Ulcerative Colitis
Conditions
Keywords
Ulcerative Colitis, Inflammatory Bowel Disease
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
Interventions
BIOLOGICALQBECO SSI
QBECO Site Specific Immunomodulators
Sponsors
Qu Biologics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Week 52 | Mayo score ≤ 2 points, with no individual subscore \>1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects in clinical remission | Week 16 | Mayo score ≤ 2 points, with no individual subscore \>1 |
| Proportion of subjects with a clinical response | Week 16 | 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 |
Other
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada
Outcome results
None listed