A Study to Evaluate the Anti-pruritic Effectiveness of ASN008 in Adults With Mild to Moderate Atopic Dermatitis

Phase 2

Completed

Conditions: Dermatitis, Atopic
Pruritus

Interventions: Other: ASN008 Matching Vehicle
Drug: ASN008

Registration Number: NCT05870865

Lead Sponsor: TrialSpark

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 144

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:
1. Doxepin, hydroxyzine, or diphenhydramine use within 1 week prior to Day 1.
2. Use of topical product containing urea or any antihistamine within 1 week prior to Day 1.
3. Use of systemic antibiotic within 2 weeks, or topical antibiotics within 1 week, prior to Day 1.
4. 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.
5. Psoralen-UV-A or UV-B phototherapy (including tanning beds) or excimer laser within 4 weeks prior to Day
6. 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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASN008 Matching Vehicle	ASN008 Matching Vehicle	ASN008 matching vehicle twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008 1.25%	ASN008	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%	ASN008	ASN008 2.5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008 5%	ASN008	ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)

Primary Outcome Measures

Name	Time	Method
Daily Peak Pruritus Numerical Rating Scale (NRS)	Baseline to Week 4	Percent change of 7-day average daily peak pruritus NRS from Baseline to Week 4

Secondary Outcome Measures

Name	Time	Method
Pruritus Response of ASN008 Topical Gel on Atopic Dermatitis (AD) Assessed by Daily Peak Pruritus NRS	Baseline to Week 4	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
Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score	Baseline to Week 4	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.
Mean Change From Baseline in Total Body Surface Area (BSA)	Baseline to Week 4	Change from Baseline in total BSA at week 4.
Mean Change From Baseline in the Patient-Oriented Eczema Measure (POEM)	Baseline to Week 4	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.

Trial Locations

Locations (27): TrialSpark Investigative Site 0101
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Los Angeles, California, United States
TrialSpark Investigative Site 0123
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Beverly Hills, California, United States
TrialSpark Investigative Site 0113
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Fremont, California, United States
TrialSpark Investigative Site 0103
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Miami Lakes, Florida, United States
TrialSpark Investigative Site 0129
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Miramar, Florida, United States
TrialSpark Investigative Site 0131
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Clarksville, Indiana, United States
TrialSpark Investigative Site 0109
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Indianapolis, Indiana, United States
TrialSpark Investigative Site 0112
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Louisville, Kentucky, United States
TrialSpark Investigative Site 0124
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Monroe, Louisiana, United States
TrialSpark Investigative Site 0107
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Auburn Hills, Michigan, United States
TrialSpark Investigative Site 0102
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Saint Joseph, Missouri, United States
TrialSpark Investigative Site 0119
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New York, New York, United States
TrialSpark Investigative Site 0105
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Wilmington, North Carolina, United States
TrialSpark Investigative Site 0125
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Mason, Ohio, United States
TrialSpark Investigative Site 0127
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Oklahoma City, Oklahoma, United States
TrialSpark Investigative Site 0130
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Pflugerville, Texas, United States
TrialSpark Investigative Site 0122
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Philadelphia, Pennsylvania, United States
TrialSpark Investigative Site 0121
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Houston, Texas, United States
TrialSpark Investigative Site 0110
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Springville, Utah, United States
TrialSpark Investigative Site 0114
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San Antonio, Texas, United States
TrialSpark Investigative Site 0117
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Richmond, Virginia, United States
TrialSpark Investigative Site 0126
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San Antonio, Texas, United States
TrialSpark Investigative Site 0128
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Spokane, Washington, United States
TrialSpark Investigative Site 0108
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Baton Rouge, Louisiana, United States
TrialSpark Investigative Site 0106
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Scottsdale, Arizona, United States
TrialSpark Investigative Site 0118
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Hot Springs, Arkansas, United States
TrialSpark Investigative Site 0115
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Kew Gardens, New York, United States