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This study will examine the safety and efficacy in subjects with moderate to severe psoriasis, as measured by Psoriasis Area and Severity Index(PASI), Body Surface Area (BSA), Dermatology Life Quality Index (DLQI) and other assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo with crossover to VB-201 160mg | Other | Subjects on placebo will crossover to VB-201 160 at week 16. |
|
| VB-201 80mg | Experimental | Subjects will receive VB-201 80mg/day for 24 weeks |
|
| VB-201 160mg | Experimental | Subjects will received 80mg twice daily for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VB-201 80mg | Drug |
| ||
| VB-201 160mg |
| Measure | Description | Time Frame |
|---|---|---|
| PASI 50 | The proportion of subjects in the VB-201 160 mg (80 mg BID) treatment group who achieve at least 50% improvement from the baseline PASI score at Weeks 16 and 24 (PASI 50) compared to the proportion of PASI 50 responders in the placebo group. | Week 16 and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| PASI 75 | Proportion of subjects in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups who achieve at least 75% improvement from the baseline PASI score (PASI 75) at Weeks 16 and 24 compared to the proportion of PASI 75 responders in the placebo group. | Week 16 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 |
| Body Surface Area |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VBL Investigative Site | Kiel | Germany | ||||
| VBL Investigative Site |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C552500 | 1-palmityl-2-(4-carboxybutyl)-sn-glycero-3-phosphocholine |
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| Placebo | Drug |
|
Change in affected Body Surface Area (BSA) from baseline to Week 16 and Week 24 in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to placebo.
| Week 16 and Week 24 |
| Physician Global Assessment | Change in PGA scores from baseline to Weeks 16 and 24 in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to the placebo group. | Week 16 and Week 24 |
| Patient Psoriasis Global Assessment | Change in Patient Psoriasis Global Assessment scores from baseline to Weeks 16 and 24 in each of the VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to the placebo group. | Week 16 and Week 24 |
| PASI 50- 80 mg/ day | The proportion of subjects in the VB-201 80 mg/day treatment group who achieve at least 50% improvement from the baseline PASI score at Weeks 16 and 24 (PASI 50) compared to the proportion of PASI 50 responders in the placebo group. | Week 16 and Week 24 |
| Change in PASI score | The mean change in the PASI score from baseline to Weeks 16 and 24 in each of the two VB-201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to the mean change in the placebo group. | Week 16 and Week 24 |
| Itching Visual Analogue Scale | Change in itching VAS from baseline to weeks 16 and 24 in each of the VB 201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to placebo. | Week 16 and Week 24 |
| Pain Visual Analogue Scale | Change in pain VAS from baseline to weeks 16 and 24 in each of the VB 201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to placebo. | Week 16 and Week 24 |
| Dermatology Life Quality Index | Change in the DLQI scores from baseline to Weeks 16 and 24 in each of the VB 201 treatment groups and in the combined (both dose groups) VB-201 treatment groups compared to placebo. | Week 16 and Week 24 |
| Netanya |
| Israel |
| VBL Investigative Site | Warsaw | Poland |
| VBL Investigative Site | Barcelona | Spain |