Clinical trial NCT03139981 (phase 1, status: completed)
Conditions: dermatitis, atopic, dermatitis eczema, dermatitis, eczematous
ICD codes: L20.89, L20.9
Drugs: asn002, placebo oral tablet
SMILES: CC1=CC(O)=CC(C)=C1Cl
Eligibility criteria:

        Inclusion criteria:

          -  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

        Exclusion criteria:

          -  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