Psoriasis
Conditions
Keywords
Severe Psoriasis, Kinase Inhibitor, Masitinib
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
Interventions
DRUGMasitinib
6 mg/kg/day
DRUGPlacebo
Placebo matching masitinib (3 mg/kg/day and 6 mg/kg/day)
Sponsors
AB Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in BSA after 12 weeks of treatment | 12 weeks |
Secondary
| 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 |
Outcome results
None listed