Clinical Trial: Alefacept in Patients With Severe Scalp Alopecia Areata

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 <

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 Summary:

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 alope
Sponsor: University of Minnesota - Clinical and Translational Science Institute

Current Primary Outcome:

  • The Proportion of Subjects Achieving at Least a 50% Reduction in Their Scalp Alopecia Areata Severity Scores (SALT Score) From Baseline Values [ Time Frame: 12 weeks ]
    Assess the therapeutic efficacy of a 12-week regimen of weekly IM administration of alefacept in subjects with chronic severe scalp alopecia
  • Number of Adverse Events [ Time Frame: 24 weeks ]
    Number of any adverse event reported throughout the study, regardless of relation to study drug


Original Primary Outcome: Assess the safety and therapeutic efficacy of a 12-week regimen of weekly IM administration of alefacept in subjects with chronic severe scalp alopecia areata

Current Secondary Outcome:

  • In Those Who Respond to Treatment, the Durability of the Response Will be Assessed Over a 12-week Post-treatment Period of Observation. [ Time Frame: 12 weeks ]
  • To Qualitatively Assess the Subjects Perception of Their Scalp Disease With Treatment, and Upon Withdrawal of Treatment, in Relation to Baseline. [ Time Frame: 12 weeks ]


Original Secondary Outcome:

  • In Those Who Respond to Treatment, the Durability of the Response Will be Assessed Over a 12-week Post-treatment Period of Observation.
  • To Qualitatively Assess the Subjects Perception of Their Scalp Disease With Treatment, and Upon Withdrawal of Treatment, in Relation to Baseline.


Information By: University of Minnesota - Clinical and Translational Science Institute

Dates:
Date Received: September 9, 2005
Date Started: July 2005
Date Completion:
Last Updated: February 27, 2013
Last Verified: February 2013