Study of OST-122 in Patients With Moderate to Severe Ulcerative Colitis

Exclusion Criteria

• •1. Has fulminant colitis, toxic megacolon, primary sclerosing cholangitis, Crohn's disease, history of moderate to severe colitis-associated colonic dysplasia, active peptic ulcer disease;
• •2. Medications of exclusion:
• •1. Topical mesalazine or steroids (i.e., enemas or suppositories) within the 7 days prior to Baseline visit
• •2. Azathioprine, 6-mercaptopurine, or methotrexate within 10 days prior to Baseline visit
• •3. Intravenous corticosteroids within the 14 days prior to Baseline visit
• •4. Tofacitinib or any other JAK inhibitor within 14 days prior to Baseline visit
• •5. Anti-diarrheal treatment within 14 days prior to Baseline visit
• •6. Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 14 days prior to Baseline visit
• •7. Adalimumab within the 14 days prior to Baseline visit
• •8. Infliximab, golimumab, etanercept, vedolizumab, ustekinumab or certolizumab within the 14 days prior to Baseline visit
• •9. NSAIDs on a daily basis from 7 days previous to Baseline visit. Low doses, without anti-inflammatory effect, to treat or prevent other diseases i.e.: ictus, cerebrovascular or cardiovascular diseases, among others; are permitted.
• •3. Has a current bacterial, parasitic, fungal, or viral infection;
• •4. Is positive for hepatitis A, B or C, HIV (Human Immunodeficiency Virus) or tuberculosis, as assessed by method available at each site;
• •5. Patient who has clinically significant diseases and/or infections captured in the medical history or evidence of clinically significant findings on physical examination and/or clinically significant ordinary laboratory evaluations (haematology, biochemistry, and urinalysis) or ECG;
• •6. Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to Baseline (or within 60 days prior to Baseline if investigational drug was a biologic product);
• •7. Demonstrated an inadequate response or loss of response to Tofacitinib or any other JAK inhibitor, with the exception of those patients who after a careful evaluation, the PI considers they may obtain a clinical benefit from the therapy;
• •8. Use of products, food supplements or medical devices, whose composition includes probiotics in the 1 month prior to Baseline visit;
• •9. Patient who has prior extensive colonic resection, subtotal or total colectomy or planned surgery for ulcerative colitis;
• •10. Patient who has past or present fistula or abdominal abscess;
• •11. Patient who is pregnant or lactating;
• •12. Inability to comply with study protocol, in opinion of the investigator;
• •13. History of alcohol, drug or chemical abuse within 6 months prior to Screening visit;
• •14. History of cancer within the last 5 years. Patients with local basal or squamous cell carcinoma of the skin that has been excised and is considered cured may be included.