discontinues from the study due to any reason
    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 months2
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years6
    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: 144
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 38
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 182
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-03-18
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed May 15 09:29:21 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA