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Safety and Efficacy of QBECO in Moderate to Severe Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
QBECO SSI
Sponsored by
Qu Biologics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis, Inflammatory Bowel Disease

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alberta
  • GI Research Institute
  • McMaster University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

QBECO SSI 0.02 mL

QBECO SSI 0.05 mL

QBECO SSI 0.1 mL

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Incidence of treatment emergent AEs and clinically significant changes or abnormalities from physical examinations, vital signs and laboratory results (composite)
Proportion of subjects in clinical remission
Mayo score ≤ 2 points, with no individual subscore >1

Secondary Outcome Measures

Proportion of subjects in clinical remission
Mayo score ≤ 2 points, with no individual subscore >1
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
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

Full Information

First Posted
April 21, 2015
Last Updated
August 23, 2017
Sponsor
Qu Biologics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02426372
Brief Title
Safety and Efficacy of QBECO in Moderate to Severe Ulcerative Colitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qu Biologics Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative Colitis, Inflammatory Bowel Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
QBECO SSI 0.02 mL
Arm Type
Experimental
Arm Description
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.
Arm Title
QBECO SSI 0.05 mL
Arm Type
Experimental
Arm Description
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.
Arm Title
QBECO SSI 0.1 mL
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
QBECO SSI
Intervention Description
QBECO Site Specific Immunomodulators
Primary Outcome Measure Information:
Title
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
Title
Proportion of subjects in clinical remission
Description
Mayo score ≤ 2 points, with no individual subscore >1
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Proportion of subjects in clinical remission
Description
Mayo score ≤ 2 points, with no individual subscore >1
Time Frame
Week 16
Title
Proportion of subjects with a clinical response
Description
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
Time Frame
Week 16
Title
Proportion of subjects with a clinical response
Description
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
Time Frame
Week 52
Other Pre-specified Outcome Measures:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Qu Biologics
Official's Role
Study Director
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
GI Research Institute
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

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Safety and Efficacy of QBECO in Moderate to Severe Ulcerative Colitis

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