NCT01314495

Abatacept Costimulatory Blockade in the Treatment of Alopecia Totalis/Universalis

A Randomized, Double Blind, Placebo Controlled Clinical Trial to Evaluate the Efficacy of Abatacept Costimulatory Blockade in the Treatment of Alopecia Totalis/Universalis

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Julian M. Mackay-Wiggan · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Alopecia Totalis/Universalis

Interventions

Type	Name	Description
DRUG	Abatacept	Abatacept will be administrated as a 30 minute intravenous infusion.
DRUG	Inactive infusion	Placebo will be administered as a 30 minute intravenous infusion.

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2011-03-14
• Last updated: 2012-11-14