Alopecia Totalis/Universalis Clinical Trial
Official title:
A Randomized, Double Blind, Placebo Controlled Clinical Trial to Evaluate the Efficacy of Abatacept Costimulatory Blockade in the Treatment of Alopecia Totalis/Universalis
Will Abatacept reduce priming of the hair follicle specific T cells and thereby reduce hair
follicle associated infiltration and improve hair growth.
This is a double blind placebo controlled study to test the safety and efficacy of Abatacept
in the treatment of 64 subjects diagnosed with alopecia totalis or alopecia universalis.
Subjects will be randomized 1:1 to the placebo or treatment arm and will receive 6 months of
treatment with the study medication or placebo, followed by a 6 month observational period.
Alopecia Areata is a common autoimmune disease, affecting 1% of the general population
resulting from autoimmune attack on the hair follicles and usually presents with patchy hair
loss. One third of these patients will experience spontaneous remissions within the first
year. However many patients will develop waxing and waning disease with some progressing to
alopecia totalis (total scalp hair loss) or alopecia universalis (loss of all body hair).
This population that suffers from a disfiguring disease represents a significant unmet
medical need. Alopecia totalis/universalis seldom, if ever, remits spontaneously or with
current treatment and is classified by the FDA as an Orphan Indication.
There is no FDA approved drug for alopecia areata. A recent Cochrane report concluded that
there was no evidence based support for any intervention in this disease. Standard of care
remains observation for mild disease and lesional/oral steroids for more advanced cases.
Abatacept is a soluble human fusion protein that selectively modulates the costimulatory
signal required for full T-cell activation. It is approved for the treatment of moderately
to severely active rheumatoid arthritis. It is also approved for the treatment of moderately
to severely active polyarticular juvenile idiopathic arthritis in children 6 years of age or
older. Abatacept is a lyophilized powder administered as a 30 minute intravenous infusion.
Dosage, as in rheumatoid arthritis, is weight based and is fixed throughout the course of
treatment. Abatacept or placebo will be administered as a 30 minute intravenous infusion at
baseline, weeks 2, 4, and every 4 weeks for 5 cycles (weeks 8, 12, 16, 20) for a total
treatment period of 6 months. There will be a 6 month observational period following the
treatment period.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment