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

Phase 2

Completed

• Conditions: Psoriasis
• Interventions: Drug: Placebo; Drug: Masitinib

• Registration Number: NCT01045577
• Lead Sponsor: AB Science

Brief 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

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2006-01
• Study Completion: 2008-02
• Study First Submitted: 2010-01-08
• Study First Submitted QC: 2010-01-08
• Study First Posted: 2010-01-11
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-06
• Last Update Posted: 2018-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo mactching masitinib	Placebo	Placebo matching masitinib
Masitinib (AB1010)	Masitinib	Masitinib (AB1010)

Primary Outcome Measures

Name	Time	Method
Change from baseline in BSA after 12 weeks of treatment	12 weeks

Secondary Outcome Measures

Name	Time	Method
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