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

NCT ID: NCT03956355

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 510 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-21
• Study Completion Date: 2020-05-26

Brief 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.

Detailed 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).

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Tapinarof (DMVT-505)

Tapinarof (DMVT-505) Cream Group

Group Type: EXPERIMENTAL

Tapinarof

Intervention Type: DRUG

Tapinarof cream, 1%, applied once daily

Vehicle Cream

Vehicle Cream Group

Group Type: PLACEBO_COMPARATOR

Vehicle Cream

Intervention Type: DRUG

Vehicle cream applied once daily

Interventions

Tapinarof

Tapinarof cream, 1%, applied once daily

Intervention Type: DRUG

Vehicle Cream

Vehicle cream applied once daily

Intervention Type: DRUG

Other Intervention Names

DMVT-505

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IQVIA Biotech

INDUSTRY

Sponsor Role: collaborator

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victoria Butners

Role: STUDY_DIRECTOR

Dermavant Sciences GmbH

Locations

Dermavant Investigative Site

Birmingham, Alabama, United States

Dermavant Investigative Site

Phoenix, Arizona, United States

Dermavant Investigative Site

Hot Springs, Arkansas, United States

Dermavant Investigative Site

Rogers, Arkansas, United States

Dermavant Investigative Site

Anaheim Hills, California, United States

Dermavant Investigative Site

Fresno, California, United States

Dermavant Investigative Site

Los Angeles, California, United States

Dermavant Investigative Site

Northridge, California, United States

Dermavant Investigative Site

San Diego, California, United States

Dermavant Investigative Site

Santa Ana, California, United States

Dermavant Investigative Site

Cromwell, Connecticut, United States

Dermavant Investigative Site

Boca Raton, Florida, United States

Dermavant Investigative Site

Brandon, Florida, United States

Dermavant Investigative Site

Hialeah, Florida, United States

Dermavant Investigative Site

Miramar, Florida, United States

Dermavant Investigative Site

Marietta, Georgia, United States

Dermavant Investigative Site

Evansville, Indiana, United States

Dermavant Investigative Site

Indianapolis, Indiana, United States

Dermavant Investigative Site

New Albany, Indiana, United States

Dermavant Investigative Site

Louisville, Kentucky, United States

Dermavant Investigative Site

Owensboro, Kentucky, United States

Dermavant Investigative Site

Baton Rouge, Louisiana, United States

Dermavant Investigative Site

New Orleans, Louisiana, United States

Dermavant Investigative Site

New Orleans, Louisiana, United States

Dermavant Investigative Site

Boston, Massachusetts, United States

Dermavant Investigative Site

Clarkston, Michigan, United States

Dermavant Investigative Site

Warren, Michigan, United States

Dermavant Investigative Site

Saint Joseph, Missouri, United States

Dermavant Investigative Site

Verona, New Jersey, United States

Dermavant Investigative Site

Kew Gardens, New York, United States

Dermavant Investigative Site

New York, New York, United States

Dermavant Investigative Site

Rochester, New York, United States

Dermavant Investigative Site

Cary, North Carolina, United States

Dermavant Investigative Site

High Point, North Carolina, United States

Dermavant Investigative Site

Norman, Oklahoma, United States

Dermavant Investigative Site

Portland, Oregon, United States

Dermavant Investigative Site

Pittsburgh, Pennsylvania, United States

Dermavant Investigative Site

Johnston, Rhode Island, United States

Dermavant Investigative Site

Arlington, Texas, United States

Dermavant Investigative Site

College Station, Texas, United States

Dermavant Investigative Site

Dripping Springs, Texas, United States

Dermavant Investigative Site

Houston, Texas, United States

Dermavant Investigative Site

San Antonio, Texas, United States

Dermavant Investigative Site

West Jordan, Utah, United States

Dermavant Investigative Site

Saint Johns, Newfoundland and Labrador, Canada

Dermavant Investigative Site

Ajax, Ontario, Canada

Dermavant Investigative Site

Coburg, Ontario, Canada

Dermavant Investigative Site

North Bay, Ontario, Canada

Dermavant Investigative Site

Richmond Hill, Ontario, Canada

Dermavant Investigative Site

Toronto, Ontario, Canada

Dermavant Investigative Site

Waterloo, Ontario, Canada

Dermavant Investigative Site

Windsor, Ontario, Canada

Dermavant Investigative Site

Montreal, Quebec, Canada

Countries

United States; Canada

References

Lebwohl MG, Stein Gold L, Strober B, Papp KA, Armstrong AW, Bagel J, Kircik L, Ehst B, Hong HC, Soung J, Fromowitz J, Guenthner S, Piscitelli SC, Rubenstein DS, Brown PM, Tallman AM, Bissonnette R. Phase 3 Trials of Tapinarof Cream for Plaque Psoriasis. N Engl J Med. 2021 Dec 9;385(24):2219-2229. doi: 10.1056/NEJMoa2103629.

Reference Type: RESULT

PMID: 34879448 (View on PubMed)

Gold LS, Bruno MJ, Lewitt GM, Hebert AA. Characteristics and management of follicular events and contact dermatitis in patients using tapinarof cream for the treatment of atopic dermatitis or plaque psoriasis. J Dermatolog Treat. 2025 Dec;36(1):2517388. doi: 10.1080/09546634.2025.2517388. Epub 2025 Jul 2.

Reference Type: DERIVED

PMID: 40600584 (View on PubMed)

Kircik L, Zirwas M, Kwatra SG, Lewitt GM, Glover H, Chao T, Brown PM, Rubenstein DS, Tallman AM. Rapid Improvements in Itch with Tapinarof Cream 1% Once Daily in Two Phase 3 Trials in Adults with Mild to Severe Plaque Psoriasis. Dermatol Ther (Heidelb). 2024 Jan;14(1):201-211. doi: 10.1007/s13555-023-01068-x. Epub 2023 Dec 21.

Reference Type: DERIVED

PMID: 38123875 (View on PubMed)

Desai SR, Stein Gold L, Cameron MC, Golant A, Lewitt GM, Bruno MJ, Martin G, Brown PM, Rubenstein DS, Butners V, Tallman AM. Tapinarof Cream 1% Once Daily for the Treatment of Plaque Psoriasis: Case Photography of Clinical Outcomes from Three Phase 3 Trials. Dermatol Ther (Heidelb). 2023 Oct;13(10):2443-2460. doi: 10.1007/s13555-023-01008-9. Epub 2023 Sep 11.

Reference Type: DERIVED

PMID: 37697121 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

DMVT-505-3001

Identifier Type: -

Identifier Source: org_study_id