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Completed

NCT Number: NCT01809275

Safety and Treatment Effect of QBECO in 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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Disease Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Calgary, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QBECO

Drug

Placebo

Drug

Primary outcomes

  1. Safety

    Time frame: 8 weeks

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

  2. Clinical improvement

    Time frame: 8 weeks

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

Secondary outcomes

  1. Clinical remission

    Time frame: 8 weeks

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

  2. Clinical response

    Time frame: 8 weeks

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

  3. Intestinal inflammation

    Time frame: 8 weeks

    Assessing the change in fecal calprotectin from baseline

  4. Systemic inflammation

    Time frame: 8 weeks

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

Sponsors and collaborators

Lead sponsor

Qu Biologics Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 12, 2013
Registry last updated
Aug 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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