Alefacept in Patients With Severe Scalp Alopecia Areata

NCT00167102 | Completed Results

• 1 other identifier: 0506M70377
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia Areata

Keywords

Alopecia Areata

Outcome Measures

Primary Outcomes (2)

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

  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

  24 weeks

• Number of Adverse Events

  Number of any adverse event reported throughout the study, regardless of relation to study drug

  24 weeks

Study Arms (2)

Alefacept

EXPERIMENTAL

Drug: Alefacept

Placebo

PLACEBO COMPARATOR

Drug: Alefacept

Interventions

Alefacept DRUG

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.

Alefacept; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead
• National Alopecia Areata Foundation: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Alopecia Areata

Interventions

Alefacept

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

CD58 Antigens; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Membrane Proteins; Recombinant Fusion Proteins; Recombinant Proteins

Limitations and Caveats

This study was limited by the number of patients randomized to receive treatment.

Results Point of Contact

• Title: Dr. Maria Hordinsky
• Organization: University of Minnesota

hordi001@umn.edu

612-624-5721

Study Officials

• Maria Hordinsky, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 14, 2005
• Study Start: July 1, 2005
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: May 22, 2019
• Results First Posted: April 9, 2013

Record last verified: 2019-05

Locations

US (1)