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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Male and female subjects ages 18 to 75 years with clinical diagnosis of chronic plaque psoriasis 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 sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study, including screening, during the treatment period, and for at least 4 weeks after the last exposure to study treatment - Capable of giving written informed consent

    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 Baseline visit - 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 or assessments during the study - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5x the upper limit of normal (ULN) - Total bilirubin > 1.5 x ULN; total bilirubin > ULN and ≤ 1.5 x ULN is acceptable if bilirubin 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 of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result, or a positive anti-hepatitis B core antigen (anti-HBc) result - Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation within 4 weeks prior to the Baseline visit and/or plans to have such exposures during the study which could potentially impact the subject's psoriasis - Use of any prohibited medication within the indicated period before the first dose of study drug - Within a minimum of 5 half-lives for biologic agents: - Within 4 weeks for systemic immunosuppressive or immunomodulating agents, fumaric acid 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 possibly worsen psoriasis, unless on a stable dose for > 12 weeks - With the exception of non-medicated emollients, 2 weeks for topical treatments including corticosteroids, immunomodulators, anthralin (dithranol), vitamin D derivatives or coal tar.
- Pregnant females or lactating females - History of sensitivity to the study drugs, or components thereof or a history of drug or 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, or twice 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 cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix - Subjects with active infection that required oral, intramuscular, or intravenous administration of antibiotics, antifungal or antiviral agents within 7 days of Baseline/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 that will affect the health of the subject or interfere with interpretation of the results

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03983980
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Dermavant Sciences GmbH
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Victoria Butners
Principal Investigator Affiliation Dermavant Sciences GmbH
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plaque Psoriasis
Additional Details

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).

Arms & Interventions

Arms

Experimental: Tapinarof (DMVT-505) Cream Group

Tapinarof cream, 1%, applied once daily

Placebo Comparator: Vehicle Cream Group

Vehicle cream applied once daily

Interventions

Drug: - Tapinarof (DMVT-505)

Tapinarof cream, 1%, applied once daily

Drug: - Vehicle Cream

Vehicle cream applied once daily

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dermavant Investigative Site, Fort Smith, Arkansas

Status

Recruiting

Address

Dermavant Investigative Site

Fort Smith, Arkansas, 72916

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Fountain Valley, California

Status

Recruiting

Address

Dermavant Investigative Site

Fountain Valley, California, 92708

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Fremont, California

Status

Recruiting

Address

Dermavant Investigative Site

Fremont, California, 94538

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Los Angeles, California

Status

Recruiting

Address

Dermavant Investigative Site

Los Angeles, California, 90045

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Oceanside, California

Status

Recruiting

Address

Dermavant Investigative Site

Oceanside, California, 92056

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, San Diego, California

Status

Recruiting

Address

Dermavant Investigative Site

San Diego, California, 92123

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Santa Monica, California

Status

Recruiting

Address

Dermavant Investigative Site

Santa Monica, California, 90404

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Denver, Colorado

Status

Recruiting

Address

Dermavant Investigative Site

Denver, Colorado, 80210

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Boynton Beach, Florida

Status

Recruiting

Address

Dermavant Investigative Site

Boynton Beach, Florida, 33437

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Margate, Florida

Status

Recruiting

Address

Dermavant Investigative Site

Margate, Florida, 33414

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Miami, Florida

Status

Recruiting

Address

Dermavant Investigative Site

Miami, Florida, 33144

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Boise, Idaho

Status

Recruiting

Address

Dermavant Investigative Site

Boise, Idaho, 83713

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Rolling Meadows, Illinois

Status

Recruiting

Address

Dermavant Investigative Site

Rolling Meadows, Illinois, 60008

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Plainfield, Indiana

Status

Recruiting

Address

Dermavant Investigative Site

Plainfield, Indiana, 46168

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Overland Park, Kansas

Status

Recruiting

Address

Dermavant Investigative Site

Overland Park, Kansas, 66215

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Louisville, Kentucky

Status

Recruiting

Address

Dermavant Investigative Site

Louisville, Kentucky, 40217

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Owensboro, Kentucky

Status

Recruiting

Address

Dermavant Investigative Site

Owensboro, Kentucky, 42301

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Metairie, Louisiana

Status

Recruiting

Address

Dermavant Investigative Site

Metairie, Louisiana, 70006

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Boston, Massachusetts

Status

Recruiting

Address

Dermavant Investigative Site

Boston, Massachusetts, 02215

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Bay City, Michigan

Status

Recruiting

Address

Dermavant Investigative Site

Bay City, Michigan, 48706

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Detroit, Michigan

Status

Recruiting

Address

Dermavant Investigative Site

Detroit, Michigan, 48202

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Fort Gratiot, Michigan

Status

Recruiting

Address

Dermavant Investigative Site

Fort Gratiot, Michigan, 48059

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Fridley, Minnesota

Status

Recruiting

Address

Dermavant Investigative Site

Fridley, Minnesota, 55432

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Omaha, Nebraska

Status

Recruiting

Address

Dermavant Investigative Site

Omaha, Nebraska, 68144

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Las Vegas, Nevada

Status

Recruiting

Address

Dermavant Investigative Site

Las Vegas, Nevada, 89148

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, East Windsor, New Jersey

Status

Recruiting

Address

Dermavant Investigative Site

East Windsor, New Jersey, 08520

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Hackensack, New Jersey

Status

Recruiting

Address

Dermavant Investigative Site

Hackensack, New Jersey, 07601

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Stony Brook, New York

Status

Recruiting

Address

Dermavant Investigative Site

Stony Brook, New York, 11790

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Wilmington, North Carolina

Status

Recruiting

Address

Dermavant Investigative Site

Wilmington, North Carolina, 28405

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Winston-Salem, North Carolina

Status

Recruiting

Address

Dermavant Investigative Site

Winston-Salem, North Carolina, 27157

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Beachwood, Ohio

Status

Recruiting

Address

Dermavant Investigative Site

Beachwood, Ohio, 44122

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Bexley, Ohio

Status

Recruiting

Address

Dermavant Investigative Site

Bexley, Ohio, 43209

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Portland, Oregon

Status

Recruiting

Address

Dermavant Investigative Site

Portland, Oregon, 97223

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Charleston, South Carolina

Status

Recruiting

Address

Dermavant Investigative Site

Charleston, South Carolina, 29414

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Nashville, Tennessee

Status

Recruiting

Address

Dermavant Investigative Site

Nashville, Tennessee, 37215

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Houston, Texas

Status

Recruiting

Address

Dermavant Investigative Site

Houston, Texas, 77056

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Pflugerville, Texas

Status

Recruiting

Address

Dermavant Investigative Site

Pflugerville, Texas, 78660

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Plano, Texas

Status

Recruiting

Address

Dermavant Investigative Site

Plano, Texas, 75024

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, San Antonio, Texas

Status

Recruiting

Address

Dermavant Investigative Site

San Antonio, Texas, 78229

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Webster, Texas

Status

Recruiting

Address

Dermavant Investigative Site

Webster, Texas, 77598

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Norfolk, Virginia

Status

Recruiting

Address

Dermavant Investigative Site

Norfolk, Virginia, 23502

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Spokane, Washington

Status

Recruiting

Address

Dermavant Investigative Site

Spokane, Washington, 99202

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

International Sites

Dermavant Investigative Site, Edmonton, Alberta, Canada

Status

Recruiting

Address

Dermavant Investigative Site

Edmonton, Alberta, T5K 1X3

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Surrey, Bristish Columbia, Canada

Status

Recruiting

Address

Dermavant Investigative Site

Surrey, Bristish Columbia, V3R 6A7

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Surrey, Bristish Columbia, Canada

Status

Recruiting

Address

Dermavant Investigative Site

Surrey, Bristish Columbia, V3V 0C6

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Etobicoke, Ontario, Canada

Status

Recruiting

Address

Dermavant Investigative Site

Etobicoke, Ontario, M9A 3P2

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Hamilton, Ontario, Canada

Status

Recruiting

Address

Dermavant Investigative Site

Hamilton, Ontario, L8N 1Y2

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Markham, Ontario, Canada

Status

Recruiting

Address

Dermavant Investigative Site

Markham, Ontario, L3P 1X2

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Oakville, Ontario, Canada

Status

Recruiting

Address

Dermavant Investigative Site

Oakville, Ontario, L6J 7W5

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Ottawa, Ontario, Canada

Status

Recruiting

Address

Dermavant Investigative Site

Ottawa, Ontario, K2C 3N2

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

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