QBECO Crohns Disease Clinical Trial., Qu Biologics’ proprietary Site Specific Immunomodulators (SSIs) are investigational treatments containing preparation of a single species of killed bacteria that were developed to stimulate the innate 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 (CD).
The clinical trial for QBECO is a Phase 1/2, randomized, placebo-controlled, double-blind clinical trial for adult participants with moderate to severe CD. 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 CD 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.
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