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Maximal Use Study of Tapinarof Cream, 1% in Pediatric Subjects With Extensive Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tapinarof cream, 1%
Sponsored by
Dermavant Sciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring eczema, pediatric, tapinarof, phase 2, topical

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female subjects age 2 to 17 with a confirmed clinical diagnosis of atopic dermatitis and present for at least 6 months for ages 6-17 years old, 3 months for ages 2-5 years old
  • BSA involvement ≥ 25% for subjects ages 12-17 years old, or ≥ 35% for subjects ages 2-11 years old, suitable for topical therapy.
  • vIGA-AD score of ≥ 3 at screening and baseline (pre-dose)
  • Female subjects of child bearing potential who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study
  • Capable of giving written informed consent
  • Negative pregnancy test at Baseline (Day 1)

Exclusion Criteria:

  • Immunocompromised at screening
  • Chronic or acute systemic or superficial infection requiring treatment with systemic antibacterials or antifungals within one week prior to baseline visit
  • Significant dermatological or inflammatory condition other than AD that, in the Investigator's opinion, would make it difficult to interpret data or assessments during the study
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0x the upper limit of normal (ULN).
  • Screening total bilirubin > 1.5x ULN
  • Current or chronic history of liver disease
  • Current or history of cancer within 5 years except for adequately treated cutaneous basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
  • Subjects who would not be considered suitable for topical therapy
  • Use of any prohibited medication or procedure within the indicated period before the baseline visit including other investigational product within 30 days or 5 half-lives of the investigational product (whichever is longer)
  • History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion, may interfere with the subject's participation in the study, interpretation of results, or ability to understand and give informed consent.
  • Pregnant or lactating females
  • History of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the -Investigator or Medical Monitor, contraindicates their participation
  • Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001)

Sites / Locations

  • Dermavant Investigative Site
  • Dermavant Investigative Site
  • Dermavant Investigative Site
  • Dermavant Investigative Site
  • Dermavant Investigative Site
  • Dermavant Investigative Site
  • Dermavant Investigative Site
  • Dermavant Investigative Site
  • Dermavant Investigative Site
  • Dermavant Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tapinarof cream

Arm Description

Tapinarof (DMVT-505) cream, 1% applied topically once daily

Outcomes

Primary Outcome Measures

Number of Participants that Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs)
Frequency, Severity, and Duration AEs (local and systemic)
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Values and Vital Signs
Change in laboratory values and vial signs were assessed for clinical relevance
Number of participants with irritation as assessed by the Local Tolerability Scale (LTS)
Local Tolerability Scale (LTS) is a clinical tool for assessing the presence and overall degree of irritation at the application sites, according to a 5-point scale. 0 indicates no irritation and 4 indicates Very Severe irritation.
Tapinarof and Tapinarof Sulfate (Metabolite) Plasma PK Parameters on Day 1: AUC0-τ
The AUC in plasma is a pharmacokinetic parameter that describes the overall exposure of the drug.
Tapinarof and Tapinarof Sulfate (Metabolite) Plasma PK Parameters on Day 1: Cmax
The Cmax is a pharmacokinetic parameter that describes the highest concentration of the drug that is achieved after dosing.
Tapinarof and Tapinarof Sulfate (Metabolite) Plasma PK Parameters on Day 1: tmax
The tmax is a pharmacokinetic parameter that describes the time point at which the highest concentration of the drug is achieved after dosing.
Tapinarof and Tapinarof Sulfate (Metabolite) Plasma concentration on Day 28: Cτ
The Cτ is a pharmacokinetic parameter that describes the time of last quantifiable concentration that is achieved after the last dose.

Secondary Outcome Measures

Change from Baseline in Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD)
The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. Score of 0 indicates no inflammatory signs of atopic dermatitis and a 4 indicates disease is widespread in extent.
Number of subjects who have a Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD) score of almost clear (0 or 1) from baseline to Day 28
The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. Score of 0 indicates no inflammatory signs of atopic dermatitis and a 4 indicates disease is widespread in extent.
Number of subjects with ≥50%, improvement in Eczema Area and Severity Index (EASI) score from Baseline to each visit
The EASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.
Number of subjects with ≥75%, improvement in Eczema Area and Severity Index (EASI) score from Baseline to each visit
The EASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.
Number of subjects with ≥90%, improvement in Eczema Area and Severity Index (EASI) score from Baseline to each visit
The EASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.
Mean change in Eczema Area and Severity Index EASI from baseline to Day 28
The EASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.
Mean change in Percent of Total Body Surface Area (%BSA) affected from Baseline to Day 28
The assessment of %BSA affected is an estimate of the percentage of total involved skin with psoriasis. For the purpose of clinical estimation, the total palmar surface of the subject's palm and digits may be assumed to be approximately equivalent to 1% BSA. The %BSA affected by psoriasis will be evaluated (from 0% to 100%). %BSA is a static assessment made without reference to previous scores.
Mean change in Total Body Surface Area (BSA) x Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD) values form Baseline to Day 28
The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. Score of 0 indicates no inflammatory signs of atopic dermatitis and a 4 indicates disease is widespread in extent. The assessment of %BSA affected is an estimate of the percentage of total involved skin with psoriasis. For the purpose of clinical estimation, the total palmar surface of the subject's palm and digits may be assumed to be approximately equivalent to 1% BSA. The %BSA affected by psoriasis will be evaluated (from 0% to 100%). %BSA is a static assessment made without reference to previous scores.
Mean change in average weekly Peak Pruritus Numerical Rating Scale (PP-NRS) score by age group from Baseline to Day 28
The PP-NRS is a scale from 0-10 used to assess itch/pruritus severity over a 24-hour period which will be used daily to assess peak pruritus. Higher PP-NRS ratings represent more itch reported.
Proportion of subjects with a Baseline Peak Pruritus Numerical Rating Scale (PP-NRS) score ≥4-point reduction in PP-NRS score from Baseline to Day 28
The PP-NRS is a scale from 0-10 used to assess itch/pruritus severity over a 24-hour period which will be used daily to assess peak pruritus. Higher PP-NRS ratings represent more itch reported.

Full Information

First Posted
November 8, 2021
Last Updated
July 1, 2023
Sponsor
Dermavant Sciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05186805
Brief Title
Maximal Use Study of Tapinarof Cream, 1% in Pediatric Subjects With Extensive Atopic Dermatitis
Official Title
Open Label Maximal Use Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Tapinarof Cream, 1% in Pediatric Subjects With Extensive Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
August 24, 2022 (Actual)
Study Completion Date
August 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dermavant Sciences, Inc.

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
This is an open-label, multicenter study to evaluate the systemic exposure and safety of topical tapinarof cream, 1% under conditions of maximal use in pediatric subjects with atopic dermatitis
Detailed Description
This is a 4-week open-label study in which subjects will be assigned to receive tapinarof cream, 1% once daily for 4 weeks. At the end of the 4-week study treatment, qualified subjects will have the option to enroll in an open-label, long-term extension study for an additional 48 weeks of treatment. Subjects who do not participate in the open-label, long-term extension study will complete a follow-up visit approximately one week after the end of treatment in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
eczema, pediatric, tapinarof, phase 2, topical

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tapinarof cream
Arm Type
Experimental
Arm Description
Tapinarof (DMVT-505) cream, 1% applied topically once daily
Intervention Type
Drug
Intervention Name(s)
Tapinarof cream, 1%
Other Intervention Name(s)
DMVT-505
Intervention Description
Tapinarof cream, 1% applied topically once daily
Primary Outcome Measure Information:
Title
Number of Participants that Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
Frequency, Severity, and Duration AEs (local and systemic)
Time Frame
Baseline to Day 28
Title
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Values and Vital Signs
Description
Change in laboratory values and vial signs were assessed for clinical relevance
Time Frame
Baseline to Day 28
Title
Number of participants with irritation as assessed by the Local Tolerability Scale (LTS)
Description
Local Tolerability Scale (LTS) is a clinical tool for assessing the presence and overall degree of irritation at the application sites, according to a 5-point scale. 0 indicates no irritation and 4 indicates Very Severe irritation.
Time Frame
Baseline to Day 28
Title
Tapinarof and Tapinarof Sulfate (Metabolite) Plasma PK Parameters on Day 1: AUC0-τ
Description
The AUC in plasma is a pharmacokinetic parameter that describes the overall exposure of the drug.
Time Frame
Day 1 and Day 28 (PK samples collected at pre-dose and at 1, 3, and 5 hours after dosing)
Title
Tapinarof and Tapinarof Sulfate (Metabolite) Plasma PK Parameters on Day 1: Cmax
Description
The Cmax is a pharmacokinetic parameter that describes the highest concentration of the drug that is achieved after dosing.
Time Frame
Day 1 and Day 28 (PK samples collected at pre-dose and at 1, 3, and 5 hours after dosing)
Title
Tapinarof and Tapinarof Sulfate (Metabolite) Plasma PK Parameters on Day 1: tmax
Description
The tmax is a pharmacokinetic parameter that describes the time point at which the highest concentration of the drug is achieved after dosing.
Time Frame
Day 1 and Day 28 (PK sample collected at pre-dose and at 1, 3, and 5 hours after dosing)
Title
Tapinarof and Tapinarof Sulfate (Metabolite) Plasma concentration on Day 28: Cτ
Description
The Cτ is a pharmacokinetic parameter that describes the time of last quantifiable concentration that is achieved after the last dose.
Time Frame
Day 28 (PK sample collected approximately 24 hours after the last dose)
Secondary Outcome Measure Information:
Title
Change from Baseline in Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD)
Description
The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. Score of 0 indicates no inflammatory signs of atopic dermatitis and a 4 indicates disease is widespread in extent.
Time Frame
Baseline to Day 28
Title
Number of subjects who have a Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD) score of almost clear (0 or 1) from baseline to Day 28
Description
The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. Score of 0 indicates no inflammatory signs of atopic dermatitis and a 4 indicates disease is widespread in extent.
Time Frame
Baseline to Day 28
Title
Number of subjects with ≥50%, improvement in Eczema Area and Severity Index (EASI) score from Baseline to each visit
Description
The EASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.
Time Frame
Baseline to Day 28
Title
Number of subjects with ≥75%, improvement in Eczema Area and Severity Index (EASI) score from Baseline to each visit
Description
The EASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.
Time Frame
Baseline to Day 28
Title
Number of subjects with ≥90%, improvement in Eczema Area and Severity Index (EASI) score from Baseline to each visit
Description
The EASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.
Time Frame
Baseline to Day 28
Title
Mean change in Eczema Area and Severity Index EASI from baseline to Day 28
Description
The EASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.
Time Frame
Baseline to Day 28
Title
Mean change in Percent of Total Body Surface Area (%BSA) affected from Baseline to Day 28
Description
The assessment of %BSA affected is an estimate of the percentage of total involved skin with psoriasis. For the purpose of clinical estimation, the total palmar surface of the subject's palm and digits may be assumed to be approximately equivalent to 1% BSA. The %BSA affected by psoriasis will be evaluated (from 0% to 100%). %BSA is a static assessment made without reference to previous scores.
Time Frame
Baseline to Day 28
Title
Mean change in Total Body Surface Area (BSA) x Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD) values form Baseline to Day 28
Description
The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. Score of 0 indicates no inflammatory signs of atopic dermatitis and a 4 indicates disease is widespread in extent. The assessment of %BSA affected is an estimate of the percentage of total involved skin with psoriasis. For the purpose of clinical estimation, the total palmar surface of the subject's palm and digits may be assumed to be approximately equivalent to 1% BSA. The %BSA affected by psoriasis will be evaluated (from 0% to 100%). %BSA is a static assessment made without reference to previous scores.
Time Frame
Baseline to Day 28
Title
Mean change in average weekly Peak Pruritus Numerical Rating Scale (PP-NRS) score by age group from Baseline to Day 28
Description
The PP-NRS is a scale from 0-10 used to assess itch/pruritus severity over a 24-hour period which will be used daily to assess peak pruritus. Higher PP-NRS ratings represent more itch reported.
Time Frame
Baseline to Day 28
Title
Proportion of subjects with a Baseline Peak Pruritus Numerical Rating Scale (PP-NRS) score ≥4-point reduction in PP-NRS score from Baseline to Day 28
Description
The PP-NRS is a scale from 0-10 used to assess itch/pruritus severity over a 24-hour period which will be used daily to assess peak pruritus. Higher PP-NRS ratings represent more itch reported.
Time Frame
Baseline to Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female subjects age 2 to 17 with a confirmed clinical diagnosis of atopic dermatitis and present for at least 6 months for ages 6-17 years old, 3 months for ages 2-5 years old BSA involvement ≥ 25% for subjects ages 12-17 years old, or ≥ 35% for subjects ages 2-11 years old, suitable for topical therapy. vIGA-AD score of ≥ 3 at screening and baseline (pre-dose) Female subjects of child bearing potential who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study Capable of giving written informed consent Negative pregnancy test at Baseline (Day 1) Exclusion Criteria: Immunocompromised at screening Chronic or acute systemic or superficial infection requiring treatment with systemic antibacterials or antifungals within one week prior to baseline visit Significant dermatological or inflammatory condition other than AD that, in the Investigator's opinion, would make it difficult to interpret data or assessments during the study Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0x the upper limit of normal (ULN). Screening total bilirubin > 1.5x ULN Current or chronic history of liver disease Current or history of cancer within 5 years except for adequately treated cutaneous basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix Subjects who would not be considered suitable for topical therapy Use of any prohibited medication or procedure within the indicated period before the baseline visit including other investigational product within 30 days or 5 half-lives of the investigational product (whichever is longer) History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion, may interfere with the subject's participation in the study, interpretation of results, or ability to understand and give informed consent. Pregnant or lactating females History of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the -Investigator or Medical Monitor, contraindicates their participation Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Villalobos
Organizational Affiliation
Dermavant Sciences, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Dermavant Investigative Site
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91320
Country
United States
Facility Name
Dermavant Investigative Site
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Dermavant Investigative Site
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Dermavant Investigative Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Dermavant Investigative Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Dermavant Investigative Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Dermavant Investigative Site
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29445
Country
United States
Facility Name
Dermavant Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Dermavant Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Dermavant Investigative Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3A 2N1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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26634191
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Maximal Use Study of Tapinarof Cream, 1% in Pediatric Subjects With Extensive Atopic Dermatitis

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