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

Dermatitis, Atopic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05870865
• Other study ID #: ASN008-201
• Status: Completed
• Phase: Phase 2
• Start date: May 3, 2023
• Est. completion date: December 28, 2023

Study information

• Verified date: March 2024
• Source: TrialSpark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: December 28, 2023
• Est. primary completion date: November 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Pruritus

Intervention

Drug:
• ASN008
ASN008 topical gel applied twice daily.

Other:
• ASN008 Matching Vehicle
The ASN008 matching vehicle formulation matches the formulation of each ASN008 topical gel dose, but contains no ASN008.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
TrialSpark

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Number of Treatment Emergent Adverse Events (TEAEs)		Baseline to Day 56
Other	Number of Investigational Product (IP)-related TEAEs		Baseline to Day 56
Other	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
Primary	Daily Peak Pruritus NRS	Percent change of 7-day average daily peak pruritus NRS from Baseline to Week 4	Baseline to Week 4
Secondary	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
Secondary	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
Secondary	Mean change from Baseline in total body surface area (BSA)	Change from Baseline in total BSA at week 4.	Baseline to Week 4
Secondary	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