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

NCT03956355 | Completed Phase 3 Results FDA Drug

• 1 other identifier: DMVT-505-3001
• Study Type: interventional
• Target: 510
• Locations: 2 countries
• Sites: 53

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)

EXPERIMENTAL

Tapinarof (DMVT-505) Cream Group

Drug: Tapinarof

Vehicle Cream

PLACEBO COMPARATOR

Vehicle Cream Group

Drug: Vehicle Cream

Interventions

Tapinarof DRUG

Tapinarof cream, 1%, applied once daily

Also known as: DMVT-505

Tapinarof (DMVT-505)

Vehicle Cream DRUG

Vehicle cream applied once daily

Vehicle Cream

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, psoralens, corticosteroids, adrenocorticotropic hormone analogs, and tazarotene

Sponsors & Collaborators

• Organon and Co: lead
• IQVIA Biotech: collaborator

Study Sites (53)

Dermavant Investigative Site

Birmingham, Alabama, 35205, United States

Location

Dermavant Investigative Site

Phoenix, Arizona, 85032, United States

Location

Dermavant Investigative Site

Hot Springs, Arkansas, 71913, United States

Location

Dermavant Investigative Site

Rogers, Arkansas, 72758, United States

Location

Dermavant Investigative Site

Anaheim Hills, California, 92807, United States

Location

Dermavant Investigative Site

Fresno, California, 93720, United States

Location

Dermavant Investigative Site

Los Angeles, California, 90033, United States

Location

Dermavant Investigative Site

Northridge, California, 91324, United States

Location

Dermavant Investigative Site

San Diego, California, 92123, United States

Location

Dermavant Investigative Site

Santa Ana, California, 92701, United States

Location

Dermavant Investigative Site

Cromwell, Connecticut, 06416, United States

Location

Dermavant Investigative Site

Boca Raton, Florida, 33431, United States

Location

Dermavant Investigative Site

Brandon, Florida, 33511, United States

Location

Dermavant Investigative Site

Hialeah, Florida, 33016, United States

Location

Dermavant Investigative Site

Miramar, Florida, 33027, United States

Location

Dermavant Investigative Site

Marietta, Georgia, 30060, United States

Location

Dermavant Investigative Site

Evansville, Indiana, 47714, United States

Location

Dermavant Investigative Site

Indianapolis, Indiana, 46250, United States

Location

Dermavant Investigative Site

New Albany, Indiana, 47150, United States

Location

Dermavant Investigative Site

Louisville, Kentucky, 40202, United States

Location

Dermavant Investigative Site

Owensboro, Kentucky, 42301, United States

Location

Dermavant Investigative Site

Baton Rouge, Louisiana, 70809, United States

Location

Dermavant Investigative Site

New Orleans, Louisiana, 70112, United States

Location

Dermavant Investigative Site

New Orleans, Louisiana, 70115, United States

Location

Dermavant Investigative Site

Boston, Massachusetts, 02115, United States

Location

Dermavant Investigative Site

Clarkston, Michigan, 48346, United States

Location

Dermavant Investigative Site

Warren, Michigan, 48088, United States

Location

Dermavant Investigative Site

Saint Joseph, Missouri, 64506, United States

Location

Dermavant Investigative Site

Verona, New Jersey, 07044, United States

Location

Dermavant Investigative Site

Kew Gardens, New York, 11374, United States

Location

Dermavant Investigative Site

New York, New York, 10029, United States

Location

Dermavant Investigative Site

Rochester, New York, 14623, United States

Location

Dermavant Investigative Site

Cary, North Carolina, 27518, United States

Location

Dermavant Investigative Site

High Point, North Carolina, 27262, United States

Location

Dermavant Investigative Site

Norman, Oklahoma, 73071, United States

Location

Dermavant Investigative Site

Portland, Oregon, 97210, United States

Location

Dermavant Investigative Site

Pittsburgh, Pennsylvania, 15213, United States

Location

Dermavant Investigative Site

Johnston, Rhode Island, 02919, United States

Location

Dermavant Investigative Site

Arlington, Texas, 76011, United States

Location

Dermavant Investigative Site

College Station, Texas, 77802, United States

Location

Dermavant Investigative Site

Dripping Springs, Texas, 78620, United States

Location

Dermavant Investigative Site

Houston, Texas, 77004, United States

Location

Dermavant Investigative Site

San Antonio, Texas, 78213, United States

Location

Dermavant Investigative Site

West Jordan, Utah, 84088, United States

Location

Dermavant Investigative Site

Saint Johns, Newfoundland and Labrador, A1C 2H5, Canada

Location

Dermavant Investigative Site

Ajax, Ontario, L1S 7K8, Canada

Location

Dermavant Investigative Site

Coburg, Ontario, K9A 0Z4, Canada

Location

Dermavant Investigative Site

North Bay, Ontario, P1B 3Z7, Canada

Location

Dermavant Investigative Site

Richmond Hill, Ontario, L4C 9M7, Canada

Location

Dermavant Investigative Site

Toronto, Ontario, M3H 5Y8, Canada

Location

Dermavant Investigative Site

Waterloo, Ontario, N2J 1C4, Canada

Location

Dermavant Investigative Site

Windsor, Ontario, N8W 5L7, Canada

Location

Dermavant Investigative Site

Montreal, Quebec, H2X 2V1, 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 RESULT

• 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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: May 16, 2019
• First Posted: May 20, 2019
• Study Start: May 21, 2019
• Primary Completion: May 26, 2020
• Study Completion: May 26, 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 (44); CA (9)