Long Term Extension Study of Tapinarof for Plaque Psoriasis in Adults (3003)

Last updated: September 16, 2022
Sponsor: Dermavant Sciences GmbH
Overall Status: Completed

Phase

3

Condition

Rosacea

Skin Wounds

Psoriasis And Psoriatic Disorders

Treatment

N/A

Clinical Study ID

NCT04053387
DMVT-505-3003
  • Ages 18-75
  • All Genders

Study Summary

This is a long-term, open-label, multicenter, study to evaluate the safety and efficacy of topical tapinarof cream, 1% in adults with plaque psoriasis. Subjects in this study completed treatment in 1 of 2 Phase 3 pivotal efficacy and safety studies (Study DMVT-505-3001 or Study DMVT-505-3002). This study will consist of up to 40 weeks of treatment and a 4-week safety follow-up period.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Completed the 12-week treatment period in 1 of the 2 parent studies (StudyDMVT-505-3001 or Study DMVT-505-3002);
  2. Male and female subjects
  3. Females of child bearing potential and male subjects who are engaging in sexualactivity that could lead to pregnancy agree to follow the specified contraceptiveguidance while on the study, and for at least 4 weeks after the last exposure to studytreatment
  4. Capable of giving written informed consent

Exclusion

Exclusion Criteria:

  1. Used a prohibited concomitant product or procedure to treat psoriasis during parentstudy
  2. Had a serious adverse event (SAE) that was potentially related to treatment orexperienced an adverse event (AE) that led to permanent discontinuation of treatmentin the parent study
  3. History of or ongoing serious illness or medical, physical, or psychiatriccondition(s) that, in the Investigator's opinion, may interfere with the subject'scompletion of the study
  4. Known hypersensitivity to tapinarof

Study Design

Total Participants: 763
Study Start date:
August 13, 2019
Estimated Completion Date:
April 06, 2021

Study Description

At the completion of the Week-12 visit of the pivotal study (Baseline [Day 1] in this study), all eligible subjects will be offered enrollment in the long-term extension 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 44 weeks.

Connect with a study center

  • Dermavant Investigative Site

    Edmonton, Alberta T5K 1X3
    Canada

    Site Not Available

  • Dermavant Investigative Site

    Surrey, British Columbia V3R 6A7
    Canada

    Site Not Available

  • Dermavant Investigative Site

    Ajax, Ontario L1S 7K8
    Canada

    Site Not Available

  • Dermavant Clinical Site

    Burlington, Ontario L7L 6W6
    Canada

    Site Not Available

  • Dermavant Investigative Site

    Cobourg, Ontario K9A 0Z4
    Canada

    Site Not Available

  • Dermavant Investigative Site

    Etobicoke, Ontario M8X 1Y9
    Canada

    Site Not Available

  • Dermavant Clinical Site

    Hamilton, Ontario L8S 1G5
    Canada

    Site Not Available

  • Dermavant Investigative Site

    Hamilton, Ontario L8N 1Y2
    Canada

    Site Not Available

  • Dermavant Clinical Site

    Markham, Ontario L3P 1X3
    Canada

    Site Not Available

  • Dermavant Investigative Site

    Markham, Ontario L3P 1X2
    Canada

    Site Not Available

  • Dermavant Investigative Site

    North Bay, Ontario P1B 3Z7
    Canada

    Site Not Available

  • Dermavant Investigative Site

    Oakville, Ontario L6J 7W5
    Canada

    Site Not Available

  • Dermavant Investigative Site

    Ottawa, Ontario K2C 3N2
    Canada

    Site Not Available

  • Dermavant Investigative Site

    Richmond Hill, Ontario L4C 9M7
    Canada

    Site Not Available

  • Dermavant Investigative Site

    Toronto, Ontario M3H 5Y8
    Canada

    Site Not Available

  • Dermavant Investigative Site

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • Dermavant Investigative Site

    Windsor, Ontario N8W 5L7
    Canada

    Site Not Available

  • Dermavant Investigative Site

    Montréal, Quebec H2X 2V1
    Canada

    Site Not Available

  • Dermavant Investigative Site

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • Dermavant Investigative Site

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Dermavant Investigative Site

    Bryant, Arkansas 72022
    United States

    Site Not Available

  • Dermavant Investigative Site

    Fort Smith, Arkansas 72916
    United States

    Site Not Available

  • Dermavant Investigative Site

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Dermavant Investigative Site

    Fremont, California 94538
    United States

    Site Not Available

  • Dermavant Investigative Site

    Fresno, California 93720
    United States

    Site Not Available

  • Dermavant Investigative Site

    Los Angeles, California 90033
    United States

    Site Not Available

  • Dermavant Investigative Site

    Northridge, California 91324
    United States

    Site Not Available

  • Dermavant Investigative Site

    Oceanside, California 92056
    United States

    Site Not Available

  • Dermavant Investigative Site

    San Diego, California 92123
    United States

    Site Not Available

  • Dermavant Investigative Site

    Santa Ana, California 92701
    United States

    Site Not Available

  • Dermavant Investigative Site

    Santa Monica, California 90404
    United States

    Site Not Available

  • Dermavant Investigative Site

    Denver, Colorado 80210
    United States

    Site Not Available

  • Dermavant Investigative Site

    Cromwell, Connecticut 06416
    United States

    Site Not Available

  • Dermavant Investigative Site

    Boca Raton, Florida 33431
    United States

    Site Not Available

  • Dermavant Investigative Site

    Boynton Beach, Florida 33437
    United States

    Site Not Available

  • Dermavant Investigative Site

    Hialeah, Florida 33016
    United States

    Site Not Available

  • Dermavant Investigative Site

    Margate, Florida 33063
    United States

    Site Not Available

  • Dermavant Investigative Site

    Miami, Florida 33144
    United States

    Site Not Available

  • Dermavant Investigative Site

    Miramar, Florida 33027
    United States

    Site Not Available

  • Dermavant Investigative Site

    Boise, Idaho 83713
    United States

    Site Not Available

  • Dermavant Investigative Site

    Rolling Meadows, Illinois 60008
    United States

    Site Not Available

  • Dermavant Investigative Site

    Evansville, Indiana 47714
    United States

    Site Not Available

  • Dermavant Investigative Site

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Dermavant Investigative Site

    New Albany, Indiana 47150
    United States

    Site Not Available

  • Dermavant Investigative Site

    Plainfield, Indiana 46168
    United States

    Site Not Available

  • Dermavant Investigative Site

    Overland Park, Kansas 66215
    United States

    Site Not Available

  • Dermavant Investigative Site

    Louisville, Kentucky 40217
    United States

    Site Not Available

  • Dermavant Investigative Site

    Owensboro, Kentucky 42303
    United States

    Site Not Available

  • Dermavant Investigative Site

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Dermavant Investigative Site

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Dermavant Investigative Site

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Dermavant Investigative Site

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Dermavant Investigative Site

    Bay City, Michigan 48706
    United States

    Site Not Available

  • Dermavant Investigative Site

    Clarkston, Michigan 48346
    United States

    Site Not Available

  • Dermavant Clinical Site

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Dermavant Investigational Site

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Dermavant Investigative Site

    Fort Gratiot, Michigan 48059
    United States

    Site Not Available

  • Dermavant Investigative Site

    Warren, Michigan 48088
    United States

    Site Not Available

  • Dermavant Investigative Site

    Fridley, Minnesota 55432
    United States

    Site Not Available

  • Dermavant Investigative Site

    Saint Joseph, Missouri 64506
    United States

    Site Not Available

  • Dermavant Investigative Site

    Omaha, Nebraska 68144
    United States

    Site Not Available

  • Dermavant Clinical Site

    Las Vegas, Nevada 89148
    United States

    Site Not Available

  • Dermavant Investigative Site

    Las Vegas, Nevada 89148
    United States

    Site Not Available

  • Dermavant Investigative Site

    East Windsor, New Jersey 08520
    United States

    Site Not Available

  • Dermavant Investigative Site

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Dermavant Investigative Site

    Verona, New Jersey 07044
    United States

    Site Not Available

  • Dermavant Clinical Site

    Brooklyn, New York 11203
    United States

    Site Not Available

  • Dermavant Investigative Site

    Forest Hills, New York 11375
    United States

    Site Not Available

  • Dermavant Investigative Site

    Kew Gardens, New York 11374
    United States

    Site Not Available

  • Dermavant Investigative Site

    New York, New York 10029
    United States

    Site Not Available

  • Dermavant Investigative Site

    Rochester, New York 14623
    United States

    Site Not Available

  • Dermavant Investigative Site

    Stony Brook, New York 11790
    United States

    Site Not Available

  • Dermavant Clinical Site

    Watertown, New York 13601
    United States

    Site Not Available

  • Dermavant Investigative Site

    Cary, North Carolina 27518
    United States

    Site Not Available

  • Dermavant Investigative Site

    High Point, North Carolina 27262
    United States

    Site Not Available

  • Dermavant Investigative Site

    Wilmington, North Carolina 28405
    United States

    Site Not Available

  • Dermavant Investigative Site

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Dermavant Investigative Site

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • Dermavant Investigative Site

    Bexley, Ohio 43209
    United States

    Site Not Available

  • Dermavant Investigate Site

    Norman, Oklahoma 73072
    United States

    Site Not Available

  • Dermavant Investigative Site

    Norman, Oklahoma 73071
    United States

    Site Not Available

  • Dermavant Clinical Site

    Gresham, Oregon 97030
    United States

    Site Not Available

  • Dermavant Investigative Site

    Portland, Oregon 97223
    United States

    Site Not Available

  • Dermavant Investigative Site

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Dermavant Investigative Site

    Johnston, Rhode Island 02919
    United States

    Site Not Available

  • Dermavant Investigative Site

    Charleston, South Carolina 29407
    United States

    Site Not Available

  • Dermavant Investigative Site

    Nashville, Tennessee 37215
    United States

    Site Not Available

  • Dermavant Investigative Site

    Arlington, Texas 76011
    United States

    Site Not Available

  • Dermavant Clinical Site

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Dermavant Investigative Site

    College Station, Texas 77845
    United States

    Site Not Available

  • Dermavant Investigative Site

    Dripping Springs, Texas 78620
    United States

    Site Not Available

  • Dermavant Clinical Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Dermavant Investigative Site

    Houston, Texas 77004
    United States

    Site Not Available

  • Dermavant Investigative Site

    Pflugerville, Texas 78660
    United States

    Site Not Available

  • Dermavant Investigative Site

    Plano, Texas 75024
    United States

    Site Not Available

  • Dermavant Investigative Site

    San Antonio, Texas 78213
    United States

    Site Not Available

  • Dermavant Investigative Site

    Webster, Texas 77598
    United States

    Site Not Available

  • Dermavant Investigative Site

    West Jordan, Utah 84088
    United States

    Site Not Available

  • Dermavant Investigative Site

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Dermavant Investigative Site

    Spokane, Washington 99202
    United States

    Site Not Available

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