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

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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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

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Masitinib
* Drug: Masitinib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female outpatients aged 18 to 75 years with chronic plaque psoriasis Plaque psoriasis covering ≥ 10% BSA Disease duration ≥ 6 months PASI ≥ 12.0 at screening Exclusion Criteria: Guttate, erythrodermic or pustular psoriasis as sole or predominant form of the disease Clinically significant psoriasis flare during screening or at time of enrollment Systemic therapy for psoriasis or systemic immunosuppressive therapy for other indications within 28 days prior to enrollment Topical treatment for psoriasis within 14 days prior to enrollment Use of CYP3A4 moderate and strong inhibitors within 4 weeks prior to randomization Active current bacterial, viral (including hepatitis B and C, HIV, EBV, CMV, herpes zoster, herpes simplex), fungal, mycobacterium, protozoan, or other infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Masitinib (AB1010)<br>Masitinib (AB1010) | Drug: Masitinib<br>* 6 mg/kg/day<br>Drug: Masitinib<br>* 3 mg/kg/day<br>|
| Placebo Comparator: Placebo mactching masitinib<br>Placebo matching masitinib | Drug: Placebo<br>* Placebo matching masitinib (3 mg/kg/day and 6 mg/kg/day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in BSA after 12 weeks of treatment |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 12 weeks | 
| Percentage change from baseline in PGA and PGPA after 12 weeks of treatment |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe Psoriasis, Kinase Inhibitor, Masitinib