Who Can Participate
Thank you for your interest in participating in Qu Biologics’ Phase 1/2 clinical trial of an investigational new treatment for Crohn’s disease.
Enrollment into this clinical trial has completed and we are no longer accepting new participants. If you are interested in receiving updates about a future clinical trial in Crohn’s disease involving Qu Biologics’ Site Specific Immunomodulators (SSIs), please email firstname.lastname@example.org indicating your request.
We sincerely appreciate your interest in our research of immune dysfunction in inflammatory bowel disease and our exploration of a new treatment option for Crohn’s disease.
Please find below a general overview of the inclusion and exclusion criteria for the clinical trial.
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