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

Phase 2

Withdrawn

Conditions: UC
ulcerative colitis
10017969

Registration Number: NL-OMON37913

Lead Sponsor: Astra Zeneca

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 12

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.

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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter is clinical response, defined as a decrease in Mayo<br /><br>score from baseline of at least 3 points and at least 30% with an accompanying<br /><br>decrease in the sub score for rectal bleeding of at least 1 point or absolute<br /><br>sub score for rectal bleeding of 0 or 1.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Change from baseline in Mayo score<br /><br>-Mucosal healing, defined as an improvement of the endoscopy subscore (from the<br /><br>Mayo score) from 3 or 2 to 0 or 1 point, or from 1 to 0 points<br /><br>-Change from baseline in partial Mayo score<br /><br>-Clinical remission, defined as Mayo score of 2 or lower with no individual<br /><br>subscore exceeding 1 point<br /><br>-Histologic disease activity: modified Riley score<br /><br>-Markers of disease activity and intestinal leakiness in serum and faeces: CRP<br /><br>and albumin (in serum), calprotectin (in faeces)<br /><br>-Immunogenicity: incidence of anti-drug antibodies (ADA) to tralokinumab in<br /><br>serum<br /><br>-Plasma pharmacokinetics (PK) parameters<br /><br>-Safety measurements</p><br>