A Study to Evaluate the Anti-pruritic Effectiveness of ASN008 in Adults With Mild to Moderate Atopic Dermatitis
Dermatitis, Atopic, Pruritus
About this trial
This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Dermatitis, Atopic, Pruritus, Eczema, Itch
Eligibility Criteria
Inclusion Criteria: Male or female participants, 18 years or older, at the time of informed consent. Diagnosis of mild to moderate AD for at least 12 months with no significant disease flares for at least 4 weeks before Screening (based upon medical chart, treating physician, or participant report with documented clinical confirmation by the Investigator) Validated Investigator Global Assessment (vIGA) score of 2 or 3 at Day 1. Body surface area (BSA) affected by AD ≤20% at Day 1. Peak Pruritus NRS ≥7 at Day 1. Body mass index (BMI) ≤40 kg/m2 at Screening. Willingness to avoid pregnancy or fathering children. Participant is willing to participate for the duration of the trial, comply with all trial procedures, and is capable of giving informed consent. Exclusion Criteria: Any female who is breastfeeding, pregnant, or who is planning to become pregnant during the trial. Active infection requiring treatment, including skin infections (including clinically infected AD). History of skin disease or presence of a skin condition that, in the opinion of the Investigator, would interfere with trial assessments. Any clinically significant medical or psychiatric condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the Investigator, put the participant at undue risk or interfere with interpretation of trial results. Use of any of the following treatments within the indicated washout period before Day 1: Doxepin, hydroxyzine, or diphenhydramine use within 1 week prior to Day 1. Use of topical product containing urea or any antihistamine within 1 week prior to Day 1. Use of systemic antibiotic within 2 weeks, or topical antibiotics within 1 week, prior to Day 1. Atopic dermatitis topical medication use within 2 weeks prior to Day 1, including, but not limited to, topical corticosteroids, crisaborole and any other topical phosphodiesterase-4 inhibitor, calcineurin inhibitors, JAK inhibitors, tars, bleach, antimicrobials, medical devices, and bleach or oatmeal baths. Psoralen-UV-A or UV-B phototherapy (including tanning beds) or excimer laser within 4 weeks prior to Day Systemic medication use including biologics that could affect AD less than 6 weeks prior to Day 1 (e.g., retinoids, calcineurin inhibitors, methotrexate, cyclosporine, hydroxycarbamide [hydroxyurea], azathioprine, oral/injectable corticosteroids), biologics and JAK inhibitors. Known hypersensitivity to ASN008 or its excipients.
Sites / Locations
- TrialSpark Investigative Site 0106
- TrialSpark Investigative Site 0118
- TrialSpark Investigative Site 0123
- TrialSpark Investigative Site 0113
- TrialSpark Investigative Site 0101
- TrialSpark Investigative Site 0103
- TrialSpark Investigative Site 0129
- TrialSpark Investigative Site 0131
- TrialSpark Investigative Site 0109
- TrialSpark Investigative Site 0112
- TrialSpark Investigative Site 0108
- TrialSpark Investigative Site 0124
- TrialSpark Investigative Site 0107
- TrialSpark Investigative Site 0102
- TrialSpark Investigative Site 0115
- TrialSpark Investigative Site 0119
- TrialSpark Investigative Site 0105
- TrialSpark Investigative Site 0125
- TrialSpark Investigative Site 0127
- TrialSpark Investigative Site 0122
- TrialSpark Investigative Site 0121
- TrialSpark Investigative Site 0130
- TrialSpark Investigative Site 0114
- TrialSpark Investigative Site 0126
- TrialSpark Investigative Site 0110
- TrialSpark Investigative Site 0117
- TrialSpark Investigative Site 0128
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
ASN008 1.25%
ASN008 2.5%
ASN008 5%
ASN008 Matching Vehicle
ASN008 1.25% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days)
ASN008 2.5% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days)
ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days)
ASN008 matching vehicle twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days)