Trust your gut again.
Take back your days from Crohn’s.
Join a local research trial evaluating an investigational drug.
If eligible and you choose to join this Crohn’s trial, participation may include:
- Trial-related care from local Crohn’s specialists
- Study medication
You may be eligible to participate if you:
- Are between the ages of 18 and 75
- Can confirm your Crohn’s Disease diagnosis with an endoscopy and histology.
If you do not have this handy, we might be able to help! - Have not found relief from corticosteroids, immunomodulators, or TNFα antagonists
Not sure if your Crohn’s medicine qualifies? No problem – we will check.
This clinical trial is evaluating whether the investigational medicine ozanimod can offer relief for moderate-to-severe Crohn’s Disease. The medication is “investigational” because it is still undergoing testing to see if it will be officially approved for use by the public.
What can I expect if I join this trial?
If you qualify and choose to enroll in this trial, you will be assigned to one of two groups:
Investigational drug: ozanimod : Placebo
About two-thirds of the people enrolled in this trial will be placed in a group receiving the investigational medicine, while everyone else will receive a placebo. The “placebo” looks just like the investigational drug being tested, but has no active drug in it.
Will I need to attend in-person appointments?
For twelve weeks, you will need to make in-person visits. The good news is that you get to schedule them to fit your life!
You can expect trial visits that may include:
- Filling out a questionnaire and discussing how you feel with your trial doctor
- Collection of vital signs
- A blood draw
- An electrocardiogram
- A physical examination
- Study drug administration
The study drug will be given as a tablet that you will swallow.
Your clinical trial team will do their best to accommodate your schedule. If possible, it is best to try and schedule your appointments for the morning—or at least try to be consistent with the time of day that you schedule your appointments.
This will help the data to reflect roughly the same timepoint in your daily digestion.
If you are reading this, you likely already know that Crohn’s is a persistent disease of the gut centered around chronic tissue inflammation. Crohn’s is known as a lifelong condition, with periods of remission punctuated by flare-ups.
Stress and diet can worsen Crohn’s, but they alone are not causes of this condition. It is likely passed on genetically, although environmental factors—including stress and diet—can trigger its onset.
Even worse, the chronic inflammation that comes with Crohn’s predisposes people to the development of conditions ranging from fistulas through cancer1.
Symptoms tend to subside when the inflammation associated with Crohn’s is addressed. Every person’s body handles inflammation differently, which is why it is hard to find one treatment that works for everyone.
Existing treatments often do not provide relief, which is why studies like this one are necessary.
1 Evie Carchman, MD, “Crohn’s Disease and the Risk of Cancer,” Clin Colon Rectal Surg., 32(4), (Jul 2019); 305–313.
The decision to join a clinical research trial is a personal one. Only you can decide if it is right for you.
People cite all sorts of reasons for their participation. People who have not been able to find successful treatments for their Crohn’s Disease might want to help drive advances in medical research into their condition
Talk to your doctor if you are interested in participating in Crohn’s research. Fill out the questionnaire to see if you are eligible to enroll, and bring any questions you may have about the study to your screener.
Keep in mind that you can choose to stop participating in a clinical research trial at any time for any reason.
Our clinical trial team members are happy to answer any questions you have, whether you are looking for clarification on these answers or if you have some other questions we did not address here
What is the point of a clinical research trial?
For a drug to be approved for doctors to prescribe, it must first be shown to be both effective as a treatment for its intended condition and safe for people to take. Clinical research studies are how this testing is done.
To keep the public safe, government agencies and Institutional Review Boards closely monitor how this testing is done. Every step of the clinical research trial must be approved. Anyone conducting a study is closely monitored to make sure they adhere to the rules.
A clinical research trial may show that an investigational drug is effective, has no effect, or even causes unexpected harm. There are guidelines for closing studies if safety concerns become evident. All three of these outcomes are important because they bring research closer to developing potential treatments that do work.
What safety measures are in place to protect me if I enroll?
Government regulatory agencies have to approve any study before it is conducted. These agencies have rigorous guidelines around what is allowed, how studies must be conducted and documented, and what precautions must be taken to protect participants.
Before the trial even starts, its plan—also known as a protocol—must first be approved by a panel of science and ethics experts, known as either an institutional review board (IRB) or ethics committee (EC). These experts scrutinize the scientific rationale behind the study and its structure, and they also make sure it protects the welfare of its participants.
Confidentiality is another critical safety measure. Only the study team is informed of your participation on a need-to-know basis (for example, if you are meeting with a study doctor, they will know that you participate). Any information gathered during the study will be kept confidential. Your data will be deidentified to ensure no identifying details are shared in trial reports.
What happens once the trial is over?
Once the clinical research trial is ended, the information regarding safety and effectiveness is analyzed and presented to regulatory bodies for review.
What if I want to stop participating?
At any point in time, you may choose to leave the clinical research trial. If you decide to stop participating, you just need to inform a member of the research team that you wish to leave the trial. While sharing your reason for departure is helpful to the clinical study team, you are not required to give a reason for your decision.