About this Crohn’s Disease Trial
|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 four weeks|
|Study period||24 weeks|
|On-site requirement||3 visits
|Location||Vancouver, BC, Canada|
|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.
Screening period is expected to take up to four weeks. The main study period will take 24 weeks, which will include three visits to a study location in Vancouver, BC. After the initial 16-week treatment period, participants will be followed up (one phone call every three months) for one year following their last dose of study treatment. Review a detailed outline of the study process.
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 assist participants with travel related costs (flights, accommodation, car rentals, taxis, etc.), Qu Biologics will provide a travel allowance for those living 150 kilometres or farther from the clinical trial site or on an island. Participants will receive the allowance in three equal installments after each of their three clinic visits and the amount of the travel allowance per person will be determined based on geographical distance. Learn more about the clinical trial travel allowance. In addition, Qu Biologics has negotiated a preferential rate at a Downtown Vancouver hotel close to the clinic for clinical trial participants. Please note, it is the participant’s responsibility to arrange their own travel to and from the clinical trial site.
The study will take place at the GI Research Institute, located in downtown Vancouver, British Columbia. Non-Vancouver residents will be able to have their laboratory testing performed in a location close to their place of residence, but will be required to attend three (3) mandatory visits to the clinic in Vancouver in the first 24 weeks of the study. 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: