Safety and Efficacy of QBECO in Moderate to Severe Ulcerative Colitis

An Open Label, Dose Ranging, Exploratory Study to Evaluate the Safety, Tolerability, Compliance, Mechanism of Action and Efficacy of QBECO Site Specific Immunomodulation for the Induction of Clinical Response and Remission in Subjects With Moderate to Severe Ulcerative Colitis

The purpose of this open-label, dose-ranging, exploratory study is to evaluate the safety, tolerability, compliance, mechanism of action and efficacy of QBECO site specific immunomodulation for the induction of clinical response and remission in subjects with moderate to severe ulcerative colitis

Inclusion Criteria:

• Male or female subjects who have reached age of majority
• Willing to learn and able to self-administer study drug
• Diagnosis of UC established at least 6 months before screening visit, by clinical and endoscopic evidence.
• Currently experiencing moderate to severe active UC defined as a Mayo score of 6-12 (inclusive) at Screening.
• Endoscopic evidence of active mucosal disease, as assessed by flexible sigmoidoscopy, with an Endoscopic Finding Sub-score of ≥2 at Screening.
• Rectal Bleeding Sub-score of ≥1 at Screening.
• Physician's Global Assessment Sub-score of ≥2 at Screening.
• Male/female subjects who agree to practice effective methods of contraception

Exclusion Criteria:

• History of colonic or rectal surgery other than hemorrhoid surgery or appendectomy
• Currently receiving total parenteral nutrition
• Disease limited to ulcerative proctitis
• Diagnosed with Crohn's disease, indeterminate colitis, microscopic colitis or, ischemic or infectious colitis
• Known or suspected hypersensitivity to any component of the product
• Known human immunodeficiency virus (HIV) infection or other immunosuppressive disorder
• Concurrently participating in another study or receiving other experimental or investigational therapies within past 3 months
• Females who are currently pregnant or lactating
• Any history of malignancy. Exceptions may apply for cervical cancer and some forms of skin cancer