Tapinarof for the Treatment of Plaque Psoriasis in Adults (3002)

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

Phase

3

Condition

Psoriasis And Psoriatic Disorders

Rosacea

Rash

Treatment

N/A

Clinical Study ID

NCT03983980
DMVT-505-3002
  • Ages 18-75
  • All Genders

Study Summary

This is a randomized double-blind vehicle-controlled Phase 3 study to evaluate the efficacy and safety of topical tapinarof cream, 1% once daily for the treatment of plaque psoriasis in adults. Approximately 500 adult subjects with plaque psoriasis will be randomized 2:1 to receive either tapinarof cream, 1% or matching vehicle cream once daily for 12 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female subjects ages 18 to 75 years with clinical diagnosis of chronic plaquepsoriasis and stable disease for at least 6 months prior to the study.
  • BSA involvement ≥ 3% and ≤ 20%
  • A PGA score of 2 (mild), 3 (moderate) or 4 (severe) at screening and baseline
  • Females of child bearing potential and male subjects who are engaging in sexualactivity that could lead to pregnancy agree to follow the specified contraceptiveguidance throughout the study, including screening, during the treatment period, andfor at least 4 weeks after the last exposure to study treatment
  • Capable of giving written informed consent

Exclusion

Exclusion Criteria:

  • Psoriasis other than plaque variant
  • Any sign of infection of any of the psoriatic lesions
  • Concurrent conditions or history of other diseases:
  • Immunocompromised at Screening
  • Chronic or acute infection requiring treatment with systemic antibiotics, antivirals,antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to the Baselinevisit
  • Acute active bacterial, fungal, or viral (herpes simplex, herpes zoster, chicken pox)skin infection within 1 week prior to the Baseline visit
  • Significant dermatologic or inflammatory condition other than plaque psoriasis that,in the Investigator's opinion, would make it difficult to interpret data orassessments during the study
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5x the upperlimit of normal (ULN)
  • Total bilirubin > 1.5 x ULN; total bilirubin > ULN and ≤ 1.5 x ULN is acceptable ifbilirubin is fractionated and direct bilirubin < 35%
  • Corrected QT interval > 475
  • Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), presence ofhepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result, ora positive anti-hepatitis B core antigen (anti-HBc) result
  • Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sourcesof UV radiation within 4 weeks prior to the Baseline visit and/or plans to have suchexposures during the study which could potentially impact the subject's psoriasis
  • Use of any prohibited medication within the indicated period before the first dose ofstudy drug
  • Within a minimum of 5 half-lives for biologic agents:
  • Within 4 weeks for systemic immunosuppressive or immunomodulating agents, fumaricacid derivatives, vitamin D3 and analogs, retinoids, psolarens, corticosteroids,adrenocorticotropic hormone analogs, and tazarotene
  • 2 weeks for immunizations with a live viral component; drugs known to possiblyworsen psoriasis, unless on a stable dose for > 12 weeks
  • With the exception of non-medicated emollients, 2 weeks for topical treatmentsincluding corticosteroids, immunomodulators, anthralin (dithranol), vitamin Dderivatives or coal tar.
  • Pregnant females or lactating females
  • History of sensitivity to the study drugs, or components thereof or a history of drugor other allergy that, in the opinion of the Investigator or Medical Monitor,contraindicates the subject's participation in the study
  • The subject has received an investigational product within 30 days, 5 half-lives, ortwice the duration of the biological effect of the study drug (whichever is longer)prior to first dose of study drug
  • Current or a history of cancer within 5 years except for fully excised skin basal cellcarcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
  • Subjects with active infection that required oral, intramuscular, or intravenousadministration of antibiotics, antifungal or antiviral agents within 7 days ofBaseline/Day 1
  • Previous known participation in a clinical study with tapinarof
  • Evidence of significant hepatic, renal, respiratory, endocrine, hematologic,neurologic, psychiatric, or CV system abnormalities or laboratory abnormality thatwill affect the health of the subject or interfere with interpretation of the results

Study Design

Total Participants: 515
Study Start date:
June 06, 2019
Estimated Completion Date:
May 29, 2020

Study Description

This study is a 12-week double-blind, vehicle-controlled treatment study in which subjects will be randomized to receive tapinarof cream, 1% or vehicle cream once daily for 12 weeks. At the end of the 12-week study treatment, qualified subjects completing the study will have the option to enter a separate open-label, long-term safety and efficacy study for an additional 40 weeks of treatment with tapinarof cream, 1%. Subjects who do not enroll in the open-label long-term study will complete a follow-up visit approximately 4 weeks after end of treatment in this study (at Week 16).

Connect with a study center

  • Dermavant Investigative Site

    Edmonton, Alberta T5K 1X3
    Canada

    Site Not Available

  • Dermavant Investigative Site

    Surrey, Bristish Columbia V3R 6A7
    Canada

    Site Not Available

  • Dermavant Investigative Site

    Etobicoke, Ontario M9A 3P2
    Canada

    Site Not Available

  • Dermavant Investigative Site

    Hamilton, Ontario L8N 1Y2
    Canada

    Site Not Available

  • Dermavant Investigative Site

    Markham, Ontario L3P 1X2
    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

    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

    Los Angeles, California 90045
    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 Monica, California 90404
    United States

    Site Not Available

  • Dermavant Investigative Site

    Denver, Colorado 80210
    United States

    Site Not Available

  • Dermavant Investigative Site

    Boynton Beach, Florida 33437
    United States

    Site Not Available

  • Dermavant Investigative Site

    Margate, Florida 33414
    United States

    Site Not Available

  • Dermavant Investigative Site

    Miami, Florida 33144
    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

    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 42301
    United States

    Site Not Available

  • Dermavant Investigative Site

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Dermavant Investigative Site

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dermavant Investigative Site

    Bay City, Michigan 48706
    United States

    Site Not Available

  • Dermavant Investigative Site

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Dermavant Investigative Site

    Fort Gratiot, Michigan 48059
    United States

    Site Not Available

  • Dermavant Investigative Site

    Fridley, Minnesota 55432
    United States

    Site Not Available

  • Dermavant Investigative Site

    Omaha, Nebraska 68144
    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

    Stony Brook, New York 11790
    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 Investigative Site

    Portland, Oregon 97223
    United States

    Site Not Available

  • Dermavant Investigative Site

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • Dermavant Investigative Site

    Nashville, Tennessee 37215
    United States

    Site Not Available

  • Dermavant Investigative Site

    Houston, Texas 77056
    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 78229
    United States

    Site Not Available

  • Dermavant Investigative Site

    Webster, Texas 77598
    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

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.