Clinical trial NCT05032859: Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults (DMVT-505-3102)
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: 2021-09-02
Enrollment: 406
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: Scottsdale
country: United States
facility: Dermavant Investigative Site
state: Arizona
city: Scottsdale
country: United States
facility: Dermavant Investigative Site
state: Arizona
city: Fort Smith
country: United States
facility: Dermavant Investigative Site
state: Arkansas
city: Cerritos
country: United States
facility: Dermavant Investigative Site
state: California
city: Huntington Beach
country: United States
facility: Dermavant Investigative Site
state: California
city: Lancaster
country: United States
facility: Dermavant Investigative Site
state: California
city: Long Beach
country: United States
facility: Dermavant Investigative Site
state: California
city: Los Angeles
country: United States
facility: Dermavant Investigative Site
state: California
city: San Diego
country: United States
facility: Dermavant Investigative Site
state: California
city: San Francisco
country: United States
facility: Dermavant Investigative Site
state: California
city: Santa Ana
country: United States
facility: Dermavant Investigative Site
state: California
city: Santa Monica
country: United States
facility: Dermavant Investigative Site
state: California
city: Boca Raton
country: United States
facility: Dermavant Investigative Site
state: Florida
city: Delray Beach
country: United States
facility: Dermavant Investigative Site
state: Florida
city: Jacksonville
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: Miami
country: United States
facility: Dermavant Investigative Site
state: Florida
city: Tampa
country: United States
facility: Dermavant Investigative Site
state: Florida
city: Snellville
country: United States
facility: Dermavant Investigative Site
state: Georgia
city: Evansville
country: United States
facility: Dermavant Investigative Site
state: Indiana
city: Overland Park
country: United States
facility: Dermavant Investigative Site
state: Kansas
city: Lexington
country: United States
facility: Dermavant Investigative Site
state: Kentucky
city: Louisville
country: United States
facility: Dermavant Investigative Site
state: Kentucky
city: Baton Rouge
country: United States
facility: Dermavant Investigative Site
state: Louisiana
city: Baton Rouge
country: United States
facility: Dermavant Investigative Site
state: Louisiana
city: New Orleans
country: United States
facility: Dermavant Investigative Site
state: Louisiana
city: Rockville
country: United States
facility: Dermavant Investigative Site
state: Maryland
city: Detroit
country: United States
facility: Dermavant Investigative Site
state: Michigan
city: Lincoln
country: United States
facility: Dermavant Investigative Site
state: Nebraska
city: Omaha
country: United States
facility: Dermavant Investigative Site
state: Nebraska
city: Las Vegas
country: United States
facility: Dermavant Investigative Site
state: Nevada
city: East Windsor
country: United States
facility: Dermavant Investigative Site
state: New Jersey
city: Brooklyn
country: United States
facility: Dermanvant Investigative Site
state: New York
city: Watertown
country: United States
facility: Dermavant Investigative Site
state: New York
city: Charlotte
country: United States
facility: Dermavant Investigative Site
state: North Carolina
city: Dayton
country: United States
facility: Dermavant Investigative Site
state: Ohio
city: Mason
country: United States
facility: Dermavant Investigative Site
state: Ohio
city: Mayfield Heights
country: United States
facility: Dermavant Investigative Site
state: Ohio
city: Tulsa
country: United States
facility: Dermavant Investigative Site
state: Oklahoma
city: Medford
country: United States
facility: Dermavant Investigative Site
state: Oregon
city: Portland
country: United States
facility: Dermavant Investigative Site
state: Oregon
city: Portland
country: United States
facility: Dermavant Investigative Site
state: Oregon
city: East Greenwich
country: United States
facility: Dermavant Investigative Site
state: Rhode Island
city: Anderson
country: United States
facility: Dermavant Investigative Site
state: South Carolina
city: North Charleston
country: United States
facility: Dermavant Investigative Site
state: South Carolina
city: Spartanburg
country: United States
facility: Dermavant Investigative Site
state: South Carolina
city: Memphis
country: United States
facility: Dermavant Investigative Site
state: Tennessee
city: Bellaire
country: United States
facility: Dermavant Investigative Site
state: Texas
city: Dripping Springs
country: United States
facility: Dermavant Investigative Site
state: Texas
city: Grapevine
country: United States
facility: Dermavant Investigative Site
state: Texas
city: Houston
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: Webster
country: United States
facility: Dermavant Investigative Site
state: Texas
city: Spokane
country: United States
facility: Dermavant Investigative Site
state: Washington
city: Surrey
country: Canada
facility: Dermavant Investigative Site
state: British Columbia
city: Barrie
country: Canada
facility: Dermavant Investigative Site
state: Ontario
city: Markham
country: Canada
facility: Dermavant Investigative Site
state: Ontario
city: Waterloo
country: Canada
facility: Dermavant Investigative Site
state: Ontario
city: Windsor
country: Canada
facility: Dermavant Investigative Site
state: Ontario
Study officials:
affiliation: Dermavant Sciences, Inc.
name: Diana Villalobos
role: STUDY_DIRECTOR
References: