Clinical trial NCT05014568: Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults
Official title: A Phase 3 Efficacy and Safety Study of Tapinarof for the Treatment of Moderate to Severe Atopic Dermatitis in Children and Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: eczema
pediatric
tapinarof
phase 3
topical
Lead sponsor: Dermavant Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-20
Enrollment: 407
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Following a 30-day screening period, eligible subjects will be randomized at a 2:1 ratio to receive once daily treatment with tapinarof cream, 1% or vehicle cream.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: 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.
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Percent of subjects with ≥ 75% improvement in Eczema Area and Severity Index (EASI) from Baseline to Week 8. Analyses were done using Multiple Imputation.
timeFrame: Baseline to Week 8
measure: Mean change in in Percent of Total Body Surface Area (%BSA) affected from Baseline to Week 8.
timeFrame: Baseline to Week 8
measure: Percent of subjects with ≥ 90% improvement in Eczema Area and Severity Index (EASI) from Baseline to Week 8. Analyses were done using Multiple Imputation.
timeFrame: Baseline to Week 8
measure: 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.
timeFrame: Baseline to Week 8
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Dermavant Investigative Site
state: Alabama
city: Phoenix
country: United States
facility: Dermavant Investigative Site
state: Arizona
city: Bryant
country: United States
facility: Dermavant Investigative Site
state: Arkansas
city: Beverly Hills
country: United States
facility: Dermavant Investigative Site
state: California
city: Fountain Valley
country: United States
facility: Dermavant Investigative Site
state: California
city: Fremont
country: United States
facility: Dermavant Investigative Site
state: California
city: Inglewood
country: United States
facility: Dermavant Investigative Site
state: California
city: Los Angeles
country: United States
facility: Dermavant Investigative Site
state: California
city: Los Angeles
country: United States
facility: Dermavant Investigative Site
state: California
city: Mission Viejo
country: United States
facility: Dermavant Investigative Site
state: California
city: Sacramento
country: United States
facility: Dermavant Investigative Site
state: California
city: Washington
country: United States
facility: Dermavant Investigative Site
state: District of Columbia
city: Boca Raton
country: United States
facility: Dermavant Investigative Site
state: Florida
city: Boca Raton
country: United States
facility: Dermavant Investigative Site
state: Florida
city: Brandon
country: United States
facility: Dermavant Investigative Site
state: Florida
city: Coral Gables
country: United States
facility: Dermavant Investigative Site
state: Florida
city: Jacksonville
country: United States
facility: Dermavant Investigative Site
state: Florida
city: Margate
country: United States
facility: Dermavant Investigative Site
state: Florida
city: Miami Lakes
country: United States
facility: Dermavant Investigative Site
state: Florida
city: Miami
country: United States
facility: Dermavant Investigative Site
state: Florida
city: Orlando
country: United States
facility: Dermavant Investigative Site
state: Florida
city: Pinellas Park
country: United States
facility: Dermavant Investigative Site
state: Florida
city: Sweetwater
country: United States
facility: Dermavant Investigative Site
state: Florida
city: Tampa
country: United States
facility: Dermavant Investigative Site
state: Florida
city: Marietta
country: United States
facility: Dermavant Investigative Site
state: Georgia
city: Sandy Springs
country: United States
facility: Dermavant Investigative Site
state: Georgia
city: Savannah
country: United States
facility: Dermavant Investigative Site
state: Georgia
city: Plainfield
country: United States
facility: Dermavant Investigative Site
state: Indiana
city: Louisville
country: United States
facility: Dermavant Investigative Site
state: Kentucky
city: Owensboro
country: United States
facility: Dermavant Investigative Site
state: Kentucky
city: Covington
country: United States
facility: Dermavant Investigative Site
state: Louisiana
city: Monroe
country: United States
facility: Dermavant Investigative Site
state: Louisiana
city: Largo
country: United States
facility: Dermavant Investigative Site
state: Maryland
city: Bay City
country: United States
facility: Dermavant Investigative Site
state: Michigan
city: Clarkston
country: United States
facility: Dermavant Investigative Site
state: Michigan
city: Warren
country: United States
facility: Dermavant Investigative Site
state: Michigan
city: Ypsilanti
country: United States
facility: Dermavant Investigative Site
state: Michigan
city: New Brighton
country: United States
facility: Dermavant Investigative Site
state: Minnesota
city: Missoula
country: United States
facility: Dermavant Investigative Site
state: Montana
city: Omaha
country: United States
facility: Dermavant Investigative Site
state: Nebraska
city: Garden City
country: United States
facility: Dermavant Investigative Site
state: New York
city: New York
country: United States
facility: Dermavant Investigative Site
state: New York
city: Bexley
country: United States
facility: Dermavant Investigative Site
state: Ohio
city: Cleveland
country: United States
facility: Dermavant Investigative Site
state: Ohio
city: Oklahoma City
country: United States
facility: Dermavant Investigative Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Dermavant Investigative Site
state: Oklahoma
city: Gresham
country: United States
facility: Dermavant Investigative Site
state: Oregon
city: Portland
country: United States
facility: Dermavant Investigative Site
state: Oregon
city: Hershey
country: United States
facility: Dermavant Investigative Site
state: Pennsylvania
city: Greenville
country: United States
facility: Dermavant Investigative Site
state: South Carolina
city: Knoxville
country: United States
facility: Dermavant Investigative Site
state: Tennessee
city: Austin
country: United States
facility: Dermavant Investigative Site
state: Texas
city: Bellaire
country: United States
facility: Dermavant Investigative Site
state: Texas
city: Cypress
country: United States
facility: Dermavant Investigative Site
state: Texas
city: Dallas
country: United States
facility: Dermavant Investigative Site
state: Texas
city: Houston
country: United States
facility: Dermavant Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Dermavant Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Dermavant Investigative Site
state: Texas
city: Sugar Land
country: United States
facility: Dermavant Investigative Site
state: Texas
city: Richmond
country: United States
facility: Dermavant Investigative Site
state: Virginia
city: Winnipeg
country: Canada
facility: Dermavant Investigative Site
state: Manitoba
city: Burlington
country: Canada
facility: Dermavant Investigative Site
state: Ontario
city: Cobourg
country: Canada
facility: Dermavant Investigative Site
state: Ontario
city: Hamilton
country: Canada
facility: Dermavant Investigative Site
state: Ontario
city: Oakville
country: Canada
facility: Dermavant Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Dermavant Investigative Site
state: Ontario
city: Montréal
country: Canada
facility: Dermavant Investigative Site
state: Quebec
Study officials:
affiliation: Dermavant Sciences, Inc.
name: Diana Villalobos
role: STUDY_DIRECTOR
References: