The ELEVATE UC trials
The ELEVATE UC trial program is made up of two clinical trials, one of which is looking at how an investigational medicine may benefit patients with UC. Would you be interested in playing a part in developing new medicines that may help to treat UC?
The key facts:
- Your involvement can last anywhere between 4 months to just over a year. You may be eligible to receive the study drug as part of an optional open-label extension (OLE) study for up to 5 years
- You will have regular study center visits where you will be seen by a doctor
- Your travel expenses may be reimbursed
- If you qualify, it will be your choice whether or not you join the study and you can leave at any point
How it works
If you want to discover if you may be eligible to participate in the study, you can pre-screen online.
You may be eligible if you:
- are 16-80 years of age
- were diagnosed with ulcerative colitis (UC) at least 3 months ago
- have previously been on a UC treatment which did not work or which you could not tolerate
are currently experiencing an active flare^
Other eligibility criteria apply.
^A flare usually consists of symptoms like frequent or urgent bowel movements, diarrhea, bloody stool, and/or abdominal pain. You may also experience fatigue, a lack of appetite, and weight loss.
If you pre-qualify, there will be a further set of eligibility requirements that you must meet. This will necessitate a number of medical tests to be conducted by a doctor at a convenient location near you.
If you are eligible to participate in an ELEVATE study and you choose to take part, you could be joining the movement to rise up against UC. You will need to make regular visits to your local study center throughout the study period.
To find out if you may be eligible and if there is a study center close to you, click on the button below and complete a short questionnaire.
Who can participate in the ELEVATE UC trials?
You may be able to take part in one of our 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
Other criteria will be reviewed by the study team on your first visit to the study center.
What is an open-label extension (OLE) study?
This is where all participants in the study are given the study treatment, meaning that no placebo (inactive pill) is being tested. The objective of the OLE study is to assess the safety and effectiveness of the long-term use of the investigational medicine. Both the researchers and the participants are aware that the participant is receiving the investigational medicine, and participants are typically informed about an OLE study at the time they are recruited into the main study.
What if I am not currently experiencing symptoms?
You can still register at this time. We’ll save your information and send you reminders to take our short survey to check if you may pre-qualify at a later date. Alternatively, you can return to this website when you are experiencing symptoms to see if you then pre-qualify.
How long is the trial?
Depending on which ELEVATE UC trial you are enrolled in, your participation could last either around 4 months or a maximum of just over a year. Some participants may also be eligible to join the separate open-label extenstion (OLE) study for up to an additional 5 years, where all participants will receive the investigational medicine.
It is important to remember that once signed up to the study, you are free to withdraw at any time.
What’s involved with study participation?
Both ELEVATE UC trials will involve taking the investigational medicine, and visiting the study center between 7 and 14 times. You'll need to complete study procedures, including study assessments during your visits.
If pre-qualified, what can I expect on my first visit to the study center?
During your first visit to a study center you will learn more about the ELEVATE UC trials. You’ll be able to speak with a study coordinator about your participation in one of the studies and about the optional long-term extension study.
- You can ask any questions you may have about the ELEVATE UC trials or about clinical research in general.
- You can determine if the ELEVATE UC trial is right for you. If you decide that they are, you will be asked to sign a consent form. Our research staff will then perform a series of screening tests to determine if you’re eligible to participate.
What is the investigational medication being tested?
Etrasimod is a pill that should be taken once a day. In people with UC, lymphocytes leave the lymph nodes and travel to the intestine where they can contribute to inflammation and tissue damage. Etrasimod is thought to work by preventing some of these lymphocytes from leaving the lymph nodes in the first place.
Has this investigational medicine been tested before?
Etrasimod has been tested in small numbers of healthy volunteers and in people with medical conditions, including UC. In the ELEVATE UC trials, etrasimod will be tested on a larger group of people with UC.
Is there a placebo?
Participants in the ELEVATE UC trials will be randomly assigned either the investigational medicine or a placebo (inactive pill). There is a two-in-three chance of receiving the investigational medicine, and neither you nor the study staff will know what you were assigned. All those who take part in the separate ELEVATE UC open-label extenstion (OLE) study will take the investigational medicine for up to an additional 5 years.
What about my current medications?
You should not discontinue any medication unless advised to do so by either the study staff or by your primary care physician. You might have to stop taking your regular medication or therapy during the study, but this will be fully discussed with you at the study center.
Where are the study centers located?
The study centers are located throughout the world, including North and South America, Europe, Asia Pacific, the Middle East, and Africa.
Does participating in this trial cost me anything?
There is no cost to either you or your insurance provider for participation in this trial. You may be reimbursed for your travel expenses.
Do I need health insurance to participate?
No, health insurance is not required to participate in the Arena IBD studies.
Why did I “not qualify”?
Research studies are rigorously designed to test the investigational medicine for safety and effectiveness. One or more of your answers have placed you outside of the strict guidelines for these particular trials. That does not mean, however, that you will not qualify for different research studies either now or in the future.
What does “flare” or “active symptoms” mean?
A “flare” or “active symptoms” usually consist of issues like frequent or urgent bowel movements, diarrhea, bloody stools, and/or abdominal pain. You may also experience fatigue, lack of appetite and weight loss.
Arena Pharmaceuticals was founded in 1997 and now operates from three locations - San Diego, California and Boston, Massachusetts in the US and Zug, Switzerland.
It is our mission to improve the lives of those suffering from IBD around the world. We know that living with IBD isn't always easy and this drives our commitment to discover new treatments and help them to become available to patients.
* This investigational medicine has been tested before in small numbers of healthy volunteers and in patients with medical conditions, including ulcerative colitis. For these studies, the investigational medicine is being tested in a larger group of patients. This investigational medicine has not been approved for commercial use for any specific condition by the United States Food and Drug Administration (FDA) or any other Health Authority. In previous Phase 2 clinical research studies with etrasimod, improvement was noted in UC symptoms and the appearance of the lining of the intestine.