A Study To Evaluate ASN002 In Subjects With Atopic Dermatitis

Completed · Phase 1 · Has a placebo group

Conditions studied: Dermatitis, Atopic, Dermatitis Eczema, Dermatitis, Eczematous

In brief

This is a dose escalation study to test the safety, tolerability and preliminary efficacy of ASN002 in people with moderate to severe atopic dermatitis (AD).

Key facts

Study ID

NCT03139981

Run by

Asana BioSciences

People needed

36

Starts

2017-04-12

Expected to finish

2017-12-05

Last updated by the study team

2023-05-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: 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 < 1.75 x 103 /μL, Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 1.5 x the upper limit of normal (ULN), Total bilirubin > ULN, 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 used oral or intravenous treatments (other than biologics) that could affect atopic dermatitis less than 4 weeks prior to Day 1.
• Has received any marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
• Currently receiving a non-biological investigational product or device or has received one within 4 weeks Day 1.
• Excessive sun exposure, is planning a trip to a sunny climate, or has used tanning booths within 4 weeks prior to baseline (Day 1), or is not willing to minimize natural and artificial sunlight exposure during the study.
• Has received or plans to receive a live attenuated vaccine within 4 weeks prior to Day 1 throughout the follow up period.
• Planned major surgical procedure during the length of the patient's participation in this study

Where it is running

• Center for Dermatology Clinical Research, Inc. — Fremont, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• TCR Medical Corporation — San Diego, California, United States
• Olympian Clinical Research — Tampa, Florida, United States
• Forward Clinical Trials, Inc. — Tampa, Florida, United States
• Dermatology Specialists Research — Louisville, Kentucky, United States
• Center for Clinical Studies, Ltd., LLP — Houston, Texas, United States
• Progressive Clinical Research, P.A. — San Antonio, Texas, United States
• Virginia Clinical Research, Inc. — Norfolk, Virginia, United States
• Innovaderm Research — Montreal, Canada

Full record on ClinicalTrials.gov

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