Phase 2B Study to Evaluate ASN002 in Subjects With Moderate to Severe Atopic Dermatitis (RADIANT)

Completed · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

This is a randomized double-blind/placebo study evaluate the efficacy of ASN002 in subjects with moderate to severe atopic dermatitis (AD).

Key facts

Study ID

NCT03531957

Run by

Asana BioSciences

People needed

244

Starts

2018-07-05

Expected to finish

2019-08-14

Last updated by the study team

2023-07-03

Who can join

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

You may qualify if…

• Written informed consent obtained prior to any study-related procedure being performed;
• Male or female, 18≤ years and ≤75 years of age with chronic AD for at least 6 months.
• At least 10% body surface area (BSA) of AD involvement at the baseline visits
• Has a body mass index (BMI) ≤35 kg/m2
• History of inadequate response to topical corticosteroids or calcineurin inhibitors as treatment for AD within 1 year before the screening visit.
• Willing to apply only a basic bland emollient once or twice-daily for at least 7 days before the baseline visit.
• Willing to comply with discontinuation of certain treatments for AD, as directed by the Investigator.
• Willing to use medically effective methods of birth control
• Females of reproductive potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at Day 1..
• Willing and able to comply with clinic visits and study-related procedures

You may not qualify if…

• Clinically infected atopic dermatitis.
• Presence of any of the following laboratory abnormalities at the screening visit: Hemoglobin < 11 g/dL, White blood cell (WBC) < 3.0 x 103 /μL, Platelet count < 125 x 103 /μL, Neutrophils < < 2.50 x 103 /μL, Lymphocytes ≤ 1.2 x 103 /μL, Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 1.5 x the upper limit of normal (ULN),Total bilirubin > ULN (except for elevated indirect bilirubin secondary to Gilbert's syndrome), Creatinine > ULN
• 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.
• Any condition requiring the use of anticoagulants.
• History of hypertrophic scarring or keloid formation in scars or suture sites.
• Any medical or psychiatric condition which, in the opinion of the investigator or the sponsor's medical monitor, would place the patient at risk, interfere with participation in the study, or interfere with the interpretation of study results
• Pregnant or breast-feeding women
• Known hypersensitivity to ASN002 or its excipients;
• Prior treatment with SYK or JAK inhibitors for which the subject received no clinical benefit, or the subject relapsed whilst on therapy.
• Has received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
• Planned major surgical procedure during the length of the patient's participation in this study
• There will be a waiting period of 4 weeks before receiving the first does for anyone who has used oral or intravenous treatments (other than biologics) that could affect atopic dermatitis, received a non-biological investigational product or device, excessive sun exposure, is planning a trip to a sunny climate, or has used tanning booths, or received or plans to receive a live attenuated vaccine one four weeks after the last day of taking the drug.

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
• 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

Full record on ClinicalTrials.gov

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