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Alefacept in Patients With Severe Scalp Alopecia Areata

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00167102
Recruitment Status : Completed
First Posted : September 14, 2005
Results First Posted : April 9, 2013
Last Update Posted : May 22, 2019
National Alopecia Areata Foundation
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 14, 2005
Results First Submitted Date  ICMJE February 27, 2013
Results First Posted Date  ICMJE April 9, 2013
Last Update Posted Date May 22, 2019
Study Start Date  ICMJE July 2005
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2017)
  • The Proportion of Subjects Achieving at Least a 50% Reduction in Their Scalp Alopecia Areata Severity Scores (SALT Score) From Baseline Values [ Time Frame: 24 weeks ]
    Assess the therapeutic efficacy of a 12-week regimen of weekly IM administration of alefacept followed by a 12 week observation period 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 Measures  ICMJE
 (submitted: September 12, 2005)
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
Change History Complete list of historical versions of study NCT00167102 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Alefacept in Patients With Severe Scalp Alopecia Areata
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Condition  ICMJE Alopecia Areata
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Alefacept
    Intervention: Drug: Alefacept
  • Placebo Comparator: Placebo
    Intervention: Drug: Alefacept
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 16, 2017)
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00167102
Other Study ID Numbers  ICMJE 0506M70377
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE National Alopecia Areata Foundation
Investigators  ICMJE
Principal Investigator: Maria Hordinsky, MD University of Minnesota
PRS Account University of Minnesota
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP