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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01809275
First Posted: March 12, 2013
Last Update Posted: August 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Qu Biologics Inc.
  Purpose
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.

Condition Intervention Phase
Crohn's Disease Inflammatory Bowel Disease Drug: QBECO Drug: Placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Qu Biologics Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: 8 weeks ]
    Assessing adverse events, concomitant therapies, clinical chemistry, hematology, urinalysis chemistry

  • Clinical improvement [ Time Frame: 8 weeks ]
    Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline


Secondary Outcome Measures:
  • Clinical remission [ Time Frame: 8 weeks ]
    Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline

  • Clinical response [ Time Frame: 8 weeks ]
    Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline

  • Intestinal inflammation [ Time Frame: 8 weeks ]
    Assessing the change in fecal calprotectin from baseline

  • Systemic inflammation [ Time Frame: 8 weeks ]
    Assessing the change in C-reactive protein (CRP) from baseline


Enrollment: 68
Study Start Date: March 2013
Study Completion Date: July 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809275


Locations
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6
University of Alberta Zeidler Ledcor Centre
Edmonton, Alberta, Canada, T6G 2X8
Canada, British Columbia
GI Research Institute
Vancouver, British Columbia, Canada, V6Z 2K5
Canada, Ontario
Toronto Digestive Disease Associates
Vaughan, Ontario, Canada, L4L 4Y7
Sponsors and Collaborators
Qu Biologics Inc.
Investigators
Study Director: M D Qu Biologics Inc.
Principal Investigator: M D GI Research Institute
  More Information

Additional Information:
Responsible Party: Qu Biologics Inc.
ClinicalTrials.gov Identifier: NCT01809275     History of Changes
Other Study ID Numbers: QBECO-01
First Submitted: March 8, 2013
First Posted: March 12, 2013
Last Update Posted: August 23, 2016
Last Verified: August 2016

Keywords provided by Qu Biologics Inc.:
Crohn's Disease
Inflammatory Bowel Disease
CDAI

Additional relevant MeSH terms:
Crohn Disease
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases