Long Term Extension Study of Tapinarof Cream, 1% for Subjects With Atopic Dermatitis

NCT ID: NCT05142774

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 728 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-28
• Study Completion Date: 2024-03-07

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tapinarof cream

Subjects entering with vIGA-AD (Validated Investigator Global Assessment of Atopic Dermatitis) ≥1 receive treatment with study drug until they achieve vIGA-AD=0, at which time treatment is discontinued and subjects are monitored for durability of response (remittive response). If/when disease worsening occurs (vIGA-AD ≥2), treatment is re-initiated and continued until vIGA-AD =0 is achieved.

Subjects entering with a vIGA-AD=0 discontinue treatment and are monitored for duration of remittive response. If/when disease worsening occurs (vIGA-AD ≥2), treatment is re-initiated and continued until vIGA-AD =0 is achieved.

This treatment and re-treatment pattern of use continue until the end of the study.

Group Type: EXPERIMENTAL

Tapinarof cream, 1%

Intervention Type: DRUG

Tapinarof cream, 1%, applied daily to affected areas by subjects or their caregivers based on vIGA-AD. Subjects are advised to choose the application time they prefer and apply the study drug at that approximate time each day of study participation.

Interventions

Tapinarof cream, 1%

Tapinarof cream, 1%, applied daily to affected areas by subjects or their caregivers based on vIGA-AD. Subjects are advised to choose the application time they prefer and apply the study drug at that approximate time each day of study participation.

Intervention Type: DRUG

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)

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diana Villalobos

Role: STUDY_DIRECTOR

Dermavant Sciences, Inc.

Locations

Dermavant Investigative Site

Birmingham, Alabama, United States

Dermavant Investigative Site

Phoenix, Arizona, United States

Dermavant Investigative Site

Scottsdale, Arizona, United States

Dermavant Investigative Site

Scottsdale, Arizona, United States

Dermavant Investigative Site

Bryant, Arkansas, United States

Dermavant Investigative Site

Fort Smith, Arkansas, United States

Dermavant Investigative Site

Cerritos, California, United States

Dermavant Investigative Site

Fountain Valley, California, United States

Dermavant Investigative Site

Fremont, California, United States

Dermavant Investigative Site

Huntington Beach, California, United States

Dermavant Investigative Site

Inglewood, California, United States

Dermavant Investigative Site

Lancaster, California, United States

Dermavant Investigative Site

Long Beach, California, United States

Dermavant Investigative Site

Los Angeles, California, United States

Dermavant Investigative Site

Los Angeles, California, United States

Dermavant Investigative Site

Los Angeles, California, United States

Dermavant Investigative Site

Mission Viejo, California, United States

Dermavant Investigative Site

Sacramento, California, 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

Thousand Oaks, California, United States

Dermavant Investigative Site

Thornton, Colorado, United States

Dermavant Investigative Site

Washington D.C., District of Columbia, United States

Dermavant Investigative Site

Boca Raton, Florida, United States

Dermavant Investigative Site

Boca Raton, Florida, United States

Dermavant Investigative Site

Brandon, Florida, United States

Dermavant Investigative Site

Coral Gables, Florida, United States

Dermavant Investigative Site

Delray Beach, Florida, United States

Dermavant Investigative Site

Hialeah, Florida, United States

Dermavant Investigative Site

Jacksonville, Florida, United States

Dermavant Investigative Site

Margate, Florida, 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

Orlando, Florida, United States

Dermavant Investigative Site

Pinellas Park, Florida, United States

Dermavant Investigative Site

Sweetwater, Florida, United States

Dermavant Investigative Site

Tampa, Florida, United States

Dermavant Investigative Site

Marietta, Georgia, United States

Dermavant Investigative Site

Sandy Springs, Georgia, United States

Dermavant Investigative Site

Savannah, Georgia, United States

Dermavant Investigative Site

Snellville, Georgia, United States

Dermavant Investigative Site

Chicago, Illinois, United States

Dermavant Investigative Site

Evansville, Indiana, United States

Dermavant Investigative Site

Plainfield, Indiana, United States

Dermavant Investigative Site

Overland Park, Kansas, United States

Dermavant Investigative Site

Lexington, Kentucky, United States

Dermavant Investigative Site

Louisville, Kentucky, United States

Dermavant Investigative Site

Louisville, Kentucky, United States

Dermavant Investigative Site

Owensboro, Kentucky, United States

Dermavant Investigative Site

Baton Rouge, Louisiana, United States

Dermavant Investigative Site

Baton Rouge, Louisiana, United States

Dermavant Investigative Site

Covington, Louisiana, United States

Dermavant Investigative Site

Monroe, Louisiana, United States

Dermavant Investigative Site

New Orleans, Louisiana, United States

Dermavant Investigative Site

Largo, Maryland, United States

Dermavant Investigative Site

Rockville, Maryland, United States

Dermavant Investigative Site

Bay City, Michigan, United States

Dermavant Investigative Site

Clarkston, Michigan, United States

Dermavant Investigative Site

Warren, Michigan, United States

Dermavant Investigative Site

Ypsilanti, Michigan, United States

Dermavant Investigative Site

New Brighton, Minnesota, United States

Dermavant Investigative Site

Missoula, Montana, United States

Dermavant Investigative Site

Omaha, Nebraska, United States

Dermavant Investigative Site

East Windsor, New Jersey, United States

Dermavant Investigative Site

Garden City, New York, United States

Dermavant Investigative Site

New York, New York, United States

Dermavant Investigative Site

Charlotte, North Carolina, United States

Dermavant Investigative Site

Bexley, Ohio, United States

Dermavant Investigative Site

Cleveland, Ohio, United States

Dermavant Investigative Site

Dayton, Ohio, United States

Dermavant Investigative Site

Mason, Ohio, United States

Dermavant Investigative Site

Mayfield Heights, Ohio, United States

Dermavant Investigative Site

Norman, Oklahoma, United States

Dermavant Investigative Site

Oklahoma City, Oklahoma, United States

Dermavant Investigative Site

Tulsa, Oklahoma, United States

Dermavant Investigative Site

Medford, Oregon, United States

Dermavant Investigative Site

Portland, Oregon, United States

Dermavant Investigative Site

Portland, Oregon, United States

Dermavant Investigative Site

Portland, Oregon, United States

Dermavant Investigative Site

Anderson, South Carolina, United States

Dermavant lnvestigative Site

Greenville, South Carolina, United States

Dermavant Investigative Site

Mt. Pleasant, South Carolina, United States

Dermavant Investigative Site

North Charleston, South Carolina, United States

Dermavant Investigative Site

Spartanburg, South Carolina, United States

Dermavant Investigative Site

Knoxville, Tennessee, United States

Dermavant Investigative Site

Memphis, Tennessee, United States

Dermavant Investigative Site

Bellaire, Texas, United States

Dermavant Investigative Site

Cypress, Texas, United States

Dermavant Investigative Site

Dallas, Texas, United States

Dermavant Investigative Site

Dripping Springs, Texas, United States

Dermavant Investigative Site

Grapevine, Texas, United States

Dermavant Investigative Site

Houston, Texas, United States

Dermavant Investigative Site

San Antonio, Texas, United States

Dermavant Investigative Site

San Antonio, Texas, United States

Dermavant Investigative Site

San Antonio, Texas, United States

Dermavant Investigative Site

Sugar Land, Texas, United States

Dermavant Investigative Site

Webster, Texas, United States

Dermavant Investigative Site

Richmond, Virginia, United States

Dermavant Investigative Site

Spokane, Washington, United States

Dermavant Investigative Site

Calgary, Alberta, Canada

Dermavant Investigative Site

Surrey, British Columbia, Canada

Dermavant Investigative Site

Winnipeg, Manitoba, Canada

Dermavant Investigative Site

Barrie, Ontario, Canada

Dermavant Investigative Site

Cobourg, Ontario, Canada

Dermavant Investigative Site

Oakville, Ontario, Canada

Dermavant Investigative Site

Ottawa, Ontario, Canada

Dermavant Investigative Site

Waterloo, Ontario, Canada

Dermavant Investigative Site

Windsor, Ontario, Canada

Dermavant Investigative Site

Montreal, Quebec, Canada

Countries

United States; Canada

References

Gold LS, Bruno MJ, Lewitt GM, Hebert AA. Characteristics and management of follicular events and contact dermatitis in patients using tapinarof cream for the treatment of atopic dermatitis or plaque psoriasis. J Dermatolog Treat. 2025 Dec;36(1):2517388. doi: 10.1080/09546634.2025.2517388. Epub 2025 Jul 2.

Reference Type: DERIVED

PMID: 40600584 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

DMVT-505-3103

Identifier Type: -

Identifier Source: org_study_id