Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults (DMVT-505-3102)

Atopic Dermatitis Clinical Trial

Official title:

A Phase 3 Efficacy and Safety Study of Tapinarof for the Treatment of Moderate to Severe Atopic Dermatitis in Children and Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05032859
• Other study ID #: DMVT-505-3102
• Status: Completed
• Phase: Phase 3
• Start date: September 23, 2021
• Est. completion date: February 8, 2023

Study information

• Verified date: March 2023
• Source: Dermavant Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a double-blind, randomized, vehicle controlled Phase 3 study to evaluate the efficacy and safety of topical tapinarof cream, 1% compared to vehicle control cream in pediatric and adult subjects with atopic dermatitis.

Description:

This study is a 8-week double-blind, vehicle-controlled treatment study in which subjects will be randomized to receive tapinarof cream, 1% or vehicle cream once daily for 8 weeks. At the end of the 8-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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 406
• Est. completion date: February 8, 2023
• Est. primary completion date: February 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

• Male and female subjects ages 2 and above with clinical diagnosis of AD
• Subject with atopic dermatitis covering =5% and = 35% of the BSA
• A vIGA-AD score of =3 at screening and baseline
• An EASI score of =6 at screening and baseline
• Atopic dermatitis present for at least 6 months for ages 6 years old and above or 3 months for ages 2 to 5 years old
• Female subjects of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use acceptable birth control methods
• Must not be pregnant
• Subject, subject's parent, or legal representative must be capable of giving written informed consent/assent

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)

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• tapinarof cream, 1%
applied topically once daily
• vehicle cream
applied topically once daily

Locations

Country	Name	City	State
Canada	Dermavant Investigative Site	Barrie	Ontario
Canada	Dermavant Investigative Site	Markham	Ontario
Canada	Dermavant Investigative Site	Surrey	British Columbia
Canada	Dermavant Investigative Site	Waterloo	Ontario
Canada	Dermavant Investigative Site	Windsor	Ontario
United States	Dermavant Investigative Site	Anderson	South Carolina
United States	Dermavant Investigative Site	Baton Rouge	Louisiana
United States	Dermavant Investigative Site	Baton Rouge	Louisiana
United States	Dermavant Investigative Site	Bellaire	Texas
United States	Dermavant Investigative Site	Birmingham	Alabama
United States	Dermavant Investigative Site	Boca Raton	Florida
United States	Dermanvant Investigative Site	Brooklyn	New York
United States	Dermavant Investigative Site	Cerritos	California
United States	Dermavant Investigative Site	Charlotte	North Carolina
United States	Dermavant Investigative Site	Dayton	Ohio
United States	Dermavant Investigative Site	Delray Beach	Florida
United States	Dermavant Investigative Site	Detroit	Michigan
United States	Dermavant Investigative Site	Dripping Springs	Texas
United States	Dermavant Investigative Site	East Greenwich	Rhode Island
United States	Dermavant Investigative Site	East Windsor	New Jersey
United States	Dermavant Investigative Site	Evansville	Indiana
United States	Dermavant Investigative Site	Fort Smith	Arkansas
United States	Dermavant Investigative Site	Grapevine	Texas
United States	Dermavant Investigative Site	Houston	Texas
United States	Dermavant Investigative Site	Houston	Texas
United States	Dermavant Investigative Site	Huntington Beach	California
United States	Dermavant Investigative Site	Jacksonville	Florida
United States	Dermavant Investigative Site	Lancaster	California
United States	Dermavant Investigative Site	Las Vegas	Nevada
United States	Dermavant Investigative Site	Lexington	Kentucky
United States	Dermavant Investigative Site	Lincoln	Nebraska
United States	Dermavant Investigative Site	Long Beach	California
United States	Dermavant Investigative Site	Los Angeles	California
United States	Dermavant Investigative Site	Louisville	Kentucky
United States	Dermavant Investigative Site	Mason	Ohio
United States	Dermavant Investigative Site	Mayfield Heights	Ohio
United States	Dermavant Investigative Site	Medford	Oregon
United States	Dermavant Investigative Site	Memphis	Tennessee
United States	Dermavant Investigative Site	Miami	Florida
United States	Dermavant Investigative Site	Miami	Florida
United States	Dermavant Investigative Site	Miami Lakes	Florida
United States	Dermavant Investigative Site	New Orleans	Louisiana
United States	Dermavant Investigative Site	North Charleston	South Carolina
United States	Dermavant Investigative Site	Omaha	Nebraska
United States	Dermavant Investigative Site	Overland Park	Kansas
United States	Dermavant Investigative Site	Portland	Oregon
United States	Dermavant Investigative Site	Portland	Oregon
United States	Dermavant Investigative Site	Rockville	Maryland
United States	Dermavant Investigative Site	San Antonio	Texas
United States	Dermavant Investigative Site	San Diego	California
United States	Dermavant Investigative Site	San Francisco	California
United States	Dermavant Investigative Site	Santa Ana	California
United States	Dermavant Investigative Site	Santa Monica	California
United States	Dermavant Investigative Site	Scottsdale	Arizona
United States	Dermavant Investigative Site	Scottsdale	Arizona
United States	Dermavant Investigative Site	Snellville	Georgia
United States	Dermavant Investigative Site	Spartanburg	South Carolina
United States	Dermavant Investigative Site	Spokane	Washington
United States	Dermavant Investigative Site	Tampa	Florida
United States	Dermavant Investigative Site	Tulsa	Oklahoma
United States	Dermavant Investigative Site	Watertown	New York
United States	Dermavant Investigative Site	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Dermavant Sciences GmbH

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of subjects who have a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear or almost clear (0 or 1) with a Minimum 2-grade Improvement from Baseline to Week 8. Analyses were done using Multiple Imputation.	The vIGA-AD is a global assessment of the current state of the disease. It is a static 5-point scale used to grade overall disease severity (scalp excluded), as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. The vIGA-AD ranges from 0 to 4 and is calculated as Clear (0), Almost clear (1), Mild (2), Moderate (3), and Severe (4). Higher vIGA-AD scores represent more severe disease.	Baseline to Week 8
Secondary	Percent of subjects with = 75% improvement in Eczema Area and Severity Index (EASI) from Baseline to Week 8. Analyses were done using Multiple Imputation.	The Eczema Area and Severity Index (EASI) is a scoring system that takes into account the overall severity of disease based on lesion severity and the extent of percent body surface area affected with atopic dermatitis. The EASI is a composite score ranging from 0 -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 percent body surface area involved for each body region relative to the whole body. A higher EASI score represents more severe disease.	Baseline to Week 8
Secondary	Mean change in in Percent of Total Body Surface Area (%BSA) affected from Baseline to Week 8.	Assessment of percent body surface area (%BSA) is an estimate of the percentage of total involved skin with atopic dermatitis. Estimates were made using the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumbs together) represented approximately 1% of the total BSA. Body regions are assigned a specific number of handprints with associated percentages (Head and neck = 10% [10 handprints], upper extremities = 20% [20 handprints], trunk (including axillae and groin) = 30% [30 handprints], lower extremities, including buttocks, = 40% [40 handprints]). Estimates of the percent involvement of each body region will be multiplied by the fraction of total body area to obtain the total %BSA involved by region and overall.	Baseline to Week 8
Secondary	Percent of subjects with = 90% improvement in Eczema Area and Severity Index (EASI) from Baseline to Week 8. Analyses were done using Multiple Imputation.	The Eczema Area and Severity Index (EASI) is a scoring system that takes into account the overall severity of disease based on lesion severity and the extent of percent body surface area affected with atopic dermatitis. The EASI is a composite score ranging from 0 -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 percent body surface area involved for each body region relative to the whole body. A higher EASI score represents more severe disease.	Baseline to Week 8
Secondary	Percent of subjects = 12 years old with a Baseline Peak Pruritis-Numeric Rating Scale (PP-NRS) score = 4 who achieve = 4-point reduction in the average weekly PP-NRS from Baseline to Week 8.	The Peak Pruritus Numeric Rating Scale (PP-NRS) is used to quickly assess itch/pruritus severity over a 24-hour period. The PP-NRS is scored on a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable". The subject will utilize the scale to assess peak pruritis once per day and record the results in their diaries. The daily ratings are averaged to generate a score for the week.	Baseline to Week 8