Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis.

• Conditions: lcerative Colitis; MedDRA version: 14.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2011-004812-40-CZ
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-29
• Last Update Posted: 5 August 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 - 75 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 post-vasectomy 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:
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