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

Sponsor

TrialSpark (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05870865

Collaborator

(none)

120

Enrollment

Locations

Arms

Anticipated Duration (Months)

6.7

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dermatitis, Atopic Pruritus	Drug: ASN008 Other: ASN008 Matching Vehicle	Phase 2

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 12) or ET visit. The trial will be considered complete when the last participant has completed their last trial visit.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 3, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Daily Peak Pruritus NRS [Baseline to Week 4]
Percent change of 7-day average daily peak pruritus NRS from Baseline to Week 4

Secondary Outcome Measures

Pruritus response of ASN008 topical gel on 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]
Change and percent change from Baseline in the EASI score at Week 4.
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]
Change from Baseline in the Patient-Oriented Eczema Measure (POEM) at Week 4

Other Outcome Measures

Inter- and Intra-subject variability of ASN008 Pharmacokinetics characterized by Peak Plasma Concentration (Cmax) [Baseline and Week 4]
ASN008 PK will be characterized using population-based methods to include Peak Plasma Concentration (Cmax).
Inter- and Intra-subject variability of ASN008 Pharmacokinetics characterized by area under the plasma concentration versus time curve (AUC) [Baseline and Week 4]
ASN008 PK will be characterized using population-based methods to include area under the plasma concentration versus time curve (AUC
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 [Baseline to Day 56]
Incidence of TEAEs leading to treatment discontinuation from first dose through completion of follow-up period (up to a maximum of 56 days)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
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.
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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TrialSpark Investigative Site 0106	Scottsdale	Arizona	United States	85255
2	TrialSpark Investigative Site 0118	Hot Springs	Arkansas	United States	71913
3	TrialSpark Investigative Site 0123	Beverly Hills	California	United States	90212
4	TrialSpark Investigative Site 0113	Fremont	California	United States	94538
5	TrialSpark Investigative Site 0101	Los Angeles	California	United States	90057
6	TrialSpark Investigative Site 0111	San Francisco	California	United States	94132
7	TrialSpark Investigative Site 0103	Miami Lakes	Florida	United States	33014
8	TrialSpark Investigative Site 0109	Indianapolis	Indiana	United States	46250
9	TrialSpark Investigative Site 0112	Louisville	Kentucky	United States	40241
10	TrialSpark Investigative Site 0108	Baton Rouge	Louisiana	United States	70808
11	TrialSpark Investigative Site 0107	Auburn Hills	Michigan	United States	48326
12	TrialSpark Investigative Site 0102	Saint Joseph	Missouri	United States	54506
13	TrialSpark Investigative Site 0115	Kew Gardens	New York	United States	11415
14	TrialSpark Investigative Site 0119	New York	New York	United States	10075
15	TrialSpark Investigative Site 0105	Wilmington	North Carolina	United States	28405
16	TrialSpark Investigative Site 0121	Houston	Texas	United States	77056
17	TrialSpark Investigative Site 0114	San Antonio	Texas	United States	78213
18	TrialSpark Investigative Site 0110	Springville	Utah	United States	84663