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

A Randomized, Double-Blind, Vehicle-Controlled, Phase 2 Trial to Evaluate the Anti-pruritic Efficacy, Safety, Tolerability, and Pharmacokinetics of ASN008 in Adults With Mild to Moderate Atopic Dermatitis

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.

Study Overview

• Status: Completed
• Conditions: Dermatitis, Atopic; Pruritus
• Intervention / Treatment: Drug: ASN008; Other: ASN008 Matching Vehicle

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.

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: TrialSpark; Phone Number: 855-271-2676; Email: soothe.eczema@trialspark.com

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • TrialSpark Investigative Site 0106
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • TrialSpark Investigative Site 0118
  • California
    • Beverly Hills, California, United States, 90212
      • TrialSpark Investigative Site 0123
    • Fremont, California, United States, 94538
      • TrialSpark Investigative Site 0113
    • Los Angeles, California, United States, 90057
      • TrialSpark Investigative Site 0101
  • Florida
    • Miami Lakes, Florida, United States, 33014
      • TrialSpark Investigative Site 0103
    • Miramar, Florida, United States, 33027
      • TrialSpark Investigative Site 0129
  • Indiana
    • Clarksville, Indiana, United States, 47129
      • TrialSpark Investigative Site 0131
    • Indianapolis, Indiana, United States, 46250
      • TrialSpark Investigative Site 0109
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • TrialSpark Investigative Site 0112
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • TrialSpark Investigative Site 0108
    • Monroe, Louisiana, United States, 71201
      • TrialSpark Investigative Site 0124
  • Michigan
    • Auburn Hills, Michigan, United States, 48326
      • TrialSpark Investigative Site 0107
  • Missouri
    • Saint Joseph, Missouri, United States, 54506
      • TrialSpark Investigative Site 0102
  • New York
    • Kew Gardens, New York, United States, 11415
      • TrialSpark Investigative Site 0115
    • New York, New York, United States, 10075
      • TrialSpark Investigative Site 0119
  • North Carolina
    • Wilmington, North Carolina, United States, 28405
      • TrialSpark Investigative Site 0105
  • Ohio
    • Mason, Ohio, United States, 45040
      • TrialSpark Investigative Site 0125
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73170
      • TrialSpark Investigative Site 0127
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • TrialSpark Investigative Site 0122
  • Texas
    • Houston, Texas, United States, 77056
      • TrialSpark Investigative Site 0121
    • Pflugerville, Texas, United States, 78660
      • TrialSpark Investigative Site 0130
    • San Antonio, Texas, United States, 78213
      • TrialSpark Investigative Site 0114
    • San Antonio, Texas, United States, 78229
      • TrialSpark Investigative Site 0126
  • Utah
    • Springville, Utah, United States, 84663
      • TrialSpark Investigative Site 0110
  • Virginia
    • Richmond, Virginia, United States, 23226
      • TrialSpark Investigative Site 0117
  • Washington
    • Spokane, Washington, United States, 99202
      • TrialSpark Investigative Site 0128

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASN008 1.25%; ASN008 1.25% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days)	Drug: ASN008; ASN008 topical gel applied twice daily.
Experimental: ASN008 2.5%; ASN008 2.5% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days)	Drug: ASN008; ASN008 topical gel applied twice daily.
Experimental: ASN008 5%; ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days)	Drug: ASN008; ASN008 topical gel applied twice daily.
Placebo Comparator: 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)	Other: ASN008 Matching Vehicle; The ASN008 matching vehicle formulation matches the formulation of each ASN008 topical gel dose, but contains no ASN008.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily Peak Pruritus NRS	Percent change of 7-day average daily peak pruritus NRS from Baseline to Week 4	Baseline to Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pruritus response of ASN008 topical gel on 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	Baseline to Week 4
Mean change from Baseline in Eczema Area and Severity Index (EASI) score	Change and percent change from Baseline in the EASI score at Week 4.	Baseline to Week 4
Mean change from Baseline in total body surface area (BSA)	Change from Baseline in total BSA at week 4.	Baseline to Week 4
Mean change from Baseline in the Patient-Oriented Eczema Measure (POEM)	Change from Baseline in the Patient-Oriented Eczema Measure (POEM) at Week 4	Baseline to Week 4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter- and Intra-subject variability of ASN008 Pharmacokinetics characterized by Peak Plasma Concentration (Cmax)	ASN008 PK will be characterized using population-based methods to include Peak Plasma Concentration (Cmax).	Baseline and Week 4
Number of Treatment Emergent Adverse Events (TEAEs)		Baseline to Day 56
Number of Investigational Product (IP)-related TEAEs		Baseline to Day 56
Incidence of TEAEs leading to treatment discontinuation	Incidence of TEAEs leading to treatment discontinuation from first dose through completion of follow-up period (up to a maximum of 56 days)	Baseline to Day 56
Inter- and Intra-subject variability of ASN008 Pharmacokinetics characterized by area under the plasma concentration versus time curve (AUC)	ASN008 PK will be characterized using population-based methods to include area under the plasma concentration versus time curve (AUC)	Baseline and Week 4

Collaborators and Investigators

• Sponsor: TrialSpark

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2023
• Primary Completion (Actual): November 27, 2023
• Study Completion (Actual): December 28, 2023

Study Registration Dates

• First Submitted: March 30, 2023
• First Submitted That Met QC Criteria: May 12, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Itch; Pruritus; Eczema; Dermatitis, Atopic
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Manifestations; Skin Diseases, Eczematous; Dermatitis; Pruritus; Dermatitis, Atopic
• Other Study ID Numbers: ASN008-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No