Suspended

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

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What is being tested

efalizumab plus placebo

+ efalizumab plus acitretin

Drug
Who is being recruted

Psoriasis+1

+ Skin Diseases

+ Skin and Connective Tissue Diseases

From 18 to 70 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: September 2008
See protocol details

Summary

Principal SponsorUniversita di Verona
Study ContactGiampiero Girolomoni, Prof
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2008

Actual date on which the first participant was enrolled.

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.

Official TitlePhase IV Study on Efficacy and Safety of the Combination Treatment Acitretin and Efalizumab in Moderate to Severe Chronic Plaque Psoriasis
NCT00707070
Principal SponsorUniversita di Verona
Study ContactGiampiero Girolomoni, Prof
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

PsoriasisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Papulosquamous

Criteria

4 inclusion criteria required to participate
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
8 exclusion criteria prevent from participating
Drug induced psoriasis
Pustular or erythrodermic psoriasis
Fertile women
Pregnancy or lactation
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
efalizumab 1 mg/Kg/week subcutaneous plus oral placebo

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Univeristy Hospital

Verona, ItalyOpen Univeristy Hospital in Google Maps
SuspendedOne Study Center