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    Summary
    EudraCT Number:2021-000091-11
    Sponsor's Protocol Code Number:PR200-102
    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:2021-04-22
    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 number2021-000091-11
    A.3Full title of the trial
    A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis
    Multicentrická, dvojitě zaslepená, placebem kontrolovaná studie fáze 2 hodnotící bezpečnost, účinnost a farmakokinetiku indukční léčby přípravkem PRA023 u subjektů se středně závažnou až závažnou aktivní ulcerózní kolitidou
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of PRA023 in patients with Ulcerative Colitis
    A.4.1Sponsor's protocol code numberPR200-102
    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 SponsorPrometheus Biosciences, 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 supportPrometheus Biosciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPrometheus Biosciences, Inc.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address9410 Carroll Park Drive
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92121
    B.5.3.4CountryUnited States
    B.5.6E-mailmm@prometheusbiosciences.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 namePRA023
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot yet assigned
    D.3.9.2Current sponsor codePRA023
    D.3.9.3Other descriptive namePRA023
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    Ulcerative colitis is a form of inflammatory bowel disease (IBD) that causes inflammation and ulcers in the colon resulting in abdominal pain and bloody diarrhea.
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    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
    1. To assess the safety and tolerability of PRA023 following 12-weeks of induction therapy
    2. To compare the efficacy of PRA023 vs placebo for induction of clinical remission at Week 12


    E.2.2Secondary objectives of the trial
    Compare the efficacy of PRA023 vs placebo for induction of:
    - endoscopic improvement
    - clinical response
    - histologic remission
    - histologic-endoscopic mucosal improvement
    - mucosal healing

    Compare the efficacy of PRA023 vs placebo for change in IBDQ

    Compare the efficacy of PRA023 vs placebo in subjects who are companion diagnostic positive (CDx+) for induction of:
    - clinical remission
    - endoscopic improvement
    - clinical response
    - histologic remission
    - histologic-endoscopic mucosal improvement
    - mucosal healing

    Compare the efficacy of PRA023 in CDx+ vs CDx- subjects for induction of clinical remission.

    Compare the efficacy of PRA023 vs placebo for change in IBDQ
    Compare the efficacy of PRA023 vs placebo in CDx+ subjects for change in IBDQ
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: Pharmacokinetic Sub-Study
    Date and Version: 11MAR2021, V01
    Objective: To better understand the PK of PRA023 in subjects with UC and to evaluate the PK of PRA023 at steady state
    E.3Principal inclusion criteria
    Subjects are required to meet the following criteria in order to be included in the study:
    1. Male or female ≥18 years of age
    2. Subjects must have had a documented diagnosis of UC (endoscopy + histology) to be eligible for study participation. For subjects with no documented confirmation of UC diagnosis or if previous diagnosis is not deemed conclusive, UC diagnosis must be confirmed at time of screening colonoscopy
    3. Moderately to severely active UC as defined by 3-component Modified Mayo Score (3 components of rectal bleeding, stool frequency, and endoscopy) of 4 to 9, inclusive, with Modified Mayo endoscopic subscore ≥2 and rectal bleeding subscore ≥ 1.
    4. Subjects must satisfy at least one of the following criteria:
    a) In the past, had an inadequate response to one or more of the following treatments:
    i. Oral prednisone ≥ 40 mg/day (or equivalent) or budesonide ≥ 9 mg/day for at least 2 weeks
    ii. Corticosteroid dependence as defined by failed to successfully taper to < 10 mg/day of prednisone equivalent (i.e., had a flare of disease) within 3 months of starting therapy, or if relapse occurs within 3 months of stopping corticosteroids
    iii. Immunosuppressants (azathioprine ≥ 2 mg/kg/day or 6-mercaptopurine ≥ 1.0 mg/kg/day [or documentation of a therapeutic concentration of 6-thioguanine nucleotide]) for at least 12 weeks
    iv. An approved anti-TNF agent at an approved labeled dose for at least 8 weeks
    v. Vedolizumab at the approved labelled dose for at least 8 weeks
    vi. An approved JAK inhibitor (e.g., tofacitinib) at an approved labelled dose for at least 8 weeks
    vii. An approved anti-IL-12/23 (e.g., ustekinumab) at an approved labelled dose for at least 8 weeks
    viii. An approved sphingosine 1-phosphate receptor (S1PR) modulator at an approved labelled dose for least 12 weeks
    OR
    b) Had been intolerant to one or more of the above-mentioned treatments (e.g., unable to achieve doses or treatment durations because of dose limiting side effects [e.g., leukopenia, psychosis, uncontrolled diabetes, elevated liver enzymes]).
    OR
    c) Currently receiving one or more of the following treatments:
    i. Oral Prednisone ≥ 10 mg/day (or equivalent) for at least 3months
    ii. Immunosuppressants [azathioprine ≥ 2 mg/kg/day or 6-mercaptopurine ≥ 1.0 mg/kg/day (or documentation of a therapeutic concentration of 6 thioguanine nucleotide)] for at least 8 weeks
    Notes on subjects who have had prior biologic/biologic-like therapy(ies) (anti-TNF, JAK inhibitor, anti-IL-23, and/or anti-integrin):
    i. The study will include a maximum of 70% subjects who have had prior biologic/biologic-like therapy(ies) experience. Upon reaching the maximum number of allowed biologic/biologic-like experienced subjects (70%), subjects who have had prior biologic/biologic-like experience will no longer be allowed to enter the study.
    ii. Subject cannot have failed (no response, insufficient response, loss of response, and/or intolerance) > 3 classes or > 4 individual biologic/biologic-like therapies (exclusion criterion #26).
    5. For subjects who are women of childbearing potential (WOCBP) involved in any sexual intercourse that could lead to pregnancy, the subject has used two highly effective methods of contraception for at least 4 weeks prior to Day 1 and agrees to continue to use two highly effective methods of contraception until at least 12 weeks after the last dose of study drug.
    6. Male subjects must use two highly effective methods of contraception from screening to 12 weeks after the last dose of study drug.
    7. Subject must meet drug stabilization requirements, as applicable:
    a) Oral corticosteroid treatment must have been reduced to the equivalent of ≤ 20 mg prednisone or ≤ 9 mg budesonide daily at a stable dose for at least 2 weeks prior to randomization.
    b) Oral aminosalicylates should be at a stable dose for at least 2 weeks prior to randomization.
    c) Azathioprine and 6-mercaptopurine should be at a stable dose for at least 4 weeks prior to randomization.
    8. Able to provide written informed consent and understand and comply with the requirements of the study.
    E.4Principal exclusion criteria
    1. WOCBP and men with WOCBP partner unwilling/ unable to use two highly effective methods of contraception
    2. Women who are pregnant or breastfeeding
    3. Women with a positive pregnancy test
    4. Diagnosis of Crohn's disease or indeterminate colitis
    5. UC limited to the rectum (<15 cm from anal verge)
    6. Current evidence of fulminant colitis, toxic megacolon, or bowel perforation
    7. Current or impending need for colostomy or ileostomy
    8. Previous total proctocolectomy or subtotal colectomy
    9. Surgical bowel resection within 3 months before screening
    10. Concomitant primary sclerosing cholangitis (PSC)
    11. Past or current evidence of colonic dysplasia that has not been completely removed
    12. Scheduled or anticipate the need for surgery, except dermatologic procedures
    13. History of clinically significant drug or alcohol abuse
    14. Concomitant illness that is likely to require systemic glucocorticosteroid therapy during study (e.g., moderate to severe asthma)
    15. Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, pulmonary, cardiac, neurological, ophthalmologic or cerebral disease that might place the subject at unacceptable risk for participation
    16. Have history of cancer within the last 5 years (other than non-melanoma skin cell cancers cured by local resection). Existing non-melanoma skin cell cancers must be removed prior to enrollment. Subjects with carcinoma in situ or localized cervical cancer, treated with definitive surgical intervention, are allowed
    17. At risk of tuberculosis (TB), specifically subjects with: (1) history of active TB; (2) current active TB OR (3) latent TB which was not successfully treated
    18. With any serious bacterial infection within the last 3 months, unless treated and resolved with antibiotics, or any chronic bacterial infection.
    19. Females who have had a breast cancer screening that is suspicious for malignancy or cannot be reasonably excluded from clinical, laboratory or other diagnostic evaluations
    20. Active bacterial or viral infections including HIV, Hepatitis B or Hepatitis C infection during screening. Hepatitis C with no recurrence for ≥ 1 year are allowed
    21. With herpes zoster reactivation or CMV that resolved less than 2 months prior to signing ICF
    22. Received any live vaccines within 3 months or who will need live vaccine during the study.
    23. Positive stool culture for enteric pathogens
    24. Stool positive for clostridium difficile toxin
    25. Any of the following lab values:
    a) Hgb < 8.0 g/dL (80 g/L)
    b) WBC < 2,500/mm3 (2.5 x 10E9/L)
    c) Neutrophils <1,000/mm3 (1 x 10E9/L)
    d) Platelets < 100,000/mm3 (100 x 10E9/L)
    e) Serum creatinine > 2 times upper limit of normal (ULN)
    f) Serum alanine aminotransferase (ALT) or aspartate aminotransferase > 2 times ULN
    g) Any other laboratory test results that show subject at unacceptable risk for participation
    26. Failed > 3 classes (anti-TNF, anti-integrin, anti-IL12/23, JAK inhibitor, S1PR modulator) or > 4 individual biologic/biologic-like therapies
    27. Any marketed biologic or biologic-like used for UC, 2 weeks for tofacitinib, 8 weeks for anti-TNF agents, 10 weeks for S1PR, and 12 weeks, for vedolizumab and ustekinumab prior to randomization or if drug level per therapeutic dose monitoring is greater than lower limit of detection.
    28. Any biologic immunomodulators not covered in #27, used for UC or other conditions within 8 weeks prior to randomization or if drug level per therapeutic dose monitoring is greater than lower limit of detection
    29. Rituximab within 1 year prior to randomization
    30. Parenteral corticosteroids within 4 weeks or rectal administration of corticosteroids within 2 weeks prior to randomization
    31. Rectal administration of 5-ASA within 2 weeks prior to randomization
    32. Tacrolimus, methotrexate, cyclosporine, mycophenolate mofetil (CellCept®), immunoadsorption columns (such as Prosorba columns), D Penicillamine, Leflunomide, Thalidomide, fish-oil preparations, probiotics, fecal transplantation, non-steroidal anti-inflammatory agents (NSAIDs), aspirin > 81 mg/day within 2 weeks prior to randomization
    33. Other investigational chemical agent within 30 days or other investigational biologic agent within 8 weeks or 5 half-lives (whichever is longer) of randomization
    34. Prior exposure to PRA023
    35. Prisoners or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness must not be enrolled into this study
    36. Legal or mental incapacitation, or inability to understand and comply with the requirements of the study
    E.5 End points
    E.5.1Primary end point(s)
    1. The proportion of subjects reporting adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and markedly abnormal laboratory values.
    2. The proportion of subjects in the 3-component Modified Mayo Score clinical remission (as defined by endoscopic subscore of 0 or 1, rectal bleeding subscore of 0, and stool frequency subscore of 0 or 1 and not greater than Baseline) at Week 12. The 3-component Modified Mayo Score ranges from 0-9 and includes rectal bleeding, stool frequency and endoscopic assessment domains.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    1. The proportion of subjects with endoscopic improvement, as defined by endoscopy subscore ≤1 with no friability) at Week 12.
    2. The proportion of subjects in 3-component Modified Mayo Score clinical response at Week 12. The 3-component Modified Mayo Score clinical response is defined by reduction from Baseline ≥2 points and ≥30% in modified Mayo Score, accompanied by a reduction ≥ 1 in rectal bleeding subscore or absolute rectal bleeding subscore ≤1.
    3. The proportion of subjects in the 3-component Modified Mayo Score clinical remission (as defined by endoscopic subscore of 0 or 1, rectal bleeding subscore of 0, and stool frequency subscore of 0 or 1 and not greater than Baseline), in CDx+ subjects (Cohort 1 + Cohort 2) treated with PRA023 compared to CDx+ placebo-treated subjects at Week 12. The 3-component Modified Mayo Score ranges from 0-9 and includes rectal bleeding, stool frequency and endoscopic assessment domains.
    4. The proportion of subjects with histologic remission (defined Geboes score ≤3.1) at Week 12.
    5. The proportion of subjects with histologic-endoscopic mucosal improvement (defined as Geboes score ≤3.1 and endoscopy subscore ≤1 with no friability) at Week 12.
    6. The proportion of subjects with endoscopic improvement, as defined by endoscopy subscore ≤1 with no friability, in CDx+ subjects (Cohort 1 + Cohort 2) treated with PRA023 compared to CDx+ placebo-treated subjects at Week 12.
    7. The proportion of subjects in 3-component Modified Mayo Score clinical response in CDx+ subjects treated with PRA023 compared to CDx+ placebo-treated subjects at Week 12. The 3-component Modified Mayo Score clinical response is defined by reduction from Baseline ≥ 2 points and ≥ 30% in modified Mayo Score, accompanied by a reduction ≥ 1 in rectal bleeding subscore or absolute rectal bleeding subscore ≤ 1.
    8. The proportion of subjects with histologic remission, defined as Geboes score ≤3.1, in CDx+ subjects (Cohort 1 + Cohort 2) treated with PRA023 compared to CDx+ placebo-treated subjects at Week 12.
    9. The proportion of subjects with histologic-endoscopic mucosal improvement (defined as Geboes score ≤3.1 and endoscopy subscore ≤1 with no friability), in CDx+ subjects (Cohort 1 + Cohort 2) treated with PRA023 compared to CDx+ placebo-treated subjects at Week 12.
    10. The proportion of subjects with clinical remission (defined as endoscopic subscore of 0 or 1, rectal bleeding subscore of 0, and stool frequency subscore of 0 or 1 and not greater than Baseline) in CDx+ subjects (Cohort 1 + Cohort 2) treated with PRA023 compared to in CDx- subjects treated with PRA023 at Week 12.
    11. The proportion of subjects with mucosal healing (defined as Geboes score ≤2B.1 and endoscopy subscore of ≤ 1) at Week 12.
    12. The proportion of subjects with mucosal healing (defined as Geboes score ≤2B.1 and endoscopy subscore of ≤ 1), in CDx+ subjects (Cohort 1 + Cohort 2) treated with PRA023 compared to CDx+ placebo-treated subjects at Week 12.
    13. The proportion of subjects with IBDQ response, as defined by ≥ 16-point increase from Baseline at Week 12.
    14. The proportion of subjects with IBDQ response, as defined by ≥ 16-point increase from Baseline, in CDx+ subjects (Cohort 1 + Cohort 2) treated with PRA023 compared to CDx+ placebo-treated subjects at Week 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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) 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 trial2
    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 EEA23
    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
    Australia
    Belarus
    Canada
    Georgia
    Israel
    Russian Federation
    Serbia
    Ukraine
    United States
    Belgium
    Bulgaria
    France
    Hungary
    Poland
    United Kingdom
    Czechia
    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 months4
    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 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: 136
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 170
    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)
    After participants have stopped taking study drug, they will undergo 12 weeks of follow-up. The investigator will talk to them about how best to continue their medical care.
    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 Decision2021-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-10
    P. End of Trial
    P.End of Trial StatusOngoing
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