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

Last updated: July 3, 2024
Sponsor: Dermavant Sciences, Inc.
Overall Status: Completed

Phase

3

Condition

Rosacea

Skin Infections/disorders

Eczema (Atopic Dermatitis - Pediatric)

Treatment

Tapinarof cream, 1%

Clinical Study ID

NCT05142774
DMVT-505-3103
  • Ages > 2
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 withclinical diagnosis of AD

  • Subjects with a vIGA-AD™ score of ≥ 3 and AD covering ≥ 40% of the BSA at Screeningand Baseline (pre-randomization), or subjects with a vIGA-AD™ score of 2 atScreening and Baseline (pre-randomization) regardless of BSA. Subjects must havescreened for the DMVT-505-3101 or DMVT-505-3102 study and failed to meet BSA and/orvIGA-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 thatcould lead to pregnancy should use acceptable birth control methods

  • Subject, subject's parent, or legal representative must be capable of giving writteninformed consent/assent

Exclusion

Exclusion Criteria:

For Rollover Subjects Only:

  1. Subjects who were not receiving study drug at the time of the last visit in thepivotal study (DMVT-505-3101, DMVT-505-3102, or DMVT-505-2104)

  2. Used a prohibited concomitant product or procedure to treat AD during the pivotalstudy.

  3. Had an SAE that was related to treatment or experienced an AE that led to permanentdiscontinuation 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 systemicantibacterials or antifungals within one week prior to baseline visit

  • Significant dermatological or inflammatory condition other than AD that, in theInvestigator's opinion, would make it difficult to interpret data or assessmentsduring the study

  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0x the upperlimit 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 cutaneousbasal 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 thebaseline visit including other investigational product within 30 days or 5half-lives of the investigational product (whichever is longer)

  • History of or ongoing serious illness or medical, physical, or psychiatriccondition(s) that, in the Investigator's opinion, may interfere with the subject'sparticipation in the study, interpretation of results, or ability to understand andgive informed consent.

  • Pregnant or lactating females

  • History of sensitivity to the study medications, or components thereof or a historyof drug or other allergy that, in the opinion of the Investigator or MedicalMonitor, contraindicates their participation

  • Previous known participation in a clinical study with tapinarof (previously known asGSK2894512 and WBI-1001)

Study Design

Total Participants: 728
Treatment Group(s): 1
Primary Treatment: Tapinarof cream, 1%
Phase: 3
Study Start date:
October 28, 2021
Estimated Completion Date:
March 07, 2024

Study 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.

Connect with a study center

  • Dermavant Investigative Site

    Calgary, Alberta T3A 2N1
    Canada

    Site Not Available

  • Dermavant Clinical Site

    Surrey, British Columbia V3R 6A7
    Canada

    Active - Recruiting

  • Dermavant Investigative Site

    Surrey, British Columbia V3R 6A7
    Canada

    Site Not Available

  • Dermavant Investigative Site

    Winnipeg, Manitoba R3M 3Z4
    Canada

    Site Not Available

  • Dermavant Clinical Site

    Barrie, Ontario L4M 7G1
    Canada

    Active - Recruiting

  • Dermavant Investigative Site

    Barrie, Ontario L4M 7G1
    Canada

    Site Not Available

  • Dermavant Investigative Site

    Cobourg, Ontario K9A 0Z4
    Canada

    Site Not Available

  • Dermavant Clinical Site

    Oakville, Ontario L6J 7W5
    Canada

    Active - Recruiting

  • Dermavant Investigative Site

    Oakville, Ontario L6J 7W5
    Canada

    Site Not Available

  • Dermavant Clinical Site

    Ottawa, Ontario K2C 3N2
    Canada

    Active - Recruiting

  • Dermavant Investigative Site

    Ottawa, Ontario K2C 3N2
    Canada

    Site Not Available

  • Dermavant Clinical Site

    Waterloo, Ontario N2J 7G1
    Canada

    Active - Recruiting

  • Dermavant Investigative Site

    Waterloo, Ontario N2J 7G1
    Canada

    Site Not Available

  • Dermavant Clinical Site

    Windsor, Ontario N8W 1E6
    Canada

    Active - Recruiting

  • Dermavant Investigative Site

    Windsor, Ontario N8W 1E6
    Canada

    Site Not Available

  • Dermavant Investigative Site

    Montréal, Quebec H2X 2V1
    Canada

    Site Not Available

  • Dermavant Clinical Site

    Birmingham, Alabama 35244
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Birmingham, Alabama 35244
    United States

    Site Not Available

  • Dermavant Clinical Site

    Phoenix, Arizona 85032
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Dermavant Clinical Site

    Scottsdale, Arizona 85260
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Scottsdale, Arizona 85255
    United States

    Site Not Available

  • Dermavant Clinical Site

    Bryant, Arkansas 72022
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Bryant, Arkansas 72022
    United States

    Site Not Available

  • Dermavant Clinical Site

    Fort Smith, Arkansas 72916
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Fort Smith, Arkansas 72916
    United States

    Site Not Available

  • Dermavant Clinical Site

    Cerritos, California 90702
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Cerritos, California 90702
    United States

    Site Not Available

  • Dermavant Clinical Site

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Dermavant Clinical Site

    Fremont, California 94538
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Fremont, California 94538
    United States

    Site Not Available

  • Dermavant Clinical Site

    Huntington Beach, California 92647
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Huntington Beach, California 92647
    United States

    Site Not Available

  • Dermavant Clinical Site

    Inglewood, California 90301
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Inglewood, California 90301
    United States

    Site Not Available

  • Dermavant Clinical Site

    Lancaster, California 93534
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Lancaster, California 93534
    United States

    Site Not Available

  • Dermavant Investigative Site

    Long Beach, California 90806
    United States

    Site Not Available

  • Dermavant Clinical Site

    Los Angeles, California 90045
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Los Angeles, California 90033
    United States

    Site Not Available

  • Dermavant Clinical Site

    Mission Viejo, California 92691
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Mission Viejo, California 92691
    United States

    Site Not Available

  • Dermavant Investigative Site

    Sacramento, California 95815
    United States

    Site Not Available

  • Dermavant Investigative Site

    San Diego, California 92123
    United States

    Site Not Available

  • Dermavant Investigative Site

    San Francisco, California 94115
    United States

    Site Not Available

  • Dermavant Clinical Site

    Santa Ana, California 92701
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Santa Ana, California 92701
    United States

    Site Not Available

  • Dermavant Clinical Site

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Santa Monica, California 90404
    United States

    Site Not Available

  • Dermavant Clinical Site

    Thousand Oaks, California 91320
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Thousand Oaks, California 91320
    United States

    Site Not Available

  • Dermavant Investigative Site

    Thornton, Colorado 80112
    United States

    Site Not Available

  • Dermavant Investigative Site

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • Dermavant Clinical Site

    Boca Raton, Florida 33486
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Boca Raton, Florida 33428
    United States

    Site Not Available

  • Dermavant Investigative Site

    Brandon, Florida 33511
    United States

    Site Not Available

  • Dermavant Clinical Site

    Coral Gables, Florida 33146
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Coral Gables, Florida 33146
    United States

    Site Not Available

  • Dermavant Clinical Site

    Delray Beach, Florida 33484
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Delray Beach, Florida 33484
    United States

    Site Not Available

  • Dermavant Clinical Site

    Hialeah, Florida 33016
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Hialeah, Florida 33016
    United States

    Site Not Available

  • Dermavant Clinical Site

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Dermavant Clinical Site

    Margate, Florida 33063
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Margate, Florida 33063
    United States

    Site Not Available

  • Dermavant Clinical Site

    Miami, Florida 33165
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Miami, Florida 33173
    United States

    Site Not Available

  • Dermavant Clinical Site

    Miami Lakes, Florida 33014
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Dermavant Clinical Site

    Orlando, Florida 32801
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Orlando, Florida 32801
    United States

    Site Not Available

  • Dermavant Clinical Site

    Pinellas Park, Florida 33781
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Pinellas Park, Florida 33781
    United States

    Site Not Available

  • Dermavant Investigative Site

    Sweetwater, Florida 33172
    United States

    Site Not Available

  • Dermavant Clinical Site

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Tampa, Florida 33607
    United States

    Site Not Available

  • Dermavant Investigative Site

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Dermavant Clinical Site

    Sandy Springs, Georgia 30328
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Dermavant Clinical Site

    Savannah, Georgia 31406
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Dermavant Investigative Site

    Snellville, Georgia 30078
    United States

    Site Not Available

  • Dermavant Investigative Site

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Dermavant Clinical Site

    Evansville, Indiana 47715
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Evansville, Indiana 47715
    United States

    Site Not Available

  • Dermavant Clinical Site

    Plainfield, Indiana 46168
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Plainfield, Indiana 46168
    United States

    Site Not Available

  • Dermavant Investigative Site

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • Dermavant Clinical Site

    Lexington, Kentucky 40517
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Lexington, Kentucky 40517
    United States

    Site Not Available

  • Dermavant Clinical Site

    Louisville, Kentucky 40217
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Louisville, Kentucky 40217
    United States

    Site Not Available

  • Dermavant Investigative Site

    Owensboro, Kentucky 42301
    United States

    Site Not Available

  • Dermavant Clinical Site

    Baton Rouge, Louisiana 70809
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Dermavant Clinical Site

    Covington, Louisiana 70433
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Covington, Louisiana 70433
    United States

    Site Not Available

  • Dermavant Clinical Site

    Monroe, Louisiana 71201
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Monroe, Louisiana 71201
    United States

    Site Not Available

  • Dermavant Clinical Site

    New Orleans, Louisiana 70115
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Dermavant Clinical Site

    Largo, Maryland 20774
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Largo, Maryland 20774
    United States

    Site Not Available

  • Dermavant Clinical Site

    Rockville, Maryland 20850
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Dermavant Clinical Site

    Bay City, Michigan 48706
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Bay City, Michigan 48706
    United States

    Site Not Available

  • Dermavant Clinical Site

    Clarkston, Michigan 48346
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Clarkston, Michigan 48346
    United States

    Site Not Available

  • Dermavant Clinical Site

    Warren, Michigan 48088
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Warren, Michigan 48088
    United States

    Site Not Available

  • Dermavant Clinical Site

    Ypsilanti, Michigan 48197
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Dermavant Clinical Site

    New Brighton, Minnesota 55112
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    New Brighton, Minnesota 55112
    United States

    Site Not Available

  • Dermavant Clinical Site

    Missoula, Montana 59808
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Missoula, Montana 59808
    United States

    Site Not Available

  • Dermavant Clinical Site

    Omaha, Nebraska 68144
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Omaha, Nebraska 68144
    United States

    Site Not Available

  • Dermavant Investigative Site

    East Windsor, New Jersey 08520
    United States

    Site Not Available

  • Dermavant Clinical Site

    Garden City, New York 11530
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Garden City, New York 11530
    United States

    Site Not Available

  • Dermavant Investigative Site

    New York, New York 10075
    United States

    Site Not Available

  • Dermavant Investigative Site

    Charlotte, North Carolina 28277
    United States

    Site Not Available

  • Dermavant Clinical Site

    Bexley, Ohio 43209
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Bexley, Ohio 43209
    United States

    Site Not Available

  • Dermavant Investigative Site

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Dermavant Clinical Site

    Dayton, Ohio 45414
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Dayton, Ohio 45414
    United States

    Site Not Available

  • Dermavant Investigative Site

    Mason, Ohio 45040
    United States

    Site Not Available

  • Dermavant Clinical Site

    Mayfield Heights, Ohio 44124
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Mayfield Heights, Ohio 44124
    United States

    Site Not Available

  • Dermavant Clinical Site

    Norman, Oklahoma 73071
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Norman, Oklahoma 73071
    United States

    Site Not Available

  • Dermavant Clinical Site

    Oklahoma City, Oklahoma 73120
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Oklahoma City, Oklahoma 73120
    United States

    Site Not Available

  • Dermavant Clinical Site

    Tulsa, Oklahoma 74114
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Tulsa, Oklahoma 74114
    United States

    Site Not Available

  • Dermavant Investigative Site

    Medford, Oregon 97504
    United States

    Site Not Available

  • Dermavant Clinical Site

    Portland, Oregon 97223
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Portland, Oregon 97210
    United States

    Site Not Available

  • Dermavant Clinical Site

    Anderson, South Carolina 29621
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • Dermavant Clinical Site

    Greenville, South Carolina 29615
    United States

    Active - Recruiting

  • Dermavant lnvestigative Site

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Dermavant Clinical Site

    Mount Pleasant, South Carolina 29445
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Mount Pleasant, South Carolina 29445
    United States

    Site Not Available

  • Dermavant Investigative Site

    North Charleston, South Carolina 29420
    United States

    Site Not Available

  • Dermavant Clinical Site

    Spartanburg, South Carolina 29303
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Dermavant Clinical Site

    Knoxville, Tennessee 37909
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Knoxville, Tennessee 37909
    United States

    Site Not Available

  • Dermavant Clinical Site

    Memphis, Tennessee 38119
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Dermavant Investigative Site

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Dermavant Clinical Site

    Cypress, Texas 77433
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Cypress, Texas 77433
    United States

    Site Not Available

  • Dermavant Investigative Site

    Dallas, Texas 75230
    United States

    Site Not Available

  • Dermavant Clinical Site

    Dripping Springs, Texas 78620
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Dripping Springs, Texas 78620
    United States

    Site Not Available

  • Dermavant Investigative Site

    Grapevine, Texas 76051
    United States

    Site Not Available

  • Dermavant Investigative Site

    Houston, Texas 77004
    United States

    Site Not Available

  • Dermavant Clinical Site

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    San Antonio, Texas 78213
    United States

    Site Not Available

  • Dermavant Clinical Site

    Sugar Land, Texas 77479
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Dermavant Investigative Site

    Webster, Texas 77598
    United States

    Site Not Available

  • Dermavant Investigative Site

    Richmond, Virginia 23226
    United States

    Site Not Available

  • Dermavant Clinical Site

    Spokane, Washington 99202
    United States

    Active - Recruiting

  • Dermavant Investigative Site

    Spokane, Washington 99202
    United States

    Site Not Available

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