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

Qu Biologics Inc.3 sites in 1 country11 target enrollmentJuly 2015

ConditionsUlcerative Colitis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Ulcerative Colitis
Sponsor: Qu Biologics Inc.
Enrollment: 11
Locations: 3
Primary Endpoint: Proportion of subjects in clinical remission
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

July 2015

End Date

December 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Qu Biologics Inc.

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Proportion of subjects in clinical remission

Time Frame: Week 52

Mayo score ≤ 2 points, with no individual subscore \>1

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