The goal of this clinical trial is to evaluate ASN008 in people with itch caused by eczema. The main questions it aims to answer are: * What is the efficacy and safety of ASN008? * What is the impact of ASN008 on itch in patients with atopic dermatitis? Participants will be asked to apply topical ASN008, or matching vehicle (placebo containing no active drug), to their eczema lesions twice daily for 4 weeks. Researchers will compare 3 different doses of ASN008 and a matching vehicle group to see which group responds best.
All participants will sign an informed consent form and undergo screening (within 28 days prior to Day 1). During the screening period, all treatments for Atopic Dermatitis (AD) (also known as eczema) and/or itch will be stopped to allow for wash out, as applicable and according to eligibility requirements. Consistent daily or twice daily use of a non-prescription emollient is required at least 7 days prior to Day 1 and throughout the trial until the follow-up (Week 8). No other products, including, but not limited to, topical corticosteroids, calcineurin inhibitors, biologics, or Janus Kinase (JAK) inhibitors (topical or oral) may be used during the trial. Eligible participants will be randomized in a 1:1:1:1 ratio to receive ASN008 gel 1.25 percent, ASN008 gel 2.5 percent, ASN008 gel 5.0 percent, or matching vehicle twice daily for 4 weeks (28 days), followed by a 4-week (28-day) follow-up period. The first dose of study treatment will be applied on Day 1 and the last dose will be applied on the morning of Day 28. Participants will be required to participate in 8 scheduled visits: Screening; Randomization (remote visit); Day 1; Week 1 (Day 8); Week 2 (Day 15); Week 3 (Day 22); Week 4 (Day 28); and Week 8 (Day 56)/early termination (ET). The trial duration per participant is up to 12 weeks (84 days): including up to 4 weeks (28 days) for the screening period, 4 weeks (28 days) for the treatment period, and up to 4 weeks (28 days) for the follow-up period. A participant is considered to have reached the end of the trial when they have completed their Day 56 (Week 8) or ET visit. The trial will be considered complete when the last participant has completed their last trial visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
144
ASN008 topical gel applied twice daily.
The ASN008 matching vehicle formulation matches the formulation of each ASN008 topical gel dose, but contains no ASN008.
TrialSpark Investigative Site 0106
Scottsdale, Arizona, United States
TrialSpark Investigative Site 0118
Hot Springs, Arkansas, United States
TrialSpark Investigative Site 0123
Beverly Hills, California, United States
TrialSpark Investigative Site 0113
Fremont, California, United States
TrialSpark Investigative Site 0101
Los Angeles, California, United States
Daily Peak Pruritus Numerical Rating Scale (NRS)
Percent change of 7-day average daily peak pruritus NRS from Baseline to Week 4
Time frame: Baseline to Week 4
Pruritus Response of ASN008 Topical Gel on Atopic Dermatitis (AD) Assessed by Daily Peak Pruritus NRS
Pruritus response defined as 7-day average of daily peak pruritus NRS reduction greater than or equal to 4 points from Baseline to Week 4
Time frame: Baseline to Week 4
Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score
This outcome measure evaluates the change and percent change in the Eczema Area and Severity Index (EASI) score from Baseline to Week 4. The EASI score measures the extent and severity of eczema across four body regions: head/neck, trunk, upper limbs, and lower limbs. Two components are assessed: severity of erythema, edema/papulation, excoriation, and lichenification (each scored 0 to 3, with 0 = none and 3 = severe) and the surface area affected (scored 0 to 6, with 0 = no involvement and 6 = 90%-100% involvement). Subscale scores are combined using weighted multipliers for each region (head/neck 0.1, upper limbs 0.2, trunk 0.3, lower limbs 0.4) to calculate the total score. The EASI is a composite score ranging from 0 (no eczema) to 72 (maximum severity and extent). Scores are summed to account for the severity of lesions and the percentage of body surface area (BSA) affected in each region.
Time frame: Baseline to Week 4
Mean Change From Baseline in Total Body Surface Area (BSA)
Change from Baseline in total BSA at week 4.
Time frame: Baseline to Week 4
Mean Change From Baseline in the Patient-Oriented Eczema Measure (POEM)
This outcome measure evaluates the change in the the Patient-Oriented Eczema Measure (POEM) score from Baseline to Week 4.The POEM is a self-assessment tool that evaluates eczema severity based on patient-reported symptoms over the previous week. It includes 7 questions addressing common symptoms: itch, sleep disturbance, bleeding, weeping, cracking, flaking, and dryness. Each question is scored on a scale from 0 to 4 based on frequency (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = every day). The scores are summed to generate a total score ranging from 0 to 28. Scores are interpreted as follows: 0-2 = clear or almost clear, 3-7 = mild eczema, 8-16 = moderate eczema, 17-24 = severe eczema, and 25-28 = very severe eczema. Higher scores indicate a greater symptom burden and worse disease severity.
Time frame: Baseline to Week 4
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TrialSpark Investigative Site 0103
Miami Lakes, Florida, United States
TrialSpark Investigative Site 0129
Miramar, Florida, United States
TrialSpark Investigative Site 0131
Clarksville, Indiana, United States
TrialSpark Investigative Site 0109
Indianapolis, Indiana, United States
TrialSpark Investigative Site 0112
Louisville, Kentucky, United States
...and 17 more locations