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

NCT05870865 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ASN008-201
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 27

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.

Conditions

Dermatitis, Atopic; Pruritus

Keywords

Dermatitis, Atopic; Pruritus; Eczema; Itch

Outcome Measures

Primary Outcomes (1)

• Daily Peak Pruritus Numerical Rating Scale (NRS)

  Percent change of 7-day average daily peak pruritus NRS from Baseline to Week 4

  Baseline to Week 4

Secondary Outcomes (4)

• Pruritus Response of ASN008 Topical Gel on Atopic Dermatitis (AD) Assessed by Daily Peak Pruritus NRS

  Baseline to Week 4

• Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score

  Baseline to Week 4

• Mean Change From Baseline in Total Body Surface Area (BSA)

  Baseline to Week 4

• Mean Change From Baseline in the Patient-Oriented Eczema Measure (POEM)

  Baseline to Week 4

Other Outcomes (5)

• Inter- and Intra-subject Variability of ASN008 Pharmacokinetics (PK) Characterized by Peak Plasma Concentration (Cmax)

  Baseline and Week 4

• Inter- and Intra-subject Variability of ASN008 Pharmacokinetics Characterized by Area Under the Plasma Concentration Versus Time Curve (AUC)

  Baseline and Week 4

• Number of Treatment Emergent Adverse Events (TEAEs)

  Baseline to Day 56

Study Arms (4)

ASN008 1.25%

EXPERIMENTAL

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 2.5%

EXPERIMENTAL

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 5%

EXPERIMENTAL

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

Drug: ASN008

ASN008 Matching Vehicle

PLACEBO COMPARATOR

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

Interventions

ASN008 DRUG

ASN008 topical gel applied twice daily.

ASN008 1.25%; ASN008 2.5%; ASN008 5%

ASN008 Matching Vehicle OTHER

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

ASN008 Matching Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Formation Bio, Inc.: lead

Study Sites (27)

TrialSpark Investigative Site 0106

Scottsdale, Arizona, 85255, United States

Location

TrialSpark Investigative Site 0118

Hot Springs, Arkansas, 71913, United States

Location

TrialSpark Investigative Site 0123

Beverly Hills, California, 90212, United States

Location

TrialSpark Investigative Site 0113

Fremont, California, 94538, United States

Location

TrialSpark Investigative Site 0101

Los Angeles, California, 90057, United States

Location

TrialSpark Investigative Site 0103

Miami Lakes, Florida, 33014, United States

Location

TrialSpark Investigative Site 0129

Miramar, Florida, 33027, United States

Location

TrialSpark Investigative Site 0131

Clarksville, Indiana, 47129, United States

Location

TrialSpark Investigative Site 0109

Indianapolis, Indiana, 46250, United States

Location

TrialSpark Investigative Site 0112

Louisville, Kentucky, 40241, United States

Location

TrialSpark Investigative Site 0108

Baton Rouge, Louisiana, 70808, United States

Location

TrialSpark Investigative Site 0124

Monroe, Louisiana, 71201, United States

Location

TrialSpark Investigative Site 0107

Auburn Hills, Michigan, 48326, United States

Location

TrialSpark Investigative Site 0102

Saint Joseph, Missouri, 54506, United States

Location

TrialSpark Investigative Site 0115

Kew Gardens, New York, 11415, United States

Location

TrialSpark Investigative Site 0119

New York, New York, 10075, United States

Location

TrialSpark Investigative Site 0105

Wilmington, North Carolina, 28405, United States

Location

TrialSpark Investigative Site 0125

Mason, Ohio, 45040, United States

Location

TrialSpark Investigative Site 0127

Oklahoma City, Oklahoma, 73170, United States

Location

TrialSpark Investigative Site 0122

Philadelphia, Pennsylvania, 19103, United States

Location

TrialSpark Investigative Site 0121

Houston, Texas, 77056, United States

Location

TrialSpark Investigative Site 0130

Pflugerville, Texas, 78660, United States

Location

TrialSpark Investigative Site 0114

San Antonio, Texas, 78213, United States

Location

TrialSpark Investigative Site 0126

San Antonio, Texas, 78229, United States

Location

TrialSpark Investigative Site 0110

Springville, Utah, 84663, United States

Location

TrialSpark Investigative Site 0117

Richmond, Virginia, 23226, United States

Location

TrialSpark Investigative Site 0128

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Pruritus; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This trial included an exploratory evaluation of ASN008 pharmacokinetics (PK) as a secondary endpoint using population-based methods. During the analysis, quantifiable levels of ASN008 were unexpectedly observed in vehicle and pre-dose plasma samples. Follow-up investigation indicated this may have been related to assay limitations, which would confound the population PK analysis. Therefore, the analysis was not pursued.

Results Point of Contact

• Title: TrialSpark
• Organization: TrialSpark

soothe.info@trialspark.com

Please Email

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: At all times, treatment and randomization information will be kept confidential and will not be released to the Sponsor's trial team until database lock is completed. Investigators, participants, and clinical staff will remain blinded throughout the trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible participants will be randomized to 1 of 4 cohorts: ASN008 gel 1.25 percent, 2.5 percent, 5 percent, or matching vehicle.

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: May 23, 2023
• Study Start: May 3, 2023
• Primary Completion: November 27, 2023
• Study Completion: December 28, 2023
• Last Updated: May 16, 2025
• Results First Posted: December 27, 2024

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (27)