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

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Masitinib; Drug: Masitinib; Drug: Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Masitinib (AB1010)	Drug: Masitinib; 6 mg/kg/day; Drug: Masitinib; 3 mg/kg/day
Placebo Comparator: Placebo mactching masitinib; Placebo matching masitinib	Drug: Placebo; Placebo matching masitinib (3 mg/kg/day and 6 mg/kg/day)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: AB Science
• Investigators: Principal Investigator: Jean-Paul ORTONNE, MD, CHU Nice

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): January 1, 2006
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: January 8, 2010
• First Submitted That Met QC Criteria: January 8, 2010
• First Posted (Estimate): January 11, 2010

Study Record Updates

• Last Update Posted (Actual): December 10, 2018
• Last Update Submitted That Met QC Criteria: December 6, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Kinase Inhibitor; Severe Psoriasis; Masitinib
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: AB04029