Trial Outcomes & Findings for Tapinarof for the Treatment of Plaque Psoriasis in Adults (3001) (NCT NCT03956355)

NCT ID: NCT03956355

Last Updated: 2025-06-12

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 510 participants
• Primary outcome timeframe: Baseline to Week 12
• Results posted on: 2025-06-12

Participant Flow

Participant milestones

Measure	Tapinarof (DMVT-505) Tapinarof (DMVT-505) Cream Group Tapinarof: Tapinarof cream, 1%, applied once daily	Vehicle Cream Vehicle Cream Group Vehicle Cream: Vehicle cream applied once daily
Overall Study STARTED	340	170
Overall Study COMPLETED	269	130
Overall Study NOT COMPLETED	71	40

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Tapinarof (DMVT-505) n=340 Participants Tapinarof (DMVT-505) Cream Group Tapinarof: Tapinarof cream, 1%, applied once daily	Vehicle Cream n=170 Participants Vehicle Cream Group Vehicle Cream: Vehicle cream applied once daily	Total n=510 Participants Total of all reporting groups
Age, Continuous	49.8 years STANDARD_DEVIATION 13.68 • n=5 Participants	49.1 years STANDARD_DEVIATION 13.25 • n=7 Participants	49.6 years STANDARD_DEVIATION 13.53 • n=5 Participants
Sex: Female, Male Female	127 Participants n=5 Participants	84 Participants n=7 Participants	211 Participants n=5 Participants
Sex: Female, Male Male	213 Participants n=5 Participants	86 Participants n=7 Participants	299 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	53 Participants n=5 Participants	34 Participants n=7 Participants	87 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	284 Participants n=5 Participants	135 Participants n=7 Participants	419 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	21 Participants n=5 Participants	4 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants	11 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) White	286 Participants n=5 Participants	146 Participants n=7 Participants	432 Participants n=5 Participants
Race (NIH/OMB) More than one race	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Physician Global Assessment 0 - clear	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Physician Global Assessment 1 - almost clear	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Physician Global Assessment 2 - mild	39 Participants n=5 Participants	21 Participants n=7 Participants	60 Participants n=5 Participants
Physician Global Assessment 3 - moderate	271 Participants n=5 Participants	133 Participants n=7 Participants	404 Participants n=5 Participants
Physician Global Assessment 4 - severe	30 Participants n=5 Participants	16 Participants n=7 Participants	46 Participants n=5 Participants
Psoriasis Area and Severity Index	8.71 units on a scale STANDARD_DEVIATION 3.979 • n=5 Participants	9.19 units on a scale STANDARD_DEVIATION 4.395 • n=7 Participants	8.87 units on a scale STANDARD_DEVIATION 4.124 • n=5 Participants
Percent Body Surface Area	7.8 Percent STANDARD_DEVIATION 4.64 • n=5 Participants	8.2 Percent STANDARD_DEVIATION 5.06 • n=7 Participants	7.9 Percent STANDARD_DEVIATION 4.78 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12

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.

Outcome measures

Measure	Tapinarof (DMVT-505) n=340 Participants Tapinarof (DMVT-505) Cream Group Tapinarof: Tapinarof cream, 1%, applied once daily	Vehicle Cream n=170 Participants Vehicle Cream Group Vehicle Cream: Vehicle cream applied once daily
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	35.4 percentage of subjects Standard Error 2.75	6.0 percentage of subjects Standard Error 2.08

SECONDARY outcome

Timeframe: Baseline to Week 12

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.

Outcome measures

Measure	Tapinarof (DMVT-505) n=340 Participants Tapinarof (DMVT-505) Cream Group Tapinarof: Tapinarof cream, 1%, applied once daily	Vehicle Cream n=170 Participants Vehicle Cream Group Vehicle Cream: Vehicle cream applied once daily
Percent of Subjects With ≥ 75% Improvement in Psoriasis Area and Severity Index (PASI) From Baseline at Week 12. Analyses Were Done Using Multiple Imputation.	36.1 percentage of subjects Standard Error 2.73	10.2 percentage of subjects Standard Error 2.43

SECONDARY outcome

Timeframe: Baseline to Week 12

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.

Outcome measures

Measure	Tapinarof (DMVT-505) n=340 Participants Tapinarof (DMVT-505) Cream Group Tapinarof: Tapinarof cream, 1%, applied once daily	Vehicle Cream n=170 Participants Vehicle Cream Group Vehicle Cream: Vehicle cream applied once daily
Percent of Subjects With a PGA Score of 0 or 1 at Week 12. Analyses Were Done Using Multiple Imputation.	37.8 percentage of subjects Standard Error 2.79	9.9 percentage of subjects Standard Error 2.51

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Tapinarof (DMVT-505) n=340 Participants Tapinarof (DMVT-505) Cream Group Tapinarof: Tapinarof cream, 1%, applied once daily	Vehicle Cream n=170 Participants Vehicle Cream Group Vehicle Cream: Vehicle cream applied once daily
Mean Change in Percent of Total Body Surface Area (%BSA) Affected From Baseline to Week 12	-3.50 Mean change from Baseline Standard Error 0.471	-0.22 Mean change from Baseline Standard Error 0.579

SECONDARY outcome

Timeframe: Baseline to Week 12

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.

Outcome measures

Measure	Tapinarof (DMVT-505) n=340 Participants Tapinarof (DMVT-505) Cream Group Tapinarof: Tapinarof cream, 1%, applied once daily	Vehicle Cream n=170 Participants Vehicle Cream Group Vehicle Cream: Vehicle cream applied once daily
Percent of Subjects With ≥90% Improvement in PASI Score From Baseline to Week 12. Analyses Were Done Using Multiple Imputation.	18.8 percentage of subjects Standard Error 2.18	1.6 percentage of subjects Standard Error 1.05

Adverse Events

Tapinarof (DMVT-505)

Serious events: 9 serious events

Other events: 131 other events

Deaths: 0 deaths

Vehicle Cream

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tapinarof (DMVT-505) n=340 participants at risk Tapinarof (DMVT-505) Cream Group Tapinarof: Tapinarof cream, 1%, applied once daily. All SAEs were deemed unrelated to treatment with tapinarof cream, 1%.	Vehicle Cream n=170 participants at risk Vehicle Cream Group Vehicle Cream: Vehicle cream applied once daily. All SAEs were deemed unrelated to treatment with tapinarof cream, 1%.
Cardiac disorders Cardiac failure congestive	0.29% 1/340 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)	0.00% 0/170 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)
Cardiac disorders Coronary artery disease	0.29% 1/340 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)	0.00% 0/170 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)
Cardiac disorders Pericardial effusion	0.29% 1/340 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)	0.00% 0/170 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)
Gastrointestinal disorders Oesophageal obstruction	0.29% 1/340 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)	0.00% 0/170 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)
Gastrointestinal disorders Pancreatitis acute	0.29% 1/340 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)	0.00% 0/170 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)
Infections and infestations Cellulitis	0.29% 1/340 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)	0.00% 0/170 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)
Injury, poisoning and procedural complications Stab wound	0.29% 1/340 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)	0.00% 0/170 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)
Respiratory, thoracic and mediastinal disorders Laryngospasm	0.29% 1/340 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)	0.00% 0/170 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)
Vascular disorders Aortic arteriosclerosis	0.29% 1/340 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)	0.00% 0/170 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)
Vascular disorders Hypertensive crisis	0.29% 1/340 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)	0.00% 0/170 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)
Vascular disorders Hypertensive urgency	0.29% 1/340 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)	0.00% 0/170 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)

Other adverse events

Measure	Tapinarof (DMVT-505) n=340 participants at risk Tapinarof (DMVT-505) Cream Group Tapinarof: Tapinarof cream, 1%, applied once daily. All SAEs were deemed unrelated to treatment with tapinarof cream, 1%.	Vehicle Cream n=170 participants at risk Vehicle Cream Group Vehicle Cream: Vehicle cream applied once daily. All SAEs were deemed unrelated to treatment with tapinarof cream, 1%.
Infections and infestations Folliculitis	23.2% 79/340 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)	1.2% 2/170 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)
Infections and infestations Nasopharyngitis	7.4% 25/340 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)	5.9% 10/170 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)
Infections and infestations Upper respiratory tract infection	1.5% 5/340 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)	2.4% 4/170 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)
Infections and infestations Viral upper respiratory tract infection	2.1% 7/340 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)	1.2% 2/170 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)
Infections and infestations Influenza	1.5% 5/340 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)	0.00% 0/170 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)
Infections and infestations Cystitis	0.00% 0/340 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)	1.2% 2/170 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)
Injury, poisoning and procedural complications Ligament sprain	0.29% 1/340 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)	1.2% 2/170 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)
Musculoskeletal and connective tissue disorders Back pain	1.2% 4/340 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)	1.2% 2/170 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)
Nervous system disorders Headache	2.9% 10/340 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)	1.8% 3/170 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)
Respiratory, thoracic and mediastinal disorders Cough	1.2% 4/340 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)	0.59% 1/170 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/340 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)	1.2% 2/170 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)
Skin and subcutaneous tissue disorders Dermatitis contact	4.4% 15/340 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)	0.59% 1/170 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)
Skin and subcutaneous tissue disorders Pruritus	2.4% 8/340 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)	0.00% 0/170 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)
Skin and subcutaneous tissue disorders Rash	1.2% 4/340 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)	0.00% 0/170 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)
Gastrointestinal disorders abdominal pain	1.2% 4/340 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)	0.00% 0/170 • Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)

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