Trial · NCT03956355
Tapinarof for the Treatment of Plaque Psoriasis in Adults (3001)
NCT03956355, Phase 3, Completed, Organon and Co; results first posted 2022-10-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tapinarof for the Treatment of Plaque Psoriasis in Adults (3001). Trials, record NCT03956355. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03956355
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tapinarof for the Treatment of Plaque Psoriasis in Adults (3001)
- NCT number
- NCT03956355
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 510 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Plaque Psoriasis
- Interventions
- Tapinarof, Vehicle Cream
- First posted
- 2019-05-20
- Last updated
- 2025-06-12
- Results first posted
- 2022-10-13
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | Percent of Subjects With ≥ 75% Improvement in Psoriasis Area and Severity Index (PASI) From Baseline at Week 12. Analyses Were Done Using Multiple Imputation. | 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. |
| Secondary | Percent of Subjects With a PGA Score of 0 or 1 at Week 12. Analyses Were Done Using Multiple Imputation. | 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. |
| Secondary | Mean Change in Percent of Total Body Surface Area (%BSA) Affected From Baseline to Week 12 | 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. |
| Secondary | Percent of Subjects With ≥90% Improvement in PASI Score From Baseline to Week 12. Analyses Were Done Using Multiple Imputation. | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Baseline to Week 12 | percentage of subjects | MEAN | |
| SECONDARY | Percent of Subjects With ≥ 75% Improvement in Psoriasis Area and Severity Index (PASI) From Baseline at Week 12. Analyses Were Done Using Multiple Imputation. | Baseline to Week 12 | percentage of subjects | MEAN | |
| SECONDARY | Percent of Subjects With a PGA Score of 0 or 1 at Week 12. Analyses Were Done Using Multiple Imputation. | Baseline to Week 12 | percentage of subjects | MEAN | |
| SECONDARY | Mean Change in Percent of Total Body Surface Area (%BSA) Affected From Baseline to Week 12 | Baseline to Week 12 | Mean change from Baseline | LEAST_SQUARES_MEAN | |
| SECONDARY | Percent of Subjects With ≥90% Improvement in PASI Score From Baseline to Week 12. Analyses Were Done Using Multiple Imputation. | Baseline to Week 12 | percentage of subjects | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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 | Tapinarof (DMVT-505) | 35.4 | Standard Error 2.75 | percentage of subjects | |
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 | Vehicle Cream | 6.0 | Standard Error 2.08 | percentage of subjects | |
| Percent of Subjects With ≥ 75% Improvement in Psoriasis Area and Severity Index (PASI) From Baseline at Week 12. Analyses Were Done Using Multiple Imputation. | Tapinarof (DMVT-505) | 36.1 | Standard Error 2.73 | percentage of subjects | |
| Percent of Subjects With ≥ 75% Improvement in Psoriasis Area and Severity Index (PASI) From Baseline at Week 12. Analyses Were Done Using Multiple Imputation. | Vehicle Cream | 10.2 | Standard Error 2.43 | percentage of subjects | |
| Percent of Subjects With a PGA Score of 0 or 1 at Week 12. Analyses Were Done Using Multiple Imputation. | Tapinarof (DMVT-505) | 37.8 | Standard Error 2.79 | percentage of subjects | |
| Percent of Subjects With a PGA Score of 0 or 1 at Week 12. Analyses Were Done Using Multiple Imputation. | Vehicle Cream | 9.9 | Standard Error 2.51 | percentage of subjects | |
| Mean Change in Percent of Total Body Surface Area (%BSA) Affected From Baseline to Week 12 | Tapinarof (DMVT-505) | -3.50 | Standard Error 0.471 | Mean change from Baseline | |
| Mean Change in Percent of Total Body Surface Area (%BSA) Affected From Baseline to Week 12 | Vehicle Cream | -0.22 | Standard Error 0.579 | Mean change from Baseline | |
| Percent of Subjects With ≥90% Improvement in PASI Score From Baseline to Week 12. Analyses Were Done Using Multiple Imputation. | Tapinarof (DMVT-505) | 18.8 | Standard Error 2.18 | percentage of subjects | |
| Percent of Subjects With ≥90% Improvement in PASI Score From Baseline to Week 12. Analyses Were Done Using Multiple Imputation. | Vehicle Cream | 1.6 | Standard Error 1.05 | percentage of subjects |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tapinarof (DMVT-505) | 340 | |
| Overall Study | STARTED | Vehicle Cream | 170 | |
| Overall Study | COMPLETED | Tapinarof (DMVT-505) | 269 | |
| Overall Study | COMPLETED | Vehicle Cream | 130 | |
| Overall Study | NOT COMPLETED | Tapinarof (DMVT-505) | 71 | |
| Overall Study | NOT COMPLETED | Vehicle Cream | 40 |
Source ClinicalTrials.gov
Adverse events52
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | abdominal pain | Gastrointestinal disorders | Tapinarof (DMVT-505) | 4 | 340 | |
| other | abdominal pain | Gastrointestinal disorders | Vehicle Cream | 0 | 170 | |
| other | Folliculitis | Infections and infestations | Tapinarof (DMVT-505) | 79 | 340 | |
| other | Folliculitis | Infections and infestations | Vehicle Cream | 2 | 170 | |
| other | Nasopharyngitis | Infections and infestations | Tapinarof (DMVT-505) | 25 | 340 | |
| other | Nasopharyngitis | Infections and infestations | Vehicle Cream | 10 | 170 | |
| other | Upper respiratory tract infection | Infections and infestations | Tapinarof (DMVT-505) | 5 | 340 | |
| other | Upper respiratory tract infection | Infections and infestations | Vehicle Cream | 4 | 170 | |
| other | Viral upper respiratory tract infection | Infections and infestations | Tapinarof (DMVT-505) | 7 | 340 | |
| other | Viral upper respiratory tract infection | Infections and infestations | Vehicle Cream | 2 | 170 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tapinarof (DMVT-505) | 0 | 340 |
| Total, all-cause mortality | Vehicle Cream | 0 | 170 |
| Total, other adverse events | Tapinarof (DMVT-505) | 131 | 340 |
| Total, other adverse events | Vehicle Cream | 27 | 170 |
| Total, serious adverse events | Tapinarof (DMVT-505) | 9 | 340 |
| Total, serious adverse events | Vehicle Cream | 0 | 170 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tapinarof (DMVT-505) vs Vehicle Cream: deaths from any cause | Trial comparisons |
| Tapinarof (DMVT-505) vs Vehicle Cream: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03956355
GET https://conductscience.org/api/trials/v1/NCT03956355/events?page=2