Phase 2B Study to Evaluate ASN002 in Subjects With Moderate to Severe Atopic Dermatitis (RADIANT)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: ASN002; Placebo Oral Tablet
Intervention description: Daily dose of ASN002 for 12 weeks; Placebo of ASN002 for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 244.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: eczema

Summary:

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

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 < < 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.