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

NCT ID: NCT05870865

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-03
• Study Completion Date: 2023-12-28

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.

Conditions

Dermatitis, Atopic; Pruritus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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)

Group Type: EXPERIMENTAL

ASN008

Intervention Type: DRUG

ASN008 topical gel applied twice daily.

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)

Group Type: EXPERIMENTAL

ASN008

Intervention Type: DRUG

ASN008 topical gel applied twice daily.

ASN008 5%

ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)

Group Type: EXPERIMENTAL

ASN008

Intervention Type: DRUG

ASN008 topical gel applied twice daily.

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)

Group Type: PLACEBO_COMPARATOR

ASN008 Matching Vehicle

Intervention Type: OTHER

The ASN008 matching vehicle formulation matches the formulation of each ASN008 topical gel dose, but contains no ASN008.

Interventions

ASN008

ASN008 topical gel applied twice daily.

Intervention Type: DRUG

ASN008 Matching Vehicle

The ASN008 matching vehicle formulation matches the formulation of each ASN008 topical gel dose, but contains no ASN008.

Intervention Type: OTHER

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:

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Formation Bio

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

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

TrialSpark Investigative Site 0108

Baton Rouge, Louisiana, United States

TrialSpark Investigative Site 0124

Monroe, Louisiana, United States

TrialSpark Investigative Site 0107

Auburn Hills, Michigan, United States

TrialSpark Investigative Site 0102

Saint Joseph, Missouri, United States

TrialSpark Investigative Site 0115

Kew Gardens, New York, United States

TrialSpark Investigative Site 0119

New York, New York, United States

TrialSpark Investigative Site 0105

Wilmington, North Carolina, United States

TrialSpark Investigative Site 0125

Mason, Ohio, United States

TrialSpark Investigative Site 0127

Oklahoma City, Oklahoma, United States

TrialSpark Investigative Site 0122

Philadelphia, Pennsylvania, United States

TrialSpark Investigative Site 0121

Houston, Texas, United States

TrialSpark Investigative Site 0130

Pflugerville, Texas, United States

TrialSpark Investigative Site 0114

San Antonio, Texas, United States

TrialSpark Investigative Site 0126

San Antonio, Texas, United States

TrialSpark Investigative Site 0110

Springville, Utah, United States

TrialSpark Investigative Site 0117

Richmond, Virginia, United States

TrialSpark Investigative Site 0128

Spokane, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ASN008-201

Identifier Type: -

Identifier Source: org_study_id