Pilot, Investigator-Initiated, Proof-of-Concept, Study of the Efficacy and Safety of Etanercept (Enbrel) in Adults With Vitiligo

University of Medicine and Dentistry of New Jersey1 site in 1 country40 target enrollmentNovember 2003

ConditionsVitiligo

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Vitiligo
Sponsor: University of Medicine and Dentistry of New Jersey
Enrollment: 40
Locations: 1
Primary Endpoint: Percent of subjects achieving 50% or more repigmentation at 6 months (Good or better on Physician's Global Assessment [PGA] score)
Status: Completed
Last Updated: 17 years ago

The purpose of this study is to investigate the efficacy and safety of etanercept in adults with vitiligo.

Subjects will self-administer etanercept 50 mg SQ twice weekly for 6 months. Lesion repigmentation will be evaluated at monthly visits.

Registry

clinicaltrials.gov

Start Date

November 2003

End Date

December 2007

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

•Vitiligo patients aged 18 years and older
•Vitiligo patients with evaluable lesions; duration of 3 months to 10 years.
•Disease interferes significantly with quality of life and/or involving 3% or more body surface area
•Subjects must have a negative tuberculin (TB) skin test at entry into the study
•If subject is a female of childbearing potential, she must agree to use adequate contraception (adequate contraception can include abstinence) and must have a negative serum pregnancy test the day of administration of study medication.
•If subject is a male and has reached puberty, he must agree to use adequate contraception during the study and for 1 month after discontinuation from study.
•Subject or designee must have the ability to self-inject investigational product or have a care giver at home who can administer subcutaneous injections
•Subject must be able to give informed consent; must authorize release and use of protected health information; and, if applicable, must assent to participate prior to enrollment to this study.

•Unable to consent
•History of non-compliance with other therapies
•Concurrent therapy for vitiligo
•Systemic or photo-therapy within 4 weeks
•Topical therapy within 2 weeks
•Any medical condition in which etanercept would be contraindicated
•Any internal malignancy within 5 years (fully excised cutaneous, basal cell carcinoma or squamous cell carcinoma are exceptions)
•Pregnancy, not practicing effective birth control, or inability to practice safe sex during the length of the study.
•Lactation
•History of alcohol or drug abuse one year before and during the study.

Percent of subjects achieving 50% or more repigmentation at 6 months (Good or better on Physician's Global Assessment [PGA] score)

Percentage of subjects achieving 75% or more repigmentation at 6 months (Excellent or better on PGA score)
Patient-Generated Global Assessment
Skin texture assessment