18 years to 75 years of age; diagnosed with alopecia areata
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 receive 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.
This study is taking place at multiple locations throughout the United States.
Burke Pharmaceutical Research
Hot Springs, Arkansas
California Dermatology & Clinical Research Institute
First OC Dermatology Research, Inc.
Fountain Valley, California
Grekin Skin Institute
Phone: 586-759-5525 ext 3
Bexley Dermatology Research
North Texas Center for Clinical Research
Austin Institute for Clinical Research
Phone: 713-985-0210 ext 1164
Progressive Clinical Research, PA
San Antonio, Texas
Jordan Valley Dermatology Center
South Jordan, Utah
Dermatology Specialists of Spokane