A clinical trial to assess the safety and effectiveness of a new drug, mirikizumab, in conventional-failed and biologic-failed patients with moderately to severely active ulcerative colitis (UC).
About this study
The primary purpose of your participation in this study is not to treat you for your condition but to help answer the following research question: How mirikizumab compares with placebo in helping patients with UC? Mirikizumab is an experimental treatment. This means that it is not an approved treatment for UC in Australia, by the Therapeutic Goods Administration.
Recruitment is closed for this study.
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.