Trial Outcomes & Findings for Maximal Use Study of Tapinarof Cream, 1% in Adults With Extensive Plaque Psoriasis (NCT NCT04042103)

NCT ID: NCT04042103

Last Updated: 2025-06-19

Results Overview

Frequency and severity of AEs (local and systemic)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 21 participants
• Primary outcome timeframe: Baseline to Week 4
• Results posted on: 2025-06-19

Participant Flow

Participant milestones

Measure	Tapinarof (DMVT-505) Cream, 1% Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
Overall Study STARTED	21
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Tapinarof (DMVT-505) Cream, 1% Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Tapinarof (DMVT-505) Cream, 1% n=21 Participants Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
Age, Continuous	51.8 years STANDARD_DEVIATION 13.91 • n=93 Participants
Sex: Female, Male Female	8 Participants n=93 Participants
Sex: Female, Male Male	13 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants
Race (NIH/OMB) White	16 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline to Week 4

Population: Safety Analysis Set: All randomized subjects who receive at least 1 application of study drug will be included in the safety analysis set.

Frequency and severity of AEs (local and systemic)

Outcome measures

Measure	Tapinarof (DMVT-505) Cream, 1% n=21 Participants Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
Number of Participants That Experienced Adverse Events (AEs), Severe Adverse Events, and Serious Adverse Events (SAEs) Experienced an AE	12 Participants
Number of Participants That Experienced Adverse Events (AEs), Severe Adverse Events, and Serious Adverse Events (SAEs) Experienced a Treatment-Related AE	6 Participants
Number of Participants That Experienced Adverse Events (AEs), Severe Adverse Events, and Serious Adverse Events (SAEs) Experienced a Grade 3 (severe) AE	2 Participants
Number of Participants That Experienced Adverse Events (AEs), Severe Adverse Events, and Serious Adverse Events (SAEs) Experienced a Grade 4 (life-threatening) AE	0 Participants
Number of Participants That Experienced Adverse Events (AEs), Severe Adverse Events, and Serious Adverse Events (SAEs) Experienced a Grade 5 (fatal) AE	0 Participants
Number of Participants That Experienced Adverse Events (AEs), Severe Adverse Events, and Serious Adverse Events (SAEs) Experienced an SAE	1 Participants
Number of Participants That Experienced Adverse Events (AEs), Severe Adverse Events, and Serious Adverse Events (SAEs) Experienced a Treatment-related SAE	0 Participants
Number of Participants That Experienced Adverse Events (AEs), Severe Adverse Events, and Serious Adverse Events (SAEs) Experienced TEAE leading to discontinuation from study/drug	0 Participants

PRIMARY outcome

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

Population: Safety Analysis Set: All randomized subjects who receive at least 1 application of study drug will be included in the safety analysis set.

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

Outcome measures

Measure	Tapinarof (DMVT-505) Cream, 1% n=21 Participants Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Biomarker Values, ECG Results or Vital Signs Clinically Meaningful changes in hematology.	0 Participants
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Biomarker Values, ECG Results or Vital Signs Clinically meaningful changes in chemistry	0 Participants
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Biomarker Values, ECG Results or Vital Signs Clinically meaningful changes in urinalysis	0 Participants
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Biomarker Values, ECG Results or Vital Signs Clinically meaningful changes in tryptase	0 Participants
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Biomarker Values, ECG Results or Vital Signs Clinically meaningful changes in ECG parameters	0 Participants
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Biomarker Values, ECG Results or Vital Signs Clinically meaningful changes in vital signs	0 Participants

PRIMARY outcome

Timeframe: Day 1, Day 15, Day 29

Population: Safety Analysis Set: All randomized subjects who receive at least 1 application of study drug will be included in the safety analysis set.

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.

Outcome measures

Measure	Tapinarof (DMVT-505) Cream, 1% n=21 Participants Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
Number of Participants With Irritation as Assessed by the Local Tolerability Scale Baseline · No Irritation	14 Participants
Number of Participants With Irritation as Assessed by the Local Tolerability Scale Baseline · Mild	5 Participants
Number of Participants With Irritation as Assessed by the Local Tolerability Scale Baseline · Moderate	1 Participants
Number of Participants With Irritation as Assessed by the Local Tolerability Scale Baseline · Severe	1 Participants
Number of Participants With Irritation as Assessed by the Local Tolerability Scale Baseline · Very Severe	0 Participants
Number of Participants With Irritation as Assessed by the Local Tolerability Scale Day 15 · No Irritation	14 Participants
Number of Participants With Irritation as Assessed by the Local Tolerability Scale Day 15 · Mild	5 Participants
Number of Participants With Irritation as Assessed by the Local Tolerability Scale Day 15 · Moderate	1 Participants
Number of Participants With Irritation as Assessed by the Local Tolerability Scale Day 15 · Severe	0 Participants
Number of Participants With Irritation as Assessed by the Local Tolerability Scale Day 15 · Very Severe	0 Participants
Number of Participants With Irritation as Assessed by the Local Tolerability Scale Day 29 · No Irritation	17 Participants
Number of Participants With Irritation as Assessed by the Local Tolerability Scale Day 29 · Mild	2 Participants
Number of Participants With Irritation as Assessed by the Local Tolerability Scale Day 29 · Moderate	0 Participants
Number of Participants With Irritation as Assessed by the Local Tolerability Scale Day 29 · Severe	0 Participants
Number of Participants With Irritation as Assessed by the Local Tolerability Scale Day 29 · Very Severe	0 Participants

PRIMARY outcome

Timeframe: 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)

Population: PK Analysis set: All subjects who have at least 1 application of study drug and have at least 1 evaluable PK assay result will be included in the PK analysis set. The majority of subjects had plasma levels of tapinarof and tapinarof sulfate that were below the level of quantitation (BQL). AUCo-tau value could not be calculated for 17 of the 21 subjects on Day 1 and 18 of the 19 subjects on Day 29, due to BQL samples. The metabolite (tapinarof sulfate) was BQL in all samples.

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

Outcome measures

Measure	Tapinarof (DMVT-505) Cream, 1% n=21 Participants Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
Tapinarof and Tapinarof Sulfate (Metabolite) Plasma PK Parameters on Day 1 and Day 29: AUCo-tau Day 1: tapinarof	8037.29 pg*h/ml Standard Error 6204.935
Tapinarof and Tapinarof Sulfate (Metabolite) Plasma PK Parameters on Day 1 and Day 29: AUCo-tau Day 29: tapinarof	1985.54 pg*h/ml Standard Error NA Subjects with a minimum of 3 postdose time points were required for determination of AUC. N=1 for Day 29

PRIMARY outcome

Timeframe: 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)

Population: PK Analysis Set: All subjects who have at least 1 application of study drug and have at least 1 evaluable PK assay result will be included in the PK analysis set. No subject had measurable concentrations of the metabolite (tapinarof sulfate) at any time point.

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

Outcome measures

Measure	Tapinarof (DMVT-505) Cream, 1% n=21 Participants Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
Tapinarof and Tapinarof Sulfate (Metabolite) Plasma PK Parameters on Day 1 and Day 29: Cmax Day 1: tapinarof Cmax	898.33 pg/mL Standard Deviation 1448.084
Tapinarof and Tapinarof Sulfate (Metabolite) Plasma PK Parameters on Day 1 and Day 29: Cmax Day 29: tapinarof Cmax	116.09 pg/mL Standard Deviation 148.424

PRIMARY outcome

Timeframe: 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)

Population: PK Analysis Set: All subjects who have at least 1 application of study drug and have at least 1 evaluable PK assay result were included in the PK analysis set. No subject had measurable concentrations of the metabolite (tapinarof sulfate) at any time point. An elimination half-life (t½) could not be determined in the majority of subjects (19/21 subjects \[90.5%\]) on Day 1 and all subjects on Day 29 due to the lack of detectable tapinarof in plasma samples in the elimination phase.

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

Outcome measures

Measure	Tapinarof (DMVT-505) Cream, 1% n=21 Participants Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
Tapinarof and Tapinarof Sulfate (Metabolite) Plasma PK Parameters on Day 1 and Day 29: Tmax and t1/2 Day 1: tmax	4.39 hours Standard Deviation 5.476
Tapinarof and Tapinarof Sulfate (Metabolite) Plasma PK Parameters on Day 1 and Day 29: Tmax and t1/2 Day 29: tmax	4.02 hours Standard Deviation 3.005
Tapinarof and Tapinarof Sulfate (Metabolite) Plasma PK Parameters on Day 1 and Day 29: Tmax and t1/2 Day 1: t1/2	6.41 hours Standard Deviation 0.691

SECONDARY outcome

Timeframe: Baseline and Day 1

Population: QT/QTc analysis set: The QT/QTc analysis set will include all subjects in the safety analysis set with measurements at Baseline as well as on-treatment with at least 1 post-dose time point with a valid ΔQTcF value.

Identify clinically relevant effect of tapinarof on cardiac conduction

Outcome measures

Measure	Tapinarof (DMVT-505) Cream, 1% n=21 Participants Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
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) Day 1 1 h Post-dose	-7.2 ms Standard Error 1.79
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) Day 1 2 h Post-dose	-1.1 ms Standard Error 2.92
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) Day 1 3 h Post-dose	-4.3 ms Standard Error 1.88
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) Day 1 4 h Post-dose	-2.3 ms Standard Error 3.04
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) Day 1 5 h Post-dose	-4.9 ms Standard Error 2.87
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) Day 1 8 h Post-dose	-3.0 ms Standard Error 2.60
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) Day 1 12 h Post-dose	-1.6 ms Standard Error 2.18
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) Day 1 24 h Post-dose	-3.4 ms Standard Error 1.97

SECONDARY outcome

Timeframe: Day 1

Population: PK/QTc Analysis Set included all subjects with at least 1 pair of post-dose PK and QTcF data from the same time point. Of the 21 total subjects, there were 10, 8, 12, 10, 11, 11, 13, and 17 subjects with tapinarof plasma concentrations BLQ at the 1, 2, 3, 4, 5, 8, 12, and 24 hour post-dose time points, respectively. The number of participants with measurable tapinarof ranged from 4 to 13 across all the timepoints. The slope is determined based on the data available for each timepoint.

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.

Outcome measures

Measure	Tapinarof (DMVT-505) Cream, 1% n=21 Participants Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
Analysis of the Relationship Between Plasma Concentration and ΔQTcF	-0.00016 ms per pg/ml Interval -0.002172 to 0.001844

SECONDARY outcome

Timeframe: Baseline to Day 29

Population: Safety Analysis Set: All randomized subjects who receive at least 1 application of study drug will be included in the safety analysis set.

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.

Outcome measures

Measure	Tapinarof (DMVT-505) Cream, 1% n=21 Participants Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
Mean Change From Baseline to Day 29 in Physician's Global Assessment (PGA)	-1.2 score on a scale Standard Deviation 1.03

SECONDARY outcome

Timeframe: Baseline to Day 29

Population: Safety Analysis Set: All randomized subjects who receive at least 1 application of study drug will be included in the safety analysis set.

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.

Outcome measures

Measure	Tapinarof (DMVT-505) Cream, 1% n=21 Participants Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
Mean Change From Baseline to Day 29 Psoriasis Area and Severity Index (PASI)	-15.14 score on a scale Interval -19.61 to -10.66

SECONDARY outcome

Timeframe: Baseline to Day 29

Population: Safety Analysis Set: All randomized subjects who receive at least 1 application of study drug will be included in the safety analysis set.

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.

Outcome measures

Measure	Tapinarof (DMVT-505) Cream, 1% n=21 Participants Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
Mean Change From Baseline to Day 29 in Percent of Total Body Surface Area (%BSA) Affected	-14.44 percentage of BSA affected Interval -19.84 to -9.04

Adverse Events

Tapinarof (DMVT-505) Cream, 1%

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tapinarof (DMVT-505) Cream, 1% n=21 participants at risk Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
Gastrointestinal disorders pancreatitis	4.8% 1/21 • Number of events 1 • Study Period (29 days) + Follow-up period (7 to 10 days)

Other adverse events

Measure	Tapinarof (DMVT-505) Cream, 1% n=21 participants at risk Tapinarof (DMVT-505) cream, 1% applied topically once daily Tapinarof cream, 1%: Tapinarof cream, 1% applied topically once daily
Gastrointestinal disorders Abdominal Pain	4.8% 1/21 • Number of events 1 • Study Period (29 days) + Follow-up period (7 to 10 days)
Gastrointestinal disorders Nausea	4.8% 1/21 • Number of events 1 • Study Period (29 days) + Follow-up period (7 to 10 days)
Gastrointestinal disorders Pancreatitis	4.8% 1/21 • Number of events 1 • Study Period (29 days) + Follow-up period (7 to 10 days)
General disorders Chest Pain	4.8% 1/21 • Number of events 1 • Study Period (29 days) + Follow-up period (7 to 10 days)
General disorders Fatigue	4.8% 1/21 • Number of events 1 • Study Period (29 days) + Follow-up period (7 to 10 days)
General disorders Pain	4.8% 1/21 • Number of events 1 • Study Period (29 days) + Follow-up period (7 to 10 days)
Infections and infestations Folliculitis	19.0% 4/21 • Number of events 4 • Study Period (29 days) + Follow-up period (7 to 10 days)
Infections and infestations Furuncle	4.8% 1/21 • Number of events 1 • Study Period (29 days) + Follow-up period (7 to 10 days)
Infections and infestations Nasopharyngitis	4.8% 1/21 • Number of events 1 • Study Period (29 days) + Follow-up period (7 to 10 days)
Metabolism and nutrition disorders Dehydration	4.8% 1/21 • Number of events 1 • Study Period (29 days) + Follow-up period (7 to 10 days)
Metabolism and nutrition disorders Diabetes mellitus	4.8% 1/21 • Number of events 1 • Study Period (29 days) + Follow-up period (7 to 10 days)
Musculoskeletal and connective tissue disorders Back pain	9.5% 2/21 • Number of events 2 • Study Period (29 days) + Follow-up period (7 to 10 days)
Nervous system disorders Headache	19.0% 4/21 • Number of events 4 • Study Period (29 days) + Follow-up period (7 to 10 days)
Skin and subcutaneous tissue disorders Pruritus	9.5% 2/21 • Number of events 2 • Study Period (29 days) + Follow-up period (7 to 10 days)
Vascular disorders Hypertension	4.8% 1/21 • Number of events 1 • Study Period (29 days) + Follow-up period (7 to 10 days)

Additional Information

Clinical Lead, Late-Stage Clinical Development

Organon and Co

Phone: 551-430-6000

Email: pdrl@organon.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place