Clinical trial NCT05870865: A Study to Evaluate the Anti-pruritic Effectiveness of ASN008 in Adults With Mild to Moderate Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dermatitis, Atopic
Pruritus
Keywords: Dermatitis, Atopic
Pruritus
Eczema
Itch
Lead sponsor: TrialSpark
Sponsor class: INDUSTRY
First posted: 2023-05-23
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Daily Peak Pruritus Numerical Rating Scale (NRS)
timeFrame: Baseline to Week 4
Secondary outcomes:
measure: Pruritus Response of ASN008 Topical Gel on Atopic Dermatitis (AD) Assessed by Daily Peak Pruritus NRS
timeFrame: Baseline to Week 4
measure: Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score
timeFrame: Baseline to Week 4
measure: Mean Change From Baseline in Total Body Surface Area (BSA)
timeFrame: Baseline to Week 4
measure: Mean Change From Baseline in the Patient-Oriented Eczema Measure (POEM)
timeFrame: Baseline to Week 4
Other outcomes:
measure: Inter- and Intra-subject Variability of ASN008 Pharmacokinetics (PK) Characterized by Peak Plasma Concentration (Cmax)
timeFrame: Baseline and Week 4
measure: Inter- and Intra-subject Variability of ASN008 Pharmacokinetics Characterized by Area Under the Plasma Concentration Versus Time Curve (AUC)
timeFrame: Baseline and Week 4
measure: Number of Treatment Emergent Adverse Events (TEAEs)
timeFrame: Baseline to Day 56
measure: Number of Investigational Product (IP)-Related TEAEs
timeFrame: Baseline to Day 56
measure: Incidence of TEAEs Leading to Treatment Discontinuation
timeFrame: Baseline to Day 56
Locations:
city: Scottsdale
country: United States
facility: TrialSpark Investigative Site 0106
state: Arizona
city: Hot Springs
country: United States
facility: TrialSpark Investigative Site 0118
state: Arkansas
city: Beverly Hills
country: United States
facility: TrialSpark Investigative Site 0123
state: California
city: Fremont
country: United States
facility: TrialSpark Investigative Site 0113
state: California
city: Los Angeles
country: United States
facility: TrialSpark Investigative Site 0101
state: California
city: Miami Lakes
country: United States
facility: TrialSpark Investigative Site 0103
state: Florida
city: Miramar
country: United States
facility: TrialSpark Investigative Site 0129
state: Florida
city: Clarksville
country: United States
facility: TrialSpark Investigative Site 0131
state: Indiana
city: Indianapolis
country: United States
facility: TrialSpark Investigative Site 0109
state: Indiana
city: Louisville
country: United States
facility: TrialSpark Investigative Site 0112
state: Kentucky
city: Baton Rouge
country: United States
facility: TrialSpark Investigative Site 0108
state: Louisiana
city: Monroe
country: United States
facility: TrialSpark Investigative Site 0124
state: Louisiana
city: Auburn Hills
country: United States
facility: TrialSpark Investigative Site 0107
state: Michigan
city: Saint Joseph
country: United States
facility: TrialSpark Investigative Site 0102
state: Missouri
city: Kew Gardens
country: United States
facility: TrialSpark Investigative Site 0115
state: New York
city: New York
country: United States
facility: TrialSpark Investigative Site 0119
state: New York
city: Wilmington
country: United States
facility: TrialSpark Investigative Site 0105
state: North Carolina
city: Mason
country: United States
facility: TrialSpark Investigative Site 0125
state: Ohio
city: Oklahoma City
country: United States
facility: TrialSpark Investigative Site 0127
state: Oklahoma
city: Philadelphia
country: United States
facility: TrialSpark Investigative Site 0122
state: Pennsylvania
city: Houston
country: United States
facility: TrialSpark Investigative Site 0121
state: Texas
city: Pflugerville
country: United States
facility: TrialSpark Investigative Site 0130
state: Texas
city: San Antonio
country: United States
facility: TrialSpark Investigative Site 0114
state: Texas
city: San Antonio
country: United States
facility: TrialSpark Investigative Site 0126
state: Texas
city: Springville
country: United States
facility: TrialSpark Investigative Site 0110
state: Utah
city: Richmond
country: United States
facility: TrialSpark Investigative Site 0117
state: Virginia
city: Spokane
country: United States
facility: TrialSpark Investigative Site 0128
state: Washington
Study officials:
References: