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 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.

Study Process

QBECO Study Treatment Process Summary
Screening period Up to six weeks
Study period 24 weeks (16 week treatment period)
Location Vancouver (BC),  Edmonton, (AB), Toronto (ON)
Administration Subcutaneous injection (just under skin) using fine needle, like an insulin injection
Study Design Phase 1/2, randomized, placebo-controlled, double-blind study for adults with moderately to severely active Crohn’s disease.

This study will take 24 weeks. After the initial 16 week treatment period, participants will be followed up for two months following the date of their last dose of study treatment.

Participant Clinic Visits
Screening Period Clinical Trial

up to 4 weeks

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Visit 1 Visit 2 Visit 3

The screening period refers to the time from when participants sign the Informed Consent Form (ICF) to when they are randomized. During this time participants will undergo a full medical review process with the study doctor, including undergoing laboratory tests (to include collection and testing of blood, urine and stool samples) and a review of their medical history. Depending on which clinical trial site you select, some of these steps can occur remotely prior to visiting the clinical trial site. However, at the end of the screening period, the participants must meet with the study doctor in person to complete the screening process (to include a physical examination). Once the screening process has been completed, the study doctor will inform the participant whether or not they are eligible to participate in this clinical trial. Participants (i.e., eligible participants who have successfully passed the screening period) will be invited back for a second appointment which they will be randomized to their respective treatment groups, and receive their first injection of either QBECO or placebo by the study nurse.

During visit 2, all participants will meet the study doctor to evaluate their response to study treatment induction. This will include: laboratory tests (to include collection and testing of blood, urine and stool samples), physical examination and a review of their participant diary. The study nurse will calculate their CDAI and HBI scores to determine whether they fall into the “responder” or “non-responder” category. “Responders” will be provided with a fresh supply of their current treatment and asked to continue their therapy as before. “Non-responders” will undergo one-week of injection training (as per visit 1) by study nurse to learn to self-administer QBECO at home.

During visit 3, all participants will meet the study doctor to evaluate their current status. This will include: a review of laboratory tests (to include collection and testing of blood, urine and stool samples), a physical examination and a review of their participant diary. The study nurse will calculate their CDAI and HBI scores.

Study Treatment

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

Study Tests

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

Study Cost and Travel Allowance

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.

Study Locations

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.

Study Assessment

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: