AMAC,PrtAmendment(18-Sep-2015), Prt UK Addendum 1.1(08-Dec-2015)

• Research type

  Research Study

• Full title

  A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis

• IRAS ID

  188354

• Contact name

  Susan Carpenter

• Contact email

  carpenter_susan@lilly.com

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2015-003123-57

• Duration of Study in the UK

  2 years, 2 months, 1 days

• Research summary

  This is a phase 2, multicenter, randomized, doubled-blind, parallel, placebo-controlled trial in which approximately 240 eligible patients, including approximately 25 patients in the UK, with moderate-to-severe ulcerative colitis (UC) will be randomized.

  UC is a chronic disease of unknown cause that is characterized by inflammation in the colon. Patients have intermittent disease flares interspersed with periods of remission; the primary symptoms are blood in the stool, diarrhea, and abdominal pain, which reduce overall quality of life. Many patients with UC experience a severe clinical course: approximately 30% require colectomy within 10 years of diagnosis. As many as 40% of patients with UC do not respond or maintain a response to conventional medications and require secondary drug treatment or colectomy, various biologics that target specific immunological pathways have been studied as potential therapeutics for UC. LY3074828 is a humanized immunoglobulin monoclonal antibody that is directed against IL-23. There is substantial experience of agents that block this pathway and another human anti-IL-23 monoclonal antibody (ustekinumab) is already licensed for conditions such as psoriasis and psoriatic arthritis. LY3074828 is being developed for the treatment of UC.

  The study is designed to determine whether LY3074828 is safe and to provide preliminary evidence that it benefits patients with moderate to severely active ulcerative colitis by inducing clinical remission at 12 week.

  This study will include male or female patients≥18 and ≤75 years of age with moderate to severely active UC. It will take about 18 months to complete the whole study but patient participation in the study is expected to last up to one year plus an additional 4 weeks of screening.

  The study will be conducted in NHS hospitals throughout UK.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  16/SC/0039

• Date of REC Opinion

  29 Mar 2016

• REC opinion

  Further Information Favourable Opinion