Enrollment into this clinical trial has completed and we are no longer enrolling new participants. Topline results from this study are expected to be available in March 2016. If you are interested in participating in and receiving updates about future clinical trials in Crohn’s disease involving Qu Biologics’ Site Specific Immunomodulators (SSIs), please email email@example.com 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.
|QBECO Clinical Trial Summary|
|Study Design||Phase 1/2, randomized, placebo-controlled, double-blinded study for adults with moderate to severe Crohn’s disease.|
|Screening period||Up to six weeks|
|Study period||24 weeks (16 week treatment period)|
|Location||Vancouver (BC), Edmonton (AB), Toronto (ON)|
|Number of participants||60|
|Administration||Subcutaneous injection (just under skin) using fine needle, like an insulin injection|
Dr. Hal Gunn talks about this Crohn’s clinical trial
Qu Biologics’ proprietary Site Specific Immunomodulators (SSIs) are investigational treatments containing a preparation of a single species of killed bacteria that were developed to stimulate the immune system in a tissue and/or organ specific manner, to reverse the chronic inflammation underlying many conditions including cancer, arthritis, and inflammatory bowel disease. QBECO is comprised of a preparation of a single species of killed bacteria that commonly infects the colon. It is being studied for its potential to treat Crohn’s disease.
The clinical trial for QBECO is a Phase 1/2, randomized, placebo-controlled, double-blind clinical trial for adult participants with moderate to severe Crohn’s disease. Participants (total number = 60) will be randomized 1:1 to receive either QBECO (30 participants) or placebo (30 participants) for the first eight weeks of the study. At eight weeks, participants will be assessed, and all participants who have responded to treatment will continue their current therapy for the remaining eight (8) weeks (16 weeks total), while all participants who have not yet responded to treatment will be provided ‘open-label’ QBECO for an additional eight weeks. The objectives of this study are two-fold: 1) to evaluate the safety profile and 2) to obtain an indication as to the therapeutic efficacy of QBECO induction treatment on clinical improvement (defined as a decrease in CDAI) in Crohn’s disease participants.
QBECO will be administered every second day by subcutaneous (just under the skin) injection by the participant using a fine needle attached to a 0.3 mL syringe (this is the same type of injection and needle as people with diabetes use to administer insulin). The dose will be individualized to the participant. Your study nurse will inject the first dose(s) while showing you how to do it yourself. You'll then be re-trained over the course of a week to self-administer the study treatment at home.
Learn how SSI treatment is administered
Blood, urine and stool samples will be collected at regular intervals throughout the study for standard laboratory testing. In addition, stool and blood samples will be tested for immune system activity and to measure intestinal inflammation.
Video: Stool Sample Collection Training
Qu Biologics will be responsible for the cost of the study drugs and pay for all of the laboratory tests and examinations that are required in this study. To minimize the financial burden of travel expenses incurred while participating in the trial, Qu Biologics is pleased to provide a travel allowance to trial participants. Some of the eligible expenses include flights, hotel, mileage, transportation costs and parking. Please contact a Qu clinical trial representative at 1.855.209.9680 to learn more about the travel reimbursement amounts and eligibility. Please note, it is the participant’s responsibility to arrange their own travel to and from the clinical trial site.
The study takes place at three sites in Canada, including, Vancouver, Edmonton and Toronto. Eligible participants will receive more information about study location prior to study start.
Participants will be assigned randomly into the SSI treatment or the placebo group in equal number. Eight weeks after SSI treatment, clinical response will be assessed by measuring the change in CDAI score from baseline. If there is no improvement or a decrease in CDAI score of greater than or equal to (=) 70 points, participants will continue their current study treatment (QBECO or placebo). If there is a decrease in CDAI score of less than (<) 70 points, participants will be switched over to SSI ‘open-label’ treatment. Please see the summary chart below: