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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42869   clinical trials with a EudraCT protocol, of which   7063   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    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:2020-001108-40
    Sponsor's Protocol Code Number:MK-5475-007
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-02-05
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-001108-40
    A.3Full title of the trial
    A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of MK-5475 in Adults with Pulmonary Arterial Hypertension
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Efficacy and Safety of MK-5475 in Adults with Pulmonary Arterial Hypertension
    A.3.2Name or abbreviated title of the trial where available
    Phase 2/3 Study of MK-5475 in Adults with Pulmonary Arterial Hypertension
    A.4.1Sponsor's protocol code numberMK-5475-007
    A.5.4Other Identifiers
    Name:INDNumber:149503
    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 SponsorMerck Sharp & Dohme LLC
    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 supportMerck Sharp & Dohme LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameMK-5475
    D.3.2Product code MK-5475
    D.3.4Pharmaceutical form Inhalation powder
    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 INNMK-5475
    D.3.9.3Other descriptive nameMK-5475
    D.3.9.4EV Substance CodeSUB190981
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number32
    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.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 nameMK-5475
    D.3.2Product code MK-5475
    D.3.4Pharmaceutical form Inhalation powder
    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 INNMK-5475
    D.3.9.3Other descriptive nameMK-5475
    D.3.9.4EV Substance CodeSUB190981
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 3
    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 nameMK-5475
    D.3.2Product code MK-5475
    D.3.4Pharmaceutical form Inhalation powder
    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 INNMK-5475
    D.3.9.3Other descriptive nameMK-5475
    D.3.9.4EV Substance CodeSUB190981
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number380
    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 powder
    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
    Pulmonary arterial hypertension
    E.1.1.1Medical condition in easily understood language
    Pulmonary arterial hypertension (Grade 1 Pulmonary Hypertension)
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10065150
    E.1.2Term Associated with pulmonary arterial hypertension
    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
    1. To evaluate the effect of MK-5475 versus placebo on the pulmonary vascular resistance (PVR) at Week 12 in the Phase 2 Cohort
    2. To evaluate the effect of MK-5475 versus placebo on 6-minute walk distance (6MWD) at Week 12 in the Phase 3 Cohort
    E.2.2Secondary objectives of the trial
    1. To evaluate the effect of MK-5475 versus placebo on 6-minute walk distance (6MWD) at Week 12 in the Phase 2 Cohort
    2. To evaluate the effect of MK-5475 versus placebo on hemodynamic parameters other than pulmonary vascular resistance (PVR) at Week 12 in the Phase 2 Cohort
    3. To evaluate the effect of MK-5475 versus placebo on 6-minute walk distance (6MWD) at Week 24 in the Phase 3 Cohort
    4. To evaluate the effect of MK-5475 versus placebo on the World Health Organization (WHO) functional pulmonary arterial hypertension (PAH) class at week 12 in the Phase 3 Cohort
    5. To evaluate the safety and tolerability of MK-5475 in the Phase 2 and Phase 3 Cohorts (independently)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Has the following PAH groups, as defined by the Updated Clinical Classification of Pulmonary Hypertension:
    a) Group 1.1 Idiopathic PAH
    b) Group 1.2 Heritable PAH
    c) Group 1.3 Drug and toxin-induced PAH
    d) Group 1.4 PAH associated with:
    ● Connective tissue disease
    ● HIV infection
    ● Simple repaired congenital systemic-to-pulmonary shunt with persistent PH ≥1 year after surgical repair and with no clinically significant residual shunt
    2. Has a diagnosis of PAH performed as standard of care, per scientific guidelines, and documented by historical RHC at any time prior to Screening; if participant is postsurgical repair of systemic-to pulmonary shunt, diagnostic RHC must have been performed at least 1 year after surgery
    3. Has an eligibility RHC, meeting all the following criteria:
    ● mean pulmonary artery pressure (mPAP) ≥25 mmHg
    ● PVR of ≥3 Wood units
    ● PCWP or LVEDP ≤15 mmHg
    For the Phase 2 Cohort, the eligibility RHC should be performed during Screening and will be centrally reviewed. A participant with RHC performed within 30 days prior to Visit 1/Screening may have the RHC results submitted for central review and, if deemed adequate, the RHC may count as baseline. In each case, the RHC should be performed after at least 90 days of stable PAH-specific therapy. For the Phase 3 Cohort, an RHC performed within 365 days prior to Visit 1/Screening may count for eligibility assessment. An RHC will be performed during Screening if an RHC performed within 365 days prior to Visit 1/Screening is not available
    4. Has WHO-FC symptoms Class II to IV
    5. Has two 6MWD measurements between 150 and 500 meters, 1 at Screening and 1 at Randomization. The relative difference between the 2 measurements must be ≤15%. If the relative difference between the two 6MWD measurements is >15%, the Randomization 6MWT may be repeated after at least 4 hours. If the relative difference between the 2 Randomization 6MWD measurements is ≤15%, the participant can be randomized and the last 6MWD will be considered the baseline value
    6. Has stable concomitant background PAH-specific therapy with any of the following agents:
    ● an ERA and/or
    ● a PDE5i and/or
    ● an oral prostacyclin analogue or oral prostacyclin receptor agonist, an intravenous prostacyclin analogue or a subcutaneous prostacyclin
    analogue
    7. If on vasodilators other than PAH-specific therapy, has stable concomitant use
    8. If on calcium channel blockers, a participant from Groups 1.1, 1.2, and 1.3 must have a history of being a nonresponder to acute pulmonary vasoreactivity testing
    9. If on anticoagulants, has stable concomitant use for at least 30 days prior to and over the duration of Screening
    10. Is male or female, from 18 years to 75 years of age inclusive, at the time of signing the informed consent
    11. Has a BMI between 18.5 kg/m2 and 40 kg/m2
    12. Is willing to comply with scheduled visits, treatment plan, laboratory tests, and/or other study procedures and study restrictions
    13. Agrees to allowing site contact via phone or email for follow-up purposes
    14. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 14 days after the last dose of study intervention:
    ● Be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent OR
    ● Must agree to use contraception unless confirmed to be azoospermic as detailed below:
    - Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant
    ● Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
    15. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
    ● Is not a WOCBP OR
    ● Is a WOCBP and:
    uses a contraceptive method that is highly effective, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle during the intervention period and for at least 14 days after the last dose of study intervention. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
    ● A WOCBP must have a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention
    ● If a urine test cannot be confirmed as negative , a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive
    16. The participant has provided documented informed consent/assent for the study. A supplemental documented informed consent/assent is required for participation in the Phase 2 Cohort Extension Period. The participant may also provide consent/assent for future biomedical research
    17. Sponsor concurrence on key criteria must be obtained before the participant is randomized into the study
    E.4Principal exclusion criteria
    1. Has Group 2 PH, Group 3 PH, Group 4 PH, or Group 5 PH according to the Updated Clinical Classification of Pulmonary Hypertension.
    2. Has Group 1.5 PAH, long-term responders to calcium channel blockers, defined by sustained clinical improvement to WHO-FC I or II and sustained hemodynamic improvement after at least 1 year on CCBs only
    3. Has Group 1.6 PAH, with overt features of venous/capillary (PVOD/PCH) involvement
    4. For participants with Group 1.4 HIV-associated PAH, has any of the following within 90 days prior to and for the duration of Screening:
    ● concomitant active opportunistic infections
    ● plasma HIV-1 RNA≥50 copies/mL or CD4+ T-cell count<200/mm3
    ● changes in antiretroviral regimen
    5. Has evidence of more-than-mild obstructive lung disease on PFT at Screening: FEV1/FVC <70%; and FEV1 <60% of predicted value after bronchodilator administration
    6. Has evidence of more-than-mild parenchymal lung disease, based on medical history and chest imaging , and/or restrictive lung disease with Total Lung Capacity <60% of predicted on PFT at Screening
    7. Has evidence of more-than-mild OSA that is untreated. Participants with well-controlled, treated OSA are eligible
    8. Has evidence or history of left heart disease, including any of the following:
    ● left ventricular ejection fraction ≤45%
    ● moderate or severe left-sided valvular disease
    ● Grade 3 and 4 left ventricular diastolic function on echocardiographic evaluation
    9. Has 3 or more of the following risk factors for heart failure with preserved ejection fraction:
    ● BMI >30 kg/m2
    ● history of essential systemic hypertension
    ● diabetes mellitus of any type
    ● history of coronary artery disease
    10. Has oxygen saturation measured by pulse oximetry <90%, despite supplemental oxygen therapy
    11. Had clinically unstable or acutely decompensated right heart failure within 30 days prior to and over the duration of Screening including, but not limited to, hospitalization or emergency room visit for acute decompensated heart failure
    12. Has stated systolic BP >160 mmHg or <90 mmHg or stated diastolic BP >100 mmHg
    13. Has significant chronic renal insufficiency, as defined by eGFR <30 mL/min/1.73 m2 or by ongoing dialytic support
    14. Has evidence of chronic liver disease, portal hypertension,
    cirrhosis, or hepatic laboratory abnormalities
    15. Is included in a cardiopulmonary rehabilitation program initiated within 90 days prior to Screening or is planning to initiate cardiopulmonary rehabilitation during the study
    16. Has acute or chronic impairment(s), limiting the ability to perform 6MWT
    17. Is a current smoker or currently uses electronic cigarettes
    18. Is unable to correctly use the DPI prior to randomization due to, but not limited to, cognitive impairment or physical limitations
    19. Has other severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or that would confound study analysis or impair study participation or cooperation
    20. Has a history of cancer. Exceptions:1) Adequately treated
    nonmelanomatous skin carcinoma or carcinoma in situ of the cervix or;2) Other malignancies which have been successfully treated, with appropriate follow up, and therefore unlikely to recur for the duration of the study, in the opinion of the investigator
    21. Has a known hypersensitivity to any of the ingredients or excipients of the IMP
    22. At the time of signing the informed consent, is a user of illicit drugs or has had a recent history of drug or alcohol abuse or dependence
    23. Has a known psychiatric or any other cognitive disorder that would, in the opinion of the investigator, interfere with the participant’s ability to cooperate with the requirements of the study
    24. Is a WOCBP who has a positive urine pregnancy test within 24 hours before the first dose of study intervention. If the urine test cannot be confirmed as negative, a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive
    25. Has used intravenous inotropes within 30 days prior to and over the duration of Screening.
    26. Has concomitant use of inhaled prostacyclin analogues, inhaled NO, or oral sGC modulators, or has used these medications within 90 days prior to and over the duration of Screening
    27. Has participated in another investigational study within 4 weeks prior to the Screening. This window will be derived from the date
    of the last dose of study medication taken in the previous study
    28. For Phase 2 Cohort Extension: has not completed Visit 6/Week 12 study assessments.
    29. For Phase 2 Cohort Extension: has discontinued study intervention or completed the Phase 2 Cohort Base Period.
    30. For Phase 3 Cohort enrollment : is currently participating in,has prematurely discontinued, or has completed the Phase 2 Cohort.
    31. Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study
    E.5 End points
    E.5.1Primary end point(s)
    1. Phase 2 Cohort: Change from Baseline in Pulmonary Vascular Resistance (PVR) at 12 Weeks
    2. Phase 3 Cohort: Change from Baseline in 6-Minute Walk Distance (6MWD) at 12 Weeks
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. At baseline and 12 weeks
    2. At baseline and 12 weeks
    E.5.2Secondary end point(s)
    1. Phase 2 Cohort: Change from Baseline in 6-Minute Walk Distance (6MWD) at 12 Weeks
    2. Phase 2 Cohort: Change from Baseline in Mean Right Arterial Pressure (mRAP) at 12 Weeks
    3. Phase 2 Cohort: Change from Baseline in Cardiac Index (CI) at 12 weeks
    4. Phase 2 Cohort: Change from Baseline in Stroke Volume Index (SVI) at 12 weeks
    5. Phase 3 Cohort: Change from Baseline in 6-Minute Walk Distance (6MWD) at 24 Weeks
    6. Phase 3 Cohort: Change from Baseline in World Health Organization Functional Class (WHO-FC) at 12 Weeks
    7. Phase 2 and 3 Cohorts: Number of Participants Who Experience an Adverse Event
    8. Phase 2 and 3 Cohorts: Number of Participants Who Discontinue Study Drug Due to an Adverse Event
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At baseline and 12 weeks
    2. At baseline and 12 weeks
    3. At baseline and 12 weeks
    4. At baseline and 12 weeks
    5. At baseline and 24 weeks
    6. At baseline and 12 weeks
    7. Phase 2 Cohort: Up to approximately 2.25 years, Phase 3 Cohort: Up to approximately 5.5 years
    8. Phase 2 Cohort: Up to approximately 2.25 years, Phase 3 Cohort: Up to approximately 5.5 years
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 Yes
    E.6.11Pharmacogenomic Yes
    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) Yes
    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
    Adaptive Design; Phase 2: 4 groups, Phase 3: 2 groups
    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 trial6
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Argentina
    Australia
    Belgium
    Canada
    Colombia
    France
    Germany
    Greece
    Israel
    Italy
    New Zealand
    Poland
    Portugal
    Russian Federation
    Sweden
    Turkey
    United Kingdom
    United States
    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 years5
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    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: 375
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 59
    F.4.2.2In the whole clinical trial 450
    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 Decision2021-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-25
    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.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    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
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA