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    Summary
    EudraCT Number:2020-001546-19
    Sponsor's Protocol Code Number:ARGX-117-2001
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-04-09
    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 number2020-001546-19
    A.3Full title of the trial
    A First-in-Human Study in Adult Subjects Hospitalized with Covid-19 to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Efficacy of ARGX-117
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A First-in-Human Study in Adult Subjects Hospitalized with Covid-19 to Investigate a new product called ARGX-117
    A.4.1Sponsor's protocol code numberARGX-117-2001
    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 Sponsorargenx BV
    B.1.3.4CountryBelgium
    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 supportargenx BV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationargenx BV
    B.5.2Functional name of contact pointRegulatory
    B.5.3 Address:
    B.5.3.1Street AddressIndustriepark Zwijnaarde 7
    B.5.3.2Town/ cityZwijnaarde
    B.5.3.3Post code9052
    B.5.3.4CountryBelgium
    B.5.4Telephone number00329310 3400
    B.5.6E-mailregulatory@argenx.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 nameARGX-117
    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 INNARGX-117
    D.3.9.3Other descriptive nameARGX-117
    D.3.9.4EV Substance CodeSUB206651
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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
    PCR-confirmed Covid-19 infection
    E.1.1.1Medical condition in easily understood language
    PCR-confirmed Covid-19 infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and tolerability of ARGX-117 IV administered in adult subjects initially hospitalized with COVID-19 infection

    In part B and part C of the trial the primary objectives will be to investigate efficacy and safety of ARGX-117 IV administered in subjects initially hospitalized with Covid-19
    E.2.2Secondary objectives of the trial
    1. To investigate the pharmacokinetics (PK) of ARGX-117 IV administered in differing dose regimens in subjects initially hospitalized with Covid-19
    2. To investigate the pharmacodynamics (PD) and immunogenicity (ADA) effects of ARGX-117 IV administered in differing dose regimens in subjects initially hospitalized with Covid-19
    3. To investigate the preliminary efficacy of ARGX-117 IV administered in differing dose regimens in subjects initially hospitalized with Covid-19
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female and at least 18 years of age, inclusive, on the day that the informed consent form (ICF) is signed. Subjects older than 75 years must have a clinical frailty score of 1, 2 or 3 before hospitalization for COVID-19 infection (Appendix 6).
    2. COVID-19 diagnosis confirmed by antigen detection test and/or PCR and/or positive serology, or any emerging and validated diagnostic laboratory test for COVID-19 (within 4 weeks prior to first dose administration)
    For part B and C of the trial only: in some patients, it may be impossible to get a confident laboratory confirmation of COVID-19 diagnosis prior to first dose administration because viral load is low and/or problems with diagnostic sensitivity. In those cases, in absence of an alternative diagnosis, and with highly suspect bilateral ground glass opacities on recent (<24h) chest-CT scan (confirmed by a radiologist and pulmonary physician as probable COVID-19), and a typical clinical and chemical diagnosis with signs of cytokine release syndrome, a patient can be enrolled as probable COVID-19 infected. In all cases, this needs confirmation by later seroconversion.
    3. Is in a specialized COVID-19 ward
    4. Part A only:
    First symptoms suggestive for COVID-19 infection appeared at least 12 days prior to dosing on day 1
    Presents with PaO2/FiO2 >350 mmHg while breathing ambient air in an upright position
    Is recovering from COVID-19 infection as demonstrated by declining CRP levels preceding the first dose per judgement of the investigator
    5. Part B and part C only:
    • Presents with bilateral infiltrates (within 48 hours of screening) on chest X-ray or CT scan
    • First symptoms suggestive of COVID-19 infection appeared between 6 and 16 days prior to dosing on day 1
    • Presents with hypoxemia as defined by PaO2/FiO2 <350 mmHg while breathing ambient air in an upright position
    6. All female subjects must have a negative serum pregnancy test at screening.
    7. All female subjects of childbearing potential for at least 1 month before dosing on day 1 have been on a stable regimen of at least one highly effective method of contraception (ie, failure rate of less than 1% per year) during the study and for 90 days after the last administration of ARGX-117
    8. Nonvasectomized male subjects who are sexually active with female partners of childbearing potential: must agree to use condoms during every penile-vaginal intercourse for the entire duration of the study and up to 90 days after the last ARGX-117 administration.
    The female partner of childbearing potential of a nonvascetomized male subject will be required to use an adequate form of contraception.
    9. Male subjects must agree not to donate semen until 90 days after the last ARGX-117 administration.
    10. Body mass index (BMI) between 18-40 kg/m2, inclusive, at screening.
    11. Understands the purpose and risks of the study, will be available for all study visits, and will provide signed and dated informed consent prior to any study-related procedures.
    E.4Principal exclusion criteria
    1. Known hypersensitivity to one of the components of the ARGX-117, or a history of a significant allergic reaction to any drug, per judgement of the investigator
    2. Known active hepatitis B or C infection or a known human immunodeficiency virus infection
    3. History of severe allergic or anaphylactic reactions
    4. Receiving high dose systemic steroids (>8 mg methylprednisolone or equivalent for more than 1 month) for a disorder unrelated to COVID-19 infection
    5. Admitted to a specialized COVID-19 ICU
    6. Receiving mechanical ventilation longer than 24 hours prior to screening
    7. Known history or any symptoms of a clinically significant illness in the 6 months before the first ARGX-117 administration that could put the subject at unacceptable risk per judgement of the investigator
    8. Clinically significant active or chronic bacterial, viral – except COVID-19 – or fungal infection at screening that could put the subject at unacceptable risk per judgement of the investigator
    9. Presents with abnormal laboratory parameter result at screening that may confound the data or pose a clinically significant safety risk for the subject per judgement of the investigator
    10. Estimated glomerular filtration rate <60 mL/min/1.73 m² as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
    11. History of malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of the ARGX-117. Subjects with the following cancer can be included at any time:
    • Adequately treated basal cell or squamous cell skin cancer
    • Carcinoma in situ of the cervix
    • Carcinoma in situ of the breast
    • Incidental histological finding of prostate cancer (TNM stage T1a or T1b)
    12. Known genetic deficiencies for the complement cascade system
    13. Clinically relevant abnormalities detected on the ECG regarding either rhythm or conduction. A first-degree heart block or sinus arrhythmia will not be considered a significant abnormality
    14. Used an investigational product within 3 months or 5 half-lives (whichever is longer) before the first dose of the ARGX-117
    15. Is unlikely to survive longer than 7 days
    16. Is an investigator, sub-investigator, research assistant, pharmacist, study coordinator, or other staff or a relative who is directly involved in the conduct of the study.
    17. Any condition or circumstance that in the opinion of the investigator may make a subject unlikely or unable to complete the study or comply with study procedures and requirements
    E.5 End points
    E.5.1Primary end point(s)
    The safety and tolerability of ARGX-117 will be assessed by the totality of safety and tolerability data, including incidence and frequency of AEs and SAEs; vital sign results; physical examination findings; ECG recordings; and clinical laboratory tests (routine hematology, clinical chemistry, and urinalysis), and specialty laboratory testing (CRP, ferritin, procalcitonin, D-dimer, cytokine panel).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety will be continuously monitored until end of study
    other endpoints D1 until D4, D6, D8, D15, D22, D29, D36, D50, D64, D92 or end of study
    E.5.2Secondary end point(s)
    • PK parameters of ARGX-117: single-dose, dose normalized
    • PD markers: free C2 concentration, total C2 concentration, and CH50
    • Incidence of ADA subject status to ARGX-117
    • Efficacy endpoints
     Clinical status according to the Ordinal scale (Appendix 6)
     Duration hospitalization since first treatment with ARGX-117
     Time to progression to invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) since first treatment with ARGX-117
     Time to progression to high-flow oxygen device since first treatment with ARGX 117
     Time to hospital discharge since first treatment with ARGX-117
    E.5.2.1Timepoint(s) of evaluation of this end point
    D1 until D4, D6, D8, D15, D22, D29, D36, D50, D64, D92 or end of study
    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 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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 No
    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 years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    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: 4
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    covid-19 patients
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    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 Decision2020-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-10-26
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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