Evaluation of Efficacy and Safety of Tralokinumab in Patients With Active, Moderate-to-severe Ulcerative Colitis
March 7, 2016 updated by: AstraZeneca
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Interventional
Enrollment (Actual)
147
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ceske Budejovice, Czech Republic
- Research Site
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Hradec Kralove, Czech Republic
- Research Site
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Olomouc, Czech Republic
- Research Site
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Praha 1, Czech Republic
- Research Site
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Praha 5, Czech Republic
- Research Site
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Praha 7, Czech Republic
- Research Site
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Amiens Cedex 1, France
- Research Site
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Caen, France
- Research Site
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Clichy, France
- Research Site
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Nice Cedex 3, France
- Research Site
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Pessac, France
- Research Site
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Rouen, France
- Research Site
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Vandoeuvre Les Nancy, France
- Research Site
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Ludwigshafen, Germany
- Research Site
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Oelde, Germany
- Research Site
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Potsdam, Germany
- Research Site
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Wangen, Germany
- Research Site
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Firenze, Italy
- Research Site
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Padova, Italy
- Research Site
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Roma, Italy
- Research Site
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Rozzano, Italy
- Research Site
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Bydgoszcz, Poland
- Research Site
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Częstochowa, Poland
- Research Site
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Sopot, Poland
- Research Site
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Warszawa, Poland
- Research Site
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Łódź, Poland
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Cambridge, United Kingdom
- Research Site
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Coventry, United Kingdom
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Oxford, United Kingdom
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Shrewsbury, United Kingdom
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: 1
tralokinumab (CAT-354) sc injection
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2 sc injections of every 2 weeks for 12 weeks.
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PLACEBO_COMPARATOR: 2
placebo sc injection
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2 sc injections of every 2 weeks for 12 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Clinical Response at Week 8 Based on Mayo Score
Time Frame: Eight week treatment period
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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.
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Eight week treatment period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in Mayo Score From Baseline to Week 8
Time Frame: Eight week treatment period
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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.
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Eight week treatment period
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Mucosal Healing at Week 8 Based on Mayo Score
Time Frame: Eight week treatment period
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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.
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Eight week treatment period
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Clinical Remission at Week 8 Based on Mayo Score
Time Frame: Eight week treatment period
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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.
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Eight week treatment period
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Change From Baseline in Partial Mayo Score
Time Frame: From baseline to Week 4, 8, 12, 16, 20, and 24.
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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.
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From baseline to Week 4, 8, 12, 16, 20, and 24.
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Change From Baseline in Modified Riley Score
Time Frame: Eight week treatment period
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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.
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Eight week treatment period
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Change From Baseline in C - Reactive Protein
Time Frame: From baseline to Week 4, 8, 12, 16, 20, and 24.
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From baseline to Week 4, 8, 12, 16, 20, and 24.
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Change From Baseline in Albumin
Time Frame: From baseline to Week 4, 8, 12, 16, 20, and 24.
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From baseline to Week 4, 8, 12, 16, 20, and 24.
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Change From Baseline in Calprotectin
Time Frame: From baseline to Week 4, 8, 12, 16, 20, and 24.
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From baseline to Week 4, 8, 12, 16, 20, and 24.
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Serum Concentration of Tralokinumab
Time Frame: Pre-dose sampling at baseline, Week 4, 8, 12, 16, 20, and 24.
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Pre-dose sampling at baseline, Week 4, 8, 12, 16, 20, and 24.
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Immunogenicity
Time Frame: Pre-dose sampling at baseline, Week 8, 12, 16, and 24.
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Incidence of anti-drug antibodies (ADA) to tralokinumab in serum.
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Pre-dose sampling at baseline, Week 8, 12, 16, and 24.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Mark Berner Hansen, MD, PhD, AstraZeneca R&D Mölndal Pepparedsleden 1, S-431 83 Mölndal, Sweden
- Principal Investigator: Silvio Danese, MD, PhD, IBD Center, Instituto Clinico Humanitas, Department of Gastroenterology, Via Manzoni 56, 20089 Rozzano, Milan, Italy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (ACTUAL)
March 1, 2013
Study Completion (ACTUAL)
June 1, 2013
Study Registration Dates
First Submitted
November 29, 2011
First Submitted That Met QC Criteria
November 30, 2011
First Posted (ESTIMATE)
December 1, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
April 5, 2016
Last Update Submitted That Met QC Criteria
March 7, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D2211C00001
- EudraCT number 2011-004812-40
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.