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Living with Crohn’s disease means suffering behind the selfies

You’re hitting the dancefloor with friends, but your mind is planning your path to the bathroom. You’re feeling spontaneous, but need to watch every last thing you eat or drink.

Crohn’s disease symptoms are often as controlling as they are invisible. Our new clinical studies are investigating if a new treatment has the potential to improve the signs and symptoms of Crohn’s disease.*

Can I take part?

The CULTIVATE study

The CULTIVATE study is testing how an oral investigational medicine works in patients with Crohn’s disease. You could join this new study and play a part in developing treatments that could improve the lives of Crohn’s disease sufferers.

The key facts:

  • Your involvement can last up to 70 weeks (excluding the screening period)
  • You will have regular study center visits (up to 17 visits throughout your participation) where you will see a doctor
  • Your travel expenses may be reimbursed
  • Your participation is voluntary, and you can withdraw at any time

How it works

Step 1

Eligibility

If you would like to find out if you might be eligible to participate in the study you must pre-screen online.

You may be eligible if you:

  • are 18-80 years of age
  • have been diagnosed with Crohn’s disease for at least 3 months
  • have previously been on a Crohn’s disease 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 bowel movements or diarrhea, bloody stool, and/or abdominal pain. You may also experience fatigue, a lack of appetite, and weight loss.

Step 2

Screening

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.

Step 3

Participation

If you are eligible to participate in the CULTIVATE study and you choose to take part, you could be joining the movement against Crohn’s disease. You will need to make regular visits to your local study center throughout the research period.

To find out if you may be eligible and if there is a study center located close to you, click on the button below and complete a short questionnaire.

Can I take part in CULTIVATE?

Coming soon

The CULTIVATE study has not yet started recruiting. Once open for recruitment you will be able to complete the CULTIVATE questionnaire to determine whether you may be eligible to take part. Please return to this website for updates regarding CULTIVATE recruitment.

FAQs

Who can participate in the CULTIVATE study?

You may be able to take part in the CULTIVATE study if you:

  • are 18-80 years of age
  • have been diagnosed with moderately to severely active Crohn’s disease for at least 3 months
  • have previously been on a Crohn’s disease treatment which did not work or which you could not tolerate
  • are currently experiencing active symptoms

Other criteria will be reviewed by the study team on your first visit to the study center.

What if I am not currently experiencing symptoms?

The CULTIVATE study has not yet started recruiting. Once open for recruitment you will be able to complete the CULTIVATE questionnaire to determine whether you may be eligible to take part. Please return to this website for updates regarding CULTIVATE recruitment.

How long is the study?

If you are enrolled in the CULTIVATE study then your participation could last up to 70 weeks. If you complete 14 weeks of treatment (active medicine or a placebo treatment) in the main study period, you will be eligible to move into the extension phase of the study where you will recieve the investigational medicine for up to 52 additional weeks.

It is important to remember that even after you enroll in the study, you are free to withdraw at any time.

What’s involved with study participation?

The CULTIVATE study involves visiting the study center and taking the study treatment, as well as completing study procedures and assessments. You may visit the study center up to 17 times in total.

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 CULTIVATE study. You’ll also be able to speak with a study coordinator about your participation and ask any questions you may have about it or about clinical research in general.
  • You can determine if the CULTIVATE study is right for you. If you decide it is, 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 medicine being tested?

Etrasimod is a pill that should be taken once a day. It is thought to work by preventing lymphocytes from leaving the lymph nodes, which can cause inflammation of the intestines.

Has this investigational medication been tested before?

Etrasimod has been tested in small numbers of healthy volunteers and in people with another inflammatory bowel disease called ulcerative colitis. In the CULTIVATE study, etrasimod will be tested in people with Crohn’s disease.

Is there a placebo?

Participants in the CULTIVATE study will be randomly assigned to either the investigational medicine or a placebo (inactive pill). There is a two- in-three chance of receiving the investigational medication. To protect the integrity of the trial neither you or the study staff will know which medication group you have been assigned to.

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 study cost me anything?

There is no cost to either you or your insurance provider for participation in this study. 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 this particular study. 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 bowel movements or diarrhea, bloody stools, and/or abdominal pain. You may also experience fatigue, lack of appetite and weight loss.

About Arena

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.