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Plaque PsoriasisPhase 3NCT03956355

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

A Phase 3 study testing Tapinarof in people with Plaque Psoriasis, run by Organon and Co at 53 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Plaque Psoriasis
What is being tested?
Tapinarof
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
510 participants
Where
53 sitesin 2 countries
Study dates
21 May 2019to 26 May 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 24Show fewer
  • 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 locations and contacts

53 sites in 2 countries.

53 sites in 2 countries

United States44 sites

  • Dermavant Investigative Site

    Anaheim Hills, California, 92807

  • Dermavant Investigative Site

    Arlington, Texas, 76011

  • Dermavant Investigative Site

    Baton Rouge, Louisiana, 70809

  • Dermavant Investigative Site

    Birmingham, Alabama, 35205

  • Dermavant Investigative Site

    Boca Raton, Florida, 33431

  • Dermavant Investigative Site

    Boston, Massachusetts, 02115

  • Dermavant Investigative Site

    Brandon, Florida, 33511

  • Dermavant Investigative Site

    Cary, North Carolina, 27518

  • Dermavant Investigative Site

    Clarkston, Michigan, 48346

  • Dermavant Investigative Site

    College Station, Texas, 77802

  • Dermavant Investigative Site

    Cromwell, Connecticut, 06416

  • Dermavant Investigative Site

    Dripping Springs, Texas, 78620

  • Dermavant Investigative Site

    Evansville, Indiana, 47714

  • Dermavant Investigative Site

    Fresno, California, 93720

  • Dermavant Investigative Site

    Hialeah, Florida, 33016

  • Dermavant Investigative Site

    High Point, North Carolina, 27262

  • Dermavant Investigative Site

    Hot Springs, Arkansas, 71913

  • Dermavant Investigative Site

    Houston, Texas, 77004

  • Dermavant Investigative Site

    Indianapolis, Indiana, 46250

  • Dermavant Investigative Site

    Johnston, Rhode Island, 02919

  • Dermavant Investigative Site

    Kew Gardens, New York, 11374

  • Dermavant Investigative Site

    Los Angeles, California, 90033

  • Dermavant Investigative Site

    Louisville, Kentucky, 40202

  • Dermavant Investigative Site

    Marietta, Georgia, 30060

  • Dermavant Investigative Site

    Miramar, Florida, 33027

  • Dermavant Investigative Site

    New Albany, Indiana, 47150

  • Dermavant Investigative Site

    New Orleans, Louisiana, 70112

  • Dermavant Investigative Site

    New Orleans, Louisiana, 70115

  • Dermavant Investigative Site

    New York, New York, 10029

  • Dermavant Investigative Site

    Norman, Oklahoma, 73071

  • Dermavant Investigative Site

    Northridge, California, 91324

  • Dermavant Investigative Site

    Owensboro, Kentucky, 42301

  • Dermavant Investigative Site

    Phoenix, Arizona, 85032

  • Dermavant Investigative Site

    Pittsburgh, Pennsylvania, 15213

  • Dermavant Investigative Site

    Portland, Oregon, 97210

  • Dermavant Investigative Site

    Rochester, New York, 14623

  • Dermavant Investigative Site

    Rogers, Arkansas, 72758

  • Dermavant Investigative Site

    Saint Joseph, Missouri, 64506

  • Dermavant Investigative Site

    San Antonio, Texas, 78213

  • Dermavant Investigative Site

    San Diego, California, 92123

  • Dermavant Investigative Site

    Santa Ana, California, 92701

  • Dermavant Investigative Site

    Verona, New Jersey, 07044

  • Dermavant Investigative Site

    Warren, Michigan, 48088

  • Dermavant Investigative Site

    West Jordan, Utah, 84088

Other trials in United States

Canada9 sites

  • Dermavant Investigative Site

    Ajax, Ontario, L1S 7K8

  • Dermavant Investigative Site

    Coburg, Ontario, K9A 0Z4

  • Dermavant Investigative Site

    Montreal, Quebec, H2X 2V1

  • Dermavant Investigative Site

    North Bay, Ontario, P1B 3Z7

  • Dermavant Investigative Site

    Richmond Hill, Ontario, L4C 9M7

  • Dermavant Investigative Site

    Saint Johns, Newfoundland and Labrador, A1C 2H5

  • Dermavant Investigative Site

    Toronto, Ontario, M3H 5Y8

  • Dermavant Investigative Site

    Waterloo, Ontario, N2J 1C4

  • Dermavant Investigative Site

    Windsor, Ontario, N8W 5L7

Other trials in Canada

About this study

Official title: A Phase 3 Efficacy and Safety Study of Tapinarof for the Treatment of Plaque Psoriasis in Adults

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.

Read the 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).

Being tested
Tapinarof, Vehicle Cream
Keywords
Tapinarof, plaque psoriasis, adult, phase 3, topical, double-blind, efficacy, safety, psoriasis
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TapinarofDrug

    Also called DMVT-505

    Tapinarof cream, 1%, applied once daily

  • Vehicle CreamDrug

    Vehicle cream applied once daily

Study groups in NCT03956355
Study groupRoleWhat they receive
Tapinarof (DMVT-505)ExperimentalTapinarof (DMVT-505) Cream Group
Receives: Drug: Tapinarof
Vehicle CreamPlacebo comparatorVehicle Cream Group
Receives: Drug: Vehicle Cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to Week 12

Secondary outcomes (4)

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

    The Psoriasis Area and Severity Index (PASI) scoring system combines the assessment of lesion severity and extent of affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, and legs). Each area is assessed for 3 signs: erythema (redness), induration (plaque thickness), and scale. The severity of each sign in each body area is assessed and scored independently using a 5-point scale, where 0=none, 1=slight, 2=mild, 3=moderate, 4=severe. Each area is also assessed for percent of skin involved: 0 = (0%), 1 = (1-<10%), 2 = (10-<30%), 3 = (30-<50%), 4 = (50 -<70%), 5 = (70-<90%), 6 = (90-100%). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores. Analyses were done using multiple imputation.

    Measured: Baseline to Week 12

  2. Percent of Subjects With a PGA Score of 0 or 1 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.

    Measured: Baseline to Week 12

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

    Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. Estimates of the % involvement in each body region will be multiplied by the fraction of total body area to obtain the total %BSA involved by region and overall.

    Measured: Baseline to Week 12

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

    The Psoriasis Area and Severity Index (PASI) scoring system combines the assessment of lesion severity and extent of affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, and legs). Each area is assessed for 3 signs: erythema (redness), induration (plaque thickness), and scale. The severity of each sign in each body area is assessed and scored independently using a 5-point scale, where 0=none, 1=slight, 2=mild, 3=moderate, 4=severe. Each area is also assessed for percent of skin involved: 0 = (0%), 1 = (1-<10%), 2 = (10-<30%), 3 = (30-<50%), 4 = (50 -<70%), 5 = (70-<90%), 6 = (90-100%). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores. Analyses were done using multiple imputation.

    Measured: Baseline to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2019
  2. Study start21 May 2019
  3. Primary completion26 May 2020
  4. Study completion26 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
510 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03956355
Sponsor's protocol ID
DMVT-505-3001
Status last verified
Sep 2022
First submitted
16 May 2019
Last updated
12 Jun 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34879448

  • 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.

    PubMed 40600584

  • 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.

    PubMed 38123875

  • 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.

    PubMed 37697121

  • Grossmann MC, Pixley JN, Feldman SR. A Review of Topical Tapinarof for the Treatment of Plaque Psoriasis. Ann Pharmacother. 2024 Jan;58(1):76-85. doi: 10.1177/10600280231164775. Epub 2023 Apr 19.

    PubMed 37076998

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tapinarof in people with Plaque Psoriasis, run by Organon and Co at 53 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03956355, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.

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