Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004812-40-DE

Enrollment

110

Registered

2011-11-25

Start date

2012-01-26

Completion date

Unknown

Last updated

2013-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Interventions

Product Name: tralokinumab Product Code: CAT-354 Pharmaceutical Form: Solution for injection INN or Proposed INN: tralokinumab CAS Number: 1044515-88-9 Current Sponsor code: CAT-354 Concentration unit

Eligibility

Sex/Gender

All

Inclusion criteria

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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 106 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to assess the effect of tralokinumab compared with placebo in patients with active UC by assessment of clinical response, as defined by the Mayo score, at week 8. ;Secondary Objective: To assess change in Mayo score from baseline to week 8. To assess mucosal healing at week 8. To assess change in partial Mayo score from baseline to week 4, 8, 12, 16, 20, and 24. To assess the proportion of patients in clinical remission, as defined by the Mayo score, after 8 weeks. To assess histology in biopsies from colonic mucosa at baseline and week 8. To assess markers of disease activity and intestinal leakiness in serum and faeces at baseline, week 4, 8, 12, 16, 20, and 24. To assess the pharmacokinetics and immunogenicity of tralokinumab. To evaluate the safety and tolerability of tralokinumab by assessment of reported Adverse Events (AEs), safety laboratory values, electrocardiograms, vital signs, weight, and physical examination findings. ;Primary end point(s): 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). ;Timepoint(s) of evaluation of this end point: At week 8.	—

Measure

Time frame

Main Objective: The primary objective of the study is to assess the effect of tralokinumab compared with placebo in patients with active UC by assessment of clinical response, as defined by the Mayo score, at week 8. ;Secondary Objective: *To assess change in Mayo score from baseline to week 8. *To assess mucosal healing at week 8. *To assess change in partial Mayo score from baseline to week 4, 8, 12, 16, 20, and 24. *To assess the proportion of patients in clinical remission, as defined by the Mayo score, after 8 weeks. *To assess histology in biopsies from colonic mucosa at baseline and week 8. *To assess markers of disease activity and intestinal leakiness in serum and faeces at baseline, week 4, 8, 12, 16, 20, and 24. *To assess the pharmacokinetics and immunogenicity of tralokinumab. *To evaluate the safety and tolerability of tralokinumab by assessment of reported Adverse Events (AEs), safety laboratory values, electrocardiograms, vital signs, weight, and physical examination findings. ;Primary end point(s): 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). ;Timepoint(s) of evaluation of this end point: At week 8.

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Secondary

Measure	Time frame
Secondary end point(s): * 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). * 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). * 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). * Clinical remission (defined as Mayo score of 2 or lower with no individual sub-score exceeding 1 point) * Histologic disease activity (assessment based on the modified Riley score). * Markers of disease activity (CRP, calprotectin) and intestinal leakiness (albumin). * Immunogenicity: incidence of anti-drug antibodies (ADA) to tralokinumab in serum. * Tralokinumab serum concentration. * Safety and tolerability of tralokinumab in terms of adverse events, safety laboratory values, electrocardiograms, vital signs, weight, and physical examination findings. ;Timepoint(s) of evaluation of this end point: * From baseline to week 8. * At week 8. * From baseline to week 4, 8, 12, 16, 20, and 24. * After 8 weeks. * At baseline and week 8. * At baseline, week 4, 8, 12, 16, 20, and 24. * Pre-dose sampling at baseline, week 8, 12, 16, and 24. * Pre-dose sampling at baseline, week 4, 8, 12, 16, 20, and 24. * From baseline to week 24	—

Measure

Time frame

Secondary end point(s): * 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). * 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). * 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). * Clinical remission (defined as Mayo score of 2 or lower with no individual sub-score exceeding 1 point) * Histologic disease activity (assessment based on the modified Riley score). * Markers of disease activity (CRP, calprotectin) and intestinal leakiness (albumin). * Immunogenicity: incidence of anti-drug antibodies (ADA) to tralokinumab in serum. * Tralokinumab serum concentration. * Safety and tolerability of tralokinumab in terms of adverse events, safety laboratory values, electrocardiograms, vital signs, weight, and physical examination findings. ;Timepoint(s) of evaluation of this end point: * From baseline to week 8. * At week 8. * From baseline to week 4, 8, 12, 16, 20, and 24. * After 8 weeks. * At baseline and week 8. * At baseline, week 4, 8, 12, 16, 20, and 24. * Pre-dose sampling at baseline, week 8, 12, 16, and 24. * Pre-dose sampling at baseline, week 4, 8, 12, 16, 20, and 24. * From baseline to week 24

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Countries

Czech Republic, Germany, Italy, Netherlands, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026