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

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, psoralens, 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 cardiovascular (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.

NCT03956355
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)

Tapinarof (DMVT-505) Cream Group

Placebo Comparator: Vehicle Cream

Vehicle Cream Group

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, Birmingham, Alabama

Status

Recruiting

Address

Dermavant Investigative Site

Birmingham, Alabama, 35205

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Phoenix, Arizona

Status

Recruiting

Address

Dermavant Investigative Site

Phoenix, Arizona, 85032

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Hot Springs, Arkansas

Status

Recruiting

Address

Dermavant Investigative Site

Hot Springs, Arkansas, 71913

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Rogers, Arkansas

Status

Recruiting

Address

Dermavant Investigative Site

Rogers, Arkansas, 72758

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Anaheim Hills, California

Status

Recruiting

Address

Dermavant Investigative Site

Anaheim Hills, California, 92807

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Fresno, California

Status

Recruiting

Address

Dermavant Investigative Site

Fresno, California, 93720

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, 90033

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Northridge, California

Status

Recruiting

Address

Dermavant Investigative Site

Northridge, California, 91324

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 Ana, California

Status

Recruiting

Address

Dermavant Investigative Site

Santa Ana, California, 92701

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Cromwell, Connecticut

Status

Recruiting

Address

Dermavant Investigative Site

Cromwell, Connecticut, 06416

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Boca Raton, Florida

Status

Recruiting

Address

Dermavant Investigative Site

Boca Raton, Florida, 33431

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Hialeah, Florida

Status

Recruiting

Address

Dermavant Investigative Site

Hialeah, Florida, 33016

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Miramar, Florida

Status

Recruiting

Address

Dermavant Investigative Site

Miramar, Florida, 33027

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Evansville, Indiana

Status

Recruiting

Address

Dermavant Investigative Site

Evansville, Indiana, 47714

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Indianapolis, Indiana

Status

Recruiting

Address

Dermavant Investigative Site

Indianapolis, Indiana, 46250

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, New Albany, Indiana

Status

Recruiting

Address

Dermavant Investigative Site

New Albany, Indiana, 47150

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, 40202

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Baton Rouge, Louisiana

Status

Recruiting

Address

Dermavant Investigative Site

Baton Rouge, Louisiana, 70809

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, New Orleans, Louisiana

Status

Recruiting

Address

Dermavant Investigative Site

New Orleans, Louisiana, 70112

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, New Orleans, Louisiana

Status

Recruiting

Address

Dermavant Investigative Site

New Orleans, Louisiana, 70115

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, 02115

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Clarkston, Michigan

Status

Recruiting

Address

Dermavant Investigative Site

Clarkston, Michigan, 48346

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Warren, Michigan

Status

Recruiting

Address

Dermavant Investigative Site

Warren, Michigan, 48088

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Saint Joseph, Missouri

Status

Recruiting

Address

Dermavant Investigative Site

Saint Joseph, Missouri, 64506

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Verona, New Jersey

Status

Recruiting

Address

Dermavant Investigative Site

Verona, New Jersey, 07044

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Kew Gardens, New York

Status

Recruiting

Address

Dermavant Investigative Site

Kew Gardens, New York, 11374

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, New York, New York

Status

Recruiting

Address

Dermavant Investigative Site

New York, New York, 10029

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Rochester, New York

Status

Recruiting

Address

Dermavant Investigative Site

Rochester, New York, 14623

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Cary, North Carolina

Status

Recruiting

Address

Dermavant Investigative Site

Cary, North Carolina, 27518

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, High Point, North Carolina

Status

Recruiting

Address

Dermavant Investigative Site

High Point, North Carolina, 27262

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Norman, Oklahoma

Status

Recruiting

Address

Dermavant Investigative Site

Norman, Oklahoma, 73071

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, 97210

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Pittsburgh, Pennsylvania

Status

Recruiting

Address

Dermavant Investigative Site

Pittsburgh, Pennsylvania, 15213

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Johnston, Rhode Island

Status

Recruiting

Address

Dermavant Investigative Site

Johnston, Rhode Island, 02919

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Arlington, Texas

Status

Recruiting

Address

Dermavant Investigative Site

Arlington, Texas, 76011

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, College Station, Texas

Status

Recruiting

Address

Dermavant Investigative Site

College Station, Texas, 77802

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Dripping Springs, Texas

Status

Recruiting

Address

Dermavant Investigative Site

Dripping Springs, Texas, 78620

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, 77004

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, 78213

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, West Jordan, Utah

Status

Recruiting

Address

Dermavant Investigative Site

West Jordan, Utah, 84088

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

International Sites

Dermavant Investigative Site, Saint Johns, Newfoundland and Labrador, Canada

Status

Recruiting

Address

Dermavant Investigative Site

Saint Johns, Newfoundland and Labrador, A1C 2H5

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Ajax, Ontario, Canada

Status

Recruiting

Address

Dermavant Investigative Site

Ajax, Ontario, L1S 7K8

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Coburg, Ontario, Canada

Status

Recruiting

Address

Dermavant Investigative Site

Coburg, Ontario, K9A 4J9

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, North Bay, Ontario, Canada

Status

Recruiting

Address

Dermavant Investigative Site

North Bay, Ontario, P1B 3Z7

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Richmond Hill, Ontario, Canada

Status

Recruiting

Address

Dermavant Investigative Site

Richmond Hill, Ontario, L4C 9M7

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Toronto, Ontario, Canada

Status

Recruiting

Address

Dermavant Investigative Site

Toronto, Ontario, M3H 5Y8

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Waterloo, Ontario, Canada

Status

Recruiting

Address

Dermavant Investigative Site

Waterloo, Ontario, N2J 1C4

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Windsor, Ontario, Canada

Status

Recruiting

Address

Dermavant Investigative Site

Windsor, Ontario, N8W 5L7

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

Dermavant Investigative Site, Montréal, Quebec, Canada

Status

Recruiting

Address

Dermavant Investigative Site

Montréal, Quebec, H2X 2V1

Site Contact

Dermavant Investigational Sites

LaShanna.Lockhart@iqvia.com

1-984-459-2403

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