Safety and Treatment Effect of QBECO in Moderate to Severe Crohn's Disease
- Conditions
- Crohn's DiseaseInflammatory Bowel Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT01809275
- Lead Sponsor
- Qu Biologics Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description QBECO QBECO Individualized maintenance dose ranging from 0.01 - 0.2 mL, administered subcutaneously, every other day for a maximum of 16 weeks Placebo Placebo Individualized maintenance dose ranging from 0.01 - 0.2 mL, administered subcutaneously, every other day for a maximum of 16 weeks
- Primary Outcome Measures
Name Time Method Clinical improvement 8 weeks Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline
Safety 8 weeks Assessing adverse events, concomitant therapies, clinical chemistry, hematology, urinalysis chemistry
- Secondary Outcome Measures
Name Time Method 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
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
Trial Locations
- Locations (4)
University of Calgary
🇨🇦Calgary, Alberta, Canada
University of Alberta Zeidler Ledcor Centre
🇨🇦Edmonton, Alberta, Canada
GI Research Institute
🇨🇦Vancouver, British Columbia, Canada
Toronto Digestive Disease Associates
🇨🇦Vaughan, Ontario, Canada
University of Calgary🇨🇦Calgary, Alberta, Canada