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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: tralokinumab; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01482884

EudraCT number 2011-004812-40

D2211C00001

Details and patient eligibility

About

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.

Full description

A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis

Enrollment: 147 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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147 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

tralokinumab (CAT-354) sc injection

Treatment:

Drug: tralokinumab

2

Placebo Comparator group

Description:

placebo sc injection

Treatment:

Drug: placebo