Vitiligo
Conditions
Keywords
vitiligo, etanercept
Brief summary
The purpose of this study is to investigate the efficacy and safety of etanercept in adults with vitiligo.
Detailed description
Subjects will self-administer etanercept 50 mg SQ twice weekly for 6 months. Lesion repigmentation will be evaluated at monthly visits.
Interventions
DRUGEtanercept
Sponsors
University of Medicine and Dentistry of New Jersey
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * Any participation in another investigational drug study during the 4 weeks preceding this study. * Known HIV-positive status; known history of any other mycobacterial disease or any other immuno-suppressing disease. * Presence of a grade 3 or 4 infection \< 30 days prior to the screening visit; between the screening visit and the first day of treatment on study; or any time during the study that, in the opinion of the Investigator, would preclude participation in the study. * Patients should not receive live vaccines for 3 months prior to, or while on, study. * A prior history of tuberculosis, and/or a positive PPD skin test and positive CXR at screening. * Patients with previous or current exposure to any of the following TNF antagonists: * etanercept (Enbrel); * adalimumab (Humira); or * infliximab (Remicade). These patients will not be eligible, even with a wash-out. Patients with previous or current exposure to Kineret will NOT be eligible, even with a wash-out. However, patients with prior or current exposure to biologics directed against T-cells (e.g. alefacept, efalizumab, siplizumab, etc.) will be eligible for enrollment into the study after a wash-out period of 4 weeks before first dose of study drug (baseline visit). It has to be protocol specific also. * The subject has, in the Investigator's opinion, a chronic, severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiovascular (congestive heart failure \[CHF\] of any severity; myocardial infarction \[MI\], cerebrovascular accident \[CVA\] or transient ischemic attack \[TIA\] within 3 months of screening visit; unstable angina pectoris; uncontrolled hypertension \[sitting systolic blood pressure (BP) \< 80 mm Hg or \> 160 or diastolic BP \> 100 mm Hg\]), or neurological disease; known systemic lupus erythematosus (SLE); diabetes; or any other concomitant medical condition that places the participant at risk by participating this study and/or that may interfere with the conduct of the study. * Chronic hepatitis B or hepatitis C, SLE, history of multiple sclerosis, transverse myelitis, optic neuritis or epilepsy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of subjects achieving 50% or more repigmentation at 6 months (Good or better on Physician's Global Assessment [PGA] score) | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects achieving 75% or more repigmentation at 6 months (Excellent or better on PGA score) | — |
| Patient-Generated Global Assessment | — |
| Skin texture assessment | — |
Countries
United States
Outcome results
None listed