Overview

Evaluation of Efficacy and Safety of Tralokinumab in Patients With Active, Moderate-to-severe Ulcerative Colitis

Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
0
Participant gender:
All
Summary
The study is designed to evaluate the clinical efficacy and safety of tralokinumab as compared to placebo. Investigational product will be administered as subcutaneous injection. All patients will continue background therapy for ulcerative colitis as per local standards of care in addition to investigational product.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Collaborator:
MedImmune Ltd
Criteria
Inclusion Criteria:

- Diagnosed ulcerative colitis at least 90 days prior randomisation.

- Men or women age 18 - 75 years.

- Non-hospitalized patients with moderate-severe ulcerative colitis treated with stable
background UC therapy (e.g. containing 5-aminosalicylates, and/or low dose of
glucocorticosteroids, and/or purine analogue) prior to randomization.

- Females of childbearing potential who are sexually active with a nonsterilized male
partner must use highly effective contraception from Day1.

- Nonsterilized males or sterilized males who are ≤1 year post-vasectomy who are
sexually active with a female partner of childbearing potential must use a highly
effective method of contraception.

Exclusion Criteria:

- Pregnant or breastfeeding women.

- History of colostomy.

- Current diagnosis of indeterminate colitis, Crohn's disease, ischemic colitis,
fulminant colitis and/or toxic megacolon and patients with ulcerative colitis limited
to the rectum (ulcerative proctitis).

- Hepatitis B, C or HIV.

- History of cancer.