Study of the Efficacy and Safety of Etanercept in Adults With Vitiligo

This study has been completed.
Information provided by:
Rutgers, The State University of New Jersey Identifier:
First received: August 22, 2005
Last updated: August 6, 2008
Last verified: August 2008

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

Condition Intervention Phase
Drug: Etanercept
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot, Investigator-Initiated, Proof-of-Concept, Study of the Efficacy and Safety of Etanercept (Enbrel) in Adults With Vitiligo

Resource links provided by NLM:

Further study details as provided by Rutgers, The State University of New Jersey:

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

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

Estimated Enrollment: 40
Study Start Date: November 2003
Estimated Study Completion Date: December 2007
Detailed Description:

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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts 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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00134368

United States, New Jersey
UMDNJ Psoriasis Center of Excellence
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Principal Investigator: Alice Gottlieb, MD, PhD UMDNJ-RWJMS
  More Information

No publications provided Identifier: NCT00134368     History of Changes
Other Study ID Numbers: 4489
Study First Received: August 22, 2005
Last Updated: August 6, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Rutgers, The State University of New Jersey:

Additional relevant MeSH terms:
Pigmentation Disorders
Skin Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents processed this record on April 21, 2014