Randomized, Double-Blind, Placebo-Controlled Phase 2a, Proof-of-Concept Trial of ADX-914 for the Treatment of Severe Alopecia Areata (SIGNAL-AA)

Study type: Clinical Trials Posting date: 10/23/2023 Last updated: 05/21/2024 Status: Active/Fully Enrolled Phase: Phase 2a Country: United States Eligibility:

18 years to 75 years of age; diagnosed with alopecia areata

Drug: ADX-914 Administration: subcutaneous injection Sponsor: Q32 Bio Sponsor Link: Click here ClinicalTrials.gov link: Click here Location: Multiple locations


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.

Investigate MD, LLC
Scottsdale, Arizona
Phone: 480-398-1550

CTI (Clinical Trials Institute of Northwest Arkansas)
Fayetteville, Arkansas
Phone: 479-544-3483

Burke Pharmaceutical Research
Hot Springs, Arkansas
Phone: 501-620-4449

California Dermatology & Clinical Research Institute
Encinitas, California
Phone: 619-787-5723

First OC Dermatology Research, Inc.
Fountain Valley, California
Phone: 714-531-2966

Torrance Clinical Research Institute Inc
Torrance, California
Phone: 310-373-8120

Well Pharma Medical Research Corporation
Miami, FLorida

ForCare Clinical Research
Tampa, Florida

DS Research of Southern Indiana
Clarksville, Indiana

Revival Research Corporation
Troy, Michigan

Grekin Skin Institute
Warren, Michigan
Phone: 586-759-5525 ext 3

Bobby Buka MD, PC (The Dermatology Specialist)
New York, New York

WDC Cosmetic and Research, PLLC
Wilmington, North Carolina

Bexley Dermatology Research
Bexley, Ohio
Phone: 614-725-5010

Dermatologists of Southwest Ohio
Mason, Ohio

Apex Clinical Research Center
Painesville, Ohio

NW Dermatology Institute
Portland, Oregon

Austin, Texas

North Texas Center for Clinical Research
Frisco, Texas
Phone: 972-704-2400

Austin Institute for Clinical Research
Houston, Texas
Phone: 713-985-0210 ext 1164

Progressive Clinical Research, PA
San Antonio, Texas
Phone: 210-614-5557

Jordan Valley Dermatology Center
South Jordan, Utah
Phone: 801-316-0266

Dermatology Specialists of Spokane
Spokane, Washington
Phone: 509-456-8444