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This study will examine the safety and efficacy in subjects with mild to moderate ulcerative colitis, as measured by Modified Mayo Score, Modified Baron Score, IBDQ, calprotectin and other assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VB-201 160mg | Experimental | Subjects will received 80mg twice daily for 24 weeks. |
|
| Placebo with crossover to VB-201 160mg | Placebo Comparator | Subjects on placebo will crossover to VB-201 160 at week 12. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VB-201 160mg | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Mayo Score indicating remission | The proportion of subjects in remission at Weeks 12 and 24 in the VB-201 160mg (80 mg BID) treatment group compared to placebo group. | Week 12 and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Mayo Score indicating response | The proportion of subjects responding at Weeks 12 and 24 in the VB-201 160mg (80 mg BID) treatment group compared to placebo group. | Week 12 and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Adverse Events | As measured by changes from baseline in physical exam, vital signs, ECG, concomitant medications, laboratory values. | From Baseline through safety follow up at Week 28 |
| Reduction in Modified Mayo Score |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VBL Investigative Site | Sofia | Bulgaria | ||||
| VBL Investigative Site |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C552500 | 1-palmityl-2-(4-carboxybutyl)-sn-glycero-3-phosphocholine |
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| Drug |
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The proportion of subjects in each arm with a 2-point or greater decrease in the Modified Mayo score at Weeks 12 and 24.
| Week 12 and Week 24 |
| Modified Baron Score | Change in the modified Baron score from Baseline to Weeks 12 and 24 in the VB-201 treatment group as compared to the placebo group. | Week 12 and Week 24 |
| Mucosal Healing | The proportion of subjects in each arm with mucosal healing at Weeks 12 and 24 in the VB-201 treatment group compared to placebo group. | Wee 12 and Week 24 |
| Szombathely |
| Hungary |
| VBL Investigative Site | Warsaw | Poland |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |