Clinical trial NCT02426372: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
Inflammatory Bowel Disease
Lead sponsor: Qu Biologics Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-24
Enrollment: 11
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Incidence of treatment emergent AEs and clinically significant changes or abnormalities from physical examinations, vital signs and laboratory results (composite)
timeFrame: Day 1 to Week 56
measure: Proportion of subjects in clinical remission
timeFrame: Week 52
Secondary outcomes:
measure: Proportion of subjects in clinical remission
timeFrame: Week 16
measure: Proportion of subjects with a clinical response
timeFrame: Week 16
measure: Proportion of subjects with a clinical response
timeFrame: Week 52
Other outcomes:
measure: 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)
timeFrame: up to Week 52
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: GI Research Institute
state: British Columbia
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: Qu Biologics
name: Study Director
role: STUDY_DIRECTOR
References: