Who Can Participate
Please find below a general overview of the inclusion and exclusion criteria for the clinical trial. Once you have familiarized yourself with the inclusion and exclusion criteria, we recommend interested participants complete the pre-screening questionnaire and registration process so that a clinical representative may assess their eligibility. If you have any questions, you may speak with a Clinical Trial Representative at 1.855.209.9680.
Please note that while the trial is currently only open to residents in Canada and the United States, we are considering opening the trial to participants from around the world. If you live outside of Canada or the United States and are interested in participating in this clinical trial, you can complete the assessment questionnaire and register so we may place you on our waitlist for international participants. Out of town participants are eligible for a travel allowance to cover the expenses related to flights and hotel.
You may be eligible to participate, if:
- You are an adult
- You have active Crohn’s disease
- You were diagnosed with Crohn’s disease AT LEAST six (6) months ago
- You are comfortable speaking, understanding, reading and writing in English
- You are currently in the care of a family doctor (Please note, your medical records must also be available in English)
- For female participants: You agree to practice two effective methods of contraception, at the same time, from the time of signing the informed consent form, during the entire study treatment and for two (2) months after taking the last dose of study treatment.
- For male participants: You agree to practice effective barrier contraception during the entire study treatment period and for two (2) months after taking the last dose of study treatment.
Who Cannot Participate
You are not eligible to participate, if:
- You are currently pregnant or breastfeeding
- You have known or suspected allergy to any component of the product (i.e., killed whole cell bacterial vaccines or phenol)
- You have previously been treated with any Qu Biologics’ Site Specific Immunomodulators (SSIs) for any disease
- You have been diagnosed with hepatitis B or C infection
- You have been diagnosed with congenital (i.e., existing at or before birth) or acquired immunodeficiency. For example, HIV infection or organ transplantation, etc.
- You have a current or recent history (within the past 12 months) of alcohol dependence or illicit drug use, with the exception of medicinal marijuana prescribed by a physician
- You have a history of cancer within the last five (5) years. Exceptions may apply for cervical cancer and some forms of skin cancer