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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Qu Biologics Inc.
- Enrollment
- 11
- Locations
- 3
- Primary Endpoint
- Proportion of subjects in clinical remission
Study 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: QBECO SSI (Biological)
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.
Intervention: QBECO SSI (Biological)
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.
Intervention: QBECO SSI (Biological)
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
Secondary Outcomes
- Proportion of subjects with a clinical response(Week 52)
- Proportion of subjects in clinical remission(Week 16)