Recruiting for Alefacept study

Source for Recruiting for Alefacept study

Purpose

The purpose of this study is to examine prospectively the safety and efficacy of alefacept in the treatment of subjects with severe alopecia areata of the scalp. Common features between psoriasis and alopecia areata, including immunologic and therapeutic aspects, suggest that alefacept, which has been shown to be a safe and statistically significant beneficial therapeutic modality for the treatment of psoriasis, may have therapeutic value in alopecia areata.

Eligibility

Ages Eligible for Study: 18 Years – 65 Years, Genders Eligible for Study: BothAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects must give written informed consent and candidates in the US must authorize the release and use of protected health information (PHI)
  • Subjects must be between the ages of 18 and 65 inclusive at the time of informed consent
  • Must have a diagnosis of scalp alopecia areata as determined by the study investigator
  • Must have 50-95% patchy scalp hair loss due to alopecia areata of at least one year duration
  • Must have CD4+ T-lymphocyte counts at or above the lower limit of normal as determined by a local laboratory.

Exclusion Criteria:

  • History of systemic or cutaneous malignancy other than treated basal cell carcinomas or 3 or less squamous cell carcinomas.
  • Nevi or cutaneous lesions currently undiagnosed but suspicious for malignancy.
  • Evidence of immunocompromise.
  • Advanced or poorly controlled diabetes.
  • Unstable cardiovascular disease.
  • Clinically significant medical or psychiatric disease as determined by the investigator.
  • History of alcohol or drug abuse within 2 years of assessment for study enrollment.
  • Serious local infection (e.g. cellulitis, abscess) or systemic infection (e.g. pneumonia, septicemia) within 3 months prior to the first dose of investigational drug.
  • Positive PPD history of incompletely treated or untreated tuberculosis.
  • Abnormal T-lymphocyte count, and/or liver function tests.
  • If female, serum hemoglobin level greater than 1 unit below accepted limit for normal or otherwise abnormal.
  • Male subjects with an abnormal serum hemoglobin.
  • Known positivity for hepatitis C antigen or hepatitis B surface antigen.
  • Known positivity for HIV antibody.
  • Diagnosis of diffuse alopecia areata.
  • Coexistent androgenetic alopecia which, in males is Norwood-Hamilton stage VI or greater, or in females, Ludwig stage III.
  • Prior treatment with alefacept.
  • Treatment with another investigational drug within 4 weeks prior to anticipated first treatment dose.
  • Unable to practice effective contraception for the duration of the study.
  • Females who are nursing, pregnant or planning to become pregnant while in the study.
  • Those who have donated blood within a month of date of screening evaluation.
  • Concomitant enrollment in other investigational drug study.
  • Unwilling to maintain a consistent hair style and to eschew shaving of scalp hair throughout the course of the study.
  • Unable to comply with the protocol.
  • Other unspecified reasons that contraindicate enrollment in the study, as determined by the study investigator.

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