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A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ASN002 in Subjects With Severe Chronic Hand Eczema Refractory to Topical Corticosteroid Therapy
Randomized double-blind/placebo study to evaluate the efficacy of ASN002 in subjects with severe chronic hand eczema.
18 Years to 75 Years
– 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
– Subject has severe CHE at Day 1, as defined by a hand PGA ≥ 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
– Subject has a body mass index (BMI) ≤ 35 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.
– 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 1.2 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.
Study Director: David Zammit, Ph.D.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03728504
Pinnacle Research Group, LLC
Anniston, Alabama 36207
Dermatology Research Associates
Los Angeles, California 90045
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana 46256
Dermatologists of Greater Colombus
Bexley, Ohio 43209
Progressive Clinical Research
San Antonio, Texas 78213
Virginia Clinical Research, Inc.
Norfolk, Virginia 23502
Innovaderm Research, Inc.