Study to Evaluate ASN002 in Subjects With Severe Chronic Hand Eczema

Conditions:Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Age Range:18 - 75
Start Date:January 3, 2019
End Date:May 2020
Contact:Peter Pelka

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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.

This is a placebo controlled study where subjects with severe chronic hand eczema will be
randomized (1:1:1) to receive ASN002 at 40 mg, 80 mg, or placebo once daily for 16 weeks
(Part A). Then, in Part B, subjects who were assigned to placebo in the first part of the
study will receive the highest dose of ASN002 (80 mg) for the rest of the treatment period
(up to Week 32). The subjects who were assigned ASN002 in the first part of the study will
continue on the same assigned treatment dose during the second part of the study (Week 16 to
Week 32). The total treatment period of 32 weeks will be followed by a 4 week follow-up
period.This study will also characterize the pharmacokinetics and pharmacodynamics of ASN002
through blood sampling and three or four biopsies from subjects who consent.

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

- 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
Day 1

- 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.

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 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.
We found this trial at
Anniston, Alabama 36207
Principal Investigator: Stacy Haynes, MD
Phone: 256-236-0055
Anniston, AL
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San Antonio, Texas 78229
Principal Investigator: Mark Lee, MD
Phone: 210-614-5556
San Antonio, TX
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2359 East Main Street
Bexley, Ohio 43209
Principal Investigator: Matthew Zirwas, MD
Phone: 614-947-1716
Bexley, OH
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Boise, Idaho
Principal Investigator: Ryan Harris, MD
Phone: 208-277-8653
Boise, ID
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Fridley, Minnesota 55432
Principal Investigator: Steven Kempers, MD
Phone: 763-571-4200
Fridley, MN
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Indianapolis, Indiana 46256
Principal Investigator: Kenneth Dawes, MD
Phone: 317-516-5030
Indianapolis, IN
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London, Ontario
Principal Investigator: Wei Jing Loo, MD
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Los Angeles, California 90045
Principal Investigator: Howard Sofen, MD
Phone: 310-337-7171
Los Angeles, CA
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11750 Southwest 40th Street
Miami, Florida 33175
Principal Investigator: Marta Delgado, M.D.
Miami, FL
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Norfolk, Virginia 23507
Principal Investigator: David Pariser, MD
Phone: 757-625-0151
Norfolk, VA
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Portsmouth, New Hampshire 03801
Principal Investigator: Abel Jarell, MD
Portsmouth, NH
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