Low Dose IL-2 for Ulcerative Colitis

• Status: Completed
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and maximum tolerated dose (MTD) of Interleukin-2 in subjects with moderate-to-severe ulcerative colitis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Scott Snapper
• Treatments: Aldesleukin; Interleukin-2

Criteria

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;

1. Hb < 8.0 g/dL, WBC < 2.5 x 103/mm3, Plt < 100 x 103/mm3.

2. Creatinine ≥ 1.5x institutional upper limit of normal (ULN).

3. Total bilirubin > 2.0 mg/dL, ALT > 2x institutional ULN, GGT > 2x institutional ULN. Elevated unconjugated bilirubin related to Gilbert's syndrome is allowed.

4. 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).