Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults

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: NCT05014568
• Other study ID #: DMVT-505-3101
• Status: Completed
• Phase: Phase 3
• Start date: September 1, 2021
• Est. completion date: April 7, 2023

Study information

• Verified date: May 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: 407
• Est. completion date: April 7, 2023
• Est. primary completion date: March 30, 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 Clinical Site	Burlington	Ontario
Canada	Dermavant Clinical Site	Cobourg	Ontario
Canada	Dermavant Clinical Site	Hamilton	Ontario
Canada	Dermavant Clinical Site	Montréal	Quebec
Canada	Dermavant Clinical Site	Oakville	Ontario
Canada	Dermavant Clinical Site	Ottawa	Ontario
Canada	Dermavant Clinical Site	Winnipeg	Manitoba
United States	Dermavant Clinical Site	Austin	Texas
United States	Dermavant Clinical Site	Bay City	Michigan
United States	Dermavant Investigative Site	Bellaire	Texas
United States	Dermavant Clinical Site	Beverly Hills	California
United States	Dermavant Clinical Site	Bexley	Ohio
United States	Dermavant Clinical Site	Birmingham	Alabama
United States	Dermavant Clinical Site	Boca Raton	Florida
United States	Dermavant Clinical Site	Boca Raton	Florida
United States	Dermavant Investigative Site	Brandon	Florida
United States	Dermavant Clinical Site	Bryant	Arkansas
United States	Dermavant Clinical Site	Clarkston	Michigan
United States	Dermavant Investigative Site	Cleveland	Ohio
United States	Dermavant Investigative Site	Coral Gables	Florida
United States	Dermavant Clinical Site	Covington	Louisiana
United States	Dermavant Clinical Site	Cypress	Texas
United States	Dermavant Clinical Site	Dallas	Texas
United States	Dermavant Clinical Site	Fountain Valley	California
United States	Dermavant Clinical Site	Fremont	California
United States	Dermavant Clinical Site	Garden City	New York
United States	Dermavant Clinical Site	Greenville	South Carolina
United States	Dermavant Clinical Site	Gresham	Oregon
United States	Dermavant Clinical Site	Hershey	Pennsylvania
United States	Dermavant Clinical Site	Houston	Texas
United States	Dermavant Clinical Site	Inglewood	California
United States	Dermavant Clinical Site	Jacksonville	Florida
United States	Dermavant Clinical Site	Knoxville	Tennessee
United States	Dermavant Clinical Site	Largo	Maryland
United States	Dermavant Clinical Site	Los Angeles	California
United States	Dermavant Clinical Site	Los Angeles	California
United States	Dermavant Clinical Site	Louisville	Kentucky
United States	Dermavant Clinical Site	Margate	Florida
United States	Dermavant Investigative Site	Marietta	Georgia
United States	Dermavant Clinical Site	Miami	Florida
United States	Dermavant Clinical Site	Miami Lakes	Florida
United States	Dermavant Clinical Site	Mission Viejo	California
United States	Dermavant Clinical Site	Missoula	Montana
United States	Dermavant Clinical Site	Monroe	Louisiana
United States	Dermavant Clinical Site	New Brighton	Minnesota
United States	Dermavant Investigative Site	New York	New York
United States	Dermavant Clinical Site	Oklahoma City	Oklahoma
United States	Dermavant Clinical Site	Oklahoma City	Oklahoma
United States	Dermavant Clinical Site	Omaha	Nebraska
United States	Dermavant Clinical Site	Orlando	Florida
United States	Dermavant Investigative Site	Owensboro	Kentucky
United States	Dermavant Clinical Site	Phoenix	Arizona
United States	Dermavant Clinical Site	Pinellas Park	Florida
United States	Dermavant Clinical Site	Plainfield	Indiana
United States	Dermavant Clinical Site	Portland	Oregon
United States	Dermavant Clinical Site	Richmond	Virginia
United States	Dermavant Investigative Site	Sacramento	California
United States	Dermavant Clinical Site	San Antonio	Texas
United States	Dermavant Clinical Site	San Antonio	Texas
United States	Dermavant Clinical Site	Sandy Springs	Georgia
United States	Dermavant Clinical Site	Savannah	Georgia
United States	Dermavant Clinical Site	Sugar Land	Texas
United States	Dermavant Investigative Site	Sweetwater	Florida
United States	Dermavant Clinical Site	Tampa	Florida
United States	Dermavant Clinical Site	Warren	Michigan
United States	Dermavant Clinical Site	Washington	District of Columbia
United States	Dermavant Clinical Site	Ypsilanti	Michigan

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