Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis

Stopped early · Phase 2

Conditions studied: Atopic Dermatitis

In brief

This is a randomized open label study to evaluate the long term safety of ASN002 in subjects with moderate to severe atopic dermatitis (AD).

Key facts

Study ID

NCT03654755

Run by

Asana BioSciences

People needed

162

Starts

2018-09-29

Expected to finish

2019-10-29

Last updated by the study team

2023-09-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject with a history of moderate to severe atopic dermatitis who participated in the preceding ASN002AD-201 and ASN002AD-101 study
• Subject must be a candidate for prolonged open label ASN002/gusacitinib treatment according to the investigator's judgment.
• Subject has been using an emollient daily for at least 1 week prior to Day 1 and agrees to continue using that same emollient daily throughout the study.
• Men and women participating in the study must use medically acceptable birth control or total abstinence from sexual intercourse
• Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.
• Subjects must be willing to comply with all study procedures and must be available for the duration of the study.
• Subject has a body mass index (BMI) ≤ 38 kg/m2.

You may not qualify if…

• Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
• Subject has clinically infected atopic dermatitis.
• A serious uncontrolled condition including hypertension, history of tuberculosis, hepatitis B or C infection, immune deficiency, heart disease, heart conduction disorder, diverticulitis, diabetes, reflux disease requiring protocol pump inhibitor therapy, malabsorption syndrome, or cancer
• Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.
• Subject has a history of eczema herpeticum within 12 months, and/or a history of 2 or more episodes of eczema herpeticum in the past.
• Willing to comply with discontinuation of certain treatments for AD, as directed by the Investigator.

Where it is running

• Pinnacle Research Group, LLC — Anniston, Alabama, United States
• Total Skin and Dermatology Center, PC. — Birmingham, Alabama, United States
• Center for Dermatology Clinical Research, Inc. — Fremont, California, United States
• L.A. Universal Research Center, Inc. — Los Angeles, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Revival Research — Doral, Florida, United States
• Clinical Physiology Associates — Fort Myers, Florida, United States
• Leavitt Medical Associates of Florida — Ormond Beach, Florida, United States
• Dermatology Consulting Services — Tampa, Florida, United States
• Forward Clinical Trials — Tampa, Florida, United States
• Dawes Fretzin Clinical Research Group — Indianapolis, Indiana, United States
• Dermatology Center of Indiana, PC — Plainfield, Indiana, United States
• The Indiana Clinical Trials Center — Plainfield, Indiana, United States
• Central Kentucky Research Associates, LLC — Lexington, Kentucky, United States
• Dermatology Specialists Research — Louisville, Kentucky, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• ActivMed Practices and Research, Inc. — Portsmouth, New Hampshire, United States
• Corning Center for Clinical Research — Corning, New York, United States
• Mt. Sinai Hospital — New York, New York, United States
• Wake Research Associates, LLC — Raleigh, North Carolina, United States
• Dermatologists of Greater Colombus — Bexley, Ohio, United States
• Wright State Physicians — Fairborn, Ohio, United States
• Unity Clinical Research — Oklahoma City, Oklahoma, United States
• Vital Prospects Clinical Research Institute — Tulsa, Oklahoma, United States
• DermDox Centers for Dermatology — Hazleton, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.