Alopecia areata is an autoimmune disease resulting in hair loss that is usually in one or more coin-shaped patches on the face, scalp or other areas of the body that grows hair. We are recruiting patients between 18 and 75 years of age with severe alopecia areata (AA) to participate in a clinical trial. The purpose is to evaluate how effective injections of the investigational drug called ADX-914 are on reducing hair loss in patients with severe AA.
The study consists of receiving an injection under the skin of the investigational product ADX-914 once a week for 4 weeks (4 doses) and then every two weeks over a 32-week period (16 doses). After your 36-week treatment period, there will be a 16-week follow-up period to observe the findings.
Your participation in the study may last up to 56 weeks, including a Screening Period of up to 30 days, 36weeks of Study Treatment Period, and a Follow-Up Period of 16 weeks. You will have a total of 26 in person visits throughout the study.
Visits will take up to 2.5 hours.
Blood samples will be collected from all participants at screening and day 1,8, 15, 22, 36, 50, 64, 78, 92, 106, 120,134, 148, 162, 176, 190, 204, 218, 232, 246, 260 302, and 358.
Medical photography, and SALT assessment will be taken at screening, and weeks 1, 6, 12, 18, 24, 30, 36, 44 and 52.
An electrocardiogram to check heart health will be taken at screening, and weeks 36 and 52.
Compensation for time and travel will be available. There will be no cost to you for taking part in this study. You will be provided with all study medication, examinations and medical care related to the study at no cost to you.
