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 subjects between 18 and 75 years of age with severe alopecia areata (AA) to participate in an investigational study. The purpose is to evaluate how effective injections of the investigational drug called ADX-914 is on reducing hair loss in patients with severe AA.
The study consists of receiving an injection under the skin of either the investigational product ADX-914 or a placebo every 2 weeks over a 24-week period. You will be randomly assigned (like the flip of a coin) to recieve the study drug or placebo. You have a 3:1 chance (75%) of receiving the investigational product. After your 24-week treatment period, there will be a 12-week follow-up period to observe the findings.
Your participation in the study may last up to 40 weeks, including a Screening Period of up to 30 days, 24 weeks of Study Treatment Period, and a Follow-Up Period of 12 weeks. You will have a total of 17 in person visits throughout the study.
Visits take approximately 1 to 2.5 hours each, except for the screening visit and end-of-study visit which may take up to 3 hours.
Blood samples will be collected from all participants at each visit.
Medical photography, and SALT assessment will be taken at screening, and weeks 1, 6, 12, 18, 24, 26, 30, and 36.
An electrocardiogram to check heart health will be taken at screening, and weeks 1, 12, 24, and 36.
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.
