Safety and Efficacy of QBECO in Moderate to Severe Ulcerative Colitis

NCT02426372 | Completed Phase 2 DMC

• 1 other identifier: QBECO-UC-01
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 3

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

Keywords

Ulcerative Colitis; Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (2)

• Incidence of treatment emergent AEs and clinically significant changes or abnormalities from physical examinations, vital signs and laboratory results (composite)

  Day 1 to Week 56

• Proportion of subjects in clinical remission

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

  Week 52

Secondary Outcomes (3)

• Proportion of subjects in clinical remission

  Week 16

• Proportion of subjects with a clinical response

  Week 16

• Proportion of subjects with a clinical response

  Week 52

Other Outcomes (1)

• 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)

  up to Week 52

Study Arms (3)

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.

Biological: QBECO SSI

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.

Biological: QBECO SSI

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.

Biological: QBECO SSI

Interventions

QBECO SSI BIOLOGICAL

QBECO Site Specific Immunomodulators

QBECO SSI 0.02 mL; QBECO SSI 0.05 mL; QBECO SSI 0.1 mL

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qu Biologics Inc.: lead

Study Sites (3)

University of Alberta

Edmonton, Alberta, Canada

Location

GI Research Institute

Vancouver, British Columbia, Canada

Location

McMaster University

Hamilton, Ontario, Canada

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Study Director

  Qu Biologics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: April 24, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 24, 2017

Record last verified: 2017-08

Locations

CA (3)