Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis
NCT ID: NCT03654755
Last Updated: 2023-09-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
162 participants
INTERVENTIONAL
2018-09-29
2019-10-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ASN002 40 mg
ASN002 40 mg
ASN002
Daily dose of ASN002 for up to 110 weeks
ASN002 60 mg
ASN002 60 mg
ASN002
Daily dose of ASN002 for up to 110 weeks
ASN002 80 mg
ASN002 80 mg
ASN002
Daily dose of ASN002 for up to 110 weeks
Interventions
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ASN002
Daily dose of ASN002 for up to 110 weeks
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Asana BioSciences
INDUSTRY
Responsible Party
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Principal Investigators
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David Zammit, Ph.D.
Role: STUDY_DIRECTOR
Asana BioSciences
Locations
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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
Synexus
Greer, South Carolina, United States
Dermatology Treatment and Research Center
Dallas, Texas, United States
Innovate Research, LLC
Fort Worth, Texas, United States
The Center for Skin Research
Houston, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Institute of Skin Advancement Medical, Surgical, Costmetic & Laser Dermatology
Calgary, , Canada
Innovaderm Research, Inc.
Montreal, , Canada
Ontario Inc.
Ottawa, , Canada
York Regional Dermatology
Richmond Hill, , Canada
NewLab Clinical Research, Inc.
St. John's, , Canada
AvantDerm
Toronto, , Canada
SkinWISE Dermatology
Winnipeg, , Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ASN002AD-201-EXT
Identifier Type: -
Identifier Source: org_study_id
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