Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis (CobAcE)

University of Verona

Status and phase: Unknown; Phase 4

Conditions: Chronic Plaque Psoriasis

Treatments: Drug: efalizumab plus acitretin; Drug: efalizumab plus placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00707070

No grants were received

Gisondi 2

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

efalizumab 1 mg/kg/week subcutaneous plus acitretin 0.4 mg/kg/day oral

Treatment:

Drug: efalizumab plus acitretin

2

Placebo Comparator group

Description:

efalizumab 1 mg/Kg/week subcutaneous plus oral placebo

Treatment:

Drug: efalizumab plus placebo