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
The primary objective is to evaluate the safety, tolerability and efficacy of two doses of etrasimod as induction therapy in participants with moderately to severely active Crohn’s disease.
Key Inclusion criteria:
- Patients may be able to take part in SSA of the CULTIVATE study if they:
- Are 18-80 years of age
- Were diagnosed with moderate to severe CD at least three months ago
- Did not respond to, are no longer responding to, or did not tolerate another CD therapy
- Are currently experiencing active symptoms
Key Exclusion criteria:
- Patients are not eligible to participate if they:
- Have a history of inadequate response to agents from ≥ 2 classes of biologics marketed for the treatment of CD
- Were diagnosed with ulcerative colitis or indeterminate colitis
- Have functional or post-operative short-bowel syndrome
- Have an ileostomy or colostomy
Additional criteria will be reviewed by the study team at the first visit.
- 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 2 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.
- The study consists of four periods:
- a screening period
- a 14-week treatment period
- a 52-week treatment period
- a follow-up period
- Participants may be eligible to receive the study drug as part of an optional long-term extension study for up to five years.
Description of treatment or intervention (mechanism of action):
- Participants in the CULTIVATE study will be randomly assigned to receive one of two doses of the investigational medication.
- Neither participants nor the study staff will know the assignment.
- In people who have CD, lymphocytes leave the 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