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VitiligoPhase 2NCT00134368

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

A Phase 2 study testing Etanercept in people with Vitiligo, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Vitiligo
What is being tested?
Etanercept
How many people
40 participants
Where
1 siteUnited States
Study dates
Nov 2003to Dec 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 22Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UMDNJ Psoriasis Center of Excellence

    New Brunswick, New Jersey, 08903

Other trials in United States

About this study

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

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

Read the detailed description

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

Conditions
Vitiligo
Being tested
Etanercept
Keywords
vitiligo, etanercept
Medical subject headings
Vitiligo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

  1. Percentage of subjects achieving 75% or more repigmentation at 6 months (Excellent or better on PGA score)

  2. Patient-Generated Global Assessment

  3. Skin texture assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2005 (estimated)
  2. Study startNov 2003
  3. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00134368
Sponsor's protocol ID
4489
Status last verified
Aug 2008
First submitted
22 Aug 2005
Last updated
7 Aug 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Etanercept in people with Vitiligo, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of subjects achieving 50% or more repigmentation at 6 months (Good or better on Physician's Global Assessment [PGA] score). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00134368.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2008; AzTrials last refreshed its copy on 8 Nov 2026.

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