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

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Medical Conditions
  • Ulcerative Colitis
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Completed
Trial source and source ID number
NCT01482884

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This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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 at Week 8 Based on Mayo Score; Eight week treatment period
Secondary Outcome Measures
    Change in Mayo Score From Baseline to Week 8; Eight week treatment period; Mucosal Healing at Week 8 Based on Mayo Score; Eight week treatment period; Clinical Remission at Week 8 Based on Mayo Score; Eight week treatment period; Change From Baseline in Partial Mayo Score; From baseline to Week 4, 8, 12, 16, 20, and 24.; Change From Baseline in Modified Riley Score; Eight week treatment period; Change From Baseline in C - Reactive Protein; From baseline to Week 4, 8, 12, 16, 20, and 24.; Change From Baseline in Albumin; From baseline to Week 4, 8, 12, 16, 20, and 24.; Change From Baseline in Calprotectin; From baseline to Week 4, 8, 12, 16, 20, and 24.; Serum Concentration of Tralokinumab; Pre-dose sampling at baseline, Week 4, 8, 12, 16, 20, and 24.; Immunogenicity; Pre-dose sampling at baseline, Week 8, 12, 16, and 24.
Publication(s)
Danese S, Rudziński J, Brandt W, Dupas JL, Peyrin-Biroulet L, Bouhnik Y, Kleczkowski D, Uebel P, Lukas M, Knutsson M, Erlandsson F, Hansen MB, Keshav S. Tralokinumab for moderate-to-severe UC: a randomised, double-blind, placebo-controlled, phase IIa study. Gut. 2015 Feb;64(2):243-9. doi: 10.1136/gutjnl-2014-308004. Epub 2014 Oct 10.; 25304132
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
18 Years - 65 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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Local Institution
Cambridge
Cambridgeshire
Local Institution
Oxford
Oxfordshire
University Hospital
Coventry
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Shrewsbury
Shropshire
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, Poland, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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 added to source

29 Nov 2011

Date updated in source

07 Mar 2016