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    Summary
    EudraCT Number:2018-005086-39
    Sponsor's Protocol Code Number:BT-11-201
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-04-08
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2018-005086-39
    A.3Full title of the trial
    A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy
    and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis
    Randomizált, placebo kontrollos, kettős vak, multicentrikus vizsgálat az orálisan alkalmazott BT-11 hatásosságának és biztonságosságának vizsgálatára enyhe-középsúlyos colitis ulcerosában szenvedő betegeknél.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy
    and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis
    Randomizált, placebo kontrollos, kettős vak, multicentrikus vizsgálat az orálisan alkalmazott BT-11 hatásosságának és biztonságosságának vizsgálatára enyhe-középsúlyos colitis ulcerosában szenvedő betegeknél.
    A.4.1Sponsor's protocol code numberBT-11-201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03861143
    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 SponsorLandos Biopharma 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 supportLandos Biopharma Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLandos Biopharma Inc.
    B.5.2Functional name of contact pointclinical trial management Group
    B.5.3 Address:
    B.5.3.1Street Address1800 Kraft Drive, Suite 216
    B.5.3.2Town/ cityBlacksburg
    B.5.3.3Post codeVA 24060
    B.5.3.4CountryUnited States
    B.5.4Telephone number+15402181767
    B.5.6E-mailclinicaltrials@landosbiopharma.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.3.2Product code BT-11
    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 INNto be requested
    D.3.9.1CAS number 1912399-91-7
    D.3.9.2Current sponsor codeBT-11
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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.3.2Product code BT-11
    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 INNto be requested
    D.3.9.1CAS number 1912399-91-7
    D.3.9.2Current sponsor codeBT-11
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mild to Moderate Ulcerative Colitis
    Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD).
    UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors.
    enyhe-középsúlyos colitis ulcerosa
    A gyulladásos bélbetegség (IBD) a gyomor-bél rendszer ismeretlen eredetű autoimmun megbetegedése, melynek elsődlegesen 2 klinikai megjelenési formája van: au ulcerative colitis (UC - fekélyes bélgyulladás) és a Crohn-betegség.
    Az UC kialakulásában a bél mikrobiomjának, a szabályozatlan immunválaszoknak, genetikai mutációknak, az étrendnek és további környezeti tényezők összetett kölcsönhatásai játszanak szerepet.
    E.1.1.1Medical condition in easily understood language
    Ulcerative colitis is an Inflammatory Bowel Disease (IBD) that effects the colon and causes the digestive tract to become inflamed and develop sores that produce pus and mucous.
    Az ulcerativ colitis (UC) egy gyulladásos bélbetegség (IBD), mely a vastagbelet érinti és a bélcsatorna gyulladását, azon genny- és nyák termelő sebek kialakulását okozza.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10009900
    E.1.2Term Colitis ulcerative
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Objectives
    induction and maintenance period
    The primary objective of this study is to establish the efficacy and safety of oral BT-11 in inducing clinical remission in mild to moderate ulcerative colitis (UC).
    Open Label extension period
    To assess the safety of the extended use of oral BT-11 in subjects with
    mild to moderate ulcerative colitis
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to evaluate the following at Week 12:
    1. The effects of BT-11 on disease activity measured by symptoms, endoscopy, histology, and biomarkers
    2. Health-related quality of life
    3. The pharmacokinetic (PK) parameters of BT-11
    4. Safety

    The exploratory objectives of this study are to evaluate the following through Week 30:
    1. The effects of BT-11 on disease activity measured by symptoms, endoscopy, histology, and biomarkers
    2. Health-related quality of life
    3. The PK parameters of BT-11
    4. Safety
    5. Target engagement and mechanism of action
    6. ExploreThe association of drug exposure in colonic mucosal tissue biopsies with clinical, endoscopic, histopathologic, cellular, and molecular outcomes.

    Open Label Extension period
    To assess the safety of the extended use of oral BT-11
    To evaluate the effects of BT 11 on measures of efficacy (based on
    subgroups defined in the statistical analysis plan)




    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Male and female subjects aged 18 to 75 years, inclusive.
    2) Diagnosis of UC for at least 3 months prior to screening.
    3) Mild to moderate UC, as defined by a total Mayo Score of 4 to 10 inclusive at baseline with a MES ≥ 2 (confirmed by central reader).
    4) If subjects have previously received biologic therapy for UC (i.e.,TNF, tumor necrosis factor [TNF] antagonists, vedolizumab or ustekinumab), they must have a washout period of 8 weeks prior to randomization, and any previous failure of biologic treatment is limited to only one class of biologic. (Note: this inclusion criterion is only applicable until 58 subjects with prior exposure to biologic therapy have been randomized).
    5) If subjects are receiving the following UC treatments, they must be on a stable dose for at least 1 month prior to randomization: 5-aminosalicylates (5-ASAs) (not exceeding 4.8 g per day), oral corticosteroids (not exceeding prednisone 20 mg, budesonide 9 mg, or equivalent).
    6) If subjects are receiving bile-salt sequestrant, they must be on a stable dose for at least 3 months prior to randomization.
    7) If subjects are receiving any nonprohibited medications, they must agree to maintain stable doses of concomitant medications for UC for the duration of the trial.
    8) Unlikely to conceive, as defined by 1 of the following: a) subject is surgically sterilized female, b) subject is postmenopausal female ≥ 45 years of age with clinical documentation of menopause (i.e., 12 months without menses), or c) subject is male or subject is woman of child bearing potential (WOCBP), and agrees to abstain from heterosexual activity, use adequate hormonal contraception, or use double barrier contraception.
    9) For WOCBP, the subject must have a negative pregnancy test at screening and within 24 hours prior to the first dose of study drug.
    10) Able to participate fully in all aspects of this clinical trial.
    11) Written informed consent must be obtained and documented.
    E.4Principal exclusion criteria
    1) A diagnosis of CD, indeterminate colitis, or presence or history of fistula with CD.
    2) Severe UC as per modified Truelove and Witts criteria (≥ 6 bloody stools per day and one or more of the following: pulse > 90 bpm, temperature > 37.8°C, hemoglobin < 10.5 g/dl, or high sensitivity C-reactive protein (hs CRP) > 30 mg/l.
    3) Disease activity limited to distal 15 cm (proctitis).
    4) Treatment with immunosuppressant (azathioprine, 6-mercaptopurine [6-MP]) within 25 days prior to randomization.
    5) History of toxic megacolon, abdominal abscess, symptomatic colonic stricture, or stoma; history or is at imminent risk of colectomy.
    6) History or current evidence of colonic dysplasia or adenomatous colonic polyps.
    7) Current bacterial or parasitic pathogenic enteric infection, including Clostridium difficile, known infection with hepatitis B or C virus, known infection with human immunodeficiency virus, infection requiring hospitalization or intravenous antimicrobial therapy, or opportunistic infection within 6 months prior to screening, any infection requiring antimicrobial therapy within 2 weeks prior to screening, history of more than 1 episode of herpes zoster or any episode of disseminated zoster.
    8) Live virus vaccination within 1 month prior to screening.
    9) Treatment with cyclosporine, mycophenolate, tacrolimus, or tofacitinib within 4 weeks prior to randomization.
    10) Treatment with intravenous corticosteroids, rectal corticosteroids, or rectal 5-ASA within 2 weeks prior to randomization.
    11) Fecal microbiota transplantation within 1 month prior to screening.
    12) A concurrent clinically significant, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, GI, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, might confound the study results or poses additional risk to the subject.
    13) Known primary or secondary immunodeficiency.
    14) History of myocardial infarction, unstable angina, transient ischemic attack, decompensated heart failure requiring hospitalization, congestive heart failure (New York Health Association [NYHA] Class 3 or 4), uncontrolled arrhythmias, cardiac revascularization, stroke, uncontrolled hypertension, or uncontrolled diabetes within 6 months of screening.
    15) Clinically meaningful laboratory abnormalities at screening, as determined and documented by the investigator.
    16) Pregnant or lactating females.
    17) Any surgical procedure requiring general anesthesia within 1 month prior to screening, or planned elective surgery during the study.
    18) History of malignant neoplasms or carcinoma in situ within 5 years prior to screening.
    19) Current or recent history of alcohol dependence or illicit drug use that in the opinion of the investigator may interfere with the subject’s ability to comply with the study procedures.
    20) Mental or legal incapacitation at the time of screening visit or a history of clinically significant psychiatric disorders that would impact the ability to participate in the trial according to the investigator.
    21) Unable to attend study visits or comply with procedures.
    22) Concurrent participation in any other interventional study.
    23) Received any investigational therapy within 30 days of initiation of study drug.
    24) Serious underlying disease other than UC that in the opinion of the investigator may interfere with the subject’s ability to participate fully in the study.
    25) Previous exposure to BT-11.
    26) Prior enrolment in the current study and had received study treatment.
    27) Current treatment with antimotility medications.
    28) Treatment with sirolimus within 4 weeks prior to randomization.

    E.5 End points
    E.5.1Primary end point(s)
    induction and maintenance period
    To assess the efficacy of BT-11 in inducing clinical remission in subjects with UC, this study will evaluate the primary efficacy endpoint of clinical remission rate at Week 12 as defined by total Mayo score ≤ 2 with all subscores ≤ 1.
    Open Label Extension period
    • Percentage of subjects with treatment emergent adverse events
    (TEAEs), serious adverse events (SAEs), and TEAEs that lead to
    discontinuation of study drug at each study visit
    • Results of vital signs and physical examination
    E.5.1.1Timepoint(s) of evaluation of this end point
    induction and maintenance period
    week 12 or visit 6
    open label extension period
    each study visit
    E.5.2Secondary end point(s)
    induction and maintenance period
    To assess the effects of BT-11 on disease activity in subjects with UC, the following evaluations will be made in the following ranked order:
    induction and maintenance period
    • Endoscopic remission rate at Week 12 defined as a Mayo endoscopic
    subscore (MES) of 0 or 1
    • Endoscopic response rate at Week 12 defined as a decrease from
    baseline in MES of ≥ 1 point)
    • Mucosal healing rate at Week 12 defined by a MES of 0 or 1 and a
    Geboes score of < 3.1
    • Histologic remission rate at Week 12 defined by a Geboes score of <
    3.1
    • Clinical response rate at Week 12 defined as decrease from baseline in
    Mayo Score of ≥ 3 points and ≥ 30 percent, with an accompanying
    decrease in the subscore for rectal bleeding of ≥ 1 point or an absolute
    subscore for rectal bleeding of 0 or 1.

    OTHER SECONDARY EFFICACY EVALUATIONS
    • Mean change in partial Mayo Score from baseline to Weeks 2, 6, and 12
    • Mean change in Mayo rectal bleeding subscore from baseline to Weeks
    2, 6, and 12
    • Mean change in Mayo stool frequency subscore from baseline to Weeks
    2, 6, and 12
    • Mean change in MES from baseline to Week 12
    • Mean change in Robarts Histopathology Index (RHI) scores from
    baseline to Week 12
    • Mean change in fecal calprotectin from baseline to Weeks 2, 6, and 12
    • Normalization of fecal calprotectin at Weeks 2, 6, and 12 in subjects
    with abnormal fecal calprotectin at baseline (abnormal defined as fecal
    calprotectin > 250 mg/kg)
    • Mean change in high-sensitivity C-reactive protein (hs-CRP) from
    baseline to Weeks 2, 6, and 12
    • Normalization of hs-CRP at Weeks 2, 6, and 12 in subjects with
    abnormal hs-CRP at baseline (abnormal defined as hs-CRP > 3.0 mg/L)
    • Mean change in UC-100 score from baseline to Week 12
    • Change in Robarts Symptom and Impacts Questionnaire for Ulcerative
    Colitis (SIQ UC) items - from baseline to Week 12
    • Mean change in Inflammatory Bowel Disease Questionnaire (IBDQ)score from baseline to Week 12
    • BT-11 concentration in serum, feces, and tissue for the active BT-11
    treatment group
    • Frequency and severity of adverse events (AEs)
    • Changes in clinical chemistry and hematology from baseline
    • Results of vital signs and physical examination
    • ECG findings

    Exploratory Week 30 endpoints:
    • Durable clinical remission defined as clinical remission at both Week
    12 and Week 30
    • Durable clinical response defined as clinical response at both Week 12
    and Week 30
    • Endoscopic remission rate at Week 30 defined by a MES of 0 or 1
    • Endoscopic response rate at Week 30 defined as a decrease from
    baseline in MES of ≥ 1 point)
    • Corticosteroid-free clinical remission at Week 30
    • Corticosteroid-free endoscopic remission at Week 30
    • Mucosal healing rate at Week 30 defined by a MES of 0 or 1 and a
    Geboes score of < 3.1
    • Histologic remission rate at Week 30 defined by a Geboes score of <
    3.1
    • Clinical response rate at Week 30 defined as decrease from baseline in
    Mayo Score of ≥ 3 points and ≥ 30 percent, with an accompanying
    decrease in the subscore for rectal bleeding of ≥ 1 point or an absolute
    subscore for rectal bleeding of 0 or 1
    • Mean change in partial Mayo Score from baseline to Weeks 18, 24, and
    30
    • Mean change in Mayo rectal bleeding subscore from baseline to Weeks
    18, 24, and 30
    • Mean change in Mayo stool frequency subscore from baseline to Weeks
    18, 24, and 30
    • Mean change in MES from baseline to Week 30
    • Mean change in RHI scores from baseline to Week 30
    • Mean change in fecal calprotectin from baseline to Weeks 18, 24, and
    30
    • Normalization of fecal calprotectin at Weeks 18, 24, and 30 in subjects
    with abnormal fecal calprotectin at baseline (abnormal defined as fecal
    calprotectin > 250 mg/kg)
    • Mean change in hs-CRP from baseline to Weeks 18, 24, and 30
    • Normalization of hs-CRP at Weeks 18, 24, and 30 in subjects with
    abnormal hs-CRP at baseline (abnormal defined as hs-CRP > 3.0 mg/L)
    • Mean change in UC-100 score from baseline to Week 30
    • Change in Robarts Symptom and Impacts Questionnaire for Ulcerative
    Colitis (SIQ-UC) items baseline to Week 30
    • Mean change in IBDQ score from baseline to Week 30
    • BT-11 concentration in serum, feces, and tissue at Week 30 in the
    active BT-11 treatment group
    • Frequency and severity of adverse events (AEs)
    • Changes in clinical chemistry and hematology from baseline
    • Results of vital signs and physical examination
    • ECG findings

    Open Label Extension period
    • Partial Mayo Score clinical remission, defined as partial Mayo Score <
    2, at each study visit
    • Partial Mayo Score clinical response, defined as partial Mayo Score
    decrease of ≥ 2 points from Day 1, at each study visit
    • Mean change in partial Mayo Score from Day 1 to each study visit
    • Mean change in Mayo rectal bleeding subscore from Day 1 to each
    study visit
    • Mean change in Mayo stool frequency subscore from Day 1 to each
    study visit

    E.5.2.1Timepoint(s) of evaluation of this end point
    induction and maintenance period
    at various timepoints during the study at baseline and week 2, 6, 12, 18, 24 and 30.
    open label extension period
    each study visit
    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 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) 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 No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Belarus
    Bosnia and Herzegovina
    Croatia
    Georgia
    Hungary
    Moldova, Republic of
    Poland
    Russian Federation
    Serbia
    Ukraine
    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
    LVLS
    utolsó beteg utolsó vizitje
    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 months6
    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: 185
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 195
    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)
    Upon completion of the study, subjects will be eligible to receive ongoing therapy as part of longer-term follow on studies.
    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 Decision2019-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-06-17
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