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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
QBECO Site Specific Immunomodulators
University of Alberta
Edmonton, Alberta, Canada
GI Research Institute
Vancouver, British Columbia, Canada
McMaster University
Hamilton, Ontario, Canada
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
Mayo score ≤ 2 points, with no individual subscore \>1
Time frame: Week 52
Proportion of subjects in clinical remission
Mayo score ≤ 2 points, with no individual subscore \>1
Time frame: Week 16
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
Time frame: Week 16
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
Time frame: Week 52
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