An Efficacy and Safety Study of Mongersen (GED-0301) in Subjects With Active Ulcerative Colitis

Exclusion Criteria

• •The presence of any of the following will exclude a subject from enrollment:
• •1. Subject has a diagnosis of Crohn's Disease (CD), indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis.
• •2. Subject has ulcerative colitis restricted to distal 15 cm or less (eg, ulcerative proctitis).
• •3. Subject had surgery as a treatment for ulcerative colitis (UC)or who, in the opinion of the Investigator, is likely to require surgery for ulcerative colitis (UC) during the study.
• •4. Subject has clinical signs suggestive of fulminant colitis or toxic megacolon.
• •5. Subject is stool positive for any enteric pathogen or Clostridium difficile (C. difficile) toxin at screening.
• •6. Subject has history of colorectal cancer or colorectal dysplasia.
• •7. Prior treatment with more than 2 Tumor necrosis factor (TNF)-α blockers (eg, infliximab, adalimumab, or golimumab).
• •8. Prior treatment with any integrin antagonists (eg, natalizumab or vedolizumab).
• •9. Use of Tumor necrosis factor (TNF)-α blockers within 8 weeks of the screening.
• •10. Subject had prior treatment with mycophenolic acid, tacrolimus, sirolimus, cyclosporine, thalidomide or apheresis (eg, Adacolumn®) for the treatment of ulcerative colitis (UC). In addition, prior use of any of these treatment modalities for an indication other than ulcerative colitis (UC) within 8 weeks of screening is also excluded.
• •11. Subject has received intravenous (IV) corticosteroids within 2 weeks of screening.
• •12. Subject has received topical treatment with 5 aminosalicylic acid (5-ASA) or corticosteroid enemas or suppositories within 2 weeks of screening.
• •13. Subject has received total parenteral nutrition (TPN) within 4 weeks of screening.
• •14. Subject has a history of any clinically significant neurological, renal, hepatic, gastrointestinal, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, or any other medical condition that, in the investigator's opinion, would prevent the subject from participation in the study.
• •15. Subject has any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she was to participate in the study or confounds the ability to interpret data from the study.
• •16. Subject is pregnant or breastfeeding.
• •17. Subject has a history of any of the following cardiac conditions within 6 months of screening: myocardial infarction, acute coronary syndrome, unstable angina, new onset atrial fibrillation, new onset atrial flutter, second- or third-degree atrioventricular block, ventricular fibrillation, ventricular tachycardia, heart failure, cardiac surgery, interventional cardiac catheterization (with or without a stent placement), interventional electrophysiology procedure, or presence of implanted defibrillator.
• •18. Subject has a known active current or history of medically important recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis and atypical mycobacterial disease and Herpes zoster), human immunodeficiency virus (HIV), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) or oral antibiotics within 4 weeks of screening.
• •19. Subject has a history of congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease).
• •20. Subject has a history of malignancy, except for:
• •1. Treated (ie, cured) basal cell or squamous cell in situ skin carcinomas
• •2. Treated (ie, cured) cervical intraepithelial neoplasia or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years
• •21. Subject has received investigational drug or device within 1 month of screening.
• •22. Subject has a history of alcohol, drug, or chemical abuse within the 6 months prior to screening.
• •23. Subject has a known hypersensitivity to oligonucleotides or any ingredient in the Investigational Product (IP).
• •24. Subject has prior treatment with GED-0301 or participated in a clinical study involving GED-0301.