A Clinical Trial to Evaluate the Efficacy of Abatacept in Moderate to Severe Alopecia Areata

Alopecia Areata Clinical Trial

Official title: A Randomized Clinical Trial to Evaluate the Efficacy of Abatacept in Moderate to Severe Alopecia Areata

Status Withdrawn

Clinical Trial Summary

The purpose of this study is to determine if receiving sub-cutaneous injections of a medication called abatacept causes regrowth of hair in people with alopecia areata.

Among patients with alopecia areata, patients with worse disease are unlikely to have satisfactory outcomes with current therapies. Our hypothesis is that Abatacept will be effective therapy in moderate to severe alopecia areata by blocking re-activation of a special type of immunecell call a memory T-Cell (CD8+NKG2D+)thereby blocking the inflammatory response underlying alopecia areata.

Clinical Trial Description

Alopecia areata (AA) is a common disease of the immune system, known as an "autoimmune" disease. In the disease, the immune system mistaken 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 AA has lagged far behind other similar diseases of the immune system. Currently, there are no Federal Drug Administration approved drugs for AA. 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 AA, 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 AA from starting. To test Abatacept, we are going to treat 60 patients with moderate to severe AA for 6 months. To make the study results meaningful, there will be a control or "placebo" group that does not receive the study drug. Patients will be randomly assigned to either receive the real or the inactive medication, and neither the patient nor the doctor will know which it is. 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. 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 even guide us to better treatments in the future. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

• NCT number: NCT01917058
• Study type: Interventional
• Source: Columbia University
• Status: Withdrawn
• Phase: Phase 2
• Start date: August 2013
• Completion date: August 2016