Evaluation of Efficacy and Safety of Tralokinumab in Patients With Active, Moderate-to-severe Ulcerative Colitis | Completed
Evaluation of Efficacy and Safety of Tralokinumab in Patients With Active, Moderate-to-severe Ulcerative Colitis
Health Conditions
  • Ulcerative Colitis
Completed
Recruitment Status
NCT01482884
Primary Trial ID Number
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.
Primary Outcome Measures
  • Clinical response (defined as a decrease in Mayo score from baseline of at least 3 points and at least 30% with an accompanying decrease in the sub score for rectal bleeding of at least 1 point or absolute sub score for rectal bleeding of 0 or 1).; At week 8.
Secondary Outcome Measures
  • Change in Mayo score (calculated as the sum of the four sub-scores: stool frequency rectal bleeding, endoscopy findings and the physician's overall assessment of the same in addition to abdominal discomfort and patient's general sense of well-being).; From baseline to week 8.; Mucosal healing (defined as an improvement of the endoscopy sub-score (from the Mayo score) at week 8 from 3 or 2 to ≤1 point, or from 1 to 0 points).; At week 8.; Change in partial Mayo score (calculated as the sum of the scoring from the three sub-score areas: stool frequency, rectal bleeding and the physician's global assessment).; From baseline to week 4, 8, 12, 16, 20, and 24.; Clinical remission (defined as Mayo score of 2 or lower with no individual sub-score exceeding 1 point).; After 8 weeks.; Histologic disease activity (assessment based on the modified Riley score).; At baseline and week 8.; Markers of disease activity (CRP, calprotectin) and intestinal leakiness (albumin).; At baseline, week 4, 8, 12, 16, 20, and 24.; Immunogenicity: incidence of anti-drug antibodies (ADA) to tralokinumab in serum.; Pre-dose sampling at baseline, week 8, 12, 16, and 24.; Tralokinumab serum concentration.; Pre-dose sampling at baseline, week 4, 8, 12, 16, 20, and 24.; Safety and tolerability of tralokinumab in terms of adverse events, safety laboratory values, electrocardiograms, vital signs, weight, and physical examination findings.; From baseline to week 24
Research Question
  • 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.
Design Type
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Ethics Approval
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Publications
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Countries of Recruitment
Czech Republic; France; Germany; Italy; Netherlands; Poland; United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to 75 Years
Participant Type
Sorry, this information is not available
Trial Sample Size
Sorry, this information is not available
Participant Inclusion 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.
Participant Exclusion 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.
Interventions
Drug; tralokinumab; 2 sc injections of every 2 weeks for 12 weeks.; [1]; Drug; placebo; 2 sc injections of every 2 weeks for 12 weeks.; [2]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Results Reporting
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Acronym
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Scientific Title
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
Secondary Trial Identifying Number
EudraCT number 2011-004812-40
Website
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Study Funded By
AstraZeneca
Funder Type
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Study Sponsored By
AstraZeneca
Study Also Sponsored By
MedImmune Ltd
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

29 Nov 2011

Last Updated

12 Jan 2015

Date Record Refreshed on UKCTG

31 Jul 2015