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

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

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

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