Safety and Efficacy of QBECO in Moderate to Severe Ulcerative Colitis

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02426372
• Other study ID #: QBECO-UC-01
• Status: Completed
• Phase: Phase 2
• First received: April 21, 2015
• Last updated: August 23, 2017
• Start date: July 2015
• Est. completion date: December 2016

Study information

• Verified date: August 2017
• Source: Qu Biologics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Biological:
• QBECO SSI
QBECO Site Specific Immunomodulators

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	McMaster University	Hamilton	Ontario
Canada	GI Research Institute	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Qu Biologics Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	Proportion of subjects in clinical remission	Mayo score = 2 points, with no individual subscore >1	Week 52
Secondary	Proportion of subjects in clinical remission	Mayo score = 2 points, with no individual subscore >1	Week 16
Secondary	Proportion of subjects with a clinical response	A decrease of the Mayo score from screening of at least 3 points and at least 30%, AND either a decrease from the pre-treatment screening sub-score for rectal bleeding of at least 1 point, OR rectal bleeding sub-score of 0 or 1	Week 16
Secondary	Proportion of subjects with a clinical response	A decrease of the Mayo score from screening of at least 3 points and at least 30%, AND either a decrease from the pre-treatment screening sub-score for rectal bleeding of at least 1 point, OR rectal bleeding sub-score of 0 or 1	Week 52