The purpose of this study is to investigate the efficacy and safety of etanercept in adults
Subjects will self-administer etanercept 50 mg SQ twice weekly for 6 months. Lesion
repigmentation will be evaluated at monthly visits.
- 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.
- 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
- 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
- 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
- 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.