Physicians of the Zane Cohen Centre

Clinical Trial for Small Bowel Crohn’s Disease

Contact: Ajani Jeyakumar, Clinical Research Coordinator
416-586-4800 ext. 5953
Ajani.Jeyakumar@sinaihelathsystem.ca

Primary Investigator: Dr. Mark Silverberg

Enrolment: Ongoing

Mount Sinai Hospital is participating in a research study to understand the safety and effectiveness of a investigational medication for treating Crohn’s Disease affecting the small bowel.

We are looking for individuals:
With Crohn’s Disease that is affecting the small bowel
Experiencing symptoms related to their Crohn’s Disease
Have previously and/or currently not responded to the following standard treatments:
•    Corticosteroids (e.g., Prednisone)
•    Immunosuppressants (e.g., Imuran, 6-MP)
•    Biologic Therapy (e.g., Remicade, Humira, Simponi, Entyvio, Stelara)

Description of Clinical Trial:
This study will last up to 24 weeks, during which you will see the study doctor and/or coordinator 10 times. Your Crohn’s Disease will be assessed and, if eligible, participants will be randomized in a 2:2:1 ratio to receive either high dose study medication, low dose study medication, or placebo ("dummy" drug) for 24 weeks. If your Crohn’s Disease has not improved by week 10 of the study, you may be eligible for future studies done by the sponsor. Reimbursement will be provided for study-related travel expenses.