Tapinarof for the Treatment of Plaque Psoriasis in Adults (3001)

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

Phase

3

Condition

Warts

Rosacea

Scalp Disorders

Treatment

N/A

Clinical Study ID

NCT03956355
DMVT-505-3001
  • 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, fumaric acidderivatives, vitamin D3 and analogs, retinoids, psoralens, corticosteroids,adrenocorticotropic hormone analogs, and tazarotene
  • 2 weeks for immunizations with a live viral component; drugs known to possibly worsenpsoriasis, 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 cardiovascular (CV) system abnormalities or laboratoryabnormality that will affect the health of the subject or interfere withinterpretation of the results

Study Design

Total Participants: 510
Study Start date:
May 21, 2019
Estimated Completion Date:
May 26, 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

    Saint Johns, Newfoundland and Labrador A1C 2H5
    Canada

    Site Not Available

  • Dermavant Investigative Site

    Ajax, Ontario L1S 7K8
    Canada

    Site Not Available

  • Dermavant Investigative Site

    Coburg, Ontario K9A 0Z4
    Canada

    Site Not Available

  • Dermavant Investigative Site

    North Bay, Ontario P1B 3Z7
    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

    Hot Springs, Arkansas 71913
    United States

    Site Not Available

  • Dermavant Investigative Site

    Rogers, Arkansas 72758
    United States

    Site Not Available

  • Dermavant Investigative Site

    Anaheim Hills, California 92807
    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

    San Diego, California 92123
    United States

    Site Not Available

  • Dermavant Investigative Site

    Santa Ana, California 92701
    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

    Brandon, Florida 33511
    United States

    Site Not Available

  • Dermavant Investigative Site

    Hialeah, Florida 33016
    United States

    Site Not Available

  • Dermavant Investigative Site

    Miramar, Florida 33027
    United States

    Site Not Available

  • Dermavant Investigative Site

    Marietta, Georgia 30060
    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

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Dermavant Investigative Site

    Owensboro, Kentucky 42301
    United States

    Site Not Available

  • Dermavant Investigative Site

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Dermavant Investigative Site

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Dermavant Investigative Site

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Dermavant Investigative Site

    Clarkston, Michigan 48346
    United States

    Site Not Available

  • Dermavant Investigative Site

    Warren, Michigan 48088
    United States

    Site Not Available

  • Dermavant Investigative Site

    Saint Joseph, Missouri 64506
    United States

    Site Not Available

  • Dermavant Investigative Site

    Verona, New Jersey 07044
    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

    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

    Norman, Oklahoma 73071
    United States

    Site Not Available

  • Dermavant Investigative Site

    Portland, Oregon 97210
    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

    Arlington, Texas 76011
    United States

    Site Not Available

  • Dermavant Investigative Site

    College Station, Texas 77802
    United States

    Site Not Available

  • Dermavant Investigative Site

    Dripping Springs, Texas 78620
    United States

    Site Not Available

  • Dermavant Investigative Site

    Houston, Texas 77004
    United States

    Site Not Available

  • Dermavant Investigative Site

    San Antonio, Texas 78213
    United States

    Site Not Available

  • Dermavant Investigative Site

    West Jordan, Utah 84088
    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.