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Completed

NCT Number: NCT01482884

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

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Hradec Králové, Czechia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tralokinumab

Drug

2 sc injections of every 2 weeks for 12 weeks.

Placebo

Drug

2 sc injections of every 2 weeks for 12 weeks.

Primary outcomes

  1. Clinical Response at Week 8 Based on Mayo Score

    Time frame: Eight week treatment period

    Clinical response was measured as a decrease in Mayo score of ≥3 points from baseline, decrease in the total Mayo score from baseline ≥30 percentage and a decrease in the sub score for rectal bleeding ≥1 or absolute sub score for rectal bleeding of 0 or 1 point. Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician's global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease.

Secondary outcomes

  1. Change in Mayo Score From Baseline to Week 8

    Time frame: Eight week treatment period

    Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician's global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease. Change from baseline: Mayo score at week 8 minus the Mayo score at baseline.

  2. Mucosal Healing at Week 8 Based on Mayo Score

    Time frame: Eight week treatment period

    Improvement of the endoscopy sub score (from the Mayo score) from 3 or 2 to 0 or 1 point, or from 1 to 0 points.

  3. Clinical Remission at Week 8 Based on Mayo Score

    Time frame: Eight week treatment period

    Participants were classified as in remission if Mayo score of ≤2 with no individual sub score exceeding 1 point. Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician's global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease.

  4. Change From Baseline in Partial Mayo Score

    Time frame: From baseline to Week 4, 8, 12, 16, 20, and 24.

    The partial Mayo score is the sum of the three sub-score areas: stool frequency, rectal bleeding, and the physician's global assessment.The partial Mayo score ranges from 0-9, with higher scores indicating a more severe disease. Change from baseline: Mayo score at each post-baseline timepoint (week 4, 8, 12, 16, 20, and 24) minus the Mayo score at baseline.

  5. Change From Baseline in Modified Riley Score

    Time frame: Eight week treatment period

    Modified Riley score is biopsy grade which range from 0-5; where 0: Normal mucosa, 1: Infiltration of lymphocytes and plasma cells in the lamina propria, 2: Infiltration of neutrophils and eosinophils in the lamina propria, 3: Infiltration of neutrophils in the epithelium, 4: Crypt destruction, 5: Erosion and/or ulceration.

  6. Change From Baseline in C - Reactive Protein

    Time frame: From baseline to Week 4, 8, 12, 16, 20, and 24.

  7. Change From Baseline in Albumin

    Time frame: From baseline to Week 4, 8, 12, 16, 20, and 24.

  8. Change From Baseline in Calprotectin

    Time frame: From baseline to Week 4, 8, 12, 16, 20, and 24.

  9. Serum Concentration of Tralokinumab

    Time frame: Pre-dose sampling at baseline, Week 4, 8, 12, 16, 20, and 24.

  10. Immunogenicity

    Time frame: Pre-dose sampling at baseline, Week 8, 12, 16, and 24.

    Incidence of anti-drug antibodies (ADA) to tralokinumab in serum.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • MedImmune Ltd

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 1, 2011
Registry last updated
Apr 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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