Study to Evaluate ASN002 in Subjects With Moderate To Severe Chronic Hand Eczema

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Hand Dermatitis

In brief

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

Key facts

Study ID

NCT03728504

Run by

Asana BioSciences

People needed

97

Starts

2019-01-03

Expected to finish

2020-04-29

Last updated by the study team

2023-05-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pinnacle Research Group, LLC — Anniston, Alabama, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Sweet Hope Research Specialty, Inc — Hialeah, Florida, United States
• RM Medical Research, Inc. — Miami, Florida, United States
• Advanced Clinical Research — Boise, Idaho, United States
• Dawes Fretzin Clinical Research Group — Indianapolis, Indiana, United States
• Dermatology Specialists Research — Louisville, Kentucky, United States
• DelRicht Research — New Orleans, Louisiana, United States
• Maryland Laser Skin and Vein — Hunt Valley, Maryland, United States
• BTC Network — Fort Gratiot, Michigan, United States
• Minnesota Clinical Research Center — Fridley, Minnesota, United States
• ActivMed Practices and Research, Inc. — Portsmouth, New Hampshire, United States
• Dermatologists of Greater Colombus — Bexley, Ohio, United States
• Lynn Health Science Institute — Oklahoma City, Oklahoma, United States
• Progressive Clinical Research — San Antonio, Texas, United States
• Virginia Clinical Research, Inc. — Norfolk, Virginia, United States
• Dermatology Specialists of Spokane — Spokane, Washington, United States
• SimcoDerm Medical and Surgical Dermatology Centre — Barrie, Ontario, Canada
• Wei Jing Loo Medicine Professional Corp. — London, Ontario, Canada
• Lynderm Research Inc. — Markham, Ontario, Canada
• G. Daniel Schachter Medicine Professional — Toronto, Ontario, Canada
• Innovaderm Research, Inc. — Montreal, Canada
• Centre de Recherche Dermatologique du Quebec metropolitain — Québec, Canada

Full record on ClinicalTrials.gov

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