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Clinical Trials/NCT00707070
NCT00707070
Unknown
Phase 4

Phase IV Study on Efficacy and Safety of the Combination Treatment Acitretin and Efalizumab in Moderate to Severe Chronic Plaque Psoriasis

Universita di Verona1 site in 1 country100 target enrollmentSeptember 2008
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ConditionsChronic Plaque Psoriasis
Interventionsefalizumab plus acitretinefalizumab plus placebo
Drugsefalizumab plus placeboefalizumab plus acitretin

Overview

Phase
Phase 4
Intervention
efalizumab plus acitretin
Conditions
Chronic Plaque Psoriasis
Sponsor
Universita di Verona
Enrollment
100
Locations
1
Primary Endpoint
PASI 75 and PASI 50 at week 24 Physician Global Assessment
Last Updated
17 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
October 2009
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Universita di Verona

Eligibility Criteria

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

Arms & Interventions

1

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

Intervention: efalizumab plus acitretin

2

efalizumab 1 mg/Kg/week subcutaneous plus oral placebo

Intervention: efalizumab plus placebo

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(week 24)

Study Sites (1)

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