Have you been diagnosed with moderate to severe UC?
You May Be Eligible for the AURORA Clinical Trial
The AURORA Clinical Trial is currently evaluating an investigational drug for its safety and effectiveness in the treatment of moderate to severe UC.
What is a Clinical Trial?
A clinical trial, also known as a research study, helps researchers answer questions about certain conditions or diseases and their treatments. By choosing to participate in a clinical trial, participants help the research team answer questions about how the drug works and monitor to see if it is safe to use before it becomes commercially available.
Why Are We Doing the AURORA Clinical Trial?
UC is an inflammatory bowel disease that causes long lasting inflammation from ulcers (sores) in your digestive tract. Cyclosporine has proven to help manage subjects with severe UC; however, when it is given in its traditional formulation, its long-term use can lead to complications and side effects. The AURORA Clinical Trial will investigate ST-0529, a new oral formulation of cyclosporine which delivers cyclosporine directly to the colon. This direct delivery limits exposure to the rest of the body, meaning that the side effects could be less than those seen with other types of cyclosporine formulations. The aim of this trial is to see how well ST-0529 can reduce your UC disease activity and to determine how much cyclosporine is absorbed by the body from ST-0529.
Am I Eligible to Participate?
You may NOT qualify for participation if:
- You have never received treatment for UC
- You have had a previous surgery for UC
- You are allergic to the traditional formulation of cyclosporine
- You are currently breastfeeding, pregnant or wanting to start breastfeeding
- You are participating in another clinical trial and/or received a study drug within 30 days
Note: There are additional eligibility requirements for this clinical research study. A clinical research team member will help determine if you meet all necessary criteria to participate.
Glossary of Terms
IBD- Inflammatory Bowel Disease
UC- Ulcerative Colitis
Clinical trial: any research study that assigns human participants or groups of humans to one or more health-related intervention to evaluate the effects on health outcomes
Cyclosporine: a compound that is isolated from a fungus, Tolypocladium inflatum, found in soil. Cyclosporine is used to reduce the activity in your immune system in order to help control various autoimmune disease conditions such as rheumatoid arthritis and to prevent transplanted organ rejection
Eligibility: suitability to be chosen, selected, or allowed to participate in the clinical trial
Inflammatory bowel disease: a group of disorders characterized by chronic inflammation of the digestive tract. UC is one of the principal types of IBD
Investigational drug: a term used to describe drugs that have received government regulatory approval for human testing, including drugs still undergoing clinical trials, but are not approved for marketing to the general public
Side effects: are unwanted or unexpected events or reactions to a drug
Systemic complications: side effects that affect the entire body
Ulcerative colitis: an IBD that causes long-lasting inflammation and ulcers (sores) in the digestive tract