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

Asana BioSciences

Status and phase: Completed; Phase 2

Conditions: Chronic Hand Dermatitis

Treatments: Drug: Placebo Oral Tablet; Drug: ASN002

Study type: Interventional

Funder types: Industry

Identifiers

NCT03728504

ASN002AD-202

Details and patient eligibility

About

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

Full description

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.

Enrollment: 97 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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97 participants in 3 patient groups, including a placebo group

ASN002 40 mg

Experimental group

Description:

40 mg ASN002

Treatment:

Drug: ASN002

ASN002 80 mg

Experimental group

Description:

80 mg ASN002

Treatment:

Drug: ASN002

Placebo oral tablet

Placebo Comparator group

Description:

Matching placebo for ASN002 doses

Treatment:

Drug: Placebo Oral Tablet