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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.


Visits
Drug administered on which days
Total
Length
Procedures
Study Length
Days
Day 1, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, 155, and 169
Total
17
Length
Up to 3 hours
Procedures
Blood samples, medical photography, electrocardiogram
Study Length
40 weeks
Summary
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.
Condition
Alopecia areata
Treatment
ADX-914

There are 23 locations for this study

Dermatology Specialists of Spokane

Dermatology Specialists of Spokane

Spokane, Washington, 99202, United States
Austin Institute for Clinical Research (Houston Location)

Austin Institute for Clinical Research (Houston Location)

Houston, Texas, 77056, United States
Jordan Valley Dermatology Center

Jordan Valley Dermatology Center

South Jordan, Utah, 84095, United States
First OC Dermatology Research Inc.

First OC Dermatology Research Inc.

Fountain Valley, California, 92708, United States
North Texas Center for Clinical Research

North Texas Center for Clinical Research

Frisco, Texas, 75034, United States
Burke Pharmaceutical Research

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States
California Dermatology & Clinical Research Institute

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States
Progressive Clinical Research

Progressive Clinical Research

San Antonio, Texas, 78213, United States
Advanced Dermatology of Michigan (Grekin Skin Institute)

Advanced Dermatology of Michigan (Grekin Skin Institute)

Warren, Michigan, 48088, United States
Dermatologists of Southwest Ohio

Dermatologists of Southwest Ohio

Mason, Ohio, 45040, United States
CenExel-FCR

CenExel-FCR

Tampa, Florida, 33606, United States
Bobby Buka MD, PC (The Dermatology Specialist)

Bobby Buka MD, PC (The Dermatology Specialist)

New York, New York, 10012, United States
Derm Research

Derm Research

Austin, Texas, 78759, United States
Bexley Dermatology Research

Bexley Dermatology Research

Bexley, Ohio, 43209, United States
Revival Research Institute

Revival Research Institute

Troy, Michigan, 48084, United States
DS Research of Southern Indiana

DS Research of Southern Indiana

Clarksville, Indiana, 47129, United States
Well Pharma Medical Research Group, Corp

Well Pharma Medical Research Group, Corp

Miami, Florida, 33173, United States
Torrance Clinical Research Institute Inc

Torrance Clinical Research Institute Inc

Lomita, California, 90503, United States
Wilmington Dermatology Center

Wilmington Dermatology Center

Wilmington, North Carolina, 28405, United States
Apex Clinical Research Center, LLC

Apex Clinical Research Center, LLC

Mayfield Heights, Ohio, 44124, United States
NW Dermatology Institute

NW Dermatology Institute

Portland, Oregon, 97210, United States
Investigate MD

Investigate MD

Scottsdale, Arizona, 85255, United States
Clinical Trials Institute of Northwest Arkansas

Clinical Trials Institute of Northwest Arkansas

Fayetteville, Arkansas, 72703, United States
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