A Phase II/III Randomized Double-blind Placebo-controlled Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy

Brief description of study

The purpose of the study is to test the safety and effectiveness of the study drug, BI 655130, in subjects with ulcerative colitis (UC). In addition, the study will find the best dose of BI 655130 that can be used in future clinical studies without causing unacceptable side effects. Different doses of the study drug BI 655130 will be tested to see which dose has less unacceptable side effects and is more effective in subjects with UC. In this study the subject will either get the study drug BI 655130 or a placebo. A placebo looks like the study drug, but does not contain any active ingredients; it is like a sugar pill. In addition, the study will test how the study drug BI 655130 is used by the body, how fast or slow the study drug moves through or out of the body, and how the body reacts to the study drug. BI 655130 has not been approved by the U.S. Food and Drug Administration (FDA) as a treatment for any disease. The study drug is experimental for this study.

Clinical Study Identifier: s17-00835
ClinicalTrials.gov Identifier: NCT03482635
Principal Investigator: Lev Ginzburg
Currently Recruiting

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