Alefacept in Patients With Severe Scalp Alopecia Areata

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Brief Title

Alefacept in Patients With Severe Scalp Alopecia Areata

Official Title

A Double-Blind, Placebo-Controlled, Randomized, Multi-Center Study to Evaluate The Safety and Therapeutic Efficacy of Intramuscular Administration of Alefacept in Patients With Chronic, Severe Scalp Alopecia Areata

Brief Summary

      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.
    

Detailed Description

      Alopecia areata (AA) is an autoimmune condition characterised by a T-cell mediated attack on
      the hair follicle. The inciting antigenic stimulus is unknown. A dense peribulbar lymphocytic
      infiltrate and reproducible immunologic abnormalities are hallmark features of the condition.
      The cellular infiltrate primarily consists of activated T-lymphocytes and antigen-presenting
      Langerhans cells. T-lymphocytes play a critical role in the pathogenesis of disease. The
      observance of hair regrowth in those with alopecia areata who are treated with cyclosporine,
      a known inhibitor of T-cell function, further confirms the central role of the T-lymphocytes
      in the development of the disease.

      Activation of T-cells is initiated by interaction of the T-cell receptor with the
      antigen/major histocompatibility complex on the antigen-presenting cells. Co-stimulatory
      interactions occur secondarily, including binding of the T-cell CD2 receptor to the
      antigen-presenting cell ligand LFA-3 (lymphocyte function-associated antigen-3 CD58).
      Induction of a molecular signaling cascade with resultant T-cell activation and proliferation
      ensues. Abrogation of this activation may result in diminished or aborted expression of
      disease, and thus suggests a potential therapeutic role for alefacept in the treatment of
      alopecia areata. Alefacept is a bioengineered LFA-3/Immunoglobulin fusion protein that binds
      to the CD2 T-cell receptor and interferes with the ligation of LFA-3. Binding of the
      immunoglobulin portion of the fusion protein to the FCy receptor on antigen-presenting cells
      potentiates apoptosis of CD-2 T-cells to thereby reduce the population of activated T-cells.

      Psoriasis is a T-cell mediated disorder that shares many immunologic features with alopecia
      areata. Accordingly, treatments that are effective in psoriasis often prove to be beneficial
      in alopecia areata. Anthralin, topical and intralesional steroids and cyclosporine are among
      several therapeutic agents that have efficacy in both disorders. Based on the impressive
      therapeutic responses seen in those with psoriasis treated with alefacept, a similarly
      beneficial outcome is tentatively anticipated with treatment of those with alopecia areata.
    


Study Type

Interventional


Primary Outcome

The Proportion of Subjects Achieving at Least a 50% Reduction in Their Scalp Alopecia Areata Severity Scores (SALT Score) From Baseline Values


Condition

Alopecia Areata

Intervention

Alefacept

Study Arms / Comparison Groups

 Alefacept
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

45

Start Date

July 2005

Completion Date

February 2008

Primary Completion Date

February 2008

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Maria Hordinsky, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00167102

Organization ID

0506M70377


Responsible Party

Sponsor

Study Sponsor

University of Minnesota

Collaborators

 National Alopecia Areata Foundation

Study Sponsor

Maria Hordinsky, MD, Principal Investigator, University of Minnesota


Verification Date

May 2019