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

• Conditions: lcerative Colitis; MedDRA version: 14.1Level: LLTClassification code 10045282Term: UCSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2011-004812-40-IT
• Lead Sponsor: ASTRAZENECA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-02
• Last Update Posted: 11 November 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. Diagnosed ulcerative colitis at least 90 days prior randomisation. 2. Men or women age18 - 65 years. 3. Non-hospitalized patients with moderate-severe ulcerative colitis treated with stable background UC therapy (e.g. containing 5- aminosalisylates, and/or low dose of glucocorticosteroids, and/or purine analogue) prior to randomization 4. Females of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective contraception from Day1. 5. Nonsterilized males or sterilized males who are = 1 year postvasectomy who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 106
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

1. Pregnant or breastfeeding women. 2. History of colostomy. 3. 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). 4. Hepatitis B, C or HIV. 5. History of cancer.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified