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

Vitiligo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00134368
• Other study ID #: 4489
• Status: Completed
• Phase: Phase 2
• First received: August 22, 2005
• Last updated: August 6, 2008
• Start date: November 2003
• Est. completion date: December 2007

Study information

• Verified date: August 2008
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitiligo

Intervention

Drug:
• Etanercept

Locations

Country	Name	City	State
United States	UMDNJ Psoriasis Center of Excellence	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of subjects achieving 50% or more repigmentation at 6 months (Good or better on Physician's Global Assessment [PGA] score)
Secondary	Percentage of subjects achieving 75% or more repigmentation at 6 months (Excellent or better on PGA score)
Secondary	Patient-Generated Global Assessment
Secondary	Skin texture assessment