Status:
COMPLETED
Evaluation of Efficacy and Safety of Tralokinumab in Patients With Active, Moderate-to-severe Ulcerative Colitis
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
MedImmune Ltd
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 con...
Detailed 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 direct...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT01482884
Start Date
March 1 2012
End Date
June 1 2013
Last Update
April 5 2016
Active Locations (28)
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1
Research Site
České Budějovice, Czechia
2
Research Site
Hradec Králové, Czechia
3
Research Site
Olomouc, Czechia
4
Research Site
Prague, Czechia