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

NCT03983980 | Completed Phase 3 Results FDA Drug

• 1 other identifier: DMVT-505-3002
• Study Type: interventional
• Target: 515
• Locations: 2 countries
• Sites: 50

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.

Conditions

Plaque Psoriasis

Keywords

Tapinarof; plaque psoriasis; adult; phase 3; topical; double-blind; efficacy; safety; psoriasis

Outcome Measures

Primary Outcomes (1)

• Percent of Subjects Who Achieve a Physician Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) With a Minimum 2-grade Improvement From Baseline at Week 12. Analyses Were Done Using Multiple Imputation

  The PGA is a clinical tool for assessing the current state/severity of a subject's psoriasis at a given timepoint. A static 5-point scale is used to grade lesions on the clinical characteristics of erythema, scaling, and plaque thickness/elevation. The PGA ranges from 0 to 4, and is calculated as Clear (0), Almost clear (1), Mild (2), Moderate (3), and Severe (4). Higher PGA scores represent more severe disease. Analyses were done using multiple imputation

  Baseline to Week 12

Secondary Outcomes (4)

• Percent of Subjects With ≥ 75% Improvement in Psoriasis Area and Severity Index (PASI) From Baseline at Week 12. Analyses Were Done Using Multiple Imputation.

  Baseline to Week 12

• Percent of Subjects With a PGA Score of 0 or 1 at Week 12. Analyses Were Done Using Multiple Imputation.

  Baseline to Week 12

• Mean Change in Percent of Total Body Surface Area (%BSA) Affected From Baseline to Week 12

  Baseline to Week 12

• Percent of Subjects With ≥90% Improvement in PASI Score From Baseline to Week 12. Analyses Were Done Using Multiple Imputation.

  Baseline to Week 12

Study Arms (2)

Tapinarof (DMVT-505) Cream Group

EXPERIMENTAL

Tapinarof cream, 1%, applied once daily

Drug: Tapinarof

Vehicle Cream Group

PLACEBO COMPARATOR

Vehicle cream applied once daily

Drug: Vehicle Cream

Interventions

Tapinarof DRUG

Tapinarof cream, 1%, applied once daily

Also known as: DMVT-505

Tapinarof (DMVT-505) Cream Group

Vehicle Cream DRUG

Vehicle cream applied once daily

Vehicle Cream Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead
• IQVIA Biotech: collaborator

Study Sites (50)

Dermavant Investigative Site

Fort Smith, Arkansas, 72916, United States

Location

Dermavant Investigative Site

Fountain Valley, California, 92708, United States

Location

Dermavant Investigative Site

Fremont, California, 94538, United States

Location

Dermavant Investigative Site

Los Angeles, California, 90045, United States

Location

Dermavant Investigative Site

Oceanside, California, 92056, United States

Location

Dermavant Investigative Site

San Diego, California, 92123, United States

Location

Dermavant Investigative Site

Santa Monica, California, 90404, United States

Location

Dermavant Investigative Site

Denver, Colorado, 80210, United States

Location

Dermavant Investigative Site

Boynton Beach, Florida, 33437, United States

Location

Dermavant Investigative Site

Margate, Florida, 33414, United States

Location

Dermavant Investigative Site

Miami, Florida, 33144, United States

Location

Dermavant Investigative Site

Boise, Idaho, 83713, United States

Location

Dermavant Investigative Site

Rolling Meadows, Illinois, 60008, United States

Location

Dermavant Investigative Site

Plainfield, Indiana, 46168, United States

Location

Dermavant Investigative Site

Overland Park, Kansas, 66215, United States

Location

Dermavant Investigative Site

Louisville, Kentucky, 40217, United States

Location

Dermavant Investigative Site

Owensboro, Kentucky, 42301, United States

Location

Dermavant Investigative Site

Metairie, Louisiana, 70006, United States

Location

Dermavant Investigative Site

Boston, Massachusetts, 02215, United States

Location

Dermavant Investigative Site

Bay City, Michigan, 48706, United States

Location

Dermavant Investigative Site

Detroit, Michigan, 48202, United States

Location

Dermavant Investigative Site

Fort Gratiot, Michigan, 48059, United States

Location

Dermavant Investigative Site

Fridley, Minnesota, 55432, United States

Location

Dermavant Investigative Site

Omaha, Nebraska, 68144, United States

Location

Dermavant Investigative Site

Las Vegas, Nevada, 89148, United States

Location

Dermavant Investigative Site

East Windsor, New Jersey, 08520, United States

Location

Dermavant Investigative Site

Hackensack, New Jersey, 07601, United States

Location

Dermavant Investigative Site

Stony Brook, New York, 11790, United States

Location

Dermavant Investigative Site

Wilmington, North Carolina, 28405, United States

Location

Dermavant Investigative Site

Winston-Salem, North Carolina, 27157, United States

Location

Dermavant Investigative Site

Beachwood, Ohio, 44122, United States

Location

Dermavant Investigative Site

Bexley, Ohio, 43209, United States

Location

Dermavant Investigative Site

Portland, Oregon, 97223, United States

Location

Dermavant Investigative Site

Charleston, South Carolina, 29414, United States

Location

Dermavant Investigative Site

Nashville, Tennessee, 37215, United States

Location

Dermavant Investigative Site

Houston, Texas, 77056, United States

Location

Dermavant Investigative Site

Pflugerville, Texas, 78660, United States

Location

Dermavant Investigative Site

Plano, Texas, 75024, United States

Location

Dermavant Investigative Site

San Antonio, Texas, 78229, United States

Location

Dermavant Investigative Site

Webster, Texas, 77598, United States

Location

Dermavant Investigative Site

Norfolk, Virginia, 23502, United States

Location

Dermavant Investigative Site

Spokane, Washington, 99202, United States

Location

Dermavant Investigative Site

Edmonton, Alberta, T5K 1X3, Canada

Location

Dermavant Investigative Site

Surrey, Bristish Columbia, V3R 6A7, Canada

Location

Dermavant Investigative Site

Surrey, Bristish Columbia, V3V 0C6, Canada

Location

Dermavant Investigative Site

Etobicoke, Ontario, M9A 3P2, Canada

Location

Dermavant Investigative Site

Hamilton, Ontario, L8N 1Y2, Canada

Location

Dermavant Investigative Site

Markham, Ontario, L3P 1X2, Canada

Location

Dermavant Investigative Site

Oakville, Ontario, L6J 7W5, Canada

Location

Dermavant Investigative Site

Ottawa, Ontario, K2C 3N2, Canada

Location

Related Publications (4)

• 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.

  PMID: 34879448 BACKGROUND

• 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.

  PMID: 40600584 DERIVED

• 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.

  PMID: 38123875 DERIVED

• 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.

  PMID: 37697121 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

tapinarof

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clinical Lead, Late-Stage Clinical Development
• Organization: Organon and Co

pdrl@organon.com

551-430-6000

Study Officials

• Victoria Butners

  Dermavant Sciences GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) The Investigator, study center staff, subject, and Sponsor will be blinded to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Following a 34-day screening period, eligible subjects will be randomized at a 2:1 ratio to receive once daily treatment with tapinarof cream, 1% or vehicle cream.

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 12, 2019
• Study Start: June 6, 2019
• Primary Completion: May 13, 2020
• Study Completion: May 29, 2020
• Last Updated: June 12, 2025
• Results First Posted: October 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (42); CA (8)