Study of OSE-127 vs Placebo in Patients With Moderate to Severe Active Ulcerative Colitis

Exclusion Criteria

• •1. Stoma, proctocolectomy, or subtotal colectomy
• •2. Physician judgment that patient is likely to require any surgery for UC during the study duration, or double-blind phase duration at least
• •3. Evidence of fulminant colitis, toxic megacolon, or perforation
• •4. Current or recent (within 4 weeks prior to screening) hospitalization for UC care and/or treatment with IV steroids
• •5. The following laboratory results at screening:
• •1. Elevation at screening of aminotransferase (AST), alanine aminotransferase (ALT) \> 3 × the upper limit of normal (ULN) or total bilirubin \> 2 × ULN (unless due to Gilbert's disease) or evidence of chronic liver disease
• •2. Platelet count \< 100,000/mm3
• •3. Hemoglobin (Hgb) \< 8.5 g/dL
• •4. Neutrophils \< 1500/mm3
• •5. Lymphocytes \< 800/mm3
• •6. Absolute white blood cell (WBC) count \< 3000/mm3
• •6. Crohn's disease or indeterminate colitis or any other diagnosis not consisting with UC
• •7. History or evidence of incompletely resected colonic dysplasia or unconventional lesion at risk of colonic adenocarcinoma
• •8. Stool culture or other examination positive for enteric pathogen, including Clostridium difficile (C. diff) toxin. If positive, the patient should be treated and rescreening is allowed.
• •9. Men or women with childbearing potential not willing to use adequate birth control during the study. Adequate birth control includes surgical sterilization, intrauterine device, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partner's vasectomy, double-barrier method (condom, diaphragm with spermicide), or abstinence during study and 30 days following the last follow-up visit. Women of childbearing potential will enter the study after a negative pregnancy test.
• •10. Breastfeeding
• •11. Chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs) from screening through the end of the study
• •12. Use of topical steroids and/or topical 5-aminosalicylic acid preparations within 2 weeks before the screening visit (all such medications should be withdrawn at least 2 weeks prior to the screening visit)
• •13. Use of antidiarrheals within 2 weeks before the screening visit (all such medications should be withdrawn at least 2 weeks prior to the screening visit)
• •14. Treatment with azathioprine, 6-MP, methotrexate (MTX), cyclosporin, tacrolimus, sirolimus, leflunomide and/or mycophenolate mofetil within 4 weeks before the screening visit (all such medications should be withdrawn at least 4 weeks prior to the screening visit)