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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QBECO SSI | Biological | QBECO Site Specific Immunomodulators |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects in clinical remission | Mayo score ≤ 2 points, with no individual subscore >1 | 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 |
| Measure | Description | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Qu Biologics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta | Edmonton | Alberta | Canada | |||
| GI Research Institute |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| 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 | Week 52 |
| Vancouver |
| British Columbia |
| Canada |
| McMaster University | Hamilton | Ontario | Canada |
| D003108 |
| Colonic Diseases |
| D007410 | Intestinal Diseases |