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Health Condition(s) or Problem
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Ulcerative Colitis
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Lay Summary
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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.
(from ClinicalTrials.gov)
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Who can enter the trial
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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.
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Who cannot enter the trial
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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.
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What will happen
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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
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Primary aim
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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).
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Secondary Aim
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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.; No; 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.; No; 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.; No; Clinical remission (defined as Mayo score of 2 or lower with no individual sub-score exceeding 1 point).; After 8 weeks.; No; Histologic disease activity (assessment based on the modified Riley score).; At baseline and week 8.; No; Markers of disease activity (CRP, calprotectin) and intestinal leakiness (albumin).; At baseline, week 4, 8, 12, 16, 20, and 24.; No; Immunogenicity: incidence of anti-drug antibodies (ADA) to tralokinumab in serum.; Pre-dose sampling at baseline, week 8, 12, 16, and 24.; No; Tralokinumab serum concentration.; Pre-dose sampling at baseline, week 4, 8, 12, 16, 20, and 24.; No; 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; Yes
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Not Recruiting
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Nation
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England
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Location
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Reading, Cambridge, Coventry, Oxford, Shrewsbury
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