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.
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
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Drug : tralokinumab, Drug : placebo
Study Arm Groups : 1, 2
See Interventions above
- 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.
- 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
Sorry, this information is not available
This is available on the Clinicaltrials.gov
18 Years - 75 Years
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- 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.
This is in the inclusion criteria above
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
Not available for this trial