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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01045577
• Other study ID #: AB04029
• Status: Completed
• Phase: Phase 2
• Start date: September 2005
• Est. completion date: February 2008

Study information

• Verified date: December 2018
• Source: AB Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2008
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Masitinib
6 mg/kg/day
• Masitinib
3 mg/kg/day
• Placebo
Placebo matching masitinib (3 mg/kg/day and 6 mg/kg/day)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AB Science

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in BSA after 12 weeks of treatment		12 weeks
Secondary	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
Secondary	Proportion of patients achieving an OLS rating of Minimal or Clear after 12 weeks		12 weeks
Secondary	Percentage change from baseline in PGA and PGPA after 12 weeks of treatment		12 weeks