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

Crohn's Disease Clinical Trial

Official title:

A Phase 1/2 Randomized, Placebo-Controlled, Double-Blind Study of the Induction of Clinical Response and Remission by QBECO in Subjects With Moderate to Severe Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01809275
• Other study ID #: QBECO-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 8, 2013
• Last updated: August 19, 2016
• Start date: March 2013
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: Qu Biologics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: July 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Drug:
• QBECO

• Placebo

Locations

Country	Name	City	State
Canada	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

Sponsors (1)

Lead Sponsor	Collaborator
Qu Biologics Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Assessing adverse events, concomitant therapies, clinical chemistry, hematology, urinalysis chemistry	8 weeks	Yes
Primary	Clinical improvement	Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline	8 weeks	No
Secondary	Clinical remission	Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline	8 weeks	No
Secondary	Clinical response	Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline	8 weeks	No
Secondary	Intestinal inflammation	Assessing the change in fecal calprotectin from baseline	8 weeks	No
Secondary	Systemic inflammation	Assessing the change in C-reactive protein (CRP) from baseline	8 weeks	No

External Links

•   Informational website for this trial