Alefacept in Patients With Severe Scalp Alopecia Areata

This study has been completed.
Sponsor:
Collaborator:
National Alopecia Areata Foundation
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00167102
First received: September 9, 2005
Last updated: February 27, 2013
Last verified: February 2013
  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.


Condition Intervention
Alopecia Areata
Drug: Alefacept

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
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

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Number of any adverse event reported throughout the study, regardless of relation to study drug


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: July 2005
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alefacept Drug: Alefacept
Study participants will receive weekly IM administration of placebo or 15 mg of alefacept for 12 weeks, to be followed by a 12-week post-treatment period during which the safety, efficacy, and durability of effect in treatment responders will be assessed on weeks 2, 4, 8 and 12.
Placebo Comparator: Placebo Drug: Alefacept
Study participants will receive weekly IM administration of placebo or 15 mg of alefacept for 12 weeks, to be followed by a 12-week post-treatment period during which the safety, efficacy, and durability of effect in treatment responders will be assessed on weeks 2, 4, 8 and 12.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00167102

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Alopecia Areata Foundation
Investigators
Principal Investigator: Maria Hordinsky, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00167102     History of Changes
Other Study ID Numbers: 0506M70377
Study First Received: September 9, 2005
Results First Received: February 27, 2013
Last Updated: February 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Alopecia Areata

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Alefacept
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014