Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis

Universita di Verona100 enrolled

Overview

It is a phase IV multicentric, placebo-controlled, clinical trial investigating the efficacy and safety of acitretin combined to efalizumab in the therapy of chronic plaque psoriasis. PASI 75 at week 24 will be the primary end point. PASI 75 at week 12, and PASI 50 at week 24 will be the secondary end points. Safety measures will be the monitoring of serum parameters including AST; ALT; gammaGT; creatinine; cholesterol and triglycerides.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Chronic Plaque Psoriasis

Interventions

efalizumab plus placeboDRUG

1 mg/kg/week subcutaneous for 24 weeks

efalizumab plus acitretinDRUG

1 mg/Kg/week for 24 weeks plus oral acitretin 0.4 mg/kg/day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Men aged 18-70 * Women in postmenopausal * Moderate to severe chronic plaque psoriasis in patients with contraindication, intolerance or non responsive to cyclosporine, methotrexate or PUVA * PASI \> 10 e/o BSA (Body Surface Area) \> 10 Exclusion Criteria: * Drug induced psoriasis * Pustular or erythrodermic psoriasis * Fertile women * Pregnancy or lactation * cholesterol \> 230mg/dL e triglyceride \> 200 mg/dL * Known intolerance to efalizumab and acitretin * Serious infection at enrollement * History of previous neoplasia

Locations (1)

Univeristy Hospital

Verona, Italy

Outcomes

Primary Outcomes

PASI 75 and PASI 50 at week 24 Physician Global Assessment

Time frame: week 12 and 24

Secondary Outcomes

SKINDEX 29 at week 24 and AST, ALT, cholesterol, triglycerides at week 12 and week 24

Time frame: week 24

Central Contacts

Giampiero Girolomoni, Prof

CONTACT

39-045-812-2547 giampiero.girolomoni@univr.it

Data from ClinicalTrials.gov

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