Extension Study of rhuMAb BETA7 in patients with Ulcerative Colitis

• Research type

  Research Study

• Full title

  A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of rhuMAb BETA7 in Patients with Moderate to Severe Ulcerative Colitis

• IRAS ID

  89604

• Contact name

  John Mansfield

• Sponsor organisation

  Genentech, Inc

• Eudract number

  2011-003409-36

• ISRCTN Number

  N/A

• Research summary

  Ulcerative colitis (UC) is a chronic condition of the colon with symptoms such as mucosal ulceration, rectal bleeding, diarrhoea & 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 & anti-tumour necrosis factor (anti-TNF) therapy. There is an unmet need for newer therapies due to corticosteroid dependence and the requirement for colectomy due to failed medical treatments. The main aims for new therapies are to reduce the dependence on corticosteroids and also to reduce need for surgery without compromising immune competence. rhuMAb Beta7 is a humanized monoclonal antibody (a type of 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 ulcerative colitis. There has been a phase I study in 48 patients with ulcerative colitis where rhuMAb Beta7 appeared to be well tolerated. This study aims to assess the long-term safety & tolerability of rhuMAb Beta7 over 104 weeks and obtain long-term data on the effectiveness, immunogenicity and exposure of rhuMAb Beta7. Approximately 120 patients will be enrolled with about 10 from the UK. They will attend for visits every 4 weeks for 104 weeks. They will then have a safety follow up visit 12 weeks after last study treatment and then an extended follow up for possible adverse events every 12 weeks, for 104 weeks. Procedures include vital signs, physical examinations, pregnancy testing, blood & urine testing, waist-hip measurement, measurement of ulcerative disease & assessment of mental status This is an open-label study with each patient receiving 300 mg of rhuMAb Beta7. The sponsor of this clinical trial is Genentech, Inc.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  11/NE/0334

• Date of REC Opinion

  2 Dec 2011

• REC opinion

  Favourable Opinion