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

June 27, 2008 updated by: Universita di Verona

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Verona, Italy, 37126
        • Univeristy Hospital
        • Contact:
        • Sub-Investigator:
          • Micol Del Giglio, MD
        • Sub-Investigator:
          • Paolo Gisondi, MD
        • Principal Investigator:
          • Giampiero Girolomoni, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
efalizumab 1 mg/kg/week subcutaneous plus acitretin 0.4 mg/kg/day oral
Drug: efalizumab plus acitretin
1 mg/Kg/week for 24 weeks plus oral acitretin 0.4 mg/kg/day
Placebo Comparator: 2
efalizumab 1 mg/Kg/week subcutaneous plus oral placebo
Drug: efalizumab plus placebo
1 mg/kg/week subcutaneous for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PASI 75 and PASI 50 at week 24 Physician Global Assessment
Time Frame: week 12 and 24
week 12 and 24

Secondary Outcome Measures

Outcome Measure
Time Frame
SKINDEX 29 at week 24 and AST, ALT, cholesterol, triglycerides at week 12 and week 24
Time Frame: week 24
week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universita di Verona

Investigators

  • Principal Investigator: Giampiero Girolomoni, Universita di Verona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Anticipated)

October 1, 2009

Study Completion (Anticipated)

October 1, 2009

Study Registration Dates

First Submitted

June 26, 2008

First Submitted That Met QC Criteria

June 27, 2008

First Posted (Estimate)

June 30, 2008

Study Record Updates

Last Update Posted (Estimate)

June 30, 2008

Last Update Submitted That Met QC Criteria

June 27, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gisondi 2
  • No grants were received

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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