18 years to 75 years of age; diagnosed with severe 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 grow hair. We are recruiting participants between 18 and 75 years of age with severe alopecia areata (AA) to take part in an investigational study. The purpose of the study is to evaluate how effective injections of the investigational drug called bempikibart (ADX-914) are on reducing hair loss in patients with severe AA.
The study consists of receiving an injection under the skin with 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, 36 weeks 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.
Study visits take approximately 1 to 2.5 hours each.
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, 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.
This study is taking place at multiple locations throughout the United States.
CTI (Clinical Trials Institute of Northwest Arkansas) Fayetteville, Arkansas Phone: 479-544-3483
California Dermatology & Clinical Research Institute Encinitas, California Phone: 619-787-5723
First OC Dermatology Research, Inc. Fountain Valley, California Phone: 714-531-2966
Dermatology Physicians of Connecticut Fairfield, Connecticut Phone: 203-675-9818
ForCare Clinical Research Tampa, Florida Phone: 813-264-2155
Equity Medical Bowling Green, Kentucky Phone: 270-213-7777
Lahey Hair Loss Center of Excellence Burlington, Massachusetts Phone: 781-744-1375
Bobby Buka MD, PC (The Dermatology Specialist) New York, New York Phone: 212-385-3700
Equity Medical New York, New York Phone: 212-466-6550
WDC Cosmetic and Research, PLLC Wilmington, North Carolina Phone: 910-256-4350
Bexley Dermatology Research Bexley, Ohio Phone: 614-725-5010
Dermatologists of Southwest Ohio Mason, Ohio Phone: 513-701-5526
Apex Clinical Research Center Painesville, Ohio Phone: 440-940-2739
Austin Institute for Clinical Research Houston, Texas Phone: 713-985-0210 ext 1164
Jordan Valley Dermatology Center South Jordan, Utah Phone: 801-316-0266
Dermatology Specialists of Spokane Spokane, Washington Phone: 509-456-8444
