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A double-blind, placebo-controlled, randomized, parallel-group study to evaluate the activity of oral AB1010 in adults patients with moderate to severe chronic plaque psoriasis
To evaluate the activity of oral AB1010, administered at two dose levels during 12 weeks to patients with moderate to severe chronic plaque psoriasis, assessed on :
i)Body Surface Area (BSA), Psoriasis Area and Severity Index (PASI), Overall Lesion Severity (OLS), Physician's Global Assessment (PGA) and Patient's Global Psoriasis Assessment (PGPA) ii)clinical and biological safety parameters iii) pharmacokinetic profile of AB1010
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Masitinib (AB1010) | Active Comparator | Masitinib (AB1010) |
|
| Placebo mactching masitinib | Placebo Comparator | Placebo matching masitinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Masitinib | Drug | 6 mg/kg/day |
| |
| Masitinib |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in BSA after 12 weeks of treatment | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in PASI score, proportion of patients reaching a 90%, 75% or 50% improvement in PASI score after 12 weeks of treatment; time to and duration of first occurrence in PASI 50, 75 and 90 | 12 weeks | |
| Proportion of patients achieving an OLS rating of Minimal or Clear after 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Paul ORTONNE, MD | Centre Hospitalier Universitaire de Nice | Principal Investigator |
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| Drug |
3 mg/kg/day |
|
| Placebo | Drug | Placebo matching masitinib (3 mg/kg/day and 6 mg/kg/day) |
|
| 12 weeks |
| Percentage change from baseline in PGA and PGPA after 12 weeks of treatment | 12 weeks |
| 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 |
|---|---|
| C526575 | masitinib |
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