---
title: Safety and Efficacy of QBECO in Moderate to Severe Ulcerative Colitis
nct_id: NCT02426372
overall_status: COMPLETED
phase: PHASE2
sponsor: Qu Biologics Inc.
study_type: INTERVENTIONAL
primary_condition: Ulcerative Colitis
countries: Canada
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02426372.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02426372"
ct_last_update_post_date: 2017-08-24
last_seen_at: "2026-05-12T06:26:16.813Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT02426372](https://clinicaltrials.gov/study/NCT02426372)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 11
- **Lead Sponsor:** Qu Biologics Inc.
- **Conditions:** Ulcerative Colitis
- **Start Date:** 2015-07
- **Completion Date:** 2016-12
- **CT.gov Last Update:** 2017-08-24

## 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

## Eligibility

- **Minimum age:** 19 Years
- **Sex:** ALL
- **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

- **QBECO SSI 0.02 mL** (EXPERIMENTAL) — 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.
- **QBECO SSI 0.05 mL** (EXPERIMENTAL) — 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.
- **QBECO SSI 0.1 mL** (EXPERIMENTAL) — 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.

## Interventions

- **QBECO SSI** (BIOLOGICAL) — QBECO Site Specific Immunomodulators

## Primary Outcomes

- **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)_
- **Proportion of subjects in clinical remission** _(time frame: Week 52)_ — Mayo score ≤ 2 points, with no individual subscore \>1

## Secondary Outcomes

- **Proportion of subjects in clinical remission** _(time frame: Week 16)_
- **Proportion of subjects with a clinical response** _(time frame: Week 16)_
- **Proportion of subjects with a clinical response** _(time frame: Week 52)_

## Locations (3)

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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of alberta|edmonton|alberta|canada` — added _(2026-05-12)_
- `locations.gi research institute|vancouver|british columbia|canada` — added _(2026-05-12)_
- `locations.mcmaster university|hamilton|ontario|canada` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT02426372*  
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