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

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

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 Overview

• Status: Completed
• Conditions: Crohn's Disease; Inflammatory Bowel Disease
• Intervention / Treatment: Drug: Placebo; Drug: QBECO

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary
    • Edmonton, Alberta, Canada, T6G 2X8
      • University of Alberta Zeidler Ledcor Centre
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2K5
      • GI Research Institute
  • Ontario
    • Vaughan, Ontario, Canada, L4L 4Y7
      • Toronto Digestive Disease Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QBECO; Individualized maintenance dose ranging from 0.01 - 0.2 mL, administered subcutaneously, every other day for a maximum of 16 weeks	Drug: QBECO
Placebo Comparator: Placebo; Individualized maintenance dose ranging from 0.01 - 0.2 mL, administered subcutaneously, every other day for a maximum of 16 weeks	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Assessing adverse events, concomitant therapies, clinical chemistry, hematology, urinalysis chemistry	8 weeks
Clinical improvement	Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical remission	Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline	8 weeks
Clinical response	Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline	8 weeks
Intestinal inflammation	Assessing the change in fecal calprotectin from baseline	8 weeks
Systemic inflammation	Assessing the change in C-reactive protein (CRP) from baseline	8 weeks

Collaborators and Investigators

• Sponsor: Qu Biologics Inc.
• Investigators: Study Director: M D, Qu Biologics Inc.; Principal Investigator: M D, GI Research Institute

Publications and helpful links

General Publications

• Sutcliffe S, Kalyan S, Pankovich J, Chen JMH, Gluck R, Thompson D, Bosiljcic M, Bazett M, Fedorak RN, Panaccione R, Axler J, Marshall JK, Mullins DW, Kabakchiev B, McGovern DPB, Jang J, Coldman A, Vandermeirsch G, Bressler B, Gunn H. Novel Microbial-Based Immunotherapy Approach for Crohn's Disease. Front Med (Lausanne). 2019 Jul 19;6:170. doi: 10.3389/fmed.2019.00170. eCollection 2019.

Helpful Links

• Informational website for this trial

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: March 8, 2013
• First Submitted That Met QC Criteria: March 8, 2013
• First Posted (Estimate): March 12, 2013

Study Record Updates

• Last Update Posted (Estimate): August 23, 2016
• Last Update Submitted That Met QC Criteria: August 19, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Inflammatory Bowel Disease; Crohn's Disease; CDAI
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases
• Other Study ID Numbers: QBECO-01