Healthcare professional adjusts patient's IV in a clinic. Text reads, "Help us to study an alternative way of treating Crohn's disease. We're aiming to take Crohn's treatment out of the hospital.

What is the Crohn’s disease study? 

The study is a clinical research study (also called a “clinical trial”) that is looking at a study drug to see if it can safely be given subcutaneously (an injection under the skin) with the goal of inducing “remission” in adults with moderate to severe Crohn’s disease (CD). Remission is the point where CD symptoms start to go away or disappear completely. 

The study drug has been tested in multiple countries for CD in adults. It is first given as an intravenous (directly into the vein) infusion with the goal of inducing remission (known as “induction therapy”). This is followed by a subcutaneous injection with the goal of keeping the patient in remission (known as “maintenance therapy”).  

Although the study drug has been tested in multiple countries, giving the study drug as a subcutaneous injection for induction therapy is investigational. 

The study will last for up to 93 weeks. 

What happens if I want to take part? 

After you have spoken to your own doctor or the study doctor, you will need to follow a few steps to see if you can enroll in the study. 

  • Answer questions about your medical history. 
  • Review, understand, and sign the Informed Consent Form. A member of the study site staff will talk you through this. 
  • Have screening tests and procedures at the study center, such as blood tests, providing stool samples, and an endoscopy. 

If you are still eligible after these steps, you will move into the study treatment period where you may start taking the study drug. 

What will my participation look like? 
  
If you are eligible to take part and choose to do so, you will need to visit the study center up to 14 times. You may also need to have phone calls with a member of the study site staff. 

You will also need to complete a daily electronic diary (eDiary) to record your symptoms. 

Once you begin taking the study drug, you will visit the study center once every 2 to 4 weeks.

Your study visits will involve procedures such as an endoscopy, blood tests, providing stool samples, and receiving the study drug. 

  • Visit frequency: Every 2 to 4 weeks for the first 28 weeks. For the open label extension that follows, visits are spaced out every 24 weeks with visits at week 52 and week 76. 
  • Visit length: Most study visits will vary from 1 to 3 hours. Visits with endoscopies will take longer. Please ask the study doctor how long these visits will take. 
  • Study length: Your time in the study could last for up to 93 weeks. 

Who can take part? 
  
You may be able to take part in this Study if you: 

  • are 18 years of age or older 
  • have a confirmed diagnosis of Crohn’s disease (CD) for at least 3 months 
  • currently have moderate to severe CD symptoms 
  • have tried at least 1 previous therapy for CD that did not work or you were intolerant to 

How do I get more information? 
  
Study participation is voluntary. If you contact us, you do not have to take part in the study. 
  
If you meet the listed eligibility criteria and would like to learn more about the study, please call (318) 525-3233 to speak with the clinical research coordinator.