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Plaque PsoriasisPhase 2NCT04042103

Maximal Use Study of Tapinarof Cream, 1% in Adults With Extensive Plaque Psoriasis

A Phase 2 study testing Tapinarof cream, 1% in people with Plaque Psoriasis, run by Organon and Co at 6 sites in United States.

Completed

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

Official record
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Trial summary

This is an open-label, multicenter study to evaluate the systemic exposure and safety of topical tapinarof cream, 1% under conditions of maximal use in adults with plaque psoriasis. 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 cream, 1%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
6 sitesUnited States
Study dates
23 Jul 2019to 9 Jan 2020
Phase
Phase 2
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 age 18 to 75 with a confirmed clinical diagnosis of plaque psoriasis and stable disease for at least 6 months prior to the study
  • BSA involvement ≥ 20%
  • PGA score of ≥ 3 at screening
  • 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
  • Capable of giving written informed consent

Who cannot join

  • Psoriasis other than plaque variant
  • Any sign of infection of any of the psoriatic lesions
  • 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 the interpretation of the results
  • 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
  • Pregnant females or lactating females
Show all 9Show fewer
  • 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
  • Previous known participation in a clinical study with tapinarof

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Dermavant Investigational Site

    Austin, Texas, 78759

  • Dermavant Investigational Site

    Encino, California, 91436

  • Dermavant Investigational Site

    Philadelphia, Pennsylvania, 19103

  • Dermavant Investigational Site

    San Antonio, Texas, 78213

  • Dermavant Investigational Site

    Sanford, Florida, 32771

  • Dermavant Investigational Site

    Spokane, Washington, 99202

Other trials in United States

About this study

Official title: Open-Label Maximal Use Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Tapinarof Cream, 1% in Adults With Extensive Plaque Psoriasis

This is an open-label, multicenter study to evaluate the systemic exposure and safety of topical tapinarof cream, 1% under conditions of maximal use in adults with plaque psoriasis.

Being tested
Tapinarof cream, 1%

What participants receive

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

  • Tapinarof cream, 1%Drug

    Also called DMVT-505

    Tapinarof cream, 1% applied topically once daily

Study groups in NCT04042103
Study groupRoleWhat they receive
Tapinarof (DMVT-505) cream, 1%ExperimentalTapinarof (DMVT-505) cream, 1% applied topically once daily
Receives: Drug: Tapinarof cream, 1%

What is being measured

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

  1. Number of Participants That Experienced Adverse Events (AEs), Severe Adverse Events, and Serious Adverse Events (SAEs)

    Frequency and severity of AEs (local and systemic)

    Measured: Baseline to Week 4

  2. Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Biomarker Values, ECG Results or Vital Signs

    Changes in laboratory values, biomarker values, ECG results and vital signs were assessed for clinical relevance.

    Measured: Baseline to Week 4 or Follow-Up (7-10 days after Week 4 Visit)

  3. Number of Participants With Irritation as Assessed by the Local Tolerability Scale

    At each specified study visit, the Investigator (or qualified evaluator) assessed the presence and overall degree of irritation at the application sites, according to the LTS. The score will ideally represent an 'average' across all application sites. To the fullest extent possible, the same Investigator (or designated evaluator) will perform all tolerability assessments for an individual participant throughout the study.

    Measured: Day 1, Day 15, Day 29

  4. Tapinarof and Tapinarof Sulfate (Metabolite) Plasma PK Parameters on Day 1 and Day 29: AUCo-tau

    The AUC in plasma is a pharmacokinetic parameter that describes the overall exposure of the drug.

    Measured: Day 1 and Day 29 (PK samples collected at pre-dose and at 1, 2, 3, 4, 5, 8, 12, and 24 hours after dosing)

  5. Tapinarof and Tapinarof Sulfate (Metabolite) Plasma PK Parameters on Day 1 and Day 29: Cmax

    The Cmax is a pharmacokinetic parameter that describes the highest concentration of the drug that is achieved after dosing.

    Measured: Day 1 and Day 29 (PK samples collected at pre-dose and at 1, 2, 3, 4, 5, 8, 12, and 24 hours after dosing)

  6. Tapinarof and Tapinarof Sulfate (Metabolite) Plasma PK Parameters on Day 1 and Day 29: Tmax and t1/2

    The tmax is a pharmacokinetic parameter that describes the time point at which the highest concentration of the drug is achieved after dosing.

    Measured: Day 1 and Day 29 (PK samples collected at pre-dose and at 1, 2, 3, 4, 5, 8, 12, and 24 hours after dosing)

Secondary outcomes (5)

  1. Change From Baseline in QTcF (ΔQTcF) at Each Post-treatment Time Point on the Sampling Day With the Higher Cmax (Day 1 or Day 29)

    Identify clinically relevant effect of tapinarof on cardiac conduction

    Measured: Baseline and Day 1

  2. Analysis of the Relationship Between Plasma Concentration and ΔQTcF

    The relationship between tapinarof plasma concentrations and ∆QTcF was investigated using a linear mixed-effects modeling approach with ΔQTcF as the dependent variable. A linear model with an intercept was fitted for tapinarof plasma concentrations, which represented the data in an acceptable way. The slope of tapinarof plasma concentration in the concentration-QTc relationship was estimated.

    Measured: Day 1

  3. Mean Change From Baseline to Day 29 in Physician's Global Assessment (PGA)

    The PGA is a clinical tool for assessing the current state/severity of a subject's psoriasis at a given timepoint. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, scaling, and plaque thickness/elevation as guidelines. Higher PGA scores represent more severe disease. This scale ranges from 0 to 5, with 0 = best outcome.

    Measured: Baseline to Day 29

  4. Mean Change From Baseline to Day 29 Psoriasis Area and Severity Index (PASI)

    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.

    Measured: Baseline to Day 29

  5. Mean Change From Baseline to Day 29 in Percent of Total Body Surface Area (%BSA) Affected

    The assessment of %BSA affected is an estimate of the percentage of total involved skin with psoriasis. For the purpose of clinical estimation, the total palmar surface of the subject's palm and digits may be assumed to be approximately equivalent to 1% BSA. The %BSA affected by psoriasis will be evaluated (from 0% to 100%). %BSA is a static assessment made without reference to previous scores.

    Measured: Baseline to Day 29

Timeline

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

  1. First posted1 Aug 2019
  2. Study start23 Jul 2019
  3. Primary completion9 Jan 2020
  4. Study completion9 Jan 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open-label, single arm study
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04042103
Sponsor's protocol ID
DMVT-505-2002
Status last verified
May 2022
First submitted
24 Jul 2019
Last updated
19 Jun 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jett JE, McLaughlin M, Lee MS, Parish LC, DuBois J, Raoof TJ, Tabolt G, Wilson T, Somerville MC, DellaMaestra W, Piscitelli SC. Tapinarof Cream 1% for Extensive Plaque Psoriasis: A Maximal Use Trial on Safety, Tolerability, and Pharmacokinetics. Am J Clin Dermatol. 2022 Jan;23(1):83-91. doi: 10.1007/s40257-021-00641-4. Epub 2021 Oct 28.

    PubMed 34713415

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tapinarof cream, 1% in people with Plaque Psoriasis, run by Organon and Co at 6 sites in United States.

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 9 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 19 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 6 sites in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 6 May 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?

Number of Participants That Experienced Adverse Events (AEs), Severe Adverse Events, and Serious Adverse Events (SAEs) (time frame: Baseline to Week 4). The study lists 6 primary outcomes in all. 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 NCT04042103, which also lists 1 linked publication.

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 19 Jun 2025.

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