Phase II Study With rhuMAb Beta7 In Patients With Ulcerative Colitis
Research type
Research Study
Full title
Phase II Randomised Double-Blind Placebo-Controlled Study To Evaluate The Efficacy And Safety Of rhuMAb BETA7 In Patients With Moderate To Severe Ulcerative Colitis
IRAS ID
81064
Sponsor organisation
Genentech, Inc
Eudract number
2011-000897-80
Clinicaltrials.gov Identifier
Research summary
Ulcerative Colitis (UC) is a chronic inflammatory condition of the colon with symptoms such as mucosal ulceration, rectal bleeding, diarrheoa and abdominal pain. Major surgery is sometimes required. The incidence is 8-10 per 100,000 individuals in westernized countries, and this condition can affect any age group.Standard treatment includes 5-aminosalicyclates, corticosteroids, purine anti-metabolites, cyclosporine and anti-tumour necrosis factor therapy. There is an unmet need for newer therapies. The main aims for new therapies are to reduce the dependence on corticosteroids and to reduce need for surgery without compromising immune competence.rhuMAb Beta7 is a humanized monoclonal antibody (a protein that is normally made by the immune system to help defend the body from infection) and is designed to block the movement of inflammatory cells to the gut lining which leads to the modification of the inflammatory response in UC.In the phase I, rhuMAb Beta7 was well tolerated in 48 patients with moderate to severely active UC. The study aim is to evaluate the efficacy & safety of rhuMAb Beta7 compared with placebo in patients with moderate to severely active UC. 120 patients will take part with 10 being from the UK. The duration of participation is 2.5 years. Participants will be required to attend for 17. After finishing the main part of the trial (6 months) they will be monitored for a further 2 years (with only 3 clinic visits). Procedures include vital signs, height, weight, medical history, physical examinations, blood, urine & stool testing, pregnancy testing, measurement of ulcerative colitis disease including flexible sigmoidoscopy with colon biopsies, ECGs, chest X-ray, assessment of mental status & health questionnaires.This is a double-blind placebo-controlled study with patients able to receive a background of concomitant medication for the treatment of UC.The sponsor of this trial is Genentech, Inc.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
11/NE/0209
Date of REC Opinion
6 Sep 2011
REC opinion
Further Information Favourable Opinion