Thalidomide in the Treatment of Chronic Plaque Psoriasis.

The objective of this study is to obtain information on the effectiveness of thalidomide in psoriasis.

Study Overview

• Status: Completed
• Conditions: Psoriasis, Plaque-type
• Intervention / Treatment: Drug: Thalidomide oral

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences Dermatology

Participation Criteria

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:

• Male or female subjects 18 years of age or older.
• Stable or worsening psoriasis that involves 5% or greater of total body surface area (BSA) involvement with a minimum PASI score of 8.
• Moderate to severe plaque-type psoriasis, defined by a minimum score of 1 for each of erythema, scaling, and plaque thickness (using a 0 - 4 scale).
• Patients receiving systemic retinoids, prednisone, methotrexate, or cyclosporine should be on a stable dose at least 28 days prior to the first dose of thalidomide.
• Patients receiving topical treatments should be consistent with such treatments throughout the study.
• The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
• The ability to understand and sign a written informed consent form, which must be obtained prior to treatment.
• The ability to understand, agree to, and comply with the requirements of the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.).**

(*Because of the known teratogenic effects of thalidomide and in an effort to prevent to the greatest extent possible any chance of fetal exposure to thalidomide, THALOMID(thalidomide) is approved for marketing only under a special restricted distribution program approved by the FDA. Under this program, the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.), only prescribers and pharmacists registered with the program are allowed to prescribe and dispense thalidomide (Zeldis JB et al. 1999). In addition, patients must be advised of, agree to, and comply with the requirements of the S.T.E.P.S. Program. To monitor patient compliance with the S.T.E.P.S. program, all patients must complete the S.T.E.P.S. program informed consent and participate in a mandatory and confidential surveillance registry.)

Exclusion Criteria:

• Unstable psoriasis
• Unable or unwilling to meet all criteria for contraception as required in STEPS.
• Known allergy to thalidomide.
• Known history of neuropathy.
• Abnormal laboratory test results that the investigator feels would compromise patient safety or evaluation of drug safety.
• The introduction of drugs for other medical conditions which are known to affect psoriasis (e.g., lithium, beta-adrenergic blockers, etc.) during the period 4 weeks prior to and during the study period.
• Use of any investigational therapy within the 4 weeks prior to the first dose of thalidomide.
• Expectation of exposure to strong sunlight during the course of the study (e.g. planned holiday in high sunlight area) or intention of sunbathing for prolonged periods of time during the course of the study.
• Current drug or alcohol abuse (drug screening not required).
• Medical conditions that preclude thalidomide therapy. Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psoriasis Area and Severity Index (PASI) Score	The change from Baseline to Week 12 (or end of treatment) in the composite score (PASI) of the signs of psoriasis (erythema, scaling, plaque thickness).	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Global Assessment	Investigator and Subject Global Assessment of Response at Weeks 2, 4, 8, 12 (or end of treatment) and at Week 16 (follow-up).	4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pruritus Score	The change in pruritus score from Baseline to Week 12 (or end of treatment). The pruritus grading system (PGS) score for each patient was based on: distribution, frequency,severity of itch and quality of sleep. Each patient's itch grade is calculated as the sum of the individual scores as: Mild grade: if total score is between 0 and 5. Moderate grade: if total score is between 6 and 11. Severe grade: if total score is between 12 and 19.	12 week

Collaborators and Investigators

• Sponsor: Wake Forest University
• Investigators: Principal Investigator: Steve Feldman, MD, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: April 1, 2003
• Primary Completion (Actual): September 1, 2005
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: June 27, 2013
• First Submitted That Met QC Criteria: July 1, 2013
• First Posted (Estimate): July 2, 2013

Study Record Updates

• Last Update Posted (Actual): August 13, 2018
• Last Update Submitted That Met QC Criteria: August 9, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Thalidomide
• Other Study ID Numbers: 03-147; 21737

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No