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Safety and Efficacy of QBECO in Moderate to Severe Ulcerative Colitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02426372
First Posted: April 24, 2015
Last Update Posted: August 24, 2017
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 open-label, dose-ranging, exploratory study is to evaluate the safety, tolerability, compliance, mechanism of action and efficacy of QBECO site specific immunomodulation for the induction of clinical response and remission in subjects with moderate to severe ulcerative colitis

Condition Intervention Phase
Ulcerative Colitis Biological: QBECO SSI Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Dose Ranging, Exploratory Study to Evaluate the Safety, Tolerability, Compliance, Mechanism of Action and Efficacy of QBECO Site Specific Immunomodulation for the Induction of Clinical Response and Remission in Subjects With Moderate to Severe Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Qu Biologics Inc.:

Primary Outcome Measures:
  • Incidence of treatment emergent AEs and clinically significant changes or abnormalities from physical examinations, vital signs and laboratory results (composite) [ Time Frame: Day 1 to Week 56 ]
  • Proportion of subjects in clinical remission [ Time Frame: Week 52 ]
    Mayo score ≤ 2 points, with no individual subscore >1


Secondary Outcome Measures:
  • Proportion of subjects in clinical remission [ Time Frame: Week 16 ]
    Mayo score ≤ 2 points, with no individual subscore >1

  • Proportion of subjects with a clinical response [ Time Frame: Week 16 ]
    A decrease of the Mayo score from screening of at least 3 points and at least 30%, AND either a decrease from the pre-treatment screening sub-score for rectal bleeding of at least 1 point, OR rectal bleeding sub-score of 0 or 1

  • Proportion of subjects with a clinical response [ Time Frame: Week 52 ]
    A decrease of the Mayo score from screening of at least 3 points and at least 30%, AND either a decrease from the pre-treatment screening sub-score for rectal bleeding of at least 1 point, OR rectal bleeding sub-score of 0 or 1


Other Outcome Measures:
  • Exploratory variables are presence or absence of single nucleotide polymorphisms; changes in immunological biomarkers in blood and colonic tissue; and changes in GI microbiome. (composite) [ Time Frame: up to Week 52 ]

Enrollment: 11
Study Start Date: July 2015
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QBECO SSI 0.02 mL
0.02 mL administered subcutaneously, every other day for 16 weeks. After completion of the initial 16-week fixed dose treatment period, subjects deemed to be responders will be randomized to one of three maintenance dosing schedules (every second day, weekly, no treatment) for an additional 36 weeks.
Biological: QBECO SSI
QBECO Site Specific Immunomodulators
Experimental: QBECO SSI 0.05 mL
0.05 mL administered subcutaneously, every other day for 16 weeks. After completion of the initial 16-week fixed dose treatment period, subjects deemed to be responders will be randomized to one of three maintenance dosing schedules (every second day, weekly, no treatment) for an additional 36 weeks.
Biological: QBECO SSI
QBECO Site Specific Immunomodulators
Experimental: QBECO SSI 0.1 mL
0.1 mL administered subcutaneously, every other day for 16 weeks. After completion of the initial 16-week fixed dose treatment period, subjects deemed to be responders will be randomized to one of three maintenance dosing schedules (every second day, weekly, no treatment) for an additional 36 weeks.
Biological: QBECO SSI
QBECO Site Specific Immunomodulators

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects who have reached age of majority
  • Willing to learn and able to self-administer study drug
  • Diagnosis of UC established at least 6 months before screening visit, by clinical and endoscopic evidence.
  • Currently experiencing moderate to severe active UC defined as a Mayo score of 6-12 (inclusive) at Screening.
  • Endoscopic evidence of active mucosal disease, as assessed by flexible sigmoidoscopy, with an Endoscopic Finding Sub-score of ≥2 at Screening.
  • Rectal Bleeding Sub-score of ≥1 at Screening.
  • Physician's Global Assessment Sub-score of ≥2 at Screening.
  • Male/female subjects who agree to practice effective methods of contraception

Exclusion Criteria:

  • History of colonic or rectal surgery other than hemorrhoid surgery or appendectomy
  • Currently receiving total parenteral nutrition
  • Disease limited to ulcerative proctitis
  • Diagnosed with Crohn's disease, indeterminate colitis, microscopic colitis or, ischemic or infectious colitis
  • Known or suspected hypersensitivity to any component of the product
  • Known human immunodeficiency virus (HIV) infection or other immunosuppressive disorder
  • Concurrently participating in another study or receiving other experimental or investigational therapies within past 3 months
  • Females who are currently pregnant or lactating
  • Any history of malignancy. 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): NCT02426372


Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada
Canada, British Columbia
GI Research Institute
Vancouver, British Columbia, Canada
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada
Sponsors and Collaborators
Qu Biologics Inc.
Investigators
Study Director: Study Director Qu Biologics
  More Information

Responsible Party: Qu Biologics Inc.
ClinicalTrials.gov Identifier: NCT02426372     History of Changes
Other Study ID Numbers: QBECO-UC-01
First Submitted: April 21, 2015
First Posted: April 24, 2015
Last Update Posted: August 24, 2017
Last Verified: August 2017

Keywords provided by Qu Biologics Inc.:
Ulcerative Colitis
Inflammatory Bowel Disease

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases