Low Dose IL-2 for Ulcerative Colitis

Inclusion Criteria

• Age 18-70 years.
• A diagnosis of UC made by standard clinical, radiological, endoscopic and histological criteria.
• Moderate to severe UC with a Mayo score of 6-12.
• Failure to tolerate or failure to respond to at least one conventional therapy with the intention of inducing or maintaining remission (examples include oral corticosteroids, oral 5-aminosalicylates, azathioprine and/or 6-mercaptopurine, or a tumor necrosis factor (TNF) antagonist). Corticosteroid dependency (inability to taper oral corticosteroids without a recurrence of disease activity) is also included in this category.
• Stable doses of concomitant medications.
• A negative pregnancy test in the 2 weeks prior to anticipated commencement of the study drug, in female subjects of child-bearing age. Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.
• Ability to provide informed consent.

Exclusion Criteria

• A diagnosis of Crohn's disease or Inflammatory Bowel Disease - Unspecified (IBD-U, a diagnostic classification formerly termed "indeterminate colitis").
• Requirement for immediate surgical, endoscopic or radiological intervention for toxic megacolon, massive hemorrhage, perforation, sepsis, or intra-abdominal or perianal abscess.
• Ileostomy, proctocolectomy or subtotal colectomy with ileorectal anastomosis.
• History of colorectal cancer or dysplasia.
• Positive stool test for Clostridium difficile.
• Current medically significant infection.
• Significant laboratory abnormalities, including;
• Hb 2.0 mg/dL, ALT > 2x institutional ULN, GGT > 2x institutional ULN. Elevated unconjugated bilirubin related to Gilbert's syndrome is allowed.
• Abnormal thyroid function tests.
• Positive serology for HIV, hepatitis B virus (HBV) or HCV.
• Positive screening test for tuberculosis (TB).
• First dose of an anti-TNF medication within 4 weeks of anticipated study commencement, or a subsequent dose within 2 weeks of commencement; or ciclosporin or tacrolimus within 2 weeks of anticipated study commencement.
• Received another investigational new drug (IND) within 5 half-lives of that agent before the planned commencement of SC IL-2.
• Malignancy within the last 5 years.
• Allergy to any component of the study drug.
• Pregnant or lactating women.
• Inability to comply with the study protocol or inability to give informed consent.
• Prior exposure to IL-2.
• Uncontrolled cardiac angina or symptomatic congestive cardiac failure (NYHA Class III or IV).