Safety and Efficacy of QBECO in Moderate to Severe Ulcerative Colitis

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

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

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Biological: QBECO SSI

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • University of Alberta
  • British Columbia
    • Vancouver, British Columbia, Canada
      • GI Research Institute
  • Ontario
    • Hamilton, Ontario, Canada
      • McMaster University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects in clinical remission	Mayo score ≤ 2 points, with no individual subscore >1	Week 16
Proportion of subjects with a clinical response	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	Week 16
Proportion of subjects with a clinical response	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	Week 52

Other Outcome Measures

Outcome Measure	Time Frame
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)	up to Week 52

Collaborators and Investigators

• Sponsor: Qu Biologics Inc.
• Investigators: Study Director: Study Director, Qu Biologics

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: April 21, 2015
• First Submitted That Met QC Criteria: April 23, 2015
• First Posted (Estimate): April 24, 2015

Study Record Updates

• Last Update Posted (Actual): August 24, 2017
• Last Update Submitted That Met QC Criteria: August 23, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Inflammatory Bowel Disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: QBECO-UC-01