<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03760003</url>
  </required_header>
  <id_info>
    <org_study_id>ABX464-103</org_study_id>
    <nct_id>NCT03760003</nct_id>
  </id_info>
  <brief_title>Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis</brief_title>
  <official_title>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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abivax S.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abivax S.A.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Phase IIb study to evaluate the efficacy and the safety of 3 dose-levels of ABX464,&#xD;
      administered daily in patients with moderate to severe Ulcerative Colitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This phase IIb study will evaluate the efficacy and the safety of 3 dose-levels of ABX464,&#xD;
      administered daily in improving Modified Mayo Score (MMS) in patients with moderate to severe&#xD;
      Ulcerative Colitis who have inadequate response, loss of response, or intolerance with at&#xD;
      least one of the following agents: immunosuppressant treatment (i.e. azathioprine,&#xD;
      6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-α] inhibitors, vedolizumab,&#xD;
      JAK inhibitors and/or corticosteroid treatment .&#xD;
&#xD;
      Eligible patients will be randomized into 4 parallel intervention/treatment groups: 25mg q.d&#xD;
      of ABX464, 50mg q.d of ABX464, 100mg q.d of ABX464, or matching placebo and will be treated&#xD;
      for 16 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 23, 2019</start_date>
  <completion_date type="Actual">April 16, 2021</completion_date>
  <primary_completion_date type="Actual">April 1, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized, double blind, placebo controlled, parallel groups</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Modified Mayo Score</measure>
    <time_frame>Week 8</time_frame>
    <description>Reduction from baseline in Modified Mayo Score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical remission</measure>
    <time_frame>Week 8 and Week 16</time_frame>
    <description>Clinical remission, based on the Mayo Scoring system, is defined as stool frequency subscore = 0 or 1 and rectal bleeding subscore = 0 and endoscopy subscore = 0 or 1 (modified to exclude friability).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical response</measure>
    <time_frame>Week 8 and Week 16</time_frame>
    <description>Clinical Response is defined as a reduction in Mayo Score of at 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endoscopic Improvement</measure>
    <time_frame>Week 8 and Week 16</time_frame>
    <description>Endoscopic improvement is defined as a Mayo endoscopic sub score of ≤1 (excluding friability)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mucosal healing</measure>
    <time_frame>Week 8 and Week 16</time_frame>
    <description>Mucosal healing is defined as both endoscopic remission and histological remission (Geboes score &lt; 2.0).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stool and rectal bleeding frequency</measure>
    <time_frame>Every visit</time_frame>
    <description>Assessment of Reduction relative to baseline in stool and rectal bleeding frequency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Partial Modified Mayo Score</measure>
    <time_frame>Every visit</time_frame>
    <description>Change from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Mayo Score</measure>
    <time_frame>Week 16</time_frame>
    <description>Change from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fecal calprotectin</measure>
    <time_frame>Week 8 and Week 16</time_frame>
    <description>Reduction from baseline in fecal calproctectin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C Reactive Protein</measure>
    <time_frame>Week 8 and Week 16</time_frame>
    <description>Reduction from baseline in CRP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>miR-124 expression</measure>
    <time_frame>Week 8 and Week 16</time_frame>
    <description>Increase in miR-124 expression in Total Blood and rectal tissue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IBDQ</measure>
    <time_frame>Week 8 and Week 16</time_frame>
    <description>Scores and changes from baseline i</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory Infiltrate</measure>
    <time_frame>Week 8 and Week 16</time_frame>
    <description>Inflammatory Infiltrate assessment in rectal/colon biopsies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IL-6, TNFα, IL-1b, IL-10 plasma concentrations</measure>
    <time_frame>Every visit</time_frame>
    <description>Change relative to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ABX464 and ABX464-N-Glu</measure>
    <time_frame>Every visit (Except D57)</time_frame>
    <description>Serum concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endoscopy Remission</measure>
    <time_frame>Week 8 and Week 16</time_frame>
    <description>Mayo endoscopic sub score of 0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and rate of all adverse events, causally-related adverse events, SAE and causally-related SAEs classified by severity</measure>
    <time_frame>Every visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment-emergent serious adverse event</measure>
    <time_frame>Every visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events leading to investigational medicinal product discontinuation</measure>
    <time_frame>Every visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of clinically-significant laboratory abnormalities</measure>
    <time_frame>Every visit</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">254</enrollment>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>ABX464</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABX464 will be administrated orally (Capsules) and daily for 16 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Matching Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo will be adminstrated orally (Capsules) and daily for 16 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABX464 25mg</intervention_name>
    <description>ABX464 25mg (One capsule of ABX464 25 mg + One capsule of placebo) once daily for 16 weeks</description>
    <arm_group_label>ABX464</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABX464 50mg</intervention_name>
    <description>ABX464 50mg (One capsule of ABX464 50 mg + One capsule of placebo) once daily for 16 weeks</description>
    <arm_group_label>ABX464</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABX464 100mg</intervention_name>
    <description>ABX464 100mg (two capsules of ABX464 50 mg) once daily for 16 weeks</description>
    <arm_group_label>ABX464</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Two capsules of placebo once daily for 16 weeks</description>
    <arm_group_label>Matching Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men or women age 18 - 75 years;&#xD;
&#xD;
          -  Diagnosis of moderate to severe active UC (including ulcerative proctitis if proximal&#xD;
             extension of disease occurs beyond 10 cm) confirmed by endoscopy and histology at&#xD;
             least 12 Weeks prior to screening visit. Moderate to severe active UC defined by&#xD;
             Modified Mayo Score (MMS) of 5 to 9 inclusive (on a scale of 0-9). Moderate to severe&#xD;
             active UC should be confirmed at screening visit with a centrally read endoscopy&#xD;
             sub-score of at least 2 (on a scale of 0-3);&#xD;
&#xD;
          -  Patients having either a documented inadequate response, no response, a loss of&#xD;
             response, or an intolerance (defined as the occurrence of at least one Adverse&#xD;
             Reaction leading to treatment discontinuation) to either immunosuppressant treatment&#xD;
             (i.e., azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor [TNF]&#xD;
             inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. Inadequate&#xD;
             response, no response, loss of response is defined as:&#xD;
&#xD;
             i. Active disease or relapse in spite of thiopurines or methotrexate given at an&#xD;
             appropriate dose for at least 3 months (i.e. azathioprine 2-2.5 mg/kg/day or&#xD;
             mercaptopurine 1-1.5 mg/kg/day in the absence of leukopenia), and/or ii. Active&#xD;
             disease despite corticosteroids treatment (prednisolone up to 0.75 mg/kg/day) over a&#xD;
             period of 4 Weeks, and/or iii. Active disease or relapse in spite of adequate&#xD;
             treatment (as defined in the SmPC) with tumor necrosis factor [TNF] inhibitors or&#xD;
             vedolizumab, and/or iv. Active disease or relapse in spite of adequate treatment with&#xD;
             JAK inhibitors over a period of at least 6 Weeks.&#xD;
&#xD;
          -  Patients receiving oral corticosteroids must have been on a stable dose of prednisone&#xD;
             or prednisone equivalent (≤20 mg/day) or on beclomethasone diproprionate (≤5mg/day) or&#xD;
             on budesonide MMX (≤9 mg/day) for at least 2 Weeks prior to the screening visit;&#xD;
&#xD;
          -  Topical corticosteroids and topical 5-aminosalicylic acid preparations must have been&#xD;
             withdrawn at least 2 Weeks prior to the screening visit;&#xD;
&#xD;
          -  Patients who are on oral 5-aminosalicylic acid must have been on a stable dose for at&#xD;
             least 4 Weeks prior to the screening visit;&#xD;
&#xD;
          -  Patients who are receiving immunosuppressants in the form of azathioprine,&#xD;
             6-mercaptopurine, or methotrexate needed to be on a stable dose for at least 4 Weeks&#xD;
             prior to screening visit. Patients taking methotrexate also are advised to take folic&#xD;
             acid 1 mg/day (or equivalent) supplementation if there is no contraindication;&#xD;
&#xD;
          -  Patients on probiotics (e.g., Culturelle® [Lactobacillus GG, i-Health, Inc.],&#xD;
             Saccharomyces boulardii) must be on stable doses for at least 2 Weeks prior to the&#xD;
             screening visit;&#xD;
&#xD;
          -  Patients on antidiarrheals (e.g., loperamide, diphenoxylate with atropine) must be on&#xD;
             stable doses for at least 2 Weeks prior to the screening visit;&#xD;
&#xD;
          -  Patients who have received tumor necrosis factor [TNF] inhibitors, vedolizumab or&#xD;
             other biologics must have discontinued therapy at least 8 Weeks prior to the screening&#xD;
             visit due to lack or insufficient efficacy or intolerance;&#xD;
&#xD;
          -  Patients previously treated with cyclosporine, tacrolimus or JAK inhibitors must have&#xD;
             discontinued therapy at least 4 Weeks prior to the screening visit due to lack or&#xD;
             insufficient efficacy or intolerance;&#xD;
&#xD;
          -  Patients previously treated with tube feeding, defined formula diets, or parenteral&#xD;
             alimentation/nutrition must have discontinued treatment 3 Weeks before the screening&#xD;
             visit and must be able to take, orally, appropriate amount of food (calories) and&#xD;
             liquids to maintain body weight;&#xD;
&#xD;
          -  Patients with surveillance colonoscopy defined as per ECCO guidelines;&#xD;
&#xD;
          -  Patients with the following hematological and biochemical laboratory parameters&#xD;
             obtained at screening:&#xD;
&#xD;
             i. Hemoglobin &gt; 9.0 g dL-1; ii. Absolute neutrophil count ≥ 750 mm-3; iii. Platelets ≥&#xD;
             100,000 mm-3; iv. Total serum creatinine ≤ 1.3 x ULN (upper limit of normal); v.&#xD;
             Creatinine clearance &gt; 90 mL min-1 by the Cockcroft-Gault equation within 60 days&#xD;
             prior to baseline; vi. Total serum bilirubin &lt; 1.5 x ULN; vii. Alkaline phosphatase,&#xD;
             AST (SGOT) and ALT (SGPT) &lt; 2 x ULN;&#xD;
&#xD;
          -  Patients are able and willing to comply with study visits and procedures as per&#xD;
             protocol;&#xD;
&#xD;
          -  Patients should understand, sign and date the written voluntary informed consent form&#xD;
             at the screening visit prior to any protocol-specific procedures are performed;&#xD;
&#xD;
          -  Patients should be affiliated to a social security regimen (for French sites only);&#xD;
&#xD;
          -  Females and males receiving the study treatment (potentially in combination with&#xD;
             immunosuppressant) and their partners must agree to use a highly effective&#xD;
             contraceptive method during the study and for 6 months after end of study or early&#xD;
             termination. Contraception should be in place at least 2 Weeks prior to study&#xD;
             participation. Women must be surgically sterile or if of childbearing potential must&#xD;
             use a highly effective contraceptive method. Women of childbearing potential (WOCBP)&#xD;
             will enter the study after confirmed menstrual period and a negative pregnancy test.&#xD;
             Highly effective methods of contraception include true abstinence, intrauterine device&#xD;
             (IUD) or hormonal contraception aiming at inhibition of ovulation, intrauterine&#xD;
             hormone releasing system, bilateral tubal ligation, vasectomized partner. True&#xD;
             abstinence is defined when this is in line with the preferred and usual lifestyle of&#xD;
             the patient. In each case of delayed menstrual period (over one month between&#xD;
             menstruations) confirmation of absence of pregnancy is required. This recommendation&#xD;
             also applies to WOCBP with an infrequent or irregular menstrual cycle. Female and male&#xD;
             patients must not be planning pregnancy during the trial and for 6 months post&#xD;
             completion of their participation in the trial. In addition, male participants should&#xD;
             use condoms and not donate sperm as long as contraception is required.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with Crohn's Disease (CD) or presence or history of fistula, indeterminate&#xD;
             colitis (IC), infectious/ischemic colitis or microscopic colitis (lymphocytic and&#xD;
             collagenous colitis);&#xD;
&#xD;
          -  History of toxic megacolon, abdominal abscess, symptomatic colonic stricture or stoma;&#xD;
             history or imminent colectomy, colonic malignancy;&#xD;
&#xD;
          -  History or current evidence of colonic dysplasia or adenomatous colonic polyps.&#xD;
             Patient with severe gastrointestinal complications; e.g., short bowel syndromes,&#xD;
             recent or planned bowel surgery, Ileostomy and/or colostomy, recent bowel perforation;&#xD;
&#xD;
          -  History of more than one episode of herpes zoster or a history (single episode) of&#xD;
             disseminated zoster;&#xD;
&#xD;
          -  Patients with active infections at screening such as infected abdominal abscess,&#xD;
             Clostridium difficile (stool antigen and toxin required), CMV (positive IgM), TB and&#xD;
             recent infectious hospitalization;&#xD;
&#xD;
          -  Patients previously treated with ABX464;&#xD;
&#xD;
          -  Acute, chronic or history of clinically relevant pulmonary, cardiovascular, hepatic,&#xD;
             pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable CNS&#xD;
             pathology such as seizure disorder, angina or cardiac arrhythmias, active malignancy&#xD;
             or any other clinically significant medical problems as determined by physical&#xD;
             examination and/or laboratory screening tests and/or medical history;&#xD;
&#xD;
          -  Acute, chronic or history of immunodeficiency or autoimmune disease;&#xD;
&#xD;
          -  History of malignancy excluding patients considered cured (5 years disease free&#xD;
             survivors);&#xD;
&#xD;
          -  Serious illness requiring systemic treatment and/or hospitalization within 3 Weeks&#xD;
             prior to baseline;&#xD;
&#xD;
          -  Pregnant or breast-feeding women;&#xD;
&#xD;
          -  Illicit drug or alcohol abuse or dependence;&#xD;
&#xD;
          -  Patients who received live vaccine 30 days or fewer before first dose of study&#xD;
             treatment and/or who's planning to receive such a vaccine during the study duration;&#xD;
&#xD;
          -  Use of any investigational or non-registered product within 3 months or within 5&#xD;
             half-lives preceding baseline, whichever is longer and during the study;&#xD;
&#xD;
          -  Any condition, which in the opinion of the investigator, could compromise the&#xD;
             patient's safety or adherence to the study protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Séverine VERMEIRE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitaire Ziekenhuizen KU Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCSD Health System</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Center for Gastroenterology, P.C</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Texas Clinical Research, LLC</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Star Research Institute, LLC</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universität Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Klagenfurt am Wörthersee</name>
      <address>
        <city>Klagenfurt</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordensklinikum Linz GmbH - Barmherzige Schwestern</name>
      <address>
        <city>Linz</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AKH - Medizinische Universität Wien</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gomel Regional Clinical Hospital</name>
      <address>
        <city>Gomel</city>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minsk city diagnostic center</name>
      <address>
        <city>Minsk</city>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Clinical Hospital</name>
      <address>
        <city>Minsk</city>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitebsk Regional Clinical Hospital</name>
      <address>
        <city>Vitebsk</city>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitebsk regoinal clinical specialized center</name>
      <address>
        <city>Vitebsk</city>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Sint-Lucas</name>
      <address>
        <city>Brugge</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C. H. U. St-Pierre</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZA</name>
      <address>
        <city>Edegem</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Gent</name>
      <address>
        <city>Gent</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brandon Medical Arts Clinic</name>
      <address>
        <city>Brandon</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Edmonton Gastroenterology</name>
      <address>
        <city>Edmonton</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LHSC - Victoria Hospital</name>
      <address>
        <city>London</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ottawa Hospital - General Campus</name>
      <address>
        <city>Ottawa</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allen Whey Khye Lim Professional Corporation</name>
      <address>
        <city>Saskatoon</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>Toronto</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice u sv. Anny v Brne</name>
      <address>
        <city>Brno</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hepato-Gastroenterologie HK s.r.o.</name>
      <address>
        <city>Hradec Kralove</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MUDr. GREGAR s.r.o.</name>
      <address>
        <city>Olomouc</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Ostrava</name>
      <address>
        <city>Ostrava-Kunčice</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemocnice Na Bulovce</name>
      <address>
        <city>Praha</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomayerova nemocnice</name>
      <address>
        <city>Praha</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemocnice Slany</name>
      <address>
        <city>Slany</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Amiens - Hopital Sud</name>
      <address>
        <city>Amiens</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Besançon - Hôpital Jean Minjoz</name>
      <address>
        <city>Besançon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Clermont Ferrand - Hôpital d'Estaing</name>
      <address>
        <city>Clermont-Ferrand</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Beaujon</name>
      <address>
        <city>Clichy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Grenoble - Hôpital Nord</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Départemental Les Oudairies</name>
      <address>
        <city>La Roche-sur-Yon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Lille - Hôpital Claude Huriez</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Nord - CHU Marseille</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Saint Eloi</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nantes - Hôtel Dieu</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nice - Hôpital de l'Archet 2</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Reims - Hôpital Robert Debré</name>
      <address>
        <city>Reims</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Rennes - Hôpital Pontchaillou</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Rouen - Hôpital Charles Nicolle</name>
      <address>
        <city>Rouen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Saint Etienne - Hôpital Nord</name>
      <address>
        <city>Saint-Étienne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Strasbourg - Hôpital Hautepierre</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Rangueil</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de Brabois Adultes</name>
      <address>
        <city>Vandœuvre-lès-Nancy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florence-Nightingale-Krankenhaus-Diakonie Kaiserswerth</name>
      <address>
        <city>Düsseldorf</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Johann Wolfgang Goethe-Universitaet</name>
      <address>
        <city>Frankfurt</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Studiengesellschaft BSF Unternehmergesellschaft haftungsbeschraenkt</name>
      <address>
        <city>Halle</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Halle (Saale)</name>
      <address>
        <city>Halle</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover</name>
      <address>
        <city>Hanover</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johanna-Etienne-Krankenhaus</name>
      <address>
        <city>Neuss</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tumorzentrum Nordthueringen MVZ GmbH</name>
      <address>
        <city>Nordhausen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Tasso Bieler</name>
      <address>
        <city>Riesa</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Ulm</name>
      <address>
        <city>Ulm</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DRC Gyogyszervizsgalo Kozpont Kft.</name>
      <address>
        <city>Balatonfured</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Obudai Egeszsegugyi Centrum Kft.</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pannonia Maganorvosi Centrum</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Semmelweis Egyetem</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem</name>
      <address>
        <city>Debrecen</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont</name>
      <address>
        <city>Debrecen</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Petz Aladar Megyei Oktato Korhaz</name>
      <address>
        <city>Győr</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi</name>
      <address>
        <city>Bologna</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Poliambulanza Istituto Ospedaliero</name>
      <address>
        <city>Brescia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Mater Domini</name>
      <address>
        <city>Catanzaro</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>I.R.C.C.S Policlinico San Donato</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Sacro Cuore Don Calabria</name>
      <address>
        <city>Negrar</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera di Padova</name>
      <address>
        <city>Padova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone</name>
      <address>
        <city>Palermo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)</name>
      <address>
        <city>Pisa</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Clinico Humanitas</name>
      <address>
        <city>Rozzano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Uniwersytecki nr 2 im.dr J. Biziela</name>
      <address>
        <city>Bydgoszcz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersyteckie Centrum Kliniczne</name>
      <address>
        <city>Gdansk</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Plejady</name>
      <address>
        <city>Kraków</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Familia Centrum Badan, Profilaktyki i Leczenia</name>
      <address>
        <city>Lodz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojskowy Szpital Kliniczny w Lublinie</name>
      <address>
        <city>Lublin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trialmed CRS</name>
      <address>
        <city>Piotrkow Trybunalski</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Grunwald</name>
      <address>
        <city>Poznan</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KO-MED Centra Kliniczne Pulawy</name>
      <address>
        <city>Pulawy</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gabinet Lekarski Bartosz Korczowski</name>
      <address>
        <city>Rzeszow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Zdrowia MDM</name>
      <address>
        <city>Warszawa</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nzoz Vivamed</name>
      <address>
        <city>Warszawa</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Zdrowia Tuchow Sp. z o.o.</name>
      <address>
        <city>Wierzchosławice</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska</name>
      <address>
        <city>Wroclaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Oporow</name>
      <address>
        <city>Wroclaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LexMedica</name>
      <address>
        <city>Wroclaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Center Zvezdara</name>
      <address>
        <city>Belgrade</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Center &quot; Dr Dragisa Misovic Dedinje&quot;</name>
      <address>
        <city>Belgrad</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Center Bezanijska Kosa</name>
      <address>
        <city>Belgrad</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital Uzice</name>
      <address>
        <city>Užice</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital &quot;Djordje Joanovic&quot;</name>
      <address>
        <city>Zrenjanin</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alian s.r.o.</name>
      <address>
        <city>Bardejov</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniq s.r.o.</name>
      <address>
        <city>Bratislava</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastromedic, s.r.o.</name>
      <address>
        <city>Nové Zámky</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastro I, s.r.o.</name>
      <address>
        <city>Prešov</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endomed, s.r.o.</name>
      <address>
        <city>Vranov Nad Topľou</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accout Center s.r.o.</name>
      <address>
        <city>Šahy</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital Celje</name>
      <address>
        <city>Celje</city>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Centre Maribor</name>
      <address>
        <city>Maribor</city>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital Murska Sobota</name>
      <address>
        <city>Murska Sobota</city>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Médico Teknon</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Reina Sofia</name>
      <address>
        <city>Córdoba</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Gran Canaria Dr. Negrin</name>
      <address>
        <city>Las Palmas De Gran Canaria</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Quironsalud Malaga</name>
      <address>
        <city>Málaga</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CNE Cherkasy Regional Hospital of Cherkasy Regional Council</name>
      <address>
        <city>Cherkasy</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital</name>
      <address>
        <city>Dnipro</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU</name>
      <address>
        <city>Ivano-Frankivs'k</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHI Kharkiv City Clinical Hospital #13</name>
      <address>
        <city>Kharkiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC</name>
      <address>
        <city>Kharkiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital</name>
      <address>
        <city>Kharkiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CI Kherson CCH</name>
      <address>
        <city>Kherson</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Khmelnytska Regional Hospital</name>
      <address>
        <city>Khmelnytskyi</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital</name>
      <address>
        <city>Kyiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU</name>
      <address>
        <city>Lviv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ternopil University Hospital</name>
      <address>
        <city>Ternopil'</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM</name>
      <address>
        <city>Vinnytsia</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU</name>
      <address>
        <city>Vinnytsia</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MCIC MC LLC Health Clinic</name>
      <address>
        <city>Vinnytsia</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CI City Clinical Hospital #6 Dept of Gastroenterology</name>
      <address>
        <city>Zaporizhzhia</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CNCE &quot;City Hospital 9&quot; Zaporizhzhia CC</name>
      <address>
        <city>Zaporizhzhia</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A. Novak Transcarpathian Regional Clinical Hospital</name>
      <address>
        <city>Úzhgorod</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairfield General Hospital</name>
      <address>
        <city>Bury</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guy's Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College London Hospitals</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham University Hospitals Queen's Medical Centre</name>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belarus</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Serbia</country>
    <country>Slovakia</country>
    <country>Slovenia</country>
    <country>Spain</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>July 26, 2021</last_update_submitted>
  <last_update_submitted_qc>July 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ABX464</keyword>
  <keyword>Refractory patients</keyword>
  <keyword>Phase 2b</keyword>
  <keyword>Dose Ranging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03760003
org study id: ABX464-103
nct id: NCT03760003
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Phase IIb study to evaluate the efficacy and the safety of 3 dose-levels of ABX464,
      administered daily in patients with moderate to severe Ulcerative Colitis.
This phase IIb study will evaluate the efficacy and the safety of 3 dose-levels of ABX464,
      administered daily in improving Modified Mayo Score (MMS) 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 .

      Eligible patients will be randomized into 4 parallel intervention/treatment groups: 25mg q.d
      of ABX464, 50mg q.d of ABX464, 100mg q.d of ABX464, or matching placebo and will be treated
      for 16 weeks.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, double blind, placebo controlled, parallel groups
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Modified Mayo Score
time frame: Week 8
description: Reduction from baseline in Modified Mayo Score
measure: Clinical remission
time frame: Week 8 and Week 16
description: Clinical remission, based on the Mayo Scoring system, is defined as stool frequency subscore = 0 or 1 and rectal bleeding subscore = 0 and endoscopy subscore = 0 or 1 (modified to exclude friability).
measure: Clinical response
time frame: Week 8 and Week 16
description: Clinical Response is defined as a reduction in Mayo Score of at 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.
measure: Endoscopic Improvement
time frame: Week 8 and Week 16
description: Endoscopic improvement is defined as a Mayo endoscopic sub score of ≤1 (excluding friability)
measure: Mucosal healing
time frame: Week 8 and Week 16
description: Mucosal healing is defined as both endoscopic remission and histological remission (Geboes score < 2.0).
measure: Stool and rectal bleeding frequency
time frame: Every visit
description: Assessment of Reduction relative to baseline in stool and rectal bleeding frequency
measure: Partial Modified Mayo Score
time frame: Every visit
description: Change from baseline
measure: Modified Mayo Score
time frame: Week 16
description: Change from baseline
measure: Fecal calprotectin
time frame: Week 8 and Week 16
description: Reduction from baseline in fecal calproctectin
measure: C Reactive Protein
time frame: Week 8 and Week 16
description: Reduction from baseline in CRP
measure: miR-124 expression
time frame: Week 8 and Week 16
description: Increase in miR-124 expression in Total Blood and rectal tissue
measure: IBDQ
time frame: Week 8 and Week 16
description: Scores and changes from baseline i
measure: Inflammatory Infiltrate
time frame: Week 8 and Week 16
description: Inflammatory Infiltrate assessment in rectal/colon biopsies
measure: IL-6, TNFα, IL-1b, IL-10 plasma concentrations
time frame: Every visit
description: Change relative to baseline
measure: ABX464 and ABX464-N-Glu
time frame: Every visit (Except D57)
description: Serum concentration
measure: Endoscopy Remission
time frame: Week 8 and Week 16
description: Mayo endoscopic sub score of 0
measure: Number and rate of all adverse events, causally-related adverse events, SAE and causally-related SAEs classified by severity
time frame: Every visit
measure: Incidence of treatment-emergent serious adverse event
time frame: Every visit
measure: Incidence of adverse events leading to investigational medicinal product discontinuation
time frame: Every visit
measure: Number of clinically-significant laboratory abnormalities
time frame: Every visit
arm group label: ABX464
arm group type: Experimental
description: ABX464 will be administrated orally (Capsules) and daily for 16 weeks
arm group label: Matching Placebo
arm group type: Placebo Comparator
description: Matching placebo will be adminstrated orally (Capsules) and daily for 16 weeks
intervention type: Drug
intervention name: ABX464 25mg
description: ABX464 25mg (One capsule of ABX464 25 mg + One capsule of placebo) once daily for 16 weeks
arm group label: ABX464
intervention type: Drug
intervention name: ABX464 50mg
description: ABX464 50mg (One capsule of ABX464 50 mg + One capsule of placebo) once daily for 16 weeks
arm group label: ABX464
intervention type: Drug
intervention name: ABX464 100mg
description: ABX464 100mg (two capsules of ABX464 50 mg) once daily for 16 weeks
arm group label: ABX464
intervention type: Drug
intervention name: Placebo
description: Two capsules of placebo once daily for 16 weeks
arm group label: Matching Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Séverine VERMEIRE, MD
role: Principal Investigator
affiliation: Universitaire Ziekenhuizen KU Leuven
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country: Austria
country: Belarus
country: Belgium
country: Canada
country: Czechia
country: France
country: Germany
country: Hungary
country: Italy
country: Poland
country: Serbia
country: Slovakia
country: Slovenia
country: Spain
country: Ukraine
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer
sharing ipd: Undecided