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   43865   clinical trials with a EudraCT protocol, of which   7286   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:2020-001807-18
    Sponsor's Protocol Code Number:0188
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-07-21
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2020-001807-18
    A.3Full title of the trial
    A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-group, Multi-center Study of an Inhaled Pan-Janus Kinase Inhibitor, TD-0903, to Treat Symptomatic Acute Lung Injury Associated with COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TD-0903 for acute lung injury associated with COVID-19
    A.3.2Name or abbreviated title of the trial where available
    TD-0903 for acute lung injury associated with COVID-19
    A.4.1Sponsor's protocol code number0188
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04402866
    A.5.4Other Identifiers
    Name:MEU Solutions numberNumber:MEUS 023
    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 SponsorTheravance Biopharma Ireland Limited
    B.1.3.4CountryIreland
    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 supportTheravance Biopharma Ireland Limited
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTheravance Biopharma US, Inc.
    B.5.2Functional name of contact pointRajeev Saggar
    B.5.3 Address:
    B.5.3.1Street Address901 Gateway Boulevard
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post codeCA 94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number0019499221158
    B.5.6E-mailrsaggar@theravance.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 nameTD-0903
    D.3.4Pharmaceutical form Inhalation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTD-0903
    D.3.9.2Current sponsor codeTD-0903
    D.3.9.3Other descriptive nameTD-0903
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.5 to 10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute lung injury associated with COVID-19
    E.1.1.1Medical condition in easily understood language
    Lung injury
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level HLT
    E.1.2Classification code 10047468
    E.1.2Term Viral lower respiratory tract infections
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1
    The objectives are:
    • Evaluate the safety and tolerability of inhaled TD-0903 in subjects with COVID-19
    • Assess the plasma pharmacokinetics (PK) of TD-0903 in subjects with COVID-19
    • Characterize the effect of TD-0903 on reducing the acute lung injury as measured by SaO2/FiO2 ratio associated with COVID-19
    • Explore the effect of TD-0903 on nasal swab viral load, and blood biomarkers

    Part 2
    The primary objectives are:
    • To characterize the efficacy of TD-0903 in reducing the acute lung injury as measured by SaO2/FiO2 ratio associated with COVID-19
    • To characterize the efficacy of TD-0903 as measured by ventilator-free days (VFDs)
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate the effect of TD-0903 on:
    • Safety and tolerability
    • Number of days not requiring care in the Intensive Care Unit (ICU-free days)
    • Subjects with improvement in oxygenation
    • Dyspnea as measured by the modified Borg Dyspnea Score
    • The proportion of subjects discharged from hospital during the study
    • Time to hospital discharge
    • The 28-day mortality rate
    • Clinical outcomes as measured by a 8-point clinical status scale
    • The proportion of subjects alive and free of ventilatory support on Day 28
    The exploratory objectives are to evaluate the effect of TD-0903 on:
    • Achieving oxygen saturation > 93% on room air
    • Changes in chest imaging (when done for clinical care reasons)
    • Changes in modified HScore
    • Changes in fever
    • Biomarker measures including Severe Acute Respiratory Syndrome-associated
    Coronavirus 2 (SARS-CoV-2) viral load, markers indicative of cytokine storm, and
    SARS-CoV-2 antibodies
    • Population PK
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Willing and able to provide written informed consent on their own prior to performing study procedures
    In the U.K., subject assent, or proxy consent as per local site procedures, may also be acceptable if both a clinician and second health professional attest that the subject understands the risks and potential benefits of the study and elects to proceed.
    Outside the U.K., written informed consent may only be obtained from the subject or legally authorized representative.
    In the event the subject loses capacity during the study, the subject consents to continued participation, except where this is not clinically indicated.
    2.Willing and able to comply with study-related procedures/assessments
    3. Age 18 to 80 years old
    4. Hospitalized (or documentation of a plan to admit to the hospital if the subject is in an emergency department) and requiring supplemental oxygen to maintain saturation > 90%
    5. Confirmed symptomatic COVID-19.
    If testing results are not immediately available, strong clinical suspicion of COVID-19 can be used for inclusion. Testing should still be done in these subjects. Strong clinical suspicion includes:
    At least 2 of the following:
    • Fever
    • Cough
    • Fatigue
    • Dyspnea; and
    At least 1 of the following
    • Radiographic evidence of viral pneumonia
    • Close contact with a patient who has previously tested positive for COVID-19
    6. Onset of COVID-19-related symptoms > 2 days and < 10 days prior to hospital admission
    E.4Principal exclusion criteria
    1. Subjects requiring ventilatory support (i.e., on mechanical ventilation, non-invasive ventilation, or high-flow nasal cannula) or those subjects who, in the opinion of the investigator, are at risk of imminent respiratory failure (e.g., prolonged respiratory rate >30, signs of respiratory muscle fatigue, or paradoxical diaphragm)
    2. Presence or suspicion of active malignancy with the exception of cancer in situ (e.g., skin cancer)
    3. Evidence of serious active infections other than COVID-19
    4. Current diagnosis of human immunodeficiency virus, hepatitis B or C
    5. In the opinion of the investigator, unlikely to survive for > 24 hours from enrollment
    6. Women who are pregnant or might be pregnant, or who are currently breast-feeding
    Subjects must agree to not donate ova or sperm through 30 days after the last dose of study medication.
    7. Presence of significant comorbidity that, in the opinion of the investigator, predisposes the subject to mortality. Such conditions might include:
    a. New York Heart Association class IV Heart Failure
    b. Hepatic dysfunction (i.e., AST or ALT >3x upper limit of normal)
    c. Renal dysfunction (i.e., estimated glomerular filtration rate (eGFR) <50 mL/min) or receiving renal replacement therapy
    8. Presence of septic shock at time of enrollment
    9. Hemoglobin < 80 g/L
    10. Evidence of neutropenia (i.e., absolute neutrophil count < 1000 cells/μL), lymphopenia (i.e., absolute lymphocyte count < 500 cells/μL) or thrombocytopenia (i.e., platelets < 50×109/μL)
    11. Hypersensitivity to TD-0903 or its components, or to other JAK inhibitors
    12. Treatment with anti-IL 6, anti-IL-6R antagonists, or with JAK inhibitors in the past 30 days, or plans to receive a JAK inhibitor during the study period
    13. Current treatment with conventional synthetic disease-modifying anti-rheumatic drugs (DMARDs)/immunosuppressive agents including:
    a. Methotrexate, cyclosporine, mycophenolate, tacrolimus, penicillamine, or sulfasalazine within 2 weeks prior to enrollment
    b. Azathioprine or cyclophosphamide within 12 weeks prior to enrollment
    c. Tumor Necrosis Factor-alpha (TNFα) inhibitors within 12 weeks prior to enrollment
    14. Participating in other clinical trials involving any other experimental treatment for COVID-19, except in the context of a single-arm antiviral compassionate-use protocol
    15. Use of chronic oral corticosteroids for a non-COVID-19-related condition in a dose higher than prednisone 5 mg or equivalent per day
    16. Subjects with active or incompletely treated pulmonary tuberculosis, or known history of non-tuberculosis mycobacterium over past 12 months
    17. Subject requires continuous oxygen supplementation for underlying cardiorespiratory history in the past 90 days
    18. Body Mass Index ≥40 kg/cm2
    19. Receipt of any live vaccine in the 4 weeks prior to visit 1 or plans to receive a live vaccine during the study period
    20. History of venous thromboembolism (VTE), deep venous thrombosis (DVT), Pulmonary Embolism (PE) or hypercoagulable state.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1:
    Endpoints (through Day 7)
    Safety
    • Change from baseline in vital signs and clinical laboratory results
    • Incidence and severity of treatment-emergent AEs (TEAEs)
    Pharmacokinetics
    • Plasma PK parameters on Day 1 and Day 7
    Pharmacodynamics (PD)
    • Change from baseline in SaO2/FiO2 ratio
    Additional Endpoints (through Day 28)
    Safety
    • Change from baseline in vital signs, and clinical laboratory results
    • Incidence and severity of TEAEs

    Part 2
    The co-primary efficacy endpoints are:
    • Change from baseline in SaO2/FiO2 ratio in mmHg on Day 7
    • Number of VFDs from randomization to Day 28
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1:
    Endpoints
    Safety (Vital signs, clinical laboratory results, TEAEs): Day 1 through 7
    PK: Day 1 pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24 hours, Day 7
    PD (SaO2/FiO2 ratio): Day 1, 2, 5, 7

    Additional Endpoints
    Safety (Vital signs, clinical laboratory results, TEAEs): Day 1 through 28

    Part 2
    The co-primary efficacy endpoints are:
    SaO2/FiO2 ratio: Day 7
    VFDs: up to Day 28
    E.5.2Secondary end point(s)
    Part 2:
    Secondary Endpoints are:
    • Number of ICU-free days from randomization to Day 28
    • AUC in SaO2/FiO2 ratio from Day 1 to Day 7
    • Change from baseline in SaO2/FiO2 ratio on Day 5
    • Proportion of subjects with a SaO2/FiO2 ratio > 315 on Days 5 and 7
    • Proportion of subjects discharged on Days 7, 14, 21 and 28
    • 28-day all-cause mortality rate
    • Time to hospital discharge
    • Change from baseline in the modified Borg Dyspnea Score on Day 7
    • Proportion of subjects in each category of the 8-point clinical status scale on Days 7, 14, 21 and 28
    • Proportion of subjects in each category of vital status (death, discharge, hospitalized) on Days 7, 14, 21 and 28
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part 2:
    • Number of ICU-free days: Day 28
    • AUC in SaO2/FiO2 ratio: Day 1 to Day 7
    • Change from baseline in SaO2/FiO2 ratio: Day 5
    • SaO2/FiO2 ratio > 315: Days 5 and 7
    • Proportion of subjects discharged: Days 7, 14, 21 and 28
    • Time to hospital discharge
    • 28-day all-cause mortality rate: Up to Day 28
    • Change from baseline in the modified Borg Dyspnea Score: Day 7
    • Proportion of subjects in each category of the 8-point clinical status scale: Days 7, 14, 21 and 28
    • Proportion of subjects in each category of vital status (death, discharge, hospitalized): Days 7, 14, 21 and 28
    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 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) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Placebo-controlled
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA1
    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
    Moldova, Republic of
    Ukraine
    Finland
    Sweden
    United Kingdom
    Romania
    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
    Last visit last subject
    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 months4
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days16
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 108
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 51
    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 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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 159
    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)
    Medication will not be provided by the sponsor to study participants at the end of the trial.

    The investigator will ensure that the participants continue to receive the best available treatment once they have completed the study, referring them back to their primary provider.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation N/A
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-04-20
    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-Sun Apr 28 20:51:33 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA