Study to Evaluate ASN002 in Subjects With Moderate To Severe Chronic Hand Eczema
Condition: Chronic Hand Dermatitis
MeSH terms: Dermatitis; Eczema
Intervention: ASN002; Placebo Oral Tablet
Intervention description: Daily dose of ASN002 for 32 weeks; Daily dose of Placebo Oral Tablet for 16 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: 97.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: eczema; hand eczema; hand dermatitis

Summary:

      Randomized double-blind/placebo study to evaluate the efficacy of ASN002 in subjects with
      severe chronic hand eczema.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent obtained prior to any study-related procedure being performed

          -  Male or female subject, aged 18 to 75 years, inclusive, at the time of consent.

          -  Subject has a history of severe CHE for at least 6 months prior to baseline

          -  Subject has hand eczema refractory to high potency or ultra-high potency topical
             corticosteroids

          -  Subject has moderate to severe CHE at Day 1, as defined by a hand PGA 3 or 4.

          -  Subject has been using an emollient on their hands and feet (except those containing
             urea or salicylic acid) every day at the same frequency for at least 1 week prior to
             Day 1

          -  Subject has a body mass index (BMI) ≤ 38 kg/m2.

          -  Female subject of childbearing potential has had a negative serum pregnancy test at
             screening and negative urine pregnancy test on Day 1.

          -  Willing and able to comply with clinical visits and study related procedures.

        Exclusion Criteria:

          -  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 < 1.80 x 103 /μL, Lymphocytes <0.9 x 103 /μL, Aspartate
             aminotransferase (AST)/alanine aminotransferase (ALT) > 2x the upper limit of normal
             (ULN),Total bilirubin > 1.2x ULN (except for elevated indirect bilirubin secondary to
             Gilbert's syndrome), Creatinine > ULN

          -  A serious uncontrolled condition including hypertension, active 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.

          -  Active skin infections of the hands and/or feet

          -  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.

          -  Subject has received any marketed or investigational biological agent within 12 weeks
             or 5 half-lives (whichever is longer) prior to Day 1.