NCT04053387

Long Term Extension Study of Tapinarof for Plaque Psoriasis in Adults (3003)

Completed Phase 3 Results posted Last updated 6 August 2025

What this trial tests

Phase 3 trial testing tapinarof cream, 1% in Plaque Psoriasis in 763 participants. Completed in 6 April 2021.

Timeline

13 August 2019

Primary endpoint
6 April 2021

6 April 2021

Quick facts

Lead sponsor	Organon and Co
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	763
Start date	13 August 2019
Primary completion	6 April 2021
Estimated completion	6 April 2021
Sites	104 locations across Canada, United States

Drugs / interventions tested

• tapinarof cream, 1%

Conditions studied

• Plaque Psoriasis — all drugs for Plaque Psoriasis →

Sponsor

Organon and Co — full company profile →

Who can join

Adults 18 to 75, any sex, with Plaque Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Subjects With Adverse Events and Serious Adverse Events Primary · Baseline to 44 weeks

All AEs reported in this extension study were considered as TEAEs except for those AEs ongoing at the end of the pivotal Phase 3 studies but resolved prior to the Visit 1 date for this extension study. All SAEs were deemed unrelated to treatment with tapinarof cream, 1%.

Adverse Events

Group	Value	95% CI
Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score	474

Serious Adverse Events

Group	Value	95% CI
Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score	19

Frequency of Adverse Events and Serious Adverse Events Primary · Baseline to 44 weeks

All AEs reported in this extension study were considered as TEAEs except for those AEs ongoing at the end of the pivotal Phase 3 studies but resolved prior to the Visit 1 date for this extension study. Subjects could have reported more than one TEAE. All SAEs were deemed unrelated to treatment with tapinarof cream, 1%.

Adverse Events

Group	Value	95% CI
Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score	1190

Serious Adverse Events

Group	Value	95% CI
Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score	21

Number of Subjects With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values and Vital Signs Primary · Baseline to 40 weeks

The mean chemistry and hematology parameters were assessed for changes and trends over the course of the study. Shifts from Baseline in chemistry and hematology parameters for individual subjects were assessed for clinical relevance. The number of subjects with clinically significant changes from baseline in laboratory values was assessed for clinical relevance.

Clinically Meaningful changes in hematology

Group	Value	95% CI
Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score	0

Clinically meaningful changes in chemistry

Group	Value	95% CI
Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score	0

Clinically meaningful changes in urinalysis

Group	Value	95% CI
Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score	0

Clinically meaningful changes in pulse rate

Group	Value	95% CI
Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score	7

Clinically meaningful changes in systolic blood pressure

Group	Value	95% CI
Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score	6

Clinically meaningful changes in diastolic blood pressure

Group	Value	95% CI
Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score	16

Remittive Effect of Treatment Success in Pivotal: Median Time to First Worsening (PGA ≥ 2) While Off Therapy for Subjects Who Entered LTE PGA = 0 (Clear) Primary · Baseline to 44 weeks

Subjects who completed 1 of the phase 3 studies evaluating the safety and efficacy of tapinarof had the option to enter this extension study. Subjects entering with a PGA = 0 had treatment discontinued and were monitored for duration of remittive response. If/when disease worsening occurred, as evidenced by a PGA ≥ 2, treatment was re-initiated and continued until a PGA = 0 was achieved. This outcome measure assesses the median time for subjects entering with a PGA = 0 to first worsening (PGA ≥ 2) while off therapy during this extension study. The PGA is an assessment of a subject's psoriasis

Group	Value	95% CI
Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score	115	85.0 – 168.0

Complete Disease Clearance During LTE: Number of Subjects Achieving Disease Clearance PGA =0 (Clear) While on Therapy for Subjects Entered LTE PGA ≥ 1 (Almost Clear) Primary · Baseline to 44 weeks

Subjects who completed 1 of the phase 3 studies evaluating the safety and efficacy of tapinarof had the option to enter this extension study. Subjects entering with a PGA ≥ 1 continued treatment with tapinarof until they achieved a PGA = 0, at which time treatment was discontinued and subjects were monitored for remittive response. If/when disease worsening occurred, as evidenced by a PGA ≥ 2, treatment was re-initiated and continued until a PGA = 0 was achieved. This outcome measure assesses the number of subjects who entered the extension study with a PGA ≥ 1 and achieved complete disease cl

Group	Value	95% CI
Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score	233

Response During LTE: Number of Subjects Achieving PGA =0 or 1 (Clear or Almost Clear) While on Therapy for Subjects Who Entered LTE With PGA ≥ 2 (Mild) Primary · Baseline to 44 weeks

Subjects who completed 1 of the phase 3 studies evaluating the safety and efficacy of tapinarof had the option to enter this extension study. Subjects entering with a PGA ≥ 1 continued treatment with tapinarof until they achieved a PGA = 0, at which time treatment was discontinued and subjects were monitored for remittive response. If/when disease worsening occurred, as evidenced by a PGA ≥ 2, treatment was re-initiated and continued until a PGA = 0 was achieved. This outcome measure assesses the number of these subjects who entered the study with a PGA≥ 2 and achieved a PGA of 0 or 1 (clear

Group	Value	95% CI
Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score	302

Remittive Effect of Treatment Success: Number of Subjects Experiencing Worsening (PGA ≥ 2) While Off Therapy for Subjects Who Entered LTE With a PGA = 0 (Clear) Primary · Baseline to 44 weeks

Subjects who completed 1 of the phase 3 studies evaluating the safety and efficacy of tapinarof had the option to enter this extension study. Subjects entering with a PGA = 0 had treatment discontinued and were monitored for duration of remittive response. If/when disease worsening occurred, as evidenced by a PGA ≥ 2, treatment was re-initiated and continued until a PGA = 0 was achieved. This treatment and re-treatment pattern of use was continued until the end of the study. This outcome measure assesses the number of these subjects entering the study with a PGA= 0 who experienced worsening (P

Group	Value	95% CI
Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score	60
Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score	19

Change From Baseline in %BSA Affected Primary · Baseline to 40 weeks

Subjects received treatment with tapinarof intermittently guided by disease severity. This outcome measure assesses the change from baseline in %BSA affected in all subjects, including those on and those off therapy. BSA affected was estimated by the handprint method, where the full palmar hand of the subject represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints (hp) with percentage \[Head and neck = 10% (10 hp), upper extremities = 20% (20 hp), Trunk (including axillae and groin) = 30% (30 hp), lower extremities (including buttocks) = 40% (40

Group	Value	95% CI
Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score	-2.03	± 4.848

Percent Change From Baseline in %BSA Affected Primary · Baseline to 40 weeks

Subjects received treatment with tapinarof intermittently guided by disease severity. This outcome measure assesses the % change from baseline in %BSA affected in all subjects, including those on and those off therapy. BSA affected was estimated by the handprint method, where the full palmar hand of the subject represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints (hp) with percentage \[Head and neck = 10% (10 hp), upper extremities = 20% (20 hp), Trunk (including axillae and groin) = 30% (30 hp), lower extremities (including buttocks) = 40% (4

Group	Value	95% CI
Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score	-18.48	± 149.908

Mean Duration (Days) of Treatment Course Primary · Baseline to 40 weeks

Subjects who completed 1 of the phase 3 studies evaluating the safety and efficacy of tapinarof had the option to enter this extension study. Subjects entering with a PGA ≥ 1 continued tapinarof until they achieved a PGA = 0, at which time treatment was discontinued. If/when disease worsening occurred, as evidenced by a PGA ≥ 2, treatment was re-initiated and continued until a PGA = 0 was achieved. Mean duration (days) of treatment episode = time (days) from date of each PGA ≥ 2 (or PGA ≥ 1 for the first episode) to 1 day before each subsequent PGA = 0. The PGA is an assessment of a subject'

Group	Value	95% CI
Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score	172.9	± 102.17

Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Primary · Baseline to 40 weeks

Subjects received treatment with tapinarof intermittently guided by disease severity. This outcome measure assesses the change from baseline in PASI score in all subjects, including those on and those off therapy. The 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

Group	Value	95% CI
Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score	-1.80	± 4.334

Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Primary · Baseline to 40 weeks

Subjects received treatment with tapinarof intermittently guided by disease severity. This outcome measure assesses the % change from baseline in PASI score in all subjects, including those on and those off therapy. The 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 assesse

Group	Value	95% CI
Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score	-11.90	± 151.684

Adverse events — posted to ClinicalTrials.gov

Time frame: subject duration: 40 weeks of treatment and a 4 week, safety follow up period Overall duration of study: 16 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score

Serious: 19/763 (2%)

Deaths: 1/763

Serious adverse events (19 terms)

Reaction	System	Continuous or Intermittent…
Pancreatitis	Gastrointestinal disorders	—
Road Traffic Accident	Injury, poisoning and procedural complications	—
Arrhythmia	Cardiac disorders	—
Myocardial Infarction	Cardiac disorders	—
Pericardial effusion	Cardiac disorders	—
Appendicitis	Infections and infestations	—
Diverticulitis	Infections and infestations	—
Pelvic inflammatory disease	Infections and infestations	—
Pneumonia	Infections and infestations	—
Tooth abscess	Infections and infestations	—
Ankle fracture	Injury, poisoning and procedural complications	—
Head injury	Injury, poisoning and procedural complications	—
Patella fracture	Injury, poisoning and procedural complications	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—
Cerebrovascular accident	Nervous system disorders	—
Intracranial aneurysm	Nervous system disorders	—
Nephrolithiasis	Renal and urinary disorders	—
Pelvi-ureteric obstruction	Renal and urinary disorders	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (2 terms — click to expand)

Reaction	System	Continuous or Intermittent…
Folliculitis	Infections and infestations	—
Dermatitis contact	Skin and subcutaneous tissue disorders	—

Most-reported serious reactions: Pancreatitis, Road Traffic Accident, Arrhythmia, Myocardial Infarction, Pericardial effusion, Appendicitis, Diverticulitis, Pelvic inflammatory disease.

Data from ClinicalTrials.gov NCT04053387 adverse events section.

Sponsor's own description

This is a long-term, open-label, multicenter, study to evaluate the safety and efficacy of topical tapinarof cream, 1% in adults with plaque psoriasis. Subjects in this study completed treatment in 1 of 2 Phase 3 pivotal efficacy and safety studies (Study DMVT-505-3001 or Study DMVT-505-3002). This study will consist of up to 40 weeks of treatment and a 4-week safety follow-up period.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. <i>Malassezia</i>-Associated Skin Diseases, the Use of Diagnostics and Treatment.
   Saunte DML, Gaitanis G, Hay RJ. · · 2020 · cited 125× · PMID 32266163 · DOI 10.3389/fcimb.2020.00112
2. More Than Resveratrol: New Insights into Stilbene-Based Compounds.
   Pecyna P, Wargula J, Murias M, Kucinska M. · · 2020 · cited 87× · PMID 32726968 · DOI 10.3390/biom10081111
3. Tapinarof Cream 1%: First Approval.
   Keam SJ. · · 2022 · cited 49× · PMID 35939180 · DOI 10.1007/s40265-022-01748-6
4. Key Signaling Pathways in Psoriasis: Recent Insights from Antipsoriatic Therapeutics.
   Ben Abdallah H, Johansen C, Johansen C, Iversen L. · · 2021 · cited 48× · PMID 34235053 · DOI 10.2147/ptt.s294173
5. The aryl hydrocarbon receptor: a rehabilitated target for therapeutic immune modulation.
   Polonio CM, McHale KA, Sherr DH, Rubenstein D, et al · · 2025 · cited 41× · PMID 40247142 · DOI 10.1038/s41573-025-01172-x
6. Tapinarof for the treatment of psoriasis.
   Nogueira S, Rodrigues MA, Vender R, Torres T. · · 2022 · cited 33× · PMID 36226669 · DOI 10.1111/dth.15931
7. New and Emerging Oral/Topical Small-Molecule Treatments for Psoriasis.
   Carmona-Rocha E, Rusiñol L, Puig L. · · 2024 · cited 28× · PMID 38399292 · DOI 10.3390/pharmaceutics16020239
8. Therapeutic Development Based on the Immunopathogenic Mechanisms of Psoriasis.
   Tseng JC, Chang YC, Huang CM, Hsu LC, et al · · 2021 · cited 27× · PMID 34371756 · DOI 10.3390/pharmaceutics13071064