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    Summary
    EudraCT Number:2019-002579-33
    Sponsor's Protocol Code Number:EE-301
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-10-30
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2019-002579-33
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Two-Phase, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 20 mg Compared to Lansoprazole 30 mg for Healing in Patients with Erosive Esophagitis and to Evaluate the Efficacy and Safety of Vonoprazan (10 mg and 20 mg) Compared to Lansoprazole 15 mg for the Maintenance of Healing in Patients with Healed Erosive Esophagitis
    Randomizované, dvojitě zaslepené, dvoufázové, multicentrické klinické hodnocení fáze 3 hodnotící účinnost a bezpečnost léčby přípravkem vonoprazan 20 mg ve srovnání s přípravkem lansoprazol 30 mg u pacientů s erozivní ezofagitidou a hodnotící účinnost a bezpečnost udržovací léčby přípravku vonoprazan (10 mg a 20 mg) v porovnání s přípravkem lansoprazol 15 mg u pacientů se zhojenou erozivní ezofagitidou
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To Evaluate the Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis
    A.4.1Sponsor's protocol code numberEE-301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04124926
    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 SponsorPhathom Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPhathom Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD
    B.5.2Functional name of contact pointMedical Monitor
    B.5.3 Address:
    B.5.3.1Street Address3900 N Paramount Parkway
    B.5.3.2Town/ cityMorrisville
    B.5.3.3Post code27560
    B.5.3.4CountryUnited States
    B.5.4Telephone number18002018725
    B.5.6E-mailRyan.Madanick@ppdi.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 nameVonoprazan 10 mg
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVONOPRAZAN
    D.3.9.1CAS number 881681-00-1
    D.3.9.2Current sponsor codeTAK-438
    D.3.9.4EV Substance CodeSUB195108
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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 Yes
    D.2.1.1.1Trade name Agopton (Lansoprazole) 15 mg
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameAgopton
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLANSOPRAZOLE
    D.3.9.3Other descriptive nameLANSOPRAZOLE
    D.3.9.4EV Substance CodeSUB08403MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 nameVonoprazan 20 mg
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVONOPRAZAN
    D.3.9.1CAS number 881681-00-1
    D.3.9.2Current sponsor codeTAK-438
    D.3.9.4EV Substance CodeSUB195108
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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: 4
    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 Yes
    D.2.1.1.1Trade name Agopton (Lansoprazole) 30 mg
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameAgopton
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLANSOPRAZOLE
    D.3.9.3Other descriptive nameLANSOPRAZOLE
    D.3.9.4EV Substance CodeSUB08403MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Erosive Esophagitis
    E.1.1.1Medical condition in easily understood language
    An inflammation of the cell layer that lines the inside of esophagus. A disease that causes heartburn, a burning sensation in the throat and difficulty and pain when swallowing.
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10063657
    E.1.2Term Erosive esophagitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Healing Phase
    - To assess the efficacy of vonoprazan (20 mg once daily [QD])
    compared to lansoprazole (30 mg QD) in healing of EE over 8 weeks
    in subjects with endoscopically proven EE.
    - To assess the safety of vonoprazan (20 mg QD) compared to
    lansoprazole (30 mg QD) in subjects with endoscopically proven EE.

    Maintenance Phase
    -To assess the efficacy in maintenance of healing of vonoprazan
    (10 mg and 20 mg QD) compared to lansoprazole (15 mg QD) in
    subjects with healed EE.
    • To assess the safety of vonoprazan (10 mg and 20 mg QD) compared
    to lansoprazole (15 mg QD) in subjects with healed EE.
    E.2.2Secondary objectives of the trial
    Healing Phase
    - To assess the efficacy of vonoprazan (20 mg QD) compared to
    lansoprazole (30 mg QD) in healing of EE over 2 weeks in subjects
    with endoscopically proven EE.
    • To assess the efficacy of vonoprazan (20 mg QD) compared to
    lansoprazole (30 mg QD) in healing of EE in subjects with
    endoscopically proven EE LA Classification Grades C or D over
    2 weeks and 8 weeks.
    • To assess relief of heartburn of vonoprazan (20 mg QD) compared to
    lansoprazole (30 mg QD) in subjects with endoscopically proven EE
    over 8 weeks and within the first 3 days of treatment.

    Maintenance Phase
    To assess the efficacy in maintenance of healing of vonoprazan
    (10 mg and 20 mg QD) compared to lansoprazole (15 mg QD) in
    subjects with healed EE with baseline LA Classification Grades C or
    D.
    • To assess the efficacy of vonoprazan (10 mg and 20 mg QD)
    compared to lansoprazole (15 mg QD) in subject symptoms by subject
    daily diary.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -The subject is ≥18 years of age at the time of informed consent signing.
    -The subject is found to have endoscopically confirmed EE of LA Classification Grades A to D during the Screening Period (Visit 1) as assessed by a central adjudicator. The target number of subjects with LA classification Grade C or D will be approximately 30% of the total number of subjects (300 total). Enrollment of EE subjects with Grade A or B will end when the number of subjects with Grade A or B EE is approximately 700 or 70% of the total planned number of subjects. Given the invasive nature of an endoscopy, any endoscopic confirmation performed in a routine clinical setting before signing the informed consent will be acceptable to use for the purpose of fulfilling the screening requirement if all of the following apply: (1)appropriate endoscopy pictures were taken;(2)appropriate gastric biopsy samples were taken;(3) the endoscopy pictures can be sent to the central adjudicator via the adjudication systems; and (4) all screening procedures(including the completion of adjudication)AND randomization can be completed within a 7 day period after the date of the endoscopy.
    -A female subject of childbearing potential who is or may be sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from the signing of informed consent until 4 weeks after the last dose of study drug.
    E.4Principal exclusion criteria
    -The subject’s endoscopic examination for entering this study fails to confirm EE within 7 days prior to randomization
    -The subject is determined to be positive for Helicobacter pylori (HP) or has had an HP infection within 45 days of randomization
    -The subject has endoscopic Barrett’s esophagus (>1 cm of columnar-lined esophagus)and/or definite dysplastic changes in the esophagus.
    -The subject has any other condition affecting the esophagus, including eosinophilic esophagitis; esophageal varices; viral or fungal infection; esophageal stricture; a history of radiation therapy, radiofrequency ablation, endoscopic mucosal resection, or cryotherapy to the esophagus; or any history of caustic or physiochemical trauma(including sclerotherapy or esophageal variceal band ligation). However, subjects diagnosed with Schatzki’s ring (mucosal tissue ring around lower esophageal sphincter) are eligible to participate.
    -The subject has scleroderma (systemic sclerosis).
    -The subject has a history of surgery or endoscopic treatment affecting
    gastroesophageal reflux, including fundoplication and dilation for esophageal stricture (except Schatzki’s ring) or a history of gastric or duodenal surgery (except endoscopic removal of benign polyps).
    -The subject has an active gastric or duodenal ulcer at the start of the Screening Period. Additionally, subjects with gastric or duodenal erosions are permitted to participate.
    -The subject has received any investigational compound (including those in post-marketing studies) within 30 days prior to the start of the Screening Period. A subject who has been screen failed from another clinical study and who has not been dosed may be considered for enrollment in this study.
    -The subject is a study site employee, an immediate family member, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or who may have consented under duress.
    -The subject has cutaneous lupus erythematosus or systemic lupus erythematosus.
    -The subject has had clinically significant upper or lower gastrointestinal bleeding within 4 weeks prior to randomization
    -The subject has Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions.
    -The subject has a history of hypersensitivity or allergies to vonoprazan (including the formulation excipients: D-mannitol, microcrystalline cellulose, hydroxypropyl cellulose, fumaric acid, croscarmellose sodium, magnesium stearate, hypromellose,macrogol 8000, titanium oxide, or red or yellow ferric oxide), PPIs, or any excipients used in the 13C-urea breath test: mannitol, citric acid, or aspartame. Skin testing may be performed according to local standard practice to confirm hypersensitivity.
    -The subject has a history of alcohol abuse, illegal drug use, or drug addiction within the 12 months prior to screening, or regularly consumes >21 units of alcohol (1 unit = 12 oz/300 mL beer, 1.5 oz/25 mL hard liquor/spirits, or 5 oz/100 mL wine) per week based on self-report. Subjects must have a negative urine drug screen at screening.
    -The subject is taking any excluded medications or treatments listed in the protocol.
    -If female, the subject is pregnant, lactating, or intending to become pregnant before, during, or within 4 weeks after participating in this study; or intending to donate ova during such time period.
    -The subject has a history or clinical manifestations of significant central nervous system, cardiovascular, pulmonary, hepatic, renal, metabolic, other gastrointestinal, urological, endocrine, or hematological disease that, in the opinion of the investigator, would confound the study results or compromise subject safety.
    -The subject requires hospitalization or has surgery scheduled during the course of the study or has undergone major surgical procedures within 30 days prior to the Screening Visit.
    -The subject has a history of malignancy (including MALToma) or has been treated for malignancy within 5 years prior to the start of the Screening Period (Visit 1). (The subject may be included in the study if he/she has cured cutaneous basal cell carcinoma or cervical carcinoma in situ).
    -The subject has acquired immunodeficiency syndrome (AIDS) or human
    immunodeficiency virus (HIV) infection, or tests positive for the hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or HCV-RNA. However, subjects who test positive for HCV antibody but negative for HCV-RNA are permitted to participate.
    -The subject has any of the following abnormal laboratory test values at the start of the Screening Period:
    a) Creatinine levels: >2 mg/dL (>177 μmol/L)
    b) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × the upper limit of normal (ULN) or total bilirubin >2 × ULN
    E.5 End points
    E.5.1Primary end point(s)
    Healing Phase:
    The percentage of subjects who have complete healing of EE by Week 8 as assessed by endoscopy

    Maintenance Phase:
    The percentage of subjects who maintain complete healing of EE after 24 weeks as assessed by endoscopy
    E.5.1.1Timepoint(s) of evaluation of this end point
    For Healing Phase Primary Endpoint - up to 8 weeks of treatment.
    For Maintenance Phase Primary Endpoint - after 24 weeks.
    E.5.2Secondary end point(s)
    Healing Phase:
    • The percentage of subjects who have complete healing of EE at Week 2 as assessed by endoscopy
    • The percentage of subjects who have complete healing of EE at Week 2 as assessed by endoscopy for subjects with baseline LA Classification Grades C or D
    • The percentage of subjects who have complete healing of EE by Week 8 as assessed by endoscopy for subjects with baseline LA Classification Grades C or D
    • The percentage of 24-hour heartburn–free days over the Healing Phase as assessed by the daily diary
    • The percentage of subjects with onset of sustained resolution of heartburn by Day 3(sustained resolution is defined as at least 7 consecutive days with no daytime or nighttime heartburn as assessed by the daily diary)

    Maintenance Phase:
    • The percentage of subjects who maintain complete healing of EE after 24 weeks as
    assessed by endoscopy for subjects with baseline LA Classification Grades C or D
    • The percentage of 24-hour heartburn–free days over the Maintenance Phase as assessed
    by the daily diary
    E.5.2.1Timepoint(s) of evaluation of this end point
    Healing Phase - after week 2, 8.
    Maintenance Phase - after week 24.
    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 No
    E.6.7Pharmacodynamic No
    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) 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 trial5
    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 EEA52
    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
    Bulgaria
    Czech Republic
    Hungary
    Poland
    United Kingdom
    United States
    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
    The end of the study is defined in the Protocol as the date on which the last subject completes the last visit (includes follow-up visit which is at 4 weeks after last study drug administration).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 800
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 288
    F.4.2.2In the whole clinical trial 1000
    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 Decision2020-02-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-06
    P. End of Trial
    P.End of Trial StatusOngoing
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