Safety and Treatment Effect of QBECO in Moderate to Severe Crohn's Disease

Qu Biologics Inc.68 enrolled

Overview

The purpose of this study is to evaluate the safety profile and to obtain an indication as to the therapeutic effect of QBECO induction treatment on clinical improvement in moderate to severe Crohn's Disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Crohn's Disease Inflammatory Bowel Disease

Interventions

QBECODRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * An adult, age 18 and above * Diagnosed with Crohn's disease AT LEAST six (6) months prior to screening * Crohn's disease diagnosis was verified by one of these procedures: 1) Colonoscopy 2) Capsule endoscopy 3) Computed Tomography (CT) scan 4) Magnetic Resonance Imaging (MRI) 5) Ultrasound * Active Crohn's disease at the time of screening * Female participants: Agree to practice two effective methods of contraception, at the same time, from the time of signing the informed consent form, during the entire study treatment and for two (2) months after taking the last dose of study treatment. * Male participants: Agree to practice effective barrier contraception during the entire study treatment period and for two (2) months after taking the last dose of study treatment. Exclusion Criteria: * Currently pregnant or breastfeeding * Have known or suspected hypersensitivity to any component of the product * Had more than three (3) small bowel resections or diagnosis of short bowel syndrome * Currently anticipate undergoing any major surgical intervention for Crohn's disease during the next six (6) months * Previously been treated with any Qu Biologics' Site Specific Immunomodulators (SSIs) for any disease * Diagnosed with chronic (i.e., long term) hepatitis B or C infection * Diagnosed with congenital (i.e., existing at or before birth) or acquired immunodeficiency (i.e., lack of body defense system). For example, human immunodeficiency virus (HIV) infection, organ transplantation (i.e., specifically received an organ from a donor), etc. * Daily use of narcotic drugs containing opiates (such as morphine, codeine, etc.) for pain control * Have a current or recent history (within the past 12 months) of alcohol dependence or illicit drug use, with the exception of medicinal marijuana prescribed by a physician * Have a history of cancer within the last five (5) years. Exceptions may apply for cervical cancer and some forms of skin cancer

Locations (4)

University of Calgary

Calgary, Alberta, Canada

University of Alberta Zeidler Ledcor Centre

Edmonton, Alberta, Canada

GI Research Institute

Vancouver, British Columbia, Canada

Toronto Digestive Disease Associates

Vaughan, Ontario, Canada

Outcomes

Primary Outcomes

Safety

Assessing adverse events, concomitant therapies, clinical chemistry, hematology, urinalysis chemistry

Time frame: 8 weeks

Clinical improvement

Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline

Time frame: 8 weeks

Secondary Outcomes

Clinical remission

Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline

Time frame: 8 weeks

Clinical response

Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline

Time frame: 8 weeks

Intestinal inflammation

Assessing the change in fecal calprotectin from baseline

Time frame: 8 weeks

Systemic inflammation

Assessing the change in C-reactive protein (CRP) from baseline

Time frame: 8 weeks

Data from ClinicalTrials.gov

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