M14-533 Ph 3 study in Mod/Severe Ulcerative Colitis Extension study
Research type
Research Study
Full title
A Phase 3 Multicenter, Open-Label Extension (OLE) Study to Evaluate the Long-Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis (UC)
IRAS ID
211480
Contact name
James Lindsay
Contact email
Eudract number
2016-000674-38
Duration of Study in the UK
5 years, 7 months, 1 days
Research summary
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). Patients currently have treatment options for UC but they are not always effective. Treatments include anti-inflammatory agents (such as mesalazine or steroids), immunomodulators (drugs that act on the immune system, such as azathioprine) and biologic agents (drugs that work by injection to modify the immune response). ABT-494 is a new drug being used in this study; it is being developed for adult patients with inflammatory diseases with the aim of controlling inflammation and reducing symptoms for those suffering from UC.
This study is for patients who participated in the M14-234 study and is designed to look at the long-term safety and effectiveness of ABT-494 in patients with UC. All patients previously on the M14-234 study who have not responded at the end of the induction period, who have lost response during the maintenance period or who have successfully completed the study will have the option to participate in the M14-533 study.
All patients will receive ABT-494 low dose once daily beginning at week 0 for a period of 288 weeks. From week 4 onwards, any patient that experiences inadequate response and have no safety concerns may have their dose escalated to high dose once daily. Study visits will take place at week 0, week 4, week 8, week 12 and then every 12 weeks until week 288. Patients who have completed the study will have a follow up call after approximately 30 days after last administration of study drug.
REC name
London - City & East Research Ethics Committee
REC reference
16/LO/1676
Date of REC Opinion
25 Nov 2016
REC opinion
Further Information Favourable Opinion