Crohn's Disease, Inflammatory Bowel Disease
Conditions
Keywords
Crohn's Disease, Inflammatory Bowel Disease, CDAI
Brief 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.
Interventions
DRUGQBECO
DRUGPlacebo
Sponsors
Qu Biologics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 8 weeks | Assessing adverse events, concomitant therapies, clinical chemistry, hematology, urinalysis chemistry |
| Clinical improvement | 8 weeks | Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical remission | 8 weeks | Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline |
| Clinical response | 8 weeks | Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline |
| Intestinal inflammation | 8 weeks | Assessing the change in fecal calprotectin from baseline |
| Systemic inflammation | 8 weeks | Assessing the change in C-reactive protein (CRP) from baseline |
Countries
Canada
Outcome results
None listed