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

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Ulcerative Colitis
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT01482884
Primary Trial ID Number
Summary
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.
Research Details
  • 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
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : tralokinumab, Drug : placebo

Study Arm Groups : 1, 2

Intervention Type
See Interventions above
Primary Outcome Measures
  • 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).; At week 8.
Secondary Outcome Measures
  • 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.; 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.; 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.; Clinical remission (defined as Mayo score of 2 or lower with no individual sub-score exceeding 1 point).; After 8 weeks.; Histologic disease activity (assessment based on the modified Riley score).; At baseline and week 8.; Markers of disease activity (CRP, calprotectin) and intestinal leakiness (albumin).; At baseline, week 4, 8, 12, 16, 20, and 24.; Immunogenicity: incidence of anti-drug antibodies (ADA) to tralokinumab in serum.; Pre-dose sampling at baseline, week 8, 12, 16, and 24.; Tralokinumab serum concentration.; Pre-dose sampling at baseline, week 4, 8, 12, 16, 20, and 24.; 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
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - 75 Years
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
  • 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.
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Shrewsbury
Cambridge
Oxford
Research Site
Coventry
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Czech Republic, France, Germany, Italy, Netherlands, Poland, United Kingdom
Scientific 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
EudraCT Number
Not available for this trial
Funder(s)
  • MedImmune Ltd
Other Study ID Numbers
D2211C00001
Sponsor(s)
AstraZeneca
Key Dates

Recruitment Start Date

Mar 2012

Recruitment End Date

Mar 2013

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

29 Nov 2011

Last Updated

12 Jan 2015