The total number to be enrolled is 40 participants.
The total duration of the study is 52 weeks. At 16 weeks, participants are evaluated and responders will continue in the study for the remaining 36 weeks. Non-responders will discontinue treatment at 16 weeks.
The trial is a Phase 2a, open-label, dose-ranging, proof-of-concept study to evaluate the safety, tolerability and efficacy of QBECO SSI for the treatment of patients with moderate-to-severe ulcerative colitis. 40 participants will be enrolled in the 52-week study with all participants receiving open-label QBECO SSI for the first 16 weeks. For the remaining 36 weeks, responders will be randomly assigned to three maintenance arms as follows: 1) continue treatment at the same dosage and same administration frequency (every second day); 2) same dosage administered once a week; 3) no maintenance, treatment administered if symptoms appear. For non-responders after 16 weeks, treatment is discontinued.
Enrollment of a second group of participants into this clinical trial is expected to begin later in the year. If you are an adult living with active ulcerative colitis and are interested in joining the second group of the ulcerative colitis clinical trial, please email firstname.lastname@example.org to request to be added to the waitlist. You will be notified once recruitment for the second group begins.
A summary of the initial Week 8 results are available. Check the Crohn's disease clinical trial page of this website to learn more.
Enrollment into this clinical trial has completed and we are no longer accepting new participants. If you are interested in receiving updates about a future clinical trial in Crohn’s disease involving Qu Biologics’ Site Specific Immunomodulators (SSIs), please email email@example.com indicating your request.
Qu Biologics is planning to initiate a multi-site clinical trial in multiple countries to study QBECO SSI for Crohn's disease in early 2017, pending results from the latest Phase 1/2 clinical trial in Crohn's disease. Anyone interested in being notified of a future clinical trial in Crohn's disease may email us at firstname.lastname@example.org indicating your request.
The mechanism of action of SSI has not yet been elucidated. Preliminary preclinical research conducted by Qu Biologics suggests that QBECO SSI acts to stimulate the innate immune system in a site-specific (i.e., organ/tissue specific) manner, and in particular, to stimulate the recruitment of specific immune cells called monocytes/macrophages to the site of disease, i.e., the bowel. Studies are currently underway to explore this hypothesis further.
The initial treatment period is 16 weeks. For the remaining 36 weeks, responders will be randomly assigned to three maintenance arms as follows: 1) continue treatment at the same dosage and same administration frequency (every second day); 2) same dosage administered once a week; 3) no maintenance, however, treatment administered if symptoms appear. For non-responders after 16 weeks, treatment is discontinued.
Study treatment (QBECO SSI or placebo) will be provided to participants in a multi-use glass vial with a rubber seal that must be stored in the fridge. Participants will be taught to self-inject the study treatment (QBECO SSI or placebo) subcutaneously (just below the skin) in the abdomen (belly) or thigh, using a fine gauge needle. It is very similar to the way that patients with diabetes inject insulin. Participants will need to record the injection volume and if present, the size of the local skin immune response (pink/red spot at the injection site) 24 hours after injection in a diary that will be provided to them for this purpose.
Blood, urine and stool samples will be collected at regular intervals throughout the study for standard laboratory testing. In addition, serum and stool samples will be tested for immune system activity and to measure intestinal inflammation.
Yes, participants will be provided with a diary that they will need to complete on a daily basis, recording the dose injected, and if present, the size of the local skin immune response (pink/red spot at the injection site), 24 hours later, as well as any other new symptoms that may or may not be related to the study treatment. In addition, at certain time points throughout the trial, participants will be required to record certain information about their bowel movements, general well-being, prescription drug use and pain levels to assist the study nurse in calculating their CDAI and/or HBI scores. For more information about these scoring methodologies, please consult the following links: Crohn's Disease Activity Index (CDAI) and Harvey-Bradshaw Index (HBI).
Participants will receive follow-up calls from the study nurse every three months for a period of one year from the time of their last dose of study treatment, for safety monitoring purposes.
Emergency contact information will be provided in the instructions provided to participants enrolled in the study. Your study nurse will be able to answer questions during each of your visits.
Yes. Participants are informed about the risks and benefits associated with this study and agree by signing the Informed Consent Form, prior to initiating the study. For participants coming from outside of Vancouver, this may occur remotely, but please note that the signed original MUST be received by the clinical trial site before the screening process can be initiated.
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. Some study participants may be eligible for reimbursement of some expenses.
Ten people with moderate to severe Crohn’s disease uncontrolled with standard treatment have been treated with QBECO to date. All 10 had improvement in symptoms. 7 of the 10 went into remission while on treatment and 3 of those people are in sustained remission after stopping all medications including QBECO SSI. The longest remission is ongoing since July 2010 (discontinued all treatment, including SSI treatment, since July 2011). While promising, this was not a randomized controlled study and therefore the current and future trials will rigorously assess efficacy.
In more than 250 participants treated with SSIs who have been followed for a maximum of four years, no serious adverse events have been observed or reported. A small number of patients reported larger than anticipated transient injection site reactions (including one or more of the following symptoms: increased redness, tenderness, induration, painful induration), and/or mild flu-like symptoms (including one or more of the following symptoms: fever, muscle aches, physical discomfort, cough). All of these symptoms were reported to resolve within a few days without any requirement for treatment.
Yes. Female participants will have to consent to practicing two effective methods of contraception from the time of signing the informed consent form through to two (2) months after the last dose of QBECO SSI is administered (approximately 7 months in total). Male participants will have to consent to practicing one effective method of barrier contraception during the entire study treatment period and through to two (2) months after the last dose of QBECO SSI is administered (approximately 6 months in total).