A Study of Tetrathiomolybdate in the Treatment of Psoriasis Vulgaris

May 20, 2015 updated by: University of Michigan

An Open Label Study of Tetrathiomolybdate in the Treatment of Psoriasis Vulgaris

Psoriasis is a common skin disease affecting an estimated 2.6% of the US population. It is a chronic, recurrent condition for which there is no cure, but there are ways to control it. Psoriasis is characterized by epidermal hyperplasia (abnormal increase in the number of normal cells of the outer layer of the skin). Tetrathiomolybdate (TM), a copper chelator (a drug that removes copper from the bloodstream) was first created to treat Wilson's disease, a disorder caused by too much copper in the blood. Studies in animals have since shown that TM may also prevent the formation of new blood vessels and may also block the key components of inflammation (swelling, redness, and pain) caused by psoriasis. TM is not approved by the FDA for any use yet. It is an investigational drug used for clinical research. We propose to test whether a new treatment with TM can in fact improve or stabilize psoriasis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate the safety and efficacy of Tetrathiomolybdate in psoriasis therapy. Psoriasis is a common skin disease affecting an estimated 2.6% of the US population. It is a chronic, recurrent condition for which there is no cure but ways to control it. Psoriasis is characterized by epidermal hyperplasia, increased dermal angiogenesis, and infiltration of activated lymphocytes. Beginning with the observation that cyclosporin A, whose primary action is to inhibit lymphokine release and proliferation of T cells, was effective in the treatment of psoriasis, the last two decades saw a major paradigm shift in the pathogenesis of psoriasis, from a view of psoriasis as a disease of epidermal origin to a view of it as an epidermal response to immunological injury. In fully activated T cells in psoriatic skin, the T1/T2 cytokine balance is shifted in favor of T1 expression, with production of IL-2 and IFN-γ. Activated T1 lymphocytes also produce TNF-α. This is a pivotal cytokine that regulates an array of proinflammatory mediators. Recently, anti-TNF-α therapy using a chimeric anti-TNF-α monoclonal antibody (infliximab) and a TNF-receptor-immunoglobulin fusion protein (etanercept) have shown to be highly effective in patients with severe psoriasis. Efforts to treat psoriasis by inhibiting neovascularization of psoriatic plaques have also been shown to be effective. A randomized phase I/II clinical trial using Neovastat, a naturally occurring inhibitor of angiogenesis, resulted in dose-dependent improvement in the Psoriasis Area and Severity Index (PASI) score, thus providing further evidence that altered angiogenesis is an integral part of psoriasis pathophysiology. Since TM has proven antiangiogenic and anti-TNF-α activities, we are very encouraged that TM therapy will be beneficial in psoriasis.

Study Type

Interventional

Enrollment

10

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Department of Dermatology

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 + years of age
  • Psoriasis vulgaris involving greater than 5% total body surface area
  • No disease states or physical conditions which would impair evaluation of the test sites
  • Willing and able to take test medications as directed in the protocol, make evaluation visits and follow protocol restrictions
  • Failed systemic therapy for psoriasis (e.g., PUVA, retinoids, systemic steroids, methotrexate, etc.)
  • Signed, written, witnessed informed consent form
  • You must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study.

Exclusion Criteria:

  • Use of any topical psoriasis treatment within weeks prior to the start of the study
  • Use of any systemic medication within 4 weeks prior to the start of the study
  • Involvement in an investigational study within the previous 4 weeks
  • Inability to give informed consent
  • History of drug dependency or alcoholism
  • Severe infection within 4 weeks prior to study entry or the presence of chronic infection
  • Significant psychiatric disorder

  • Screening laboratory values which exceed the following limits:

    • Hematology - WBC <3,500 cells/mm3, Hb <10.5g/dl, platelets <100,000 cells/mm3;
    • Renal function test - creatinine >1.5 mg/dl;
    • Liver function tests - AST, alkaline phosphatase or total bilirubin more than twice the upper limits of normal, and a prothrombin time above the normal range.
  • Pregnancy or breast feeding a baby. Sexually active women of reproductive age must use an acceptable form of birth control.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Improvement in psoriasis as measured by PASI (psoriasis area and severity index)
Erythema, scaling, and thickness of target lesions

Secondary Outcome Measures

Outcome Measure
Cytokine and laboratory values will be compared to baseline to test the hypothesis that TM will affect the level of TNF alpha, IL-1, C-protein, and TGF.

Collaborators and Investigators

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

Sponsor

University of Michigan

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

June 1, 2004

Study Completion

June 1, 2005

Study Registration Dates

First Submitted

June 8, 2005

First Submitted That Met QC Criteria

June 8, 2005

First Posted (Estimate)

June 9, 2005

Study Record Updates

Last Update Posted (Estimate)

May 21, 2015

Last Update Submitted That Met QC Criteria

May 20, 2015

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Derm 508

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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