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

AB Science

Status and phase

Completed

Phase 2

Conditions

Psoriasis

Treatments

Drug: Masitinib

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01045577

AB04029

Details and patient eligibility

About

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

Full description

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

Enrollment

25 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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