Clinical trial NCT05142774: Long Term Extension Study of Tapinarof Cream, 1% for Subjects With Atopic Dermatitis
Official title: An Open-Label, Long-Term Extension Study to Evaluate the Safety and Efficacy of Tapinarof Cream, 1% in Subjects With Atopic Dermatitis
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: 2021-12-03
Enrollment: 728
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, long-term multicenter, study to evaluate the safety and efficacy of topical tapinarof cream, 1% in subjects with atopic dermatitis. Subjects in this study have completed treatment in one of two Phase 3 pivotal studies (DMVT-505-3101 or DMVT-505-3102) or completed treatment in the DMVT-505-2104 study, or directly enrolled into this study. This study will consist of up to 48 weeks of treatment and a 1 week safety follow-up period.

Detailed description: At the completion of the Week 8 visit of study DMVT-505-3101 (NCT05014568) or study DMVT-505-3102 (NCT05032859) or the Day 28 visit of study DMVT-505-2104 (NCT05186805) (Day 1 \[Baseline\] in this study), all eligible subjects will be offered enrollment in this open-label long-term extension (OL-LTE) study. Approximately 125 additional pediatric subjects ages 2 to \< 18 years who are not eligible for participation in the Phase 3 pivotal studies (DMVT-505-3101 or DMVT-505-3102) will be enrolled directly into this OL-LTE study. Study visits during the treatment period for all subjects will occur every 4 weeks (± 3 days). The total duration of study participation will be approximately 48 weeks for rollover subjects (Baseline to Final Visit) with a 1-week Safety Follow-up Period and approximately 52 weeks for direct-enrolling subjects (Screening to Final Visit) with a 1-week Safety Follow-up Period.

Eligibility criteria: Inclusion Criteria:

For Roll-over Subjects Only:

* Met the criteria as a Study Completer in one of three studies (DMVT-505-3101 study, DMVT-505-3102 study, or DMVT-505-2104 study).
* Must not be pregnant at Baseline

For Direct-Enrolling Subjects Only:

* Male and female subjects ages 2 years to \< 18 years at the time of consent with clinical diagnosis of AD
* Subjects with a vIGA-AD™ score of ≥ 3 and AD covering ≥ 40% of the BSA at Screening and Baseline (pre-randomization), or subjects with a vIGA-AD™ score of 2 at Screening and Baseline (pre-randomization) regardless of BSA. Subjects must have screened for the DMVT-505-3101 or DMVT-505-3102 study and failed to meet BSA and/or vIGA-AD™ eligibility criteria.
* AD present for at least 6 months for ages 6 years old and above or 3 months for ages 2 to 5 years old
* Must not be pregnant at Screening or Baseline

For All Subjects:

* Female subjects of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use acceptable birth control methods
* Subject, subject's parent, or legal representative must be capable of giving written informed consent/assent

Exclusion Criteria:

For Rollover Subjects Only:

1. Subjects who were not receiving study drug at the time of the last visit in the pivotal study (DMVT-505-3101, DMVT-505-3102, or DMVT-505-2104)
2. Used a prohibited concomitant product or procedure to treat AD during the pivotal study.
3. Had an SAE that was related to treatment or experienced an AE that led to permanent discontinuation of treatment in the pivotal study.
4. Pregnant females

For Direct-Enrolling Subjects:

* 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: Number of Subjects With Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events
timeFrame: Baseline to Week 49
measure: Frequency of Adverse Events and Serious Adverse Events
timeFrame: Baseline up to Week 49
measure: Number of Subjects With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values and Vital Signs
timeFrame: Baseline up to Week 48
measure: Complete Disease Clearance During LTE: Number of Subjects Achieving Disease Clearance vIGA-AD =0 (Clear) While on Therapy for Subjects Entered LTE vIGA-AD ≥ 1 (Almost Clear )
timeFrame: Baseline to 49 weeks
measure: Response During LTE: Number of Subjects Achieving vIGA-AD =0 or 1 (Clear or Almost Clear) While on Therapy for Subjects Who Entered LTE With vIGA-AD ≥ 2 (Mild)
timeFrame: Baseline to 49 weeks
measure: Change From Baseline in %BSA Affected
timeFrame: Baseline to 48 weeks
measure: Percent Change From Baseline in %BSA Affected
timeFrame: Baseline to 48 weeks
measure: Change From Baseline in Eczema Area and Severity Index (EASI) Score
timeFrame: Time Frame: Baseline to 48 weeks
measure: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score
timeFrame: Baseline to 48 weeks
measure: Percent of Subjects With ≥ 50% Improvement in Eczema Area and Severity Index (EASI) From Baseline at Week 48.
timeFrame: Baseline to Week 48
measure: Percent of Subjects With ≥ 75% Improvement in Eczema Area and Severity Index (EASI) From Baseline at Week 48.
timeFrame: Baseline to Week 48
measure: Percent of Subjects With ≥ 90% Improvement in Eczema Area and Severity Index (EASI) From Baseline at Week 48.
timeFrame: Baseline to Week 48
measure: Mean change in Peak Pruritis-Numeric Rating Scale (PP-NRS) from Baseline
timeFrame: Baseline to Week 48
measure: Number of subjects with a Baseline Peak Pruritis-Numeric Rating Scale (PP-NRS) score ≥ 4 who achieve ≥ 4-point reduction in the PP-NRS from Baseline
timeFrame: Baseline to Week 48
Secondary outcomes:
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: Scottsdale
country: United States
facility: Dermavant Investigative Site
state: Arizona
city: Scottsdale
country: United States
facility: Dermavant Investigative Site
state: Arizona
city: Bryant
country: United States
facility: Dermavant Investigative Site
state: Arkansas
city: Fort Smith
country: United States
facility: Dermavant Investigative Site
state: Arkansas
city: Cerritos
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: Huntington Beach
country: United States
facility: Dermavant Investigative Site
state: California
city: Inglewood
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: 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: 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: Thousand Oaks
country: United States
facility: Dermavant Investigative Site
state: California
city: Thornton
country: United States
facility: Dermavant Investigative Site
state: Colorado
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: Delray Beach
country: United States
facility: Dermavant Investigative Site
state: Florida
city: Hialeah
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: 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: Snellville
country: United States
facility: Dermavant Investigative Site
state: Georgia
city: Chicago
country: United States
facility: Dermavant Investigative Site
state: Illinois
city: Evansville
country: United States
facility: Dermavant Investigative Site
state: Indiana
city: Plainfield
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: Louisville
country: United States
facility: Dermavant Investigative Site
state: Kentucky
city: Owensboro
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: Covington
country: United States
facility: Dermavant Investigative Site
state: Louisiana
city: Monroe
country: United States
facility: Dermavant Investigative Site
state: Louisiana
city: New Orleans
country: United States
facility: Dermavant Investigative Site
state: Louisiana
city: Largo
country: United States
facility: Dermavant Investigative Site
state: Maryland
city: Rockville
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: East Windsor
country: United States
facility: Dermavant Investigative Site
state: New Jersey
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: Charlotte
country: United States
facility: Dermavant Investigative Site
state: North Carolina
city: Bexley
country: United States
facility: Dermavant Investigative Site
state: Ohio
city: Cleveland
country: United States
facility: Dermavant Investigative Site
state: Ohio
city: Dayton
country: United States
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state: Ohio
city: Mason
country: United States
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state: Ohio
city: Mayfield Heights
country: United States
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state: Ohio
city: Norman
country: United States
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state: Oklahoma
city: Oklahoma City
country: United States
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state: Oklahoma
city: Tulsa
country: United States
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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: Portland
country: United States
facility: Dermavant Investigative Site
state: Oregon
city: Anderson
country: United States
facility: Dermavant Investigative Site
state: South Carolina
city: Greenville
country: United States
facility: Dermavant lnvestigative Site
state: South Carolina
city: Mount Pleasant
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: Knoxville
country: United States
facility: Dermavant Investigative Site
state: Tennessee
city: Memphis
country: United States
facility: Dermavant Investigative Site
state: Tennessee
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: 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: San Antonio
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: Webster
country: United States
facility: Dermavant Investigative Site
state: Texas
city: Richmond
country: United States
facility: Dermavant Investigative Site
state: Virginia
city: Spokane
country: United States
facility: Dermavant Investigative Site
state: Washington
city: Calgary
country: Canada
facility: Dermavant Investigative Site
state: Alberta
city: Surrey
country: Canada
facility: Dermavant Investigative Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Dermavant Investigative Site
state: Manitoba
city: Barrie
country: Canada
facility: Dermavant Investigative Site
state: Ontario
city: Cobourg
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: Waterloo
country: Canada
facility: Dermavant Investigative Site
state: Ontario
city: Windsor
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: