Tralokinumab vs Placebo in moderate-severe Ulcerative Colitis - V1.0
Research type
Research Study
Full title
A phase IIa, randomised double-blind, placebo-controlled, parallel-arm, multicentre 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
IRAS ID
98795
Contact name
Satish Keshav
Sponsor organisation
AstraZeneca
Eudract number
2011-004812-40
Clinicaltrials.gov Identifier
Research summary
AstraZeneca is conducting a research study that will compare Tralokinumab (a potential new medicine) to placebo, in patients with moderate-to-severe Ulcerative Colitis (UC) when added to medications these patients currently take. The existing therapies for moderate to severe UC frequently fail to prevent ill health and death and therefore, represent an area of unmet medical need. Tralokinumab has previously been shown to be a potentially safe and effective therapy in patients with moderate to severe asthma. The drug targets IL-13, a protein produced by the body, which has been implicated in causing disease conditions associated with UC, and therefore, may prove to be a useful new therapy for UC, but there is no guarantee. Participants of this study will be assigned randomly (by chance) to receive either Tralokinumab or placebo. It??s important to note that neither the patient, nor the doctor or study team, would be allowed to choose which treatment regimen patients are assigned. If patients consent to enter this study they will be asked to attend hospital visits a regular basis and will undergo assessments to check on their health and to see how the drug is working.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
12/SC/0119
Date of REC Opinion
19 Mar 2012
REC opinion
Further Information Favourable Opinion