Summary:
If you have Ulcerative Colitis (UC), you may want to consider the OASIS clinical study. The OASIS clinical study is being done to find out if an investigational medication is safe and if it works well in adults with moderate to severe UC.
What is ulcerative colitis?
UC is a chronic disease of the colon, where the lining of the colon becomes inflamed and forms ulcers. Typical symptoms of UC include:
- Loose and urgent bowel movements
- Frequent diarrhea
- Blood in your stool
- Stomach pain
The availability of an oral medication such as the one being studied in the OASIS clinical study could offer patients an additional, more convenient treatment for UC.
What is the purpose of the OASIS study?
The goal of the OASISclinical study is to learn whether an investigational medication is safe and if it will effectively reduce the inflammation of the gut in patients with UC.
What is the investigational medication?
The investigational medication in the OASIS clinicalstudy is being evaluated as a treatment option for auto-immune diseases, including UC. It aims to reduce the inflammation in the gut in patients with moderately to severely active UC. The medication is considered investigational because it is not approved by health authorities, including the U.S. Food and Drug Administration (FDA), for the treatment of UC.
Who can participate?
About 240 people with UC will participate in the study.
You may be able to join the study if you:
- Are 18 to 80 years old
- Have been diagnosed with UC for at least 6 months
- Have failed to respond to at least 1 medication to treat UC
There are other eligibility criteria that you must meet to participate. The study staff can discuss these criteria with you in greater detail.
What will happen if I join the study?
Participants will be randomly assigned to receive placebo or one of two doses of the investigational medication. Placebo looks like the investigational medication but has no active ingredients. You will have a two in three chance of receiving the investigational medication. Neither you nor your doctor will know whether you are receiving the investigational medication or placebo.
If you complete the OASIS clinical study, you will have the opportunity to participate in an extension study for up to 40 weeks.
If you qualify and agree to participate in the study, you will be required to:
- Attend between 7 and10 study visits
- Take the investigational medication or placebo once daily
- Record your UC symptoms in an electronic dairy
- Receive an endoscopy and biopsy before you begin the study and after the study ends
- Provide urine, stool, and blood samples
- Wear a device (Holter monitor) for 48 hours to track your heart’s electrical activity
- Follow all directions from the study staff
What are the potential risks and benefits?
Everyone who participates in a research study must first complete a screening visit. During the screening visit, the study doctor will explain to you the study details and the potential risks and benefits of participation in the study.
The information learned from the study and yourparticipation may help improve future treatment options for peoplewith UC.
Study participation is voluntary. If you choose to participate, youmay leave the study at any time for any reason. The study doctor and staff will be available to help you throughout the study and to address any questions you may have.