Evaluation of Efficacy and Safety of Tralokinumab in Patients With Active, Moderate-to-severe Ulcerative Colitis

• 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). [ Time Frame: At week 8. ] [ Designated as safety issue: No ]
  

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

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