About the ELEVATE UC Trials:
The ELEVATE UC program consists of two worldwide clinical trials and an open-label extension study to test how an oral investigational medication works in patients with UC. You may be able to take part in one of the ELEVATE UC trials if you:
- Are 16-80 years of age
- Were diagnosed with moderate to severe ulcerative colitis (UC) at least 3 months ago
- Did not respond to, are no longer responding to, or did not tolerate another UC therapy
- Are currently experiencing active symptoms
There are additional criteria that are reviewed by the study team at the study center at the first visit.
An open-label extension (OLE) study is a type of study in which all participants are given the study treatment, meaning no placebo (inactive pill) is being tested. Both the researchers and participants know that the participant is receiving the study treatment. The objective of the OLE study is to assess the safety of the long-term use of the study treatment. Participants are typically informed about an OLE study at the time they are recruited into the main study.
You can still register at this time to have your information saved and we’ll send you reminders to come back and take the short survey to see if you may pre-qualify. You can also bookmark this website and come back when you are experiencing symptoms to see if you pre-qualify.
If eligible, depending on which of the ELEVATE UC trials you are enrolled in, participation can last either around 4 months or a maximum of a little over 1 year. Some participants may also be eligible to join a separate ELEVATE UC study for up to an additional 5 years where all participants will receive the investigational medication. The study coordinator can answer any questions you have about the ELEVATE UC program.
Both ELEVATE UC trials will involve taking the study treatment, visiting the study center, and completing study procedures, including study assessments. Depending on the trial, you may visit the study center 7-14 times.
This initial appointment is an opportunity for you to:
- Learn more about the ELEVATE UC program. You’ll be speaking with a study coordinator at the study center to learn more regarding your participation in one of the ELEVATE UC trials and optional long-term extension study.
- Ask any important questions you may have. These can be any questions you may have about the ELEVATE UC trials or clinical research in general.
- Determine if the ELEVATE UC trials may be right for you. After speaking with the study coordinator and learning details about the ELEVATE UC program, the research staff will perform a series of screening tests to determine if you are eligible to participate in one of the ELEVATE UC trials. If you’re eligible, you will be given an opportunity to decide if participation in one of the ELEVATE UC trials is right for you. If you agree to take part, the center will ask you to sign a consent form.
The oral investigational medication being studied in the ELEVATE UC trials is a pill, taken once a day.
In people with UC, lymphocytes leave lymph nodes and travel to the intestine where they may contribute to inflammation and tissue damage. Etrasimod is thought to work by preventing some lymphocytes from leaving lymph nodes. This may reduce the number of lymphocytes that travel to the intestine, which may lead to improvement in the symptoms of UC.
Etrasimod is a pill that has been previously tested in small numbers of healthy volunteers and in people with medical conditions, including UC. In the ELEVATE UC trials, etrasimod is being tested in a larger group of people with UC.
If you qualify for one of the ELEVATE UC trials, you will be randomly assigned to either the investigational medication or a placebo. You have a 2-in-3 chance of receiving the investigational medication, and a 1-in-3 chance of receiving a placebo (inactive pill). Neither you nor the study staff will know your assignment. Some participants may also be eligible to join a separate ELEVATE UC study for up to an additional 5 years where all participants will receive the investigational medication.
Do not discontinue any medication unless you are advised to do so by the study center staff or your primary care physician. You might have to stop taking your regular medication or therapy during the study, but this will be discussed with you at the study center.
The study centers are located in multiple regions throughout the world including North America, South America, Asia Pacific, Europe, the Middle East, and Africa.
There is no cost to you or your insurance provider for participating in the trial. If you qualify for the trial, you may be reimbursed for your travel expenses.
No, health insurance is not needed in order to participate.
Research studies are designed in specific ways to test the investigational medication for safety and effectiveness. One or more of the answers that you provided were outside of the guidelines for this trial. This does not mean you will not qualify for different research studies. If you are not currently experiencing UC symptoms, please visit the website to pre-screen again when you are experiencing your UC symptoms to see if you pre-qualify.
About Ulcerative Colitis (UC):
Ulcerative colitis, also known as UC, is a “chronic” condition that causes inflammation in the lining of the colon.