Overview

Safety and Treatment Effect of QBECO in Moderate to Severe Crohn's Disease

Status:
Completed
Trial end date:
2016-07-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the safety profile and to obtain an indication as to the therapeutic effect of QBECO induction treatment on clinical improvement in moderate to severe Crohn's Disease.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Qu Biologics Inc.
Criteria
Inclusion Criteria:

- An adult, age 18 and above

- Diagnosed with Crohn's disease AT LEAST six (6) months prior to screening

- Crohn's disease diagnosis was verified by one of these procedures: 1) Colonoscopy 2)
Capsule endoscopy 3) Computed Tomography (CT) scan 4) Magnetic Resonance Imaging (MRI)
5) Ultrasound

- Active Crohn's disease at the time of screening

- Female participants: 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.

- Male participants: 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.

Exclusion Criteria:

- Currently pregnant or breastfeeding

- Have known or suspected hypersensitivity to any component of the product

- Had more than three (3) small bowel resections or diagnosis of short bowel syndrome

- Currently anticipate undergoing any major surgical intervention for Crohn's disease
during the next six (6) months

- Previously been treated with any Qu Biologics' Site Specific Immunomodulators (SSIs)
for any disease

- Diagnosed with chronic (i.e., long term) hepatitis B or C infection

- Diagnosed with congenital (i.e., existing at or before birth) or acquired
immunodeficiency (i.e., lack of body defense system). For example, human
immunodeficiency virus (HIV) infection, organ transplantation (i.e., specifically
received an organ from a donor), etc.

- Daily use of narcotic drugs containing opiates (such as morphine, codeine, etc.) for
pain control

- 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

- Have a history of cancer within the last five (5) years. Exceptions may apply for
cervical cancer and some forms of skin cancer