NCT01045577

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: AB Science · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Masitinib	6 mg/kg/day
DRUG	Masitinib	3 mg/kg/day
DRUG	Placebo	Placebo matching masitinib (3 mg/kg/day and 6 mg/kg/day)

Timeline

• Start date: 2005-09-01
• Primary completion: 2006-01-01
• Completion: 2008-02-01
• First posted: 2010-01-11
• Last updated: 2018-12-10