A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease

Study Description:

• Patients diagnosed with moderate to severe CD may be eligible to participate in this study. CD is a life-long condition, which causes inflammation (pain, swelling, and redness) of the digestive system (mouth, stomach and intestines) caused by an over-reaction of the immune system (the body’s defense system, which fights infection).
• This is a Phase 2b study, which means that the study drug has been previously tested in small numbers of healthy volunteers, and in participants with medical conditions, including ulcerative colitis and CD.
• The study consists of four periods:
  • a screening period
  • a 14-week treatment period
  • a 6-week extended treatment period (if applicable)
  • a follow-up period
• Participants who complete treatment may be eligible for a 38-week maintenance study followed by a long-term extension study, where they may receive study drug for up to five years.

Description of treatment or intervention (mechanism of action):

• Patients qualifying for the CULTIVATE study will be randomly assigned to receive one of two doses of the study drug or placebo (inactive pill).
• They will have a two-in-three chance of receiving the study drug and a one-in-three chance of receiving placebo.
• Neither participants nor study staff will know the assignment.
• In people who have CD, 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 CD.

Possible risks and side effects:

• Based on the mode of action of etrasimod, and other medicines that work in a similar way, there are potential risks associated with the study drug, including:
  • an increased risk of infection (due to a reduction in the white blood cells that are part of the immune system)
  • an increase of blood pressure
  • macular edema (swelling in part of the retina, in the eye)
  • a decrease in lung function
  • changes in the blood results that look at liver function
  • risks to an unborn child if a woman receives the treatment during pregnancy