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    Summary
    EudraCT Number:2018-003558-26
    Sponsor's Protocol Code Number:ABX464-103
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-04-12
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2018-003558-26
    A.3Full title of the trial
    A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-α] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.
    A.4.1Sponsor's protocol code numberABX464-103
    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 SponsorABIVAX
    B.1.3.4CountryFrance
    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 supportABIVAX
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbivax
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address5 Rue dela Baume
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75008
    B.5.3.4CountryFrance
    B.5.4Telephone number+3315383 0961
    B.5.6E-mailPaul.Gineste@abivax.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 ABX464
    D.3.4Pharmaceutical form Capsule, hard
    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 INNABX464
    D.3.9.2Current sponsor codeABX464
    D.3.9.3Other descriptive nameABX464
    D.3.9.4EV Substance CodeSUB184487
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 ABX464
    D.3.4Pharmaceutical form Capsule, hard
    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 INNABX464
    D.3.9.2Current sponsor codeABX464
    D.3.9.3Other descriptive nameABX464
    D.3.9.4EV Substance CodeSUB184487
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboCapsule, hard
    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
    Moderate to Severe Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    In Ulcerative Colitis the lining of the colon becomes inflamed and develops tiny open sores that produce pus and mucous.This causes abdominal discomfort and frequent emptying of the colon (diarrhoea).
    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 10066678
    E.1.2Term Acute 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
    The primary objective of the study is to determine an optimal ABX464 dose to be used in moderate to severe active ulcerative colitis patients who have failed or are intolerant to immunomodulators, Anti-TNFα, vedolizumab, JAK inhibitors and/or corticosteroids by comparing the mean change from baseline in the MMS at week 8 between each ABX464 group and placebo.
    E.2.2Secondary objectives of the trial
    ▪ To evaluate the global effect of ABX464 on MMS at Week (W) 8 and W16 and on partial Modified Mayo Score (MMS) at every study visit vs placebo.
    To evaluate the effect of the different dose groups ofABX464 vs placebo:
    ▪ on MMS at W16 and on partial MMS at every study visit. ▪ on clinical remission at W8 and atW16 ▪ on clinical response at W8 and atW16
    ▪ on endoscopic improvement/remission, by segment, at W8 and W16 ▪ on mucosal healing, at W8 and W16▪ on stool and rectal bleeding frequency at every study visit ▪ on fecal calprotectin and CRP levels at W8 and W16
    ▪ on miR-124 expression in tissue at W8 and W16 and in total blood at everytimepoint▪ on the rectal/sigmoidal infiltrates using the Robarts Histopat.Index, the Geboes and Nancy Hist. Scor Scales at W8 and W16▪ on Quality of Life measured by the IBDQ at W8 and W16 ▪ on IL-6, TNFα, IL-1b, IL-10 plasma concentrat. at every timepoint▪ its safety profile▪ To assess the pharmacok.ofABX464 and its main active metabol. ABX464-N-Glu
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A patient will be eligible to participate in this study if ALL the following criteria are met:
    ▪ Men or women age 18 - 75 years;▪ Diagnosis of moderate to severe active UC (including ulcerative proctitis if proximal extension of disease occurs beyond 10 cm) confirmed by endoscopy and histology at least 12 Wk prior to scr. visit. Moderate to severe active UC defined by MMS of 5 to 9 inclusive (on scale 0-9). Moderate to severe active UC should be confirmed at scr. visit with a centrally read endoscopy sub-score of at least 2 (on a scale of 0-3);
    ▪ Patients having either a documented inadequate response, no response, a loss of response, or an intolerance to either immunosuppressant treatment, TNF inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. Inadequate response, no response, loss of response is defined as:
    o Active disease or relapse in spite of thiopurines or methotrexate given at an appropriate dose for at least 3 months (i.e. azathioprine 2–2.5 mg/kg/day or mercaptopurine 1–1.5 mg/kg/day in the absence of leukopenia), and/or
    o Active disease despite corticosteroids treatment (prednisolone up to 0.75 mg/kg/day) over a period of 4 Weeks, and/or
    o Active disease or relapse in spite of adequate treatment with tumor necrosis factor [TNF] inhibitors or vedolizumab, and/or
    o Active disease or relapse in spite of adequate treatment with JAK inhibitors over a period of at least 6 Weeks.▪ Patients receiving oral corticosteroids must have been on a stable dose of prednisone or prednisone equivalent (≤20mg/day) or on beclomethasone diproprionate (≤5mg/day) or on budesonide MMX (≤9mg/day)for at least 2Weeks prior to the screening visit;
    ▪ Topical corticosteroids and topical 5-aminosalicylic acid preparations must have been withdrawn at least 2 Weeks prior to the screening visit;▪ Patients who are on oral 5-aminosalicylic acid must have been on a stable dose for at least 4 Weeks prior to the screening visit;▪ Patients who are receiving immunosuppressants in the form of azathioprine, 6-mercaptopurine or methotrexate needed to be on a stable dose for at least 4 Weeks prior to screening visit Patients taking methotrexate also are advised to take folic acid 1 mg/day (or equivalent) supplementation if there is no contraindication
    ▪ Patients on probiotics must be on stable doses for at least 2 Weeks prior to the screening visit;▪ Patients on antidiarrheals must be on stable doses for at least 2 Weeks prior to the screening visit;▪ Patients who have received[TNF] inhibitors, vedolizumab or other biologics must have discontinued therapy at least 8Weeks prior to the screening visit due to lack or insufficient efficacy or intolerance
    ▪ Patients previously treated with cyclosporine, tacrolimus or JAK inhibitors must have discontinued therapy at least 4week prior to the screening visit due to lack or insufficient efficacy or intolerance;▪ Patients previously treated with tube feeding, defined formula diets, or parenteral alimentation/nutrition must have discontinued treatment 3weeks before the screening visit and must be able to take, orally, appropriate amount of food (calories) and liquids to maintain body weight
    ▪ Patients with surveillance colonoscopy defined as per ECCO guidelines
    ▪ Patients with the following hematol. and bioch. lab. parameters obtained at screening:
    o Hemoglobin>9.0 g dL-1 o Absolute neutrophil count≥750 mm-3 o Platelets ≥ 100,000 mm-3 o Total serum creatinine ≤ 1.3 x ULN (upper limit of normal)
    o Creatinine clearance > 90 mL min-1 by the Cockcroft-Gault equation within60 days prior to baseline; o Total serum bilirubin < 1.5 x ULN
    o Alkaline phosphatase, AST (SGOT) and ALT (SGPT) < 2 x ULN;
    ▪ Patients are able and willing to comply with study visits and procedures as per protocol;▪ Patients should understand, sign and date the written voluntary ICF at the screening visit prior to any protocol-specific procedures are performed;▪ Patients should be affiliated to a social security regimen (for French sites only);▪ Females and males receiving the study treatment and their partners must agree to use a highly effective contraceptive method during the study and for 6 months after end of study or early termination. Contraception should be in place at least 2 Weeks prior to study participation. Women must be surgically sterile or if of childbearing potential must use a highly effective contraceptive method. Women of childbearing potential (WOCBP) will enter the study after confirmed menstrual period and a negative pregnancy test. In each case of delayed menstrual period (over 1 month between menstruations) confirmation of absence of pregnancy is required. This recommendation also applies to WOCBP with an infrequent or irregular menstrual cycle. Female and male patients must not be planning pregnancy during the trial and for 6 months post completion of their participation. Male should use condoms and not donate sperm as long as contraception is required.
    E.4Principal exclusion criteria
    Patients who meet any of the following exclusion criteria will be excluded from the study:
    ▪ Patients with Crohn's Disease (CD) or presence or history of fistula, indeterminate colitis (IC), infectious/ischemic colitis or microscopic colitis (lymphocytic and collagenous colitis);
    ▪ History of toxic megacolon, abdominal abscess, symptomatic colonic stricture or stoma; history or imminent colectomy, colonic malignancy;
    ▪ History or current evidence of colonic dysplasia or adenomatous colonic polyps. Patient with severe gastrointestinal complications; e.g., short bowel syndromes, recent or planned bowel surgery, Ileostomy and/or colostomy, recent bowel perforation;
    ▪ History of more than one episode of herpes zoster or a history (single episode) of disseminated zoster;
    ▪ Patients with active infections at screening such as infected abdominal abscess, Clostridium difficile (stool antigen and toxin required), CMV[(positive immunoglobulin M (IgM)], TB colitis and recent infectious hospitalization;
    ▪ Patients previously treated with ABX464;
    ▪ Acute, chronic or history of clinically relevant pulmonary, cardiovascular, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable CNS pathology such as seizure disorder, angina or cardiac arrhythmias, active malignancy or any other clinically significant medical problems as determined by physical examination and/or laboratory screening tests and/or medical history;
    ▪ Acute, chronic or history of immunodeficiency or autoimmune disease;
    ▪ History of malignancy excluding patients considered cured (5 years disease free survivors);
    ▪ Serious illness requiring systemic treatment and/or hospitalization within 3 Weeks prior to baseline;
    ▪ Pregnant or breast-feeding women;
    ▪ Illicit drug or alcohol abuse or dependence;
    ▪ Patients who received live vaccine 30 days or fewer before first dose of
    study treatment and/or who's planning to receive such a vaccine during
    the study duration;
    ▪ Use of any investigational or non-registered product within 3 months preceding baseline;
    ▪ Any condition, which in the opinion of the investigator, could compromise the patient's safety or adherence to the study protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Reduction from baseline in Modified Mayo Score at Week 8.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 8
    E.5.2Secondary end point(s)
    ▪ Number and rate of patients in clinical remission at Week 8, per each intervention/treatment group. Clinical remission, based on the Mayo Scoring system, is defined as a rectal bleeding sub-score = 0 and an Endoscopy sub-score ≤1 (excluding friability) and at least one-point decrease in stool frequency sub score from baseline to achieve a stool frequency sub-score ≤1
    ▪ Combined number and rate of patients in clinical remission at Week 8 and at Week 16, per each intervention/treatment group.
    ▪ Number and rate of patients with clinical response at Week 8 and Week 16 per intervention/treatment group. Clinical Response is defined as a reduction in Mayo Score of the least 2 points and greater than or equal to 30 percent from baseline with an accompanying decrease in rectal bleeding sub-score of greater than or equal to 1 point or absolute rectal bleeding sub-score of less than or equal to 1 point.
    ▪ Number and rate of patients with endoscopic improvement, by segment, and number and rate of patients with endoscopic remission, by segment, at Week 8 and at Week 16 (if available) per intervention/treatment group. Endoscopic improvement is defined as a Mayo endoscopic sub score of ≤1 (excluding friability) and endoscopic remission defined as sub score of 0.
    ▪Number and rate of patients with mucosal healing. Mucosal healing is
    defined as both endoscopic remission and histological remission (Geboes
    score < 2.0).
    ▪ Number and rate of patients with endoscopic improvement.
    ▪ Reduction relative to baseline in stool and rectal bleeding frequency at every study visit by ABX464 dose group and versus placebo.
    ▪ Reduction relative to baseline in partial Modified Mayo Score at every study visit and Modified Mayo Score at Week 16 (if available) by ABX464 dose group and versus placebo.
    ▪ Reduction relative to baseline in fecal calprotectin and CRP levels at Week 8 and Week 16 by intervention/treatment group.
    ▪ Change relative to baseline in miRNA-124 expression in rectal/sigmoidal biopsies at Week 8 and Week 16 and in total blood at every timepoints by intervention/treatment group.
    ▪ The scores and changes from baseline in IBDQ at Week 8 and Week 16 per intervention treatment group.
    ▪ Reduction relative to baseline of infiltrate/histopathology (rectal/sigmoidal biopsies) using the Robarts Histopathology Index (RHI), the Geboes and Nancy Histology Scoring Scales at Week 8 and Week 16 (if available) per intervention/treatment group.
    ▪ Change relative to baseline in IL-6, TNFα, IL-1b, IL-10 plasma concentrations at every timepoints by intervention/treatment group.
    ▪ Serum concentration of ABX464 and N-Glu ABX464 according to dose group.
    ▪ Number and rate of all adverse events, causally-related adverse events, all SAE and causally-related SAEs classified by severity per intervention/treatment group.
    ▪ Incidence of treatment-emergent serious adverse event per intervention/treatment group.
    ▪ Incidence of adverse events leading to investigational product discontinuation per intervention/treatment group.
    ▪ The number of clinically-significant laboratory abnormalities per intervention/treatment group.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. at the end of Week 8, per each intervention/treatment group
    2. at W 8 and at W16, per each intervention/treatment group
    3. at W 8 and at W16, per each intervention/treatment group
    4. at W 8 and at W16 (if available) per intervention/treatment group
    5. at W8 and at W6 6. at W8 and at W16
    7. at every study visit by ABX464 dose group and versus placebo
    8. at Week 16 (if available) by ABX464 dose group and versus placebo
    9. at Week 8 and Week 16 by intervention/treatment group
    10. in rectal/sigmoidal biopsies at Week 8 and Week 16 and in total blood at every timepoints by intervention/treatment group 11. at W8 and W16 12. at W8 and W16 (if available)
    13. at every timepoints 14. through the study 15. through the study .through the study17.through the study18.through the study
    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 Yes
    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 trial4
    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 concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA140
    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
    Austria
    Belarus
    Belgium
    Canada
    Czechia
    France
    Germany
    Hungary
    Italy
    Poland
    Serbia
    Slovakia
    Slovenia
    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 years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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: 232
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 194
    F.4.2.2In the whole clinical trial 244
    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)
    At week 16, patients willing to continue the study treatment will be eligible for enrollment in an open label extension(will be submitted through another protocol)
    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 Decision2019-05-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-10
    P. End of Trial
    P.End of Trial StatusOngoing
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