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   37219   clinical trials with a EudraCT protocol, of which   6124   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).
     
    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:2018-003673-10
    Sponsor's Protocol Code Number:AV003
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2018-12-27
    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 ConcernedGermany - BfArM
    A.2EudraCT number2018-003673-10
    A.3Full title of the trial
    A Long-term, Randomized, Double-blind, Multicenter, Parallel-group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT007 Administered as Needed in Response to Symptoms in Symptomatic Adults and Children 4 Years of Age or Older with Asthma (MANDALA).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to evaluate the efficacy and safety of PT027 compared to PT007 in asthma patients 4 years of age or older (MANDALA).
    A.3.2Name or abbreviated title of the trial where available
    MANDALA
    A.4.1Sponsor's protocol code numberAV003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03769090
    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 SponsorBond Avillion 2 Development LP
    B.1.3.4CountryGuernsey
    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 supportBond Avillion 2 Development LP
    B.4.2CountryGuernsey
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationinVentiv Health Clinical, LLC, a Syneos Health Company
    B.5.2Functional name of contact pointProject Management
    B.5.3 Address:
    B.5.3.1Street Address3201 Beechleaf Court, Suite 600
    B.5.3.2Town/ cityRaleigh, North Carolina
    B.5.3.3Post code27604-1547
    B.5.3.4CountryUnited States
    B.5.4Telephone number+48606486648
    B.5.6E-mailpiotr.bernat@syneoshealth.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 nameBudesonide/Albuterol Sulfate Pressurized Inhalation Suspension (BDA MDI)
    D.3.2Product code PT027
    D.3.4Pharmaceutical form Pressurised inhalation, suspension
    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 INNBUDESONIDE
    D.3.9.1CAS number 51333-22-3
    D.3.9.4EV Substance CodeSUB05955MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSALBUTAMOL SULFATE
    D.3.9.1CAS number 51022-70-9
    D.3.9.2Current sponsor codeAlbuterol sulfate
    D.3.9.3Other descriptive nameAlbuterol sulfate
    D.3.9.4EV Substance CodeSUB04303MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number108
    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 Yes
    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 nameBudesonide/Albuterol Sulfate Pressurized Inhalation Suspension (BDA MDI)
    D.3.2Product code PT027
    D.3.4Pharmaceutical form Pressurised inhalation, suspension
    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 INNBUDESONIDE
    D.3.9.1CAS number 51333-22-3
    D.3.9.4EV Substance CodeSUB05955MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSALBUTAMOL SULFATE
    D.3.9.1CAS number 51022-70-9
    D.3.9.2Current sponsor codeAlbuterol sulfate
    D.3.9.3Other descriptive nameAlbuterol sulfate
    D.3.9.4EV Substance CodeSUB04303MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number108
    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 Yes
    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 RoleComparator
    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 nameAlbuterol Sulfate Pressurized Inhalation Suspension (AS MDI)
    D.3.2Product code PT007
    D.3.4Pharmaceutical form Pressurised inhalation, suspension
    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 INNSALBUTAMOL SULFATE
    D.3.9.1CAS number 51022-70-9
    D.3.9.2Current sponsor codeAlbuterol sulfate
    D.3.9.3Other descriptive nameAlbuterol sulfate
    D.3.9.4EV Substance CodeSUB04303MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number108
    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 Yes
    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
    Moderate to severe asthma
    E.1.1.1Medical condition in easily understood language
    Asthma
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10015575
    E.1.2Term Exacerbation of asthma
    E.1.2System Organ Class 100000004855
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10003561
    E.1.2Term Asthma, unspecified
    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
    To evaluate the efficacy of budesonide/albuterol metered-dose inhaler 80/180 μg and 160/180 μg administered prn in response to symptoms compared to albuterol metered-dose inhaler 180 μg.
    E.2.2Secondary objectives of the trial
    To characterize the effect of budesonide/albuterol metered-dose inhaler 80/180 μg and 160/180 μg administered prn in response to symptoms compared to albuterol metered-dose inhaler 180 μg.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the study, subjects must fulfill the following criteria within the screening period:
    1 Able and willing to provide written informed consent or sign age-appropriate forms, subjects below legal age of consent must have parent(s) or guardian sign the ICF before participation;
    2 Female or male aged ≥4 years at the time of informed consent in all countries with the exception of the following: in Italy, only subjects ≥6 years of age will be enrolled; in Serbia and Spain, only subjects ≥12 years old will be enrolled; in Germany, Slovakia, and Ukraine, only subjects ≥18 years old will be enrolled;
    3 Diagnosis of asthma as defined by GINA criteria at least 1 year before Visit 1;
    4 Receiving 1 of the following scheduled asthma maintenance therapies for 3 months with stable dosing for at least the last 4 weeks before Visit 1;
    (a) Medium-to-high-dose ICS;
    (b) Medium-to-high-dose ICS and 1 additional maintenance therapy from the following: LTRA, LAMA, or theophylline;
    (c) Low-to-high-dose ICS in combination with LABA with or without 1 additional maintenance therapy from the following: LTRA, LAMA, or theophylline;
    5 Prebronchodilator forced expiratory volume in 1 second (FEV1) of ≥40 to <90% predicted normal value for adults and adolescents, and ≥60 to <100% predicted normal value for subjects aged 4 to 11 years after withholding the medications specified in Table 4. If FEV1 values are not within the permitted range at Visit 1, 1 re-test must be performed at Visit 1a before advancing to Visit 2 or confirming screen failure;
    6 Demonstrate reversibility at Visit 1, with an increase in FEV1 ≥12% (and ≥200 mL for subjects aged ≥18 years) relative to baseline after administration of Sponsor provided Ventolin via central spirometry. If reversibility is not demonstrated at Visit 1, 1 re-test for reversibility testing must be done at Visit 1a before advancing to Visit 2 or confirming screen failure;
    7 Demonstrate acceptable spirometry performance;
    8 A documented history of at least 1 severe asthma exacerbation within 12 months before Visit 1;
    9 Asthma Control Questionnaire-7 (ACQ-7) score ≥1.5 assessed at Visit 1
    10 ACQ-5 score ≥1.5 assessed at Visit 2;
    11 Use of Sponsor provided Ventolin prn medication because of asthma symptoms on at least 3 days during the last week of the run-in period before Visit 2;
    12 Demonstrate acceptable MDI administration technique as assessed by the investigator, use of spaciers prohibited;
    13 Able to perform acceptable and reproducible peak expiratory flow (PEF) measurements as assessed by the investigator;
    14 Body mass index <40 kg/m2;
    15 Willing to remain at the study site as required per protocol and complete all visit assessments;
    16 Negative pregnancy test (serum at Visit 1) for female subjects of childbearing potential;
    17 Women of childbearing potential and sexually active in heterosexual relationships must agree to 1 of the following options to prevent pregnancy:
    (a) Practice complete abstinence;
    (b) If a female of childbearing potential agrees to prevent pregnancy by using 1 of the following methods of birth control from the date the ICF is signed until 2 weeks after the final dose of IP is taken:
    i. Hormonal contraception (eg., oral contraceptive, contraceptive implant, or injectable hormonal contraceptive);
    ii. Double-barrier birth control (eg., a combination of male condom with either cap, diaphragms, or sponge with spermicide);
    iii. Maintenance of a monogamous sexual relationship with a male partner who has been surgically sterilized by vasectomy provided that the male partner is the sole sexual partner of the female (of child bearing potential) participant and that the vasectomized partner has received medical assessment of the surgical success (ie, documented history of medical confirmation of success of vasectomy);
    18 Male subjects who are sexually active in heterosexual relationships must be surgically sterile or agree to use a double-barrier method of contraception (a combination of male condom with either cap, diaphragms, or sponge with spermicide) from the first dose of randomized IP until 2 weeks after their last dose. Male subjects must not donate sperm during their study participation period.

    Please refer to protocol for complete inclusion critieria.
    E.4Principal exclusion criteria
    Subjects must not enter the study if any of the following exclusion criteria are fulfilled within the screening period:
    1 Chronic obstructive pulmonary disease or other significant lung disease;
    2 Oral/SCS use (any dose and any indication) within 6 weeks before Visit 1;
    3 Chronic use of oral corticosteroids (OCS, ≥3 weeks use in 3 months prior to Visit 1);
    4 Having received any marketed (eg., omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab) or investigational biologic within 3 months or 5 half-lives before Visit 1, whichever is longer, or any other prohibited medication;
    5 Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking <6 months before Visit 1 (including all forms of tobacco, e-cigarettes [vaping], and marijuana);
    6 Life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s) within 5 years of Visit 1;
    7 Completed treatment for lower respiratory infection or asthma exacerbation within 6 weeks of Visit 1;
    8 Upper respiratory infection involving antibiotic treatment not resolved within 7 days before Visit 1;
    9 Clinically significant laboratory abnormalities, in the opinion of the investigator;
    10 Having any of the following results at Visit 1:
    (a) an abnormal electrocardiogram (ECG) that is, in the investigator’s opinion, clinically significant;
    (b) a QTCF interval >480 ms (subjects aged ≥12 years)/ ≥460 ms (subjects aged 4 to 11 years, based on the Fridericia correction where QTCF=QT/RR0.33);
    11 Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular (eg., congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia, coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine (eg., uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison’s disease, Cushing’s syndrome), or gastrointestinal (eg., poorly controlled peptic ulcer, gastroesophageal reflux disease) disorders. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation, or that could affect the efficacy or safety analysis if the disease/condition exacerbated during the study;
    12 Cancer not in complete remission for at least 5 years before Visit 1;
    13 Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit 1;
    14 History of psychiatric disease, intellectual deficiency, poor motivation, or other conditions if their magnitude is limiting informed consent validity;
    15 Significant abuse of alcohol or drugs, in the opinion of the investigator;
    16 Having a known or suspected hypersensitivity to albuterol/salbutamol, or budesonide and/or their excipients;
    17 Having a scheduled/planned hospitalization during the study;
    18 Inability to abstain from protocol-defined prohibited medications during the study;
    19 Using any herbal products by inhalation or nebulizer within 2 weeks of Visit 1 and not agreeing to stop during the study duration;
    20 Having received a live attenuated vaccination within 7 days of Visit 1;
    21 Currently pregnant and breastfeeding;
    22 Study investigators, subinvestigators, coordinators, and their employees or immediate family members, or employees of the Sponsor;
    23 Treatment with any investigational treatment or device in another clinical study within the last 30 days (or 5 half-lives, whichever is longer) of Visit 1;
    24 Currently participating in any interventional study;
    25 Having previously been enrolled in this study or any other PT007 or PT027 clinical study.
    26 Subjects who experience >1 asthma exacerbatin during the screening period
    E.5 End points
    E.5.1Primary end point(s)
    Time to first severe asthma exacerbation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time to first severe asthma exacerbation will be calculated as the time from randomization until the start date of the first severe asthma exacerbation.
    E.5.2Secondary end point(s)
    • Severe exacerbation rate (annualized)
    • Total corticosteroid exposure over the treatment period
    • Asthma Control Questionnaire -5 change from baseline and responder analysis at Week 24
    • Asthma Quality of Life Questionnaire for 12 years and older/PAQLQ change from baseline and responder analysis at Week 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study and as defined within the end points.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Superiority
    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) No
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned60
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA111
    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
    Austria
    Canada
    Chile
    Czech Republic
    Germany
    Italy
    Serbia
    Slovakia
    South Africa
    Spain
    Ukraine
    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 years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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 Yes
    F.1.1Number of subjects for this age range: 200
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 100
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 100
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2850
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children and adolescents aged =4-17 years are included in the trial
    though in Germany, only subjects ≥ 18 years old will be included.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state600
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1250
    F.4.2.2In the whole clinical trial 3100
    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)
    There are no plans to provide study treatment after termination of the study. Patients can return to their usual medication after completing the study.
    The Investigator is responsible for ensuring that consideration has been given to the post-study medical care of the patient’s medical condition.
    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 MeDiNova Limited
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-05-20
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusRestarted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA