CompletedPhase 2

An Open-Label Single-Arm Clinical Trial to Evaluate The Efficacy of Abatacept in Moderate to Severe Patch Type Alopecia Areata

United States15 participantsStarted 2013-09

Plain-language summary

Alopecia areata (AA) is a common disease of the immune system, known as an "autoimmune" disease. In this disease, the immune system mistakenly destroys the hair follicle, causing hair to fall out. Despite many people having this disease, research into its cause and into new, better ways to treat Alopecia Areata has lagged far behind other similar diseases of the immune system. Currently, there are no Federal Drug Administration approved drugs for Alopecia Areata. Abatacept (made by Bristol-Myers Squibb) is a safe intervention known to effectively treat rheumatoid arthritis, another "autoimmune" disease, by fighting inflammation. There are some genetic and chemical similarities between those with active rheumatoid arthritis and Alopecia Areata, suggesting that treatment with the same drug is likely to be effective. In mice specially designed for testing drugs for the treatment of human alopecia, this medication worked to prevent the disease Alopecia Areata from starting. To test Abatacept, we are going to treat 15 patients with moderate to severe Alopecia Areata for 6 months. Each person enrolling into this study will receive the active study drug. The effectiveness of the medication will be measured by changes in hair re-growth as determined by physical exam and photography, as well as by patient and physician scoring. Patients will be followed for another 6 months off of the drug to see if the effects of treatment last and if there is delayed response. We have recently changed the study to allow testing of abatacept in a few patients with alopecia totalis and universalis. Small scalp biopsies and peripheral blood will be taken at the beginning of the study before treatment and then after 4,12 and 24 weeks. The chemical analysis of these skin samples and blood will help us to understand how the disease happens, how the treatment works, and perhaps even guide us to better treatments in the future.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion Criteria: * Signed Written Informed Consent Before any study procedures are performed, subjects will have the details of the study described to them, and they will be given a written informed consent document to read. Then, if subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnel. * Must be between 18 and 75 years of age. * Must have a diagnosis of moderate to severe AA - defined as the presence of equal to or more than 30% and equal to or less than 95% total scalp hair loss at baseline as measured using the SALT score. In addition, a few patients with 100% scalp hair loss will be enrolled. * Duration of hair loss must be at least 3 months. * There may be no evidence of regrowth present at baseline. * Subjects may be naïve to treatment or unresponsive to intralesional (IL) steroids or other treatments for AA. * Must be willing to avoid live vaccines while on the study medication, and within 3 months of its discontinuation. * Women of childbearing potential (WOCBP) must use highly effective methods of birth control \[for up to 12 weeks after the last dose of investigational product\] to minimize the risk of pregnancy\]. WOCBP must follow instructions for birth control for the entire duration of the study including a minimum of 90 days after dosing has been completed. (Acceptable methods of highly effective birth control include: Condom with spermicide, Dia…

What they're measuring

Total Number of Participants With At Least 50% Hair Regrowth

Timeframe: Week 24

Trial details

NCT IDNCT02018042

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-07-31

Results submitted2019-03-27