Safety and Efficacy of QBECO in Moderate to Severe Ulcerative Colitis

NCT ID: NCT02426372

Last Updated: 2017-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-12-31

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

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

QBECO SSI

Intervention Type: BIOLOGICAL

QBECO Site Specific Immunomodulators

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.

Group Type: EXPERIMENTAL

QBECO SSI

Intervention Type: BIOLOGICAL

QBECO Site Specific Immunomodulators

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.

Group Type: EXPERIMENTAL

QBECO SSI

Intervention Type: BIOLOGICAL

QBECO Site Specific Immunomodulators

Interventions

QBECO SSI

QBECO Site Specific Immunomodulators

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qu Biologics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Qu Biologics

Locations

University of Alberta

Edmonton, Alberta, Canada

GI Research Institute

Vancouver, British Columbia, Canada

McMaster University

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

QBECO-UC-01

Identifier Type: -

Identifier Source: org_study_id