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

Primary Purpose

Dermatitis, Atopic, Pruritus

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ASN008
ASN008 Matching Vehicle
Sponsored by
TrialSpark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Dermatitis, Atopic, Pruritus, Eczema, Itch

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 (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: 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.

Sites / Locations

  • TrialSpark Investigative Site 0106
  • TrialSpark Investigative Site 0118
  • TrialSpark Investigative Site 0123
  • TrialSpark Investigative Site 0113
  • TrialSpark Investigative Site 0101
  • TrialSpark Investigative Site 0103
  • TrialSpark Investigative Site 0129
  • TrialSpark Investigative Site 0131
  • TrialSpark Investigative Site 0109
  • TrialSpark Investigative Site 0112
  • TrialSpark Investigative Site 0108
  • TrialSpark Investigative Site 0124
  • TrialSpark Investigative Site 0107
  • TrialSpark Investigative Site 0102
  • TrialSpark Investigative Site 0115
  • TrialSpark Investigative Site 0119
  • TrialSpark Investigative Site 0105
  • TrialSpark Investigative Site 0125
  • TrialSpark Investigative Site 0127
  • TrialSpark Investigative Site 0122
  • TrialSpark Investigative Site 0121
  • TrialSpark Investigative Site 0130
  • TrialSpark Investigative Site 0114
  • TrialSpark Investigative Site 0126
  • TrialSpark Investigative Site 0110
  • TrialSpark Investigative Site 0117
  • TrialSpark Investigative Site 0128

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

ASN008 1.25%

ASN008 2.5%

ASN008 5%

ASN008 Matching Vehicle

Arm Description

ASN008 1.25% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days)

ASN008 2.5% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days)

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

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

Outcomes

Primary Outcome Measures

Daily Peak Pruritus NRS
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
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
Change and percent change from Baseline in the EASI score at Week 4.
Mean change from Baseline in total body surface area (BSA)
Change from Baseline in total BSA at week 4.
Mean change from Baseline in the Patient-Oriented Eczema Measure (POEM)
Change from Baseline in the Patient-Oriented Eczema Measure (POEM) at Week 4

Full Information

First Posted
March 30, 2023
Last Updated
October 13, 2023
Sponsor
TrialSpark
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1. Study Identification

Unique Protocol Identification Number
NCT05870865
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 3, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TrialSpark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic, Pruritus
Keywords
Dermatitis, Atopic, Pruritus, Eczema, Itch

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASN008 1.25%
Arm Type
Experimental
Arm Description
ASN008 1.25% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days)
Arm Title
ASN008 2.5%
Arm Type
Experimental
Arm Description
ASN008 2.5% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days)
Arm Title
ASN008 5%
Arm Type
Experimental
Arm Description
ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days)
Arm Title
ASN008 Matching Vehicle
Arm Type
Placebo Comparator
Arm Description
ASN008 matching vehicle twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days)
Intervention Type
Drug
Intervention Name(s)
ASN008
Intervention Description
ASN008 topical gel applied twice daily.
Intervention Type
Other
Intervention Name(s)
ASN008 Matching Vehicle
Intervention Description
The ASN008 matching vehicle formulation matches the formulation of each ASN008 topical gel dose, but contains no ASN008.
Primary Outcome Measure Information:
Title
Daily Peak Pruritus NRS
Description
Percent change of 7-day average daily peak pruritus NRS from Baseline to Week 4
Time Frame
Baseline to Week 4
Secondary Outcome Measure Information:
Title
Pruritus response of ASN008 topical gel on AD assessed by Daily Peak Pruritus NRS
Description
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
Time Frame
Baseline to Week 4
Title
Mean change from Baseline in Eczema Area and Severity Index (EASI) score
Description
Change and percent change from Baseline in the EASI score at Week 4.
Time Frame
Baseline to Week 4
Title
Mean change from Baseline in total body surface area (BSA)
Description
Change from Baseline in total BSA at week 4.
Time Frame
Baseline to Week 4
Title
Mean change from Baseline in the Patient-Oriented Eczema Measure (POEM)
Description
Change from Baseline in the Patient-Oriented Eczema Measure (POEM) at Week 4
Time Frame
Baseline to Week 4
Other Pre-specified Outcome Measures:
Title
Inter- and Intra-subject variability of ASN008 Pharmacokinetics characterized by Peak Plasma Concentration (Cmax)
Description
ASN008 PK will be characterized using population-based methods to include Peak Plasma Concentration (Cmax).
Time Frame
Baseline and Week 4
Title
Inter- and Intra-subject variability of ASN008 Pharmacokinetics characterized by area under the plasma concentration versus time curve (AUC)
Description
ASN008 PK will be characterized using population-based methods to include area under the plasma concentration versus time curve (AUC)
Time Frame
Baseline and Week 4
Title
Number of Treatment Emergent Adverse Events (TEAEs)
Time Frame
Baseline to Day 56
Title
Number of Investigational Product (IP)-related TEAEs
Time Frame
Baseline to Day 56
Title
Incidence of TEAEs leading to treatment discontinuation
Description
Incidence of TEAEs leading to treatment discontinuation from first dose through completion of follow-up period (up to a maximum of 56 days)
Time Frame
Baseline to Day 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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.
Facility Information:
Facility Name
TrialSpark Investigative Site 0106
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
Facility Name
TrialSpark Investigative Site 0118
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
TrialSpark Investigative Site 0123
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
Facility Name
TrialSpark Investigative Site 0113
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
TrialSpark Investigative Site 0101
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
TrialSpark Investigative Site 0103
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
TrialSpark Investigative Site 0129
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
TrialSpark Investigative Site 0131
City
Clarksville
State/Province
Indiana
ZIP/Postal Code
47129
Country
United States
Facility Name
TrialSpark Investigative Site 0109
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
TrialSpark Investigative Site 0112
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
TrialSpark Investigative Site 0108
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
TrialSpark Investigative Site 0124
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
TrialSpark Investigative Site 0107
City
Auburn Hills
State/Province
Michigan
ZIP/Postal Code
48326
Country
United States
Facility Name
TrialSpark Investigative Site 0102
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
54506
Country
United States
Facility Name
TrialSpark Investigative Site 0115
City
Kew Gardens
State/Province
New York
ZIP/Postal Code
11415
Country
United States
Facility Name
TrialSpark Investigative Site 0119
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
TrialSpark Investigative Site 0105
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28405
Country
United States
Facility Name
TrialSpark Investigative Site 0125
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
TrialSpark Investigative Site 0127
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73170
Country
United States
Facility Name
TrialSpark Investigative Site 0122
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
TrialSpark Investigative Site 0121
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
TrialSpark Investigative Site 0130
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
TrialSpark Investigative Site 0114
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
TrialSpark Investigative Site 0126
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
TrialSpark Investigative Site 0110
City
Springville
State/Province
Utah
ZIP/Postal Code
84663
Country
United States
Facility Name
TrialSpark Investigative Site 0117
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
TrialSpark Investigative Site 0128
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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