Trial · NCT04053387
Long Term Extension Study of Tapinarof for Plaque Psoriasis in Adults (3003)
NCT04053387, Phase 3, Completed, Organon and Co; results first posted 2022-08-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long Term Extension Study of Tapinarof for Plaque Psoriasis in Adults (3003). Trials, record NCT04053387. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04053387
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long Term Extension Study of Tapinarof for Plaque Psoriasis in Adults (3003)
- NCT number
- NCT04053387
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 763 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Plaque Psoriasis
- Interventions
- tapinarof cream, 1%
- First posted
- 2019-08-12
- Last updated
- 2025-08-06
- Results first posted
- 2022-08-08
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Adverse Events and Serious Adverse Events | 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%. |
| Primary | Frequency of Adverse Events and Serious Adverse Events | 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%. |
| Primary | Number of Subjects With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values and Vital Signs | 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. |
| Primary | 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) | 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 using a static 5-point scale to grade lesions on the clinical characteristics of erythema, scaling, and plaque thickness/elevation. The PGA ranges from 0 to 4, where 0 = clear, 1= almost clear, 2 = mild, 3 = moderate, and 4 = severe. |
| Primary | 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) | 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 clearance (PGA=0) while on therapy during this extension study. The PGA is an assessment of a subject's psoriasis using a static 5-point scale to grade lesions on the clinical characteristics of erythema, scaling, and plaque thickness/elevation. The PGA ranges from 0 to 4, where 0 = clear, 1= almost clear, 2 = mild, 3 = moderate, and 4 = severe. Higher PGA scores represent more severe disease. |
| Primary | 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) | 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 or almost clear) while on therapy during this extension study. The PGA is an assessment of a subject's psoriasis using a static 5-point scale to grade lesions on the clinical characteristics of erythema, scaling, and plaque thickness/elevation. The PGA ranges from 0 to 4, where 0 = clear, 1= almost clear, 2 = mild, 3 = moderate, and 4 = severe. Higher PGA scores represent more severe disease. |
| Primary | 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) | 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 (PGA ≥ 2) while off therapy at least once during this extension study. The PGA is an assessment of a subject's psoriasis using a static 5-point scale to grade lesions on the clinical characteristics of erythema, scaling, and plaque thickness/elevation. The PGA ranges from 0 to 4, where 0 = clear, 1= almost clear, 2 = mild, 3 = moderate, and 4 = severe. |
| Primary | Change From Baseline in %BSA Affected | 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 \[Head and neck = 10% (10 hp), upper extremities = 20% (20 hp), Trunk (including axillae and groin) = 30% (30 hp), lower extremities (including buttocks) = 40% (40 hp)\]. The total %BSA involved was estimated = % involvement |
| Primary | Percent Change From Baseline in %BSA Affected | 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 \[Head and neck = 10% (10 hp), upper extremities = 20% (20 hp), Trunk (including axillae and groin) = 30% (30 hp), lower extremities (including buttocks) = 40% (40 hp)\]. The total %BSA involved was estimated = % involvement |
| Primary | Mean Duration (Days) of Treatment Course | 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's psoriasis using a static 5-point scale to grade lesions on the clinical characteristics of erythema, scaling, and plaque thickness/elevation. The PGA ranges from 0 to 4, where 0 = clear, 1= almost clear, 2 = mild, 3 = moderate, and 4 = severe. Higher PGA scores represent more severe disease. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Adverse Events and Serious Adverse Events | Baseline to 44 weeks | Subjects entering with a PGA = 0 had treatment discontinued. Subjects entering with a PGA ≥ 1 received tapinarof until they achieved a PGA = 0 and had treatment discontinued. If/when disease worsening (PGA ≥ 2) occurred 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. The ITT population includes all subjects who signed the informed consent and enrolled in this extension study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Frequency of Adverse Events and Serious Adverse Events | Baseline to 44 weeks | Subjects entering with a PGA = 0 had treatment discontinued. Subjects entering with a PGA ≥ 1 received tapinarof until they achieved a PGA = 0 and had treatment discontinued. If/when disease worsening (PGA ≥ 2) occurred 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. The ITT population includes all subjects who signed the informed consent and enrolled in this extension study. | events | NUMBER |
| PRIMARY | Number of Subjects With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values and Vital Signs | Baseline to 40 weeks | Subjects entering with a PGA = 0 had treatment discontinued. Subjects entering with a PGA ≥ 1 received tapinarof until they achieved a PGA = 0 and had treatment discontinued. If/when disease worsening (PGA ≥ 2) occurred 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. The ITT population includes all subjects who signed the informed consent and enrolled in this extension study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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) | Baseline to 44 weeks | Subjects entering with a PGA = 0 had treatment discontinued. Subjects entering with a PGA ≥ 1 received tapinarof until they achieved a PGA = 0 and had treatment discontinued. If/when disease worsening (PGA ≥ 2) occurred 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. The ITT population includes all subjects who signed the informed consent and enrolled in this extension study. | days from baseline visit | MEDIAN |
| PRIMARY | 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) | Baseline to 44 weeks | Subjects entering with a PGA = 0 had treatment discontinued. Subjects entering with a PGA ≥ 1 received tapinarof until they achieved a PGA = 0 and had treatment discontinued. If/when disease worsening (PGA ≥ 2) occurred 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. The ITT population includes all subjects who signed the informed consent and enrolled in this extension study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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) | Baseline to 44 weeks | Subjects entering with a PGA = 0 had treatment discontinued. Subjects entering with a PGA ≥ 1 received tapinarof until they achieved a PGA = 0 and had treatment discontinued. If/when disease worsening (PGA ≥ 2) occurred 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. The ITT population includes all subjects who signed the informed consent and enrolled in this extension study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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) | Baseline to 44 weeks | Subjects entering with a PGA = 0 had treatment discontinued. Subjects entering with a PGA ≥ 1 received tapinarof until they achieved a PGA = 0 and had treatment discontinued. If/when disease worsening (PGA ≥ 2) occurred 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. The ITT population includes all subjects who signed the informed consent and enrolled in this extension study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in %BSA Affected | Baseline to 40 weeks | Subjects entering with a PGA = 0 had treatment discontinued. Subjects entering with a PGA ≥ 1 received tapinarof until they achieved a PGA = 0 and had treatment discontinued. If/when disease worsening (PGA ≥ 2) occurred 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. The ITT population includes all subjects who signed the informed consent and enrolled in this extension study. | percentage of BSA affected | MEAN |
| PRIMARY | Percent Change From Baseline in %BSA Affected | Baseline to 40 weeks | Subjects entering with a PGA = 0 had treatment discontinued. Subjects entering with a PGA ≥ 1 received tapinarof until they achieved a PGA = 0 and had treatment discontinued. If/when disease worsening (PGA ≥ 2) occurred 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. The ITT population includes all subjects who signed the informed consent and enrolled in this extension study. | percentage change | MEAN |
| PRIMARY | Mean Duration (Days) of Treatment Course | Baseline to 40 weeks | Subjects entering with a PGA = 0 had treatment discontinued. Subjects entering with a PGA ≥ 1 received tapinarof until they achieved a PGA = 0 and had treatment discontinued. If/when disease worsening (PGA ≥ 2) occurred 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. The ITT population includes all subjects who signed the informed consent and enrolled in this extension study. | days | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Adverse Events and Serious Adverse Events | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | Adverse Events | 474 | Participants | |
| Number of Subjects With Adverse Events and Serious Adverse Events | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | Serious Adverse Events | 19 | Participants | |
| Frequency of Adverse Events and Serious Adverse Events | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | Adverse Events | 1190 | events | |
| Frequency of Adverse Events and Serious Adverse Events | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | Serious Adverse Events | 21 | events | |
| Number of Subjects With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values and Vital Signs | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | Clinically Meaningful changes in hematology | 0 | Participants | |
| Number of Subjects With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values and Vital Signs | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | Clinically meaningful changes in chemistry | 0 | Participants | |
| Number of Subjects With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values and Vital Signs | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | Clinically meaningful changes in urinalysis | 0 | Participants | |
| Number of Subjects With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values and Vital Signs | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | Clinically meaningful changes in pulse rate | 7 | Participants | |
| Number of Subjects With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values and Vital Signs | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | Clinically meaningful changes in systolic blood pressure | 6 | Participants | |
| Number of Subjects With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values and Vital Signs | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | Clinically meaningful changes in diastolic blood pressure | 16 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 763 | |
| Overall Study | COMPLETED | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 531 | |
| Overall Study | NOT COMPLETED | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 232 |
Source ClinicalTrials.gov
Adverse events21
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 | Folliculitis | Infections and infestations | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 173 | 763 | |
| other | Dermatitis contact | Skin and subcutaneous tissue disorders | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 42 | 763 | |
| serious | Arrhythmia | Cardiac disorders | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 1 | 763 | |
| serious | Myocardial Infarction | Cardiac disorders | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 1 | 763 | |
| serious | Pericardial effusion | Cardiac disorders | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 1 | 763 | |
| serious | Pancreatitis | Gastrointestinal disorders | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 2 | 763 | |
| serious | Appendicitis | Infections and infestations | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 1 | 763 | |
| serious | Diverticulitis | Infections and infestations | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 1 | 763 | |
| serious | Pelvic inflammatory disease | Infections and infestations | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 1 | 763 | |
| serious | Pneumonia | Infections and infestations | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 1 | 763 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 1 | 763 |
| Total, other adverse events | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 204 | 763 |
| Total, serious adverse events | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 19 | 763 |
Source ClinicalTrials.gov
Papers3
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04053387
GET https://conductscience.org/api/trials/v1/NCT04053387/results?page=2