Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT03956355 | Psoriasis | 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 | Tapinarof (DMVT-505) | 35.4 percentage of subjects (±2.75 Standard Error) |
| Vehicle Cream | 6.0 percentage of subjects (±2.08 Standard Error) | |||
| NCT03983980 | Psoriasis | 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 | Tapinarof (DMVT-505) Cream Group | 40.2 percentage of subjects (±2.82 Standard Error) |
| Vehicle Cream Group | 6.3 percentage of subjects (±1.99 Standard Error) | |||
| NCT04053387 | Psoriasis | Change From Baseline in %BSA Affected Baseline to 40 weeks | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | -2.03 percentage of BSA affected (±4.848 Standard Deviation) |
| NCT04053387 | Psoriasis | Change From Baseline in Disease Impact on Daily Activities, as Measured by the Dermatology Life Quality Index (DLQI) Baseline to 40 weeks | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | -2.0 scores on a scale (±4.31 Standard Deviation) |
| NCT04053387 | Psoriasis | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Baseline to 40 weeks | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | -1.80 scores on a scale (±4.334 Standard Deviation) |
| NCT04053387 | Psoriasis | 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 | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 233 Participants |
| NCT04053387 | Psoriasis | Frequency of Adverse Events and Serious Adverse Events Baseline to 44 weeks | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 21 events |
| Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 1190 events | |||
| NCT04053387 | Psoriasis | Mean Duration (Days) of Treatment Course Baseline to 40 weeks | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 172.9 days (±102.17 Standard Deviation) |
| NCT04053387 | Psoriasis | Number of Subjects With Adverse Events and Serious Adverse Events Baseline to 44 weeks | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 19 Participants |
| Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 474 Participants | |||
| NCT04053387 | Psoriasis | Number of Subjects With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values and Vital Signs Baseline to 40 weeks | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 7 Participants |
| Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 0 Participants | |||
| Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 0 Participants | |||
| Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 0 Participants | |||
| Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 6 Participants | |||
| Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 16 Participants | |||
| NCT04053387 | Psoriasis | Percent Change From Baseline in %BSA Affected Baseline to 40 weeks | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | -18.48 percentage change (±149.908 Standard Deviation) |
| NCT04053387 | Psoriasis | Percent Change From Baseline in Disease Impact on Daily Activities, as Measured by the Dermatology Life Quality Index (DLQI) Baseline to 40 weeks | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | -37.1 percentage change (±121.35 Standard Deviation) |
| NCT04053387 | Psoriasis | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Baseline to 40 weeks | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | -11.90 percentage change (±151.684 Standard Deviation) |
| NCT04053387 | Psoriasis | 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 | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 115 days from baseline visit |
| NCT04053387 | Psoriasis | 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 | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 19 Participants |
| Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 60 Participants | |||
| NCT04053387 | Psoriasis | 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 | Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score | 302 Participants |
| NCT05014568 | Dermatitis, Atopic | Percent of Subjects Who Have a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of Clear or Almost Clear (0 or 1) With a Minimum 2-grade Improvement From Baseline to Week 8. Analyses Were Done Using Multiple Imputation. Baseline to Week 8 | Tapinarof Cream | 45.4 Percentage of participants |
| Vehicle Cream | 13.9 Percentage of participants | |||
| NCT05032859 | Dermatitis, Atopic | Percent of Subjects Who Have a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of Clear or Almost Clear (0 or 1) With a Minimum 2-grade Improvement From Baseline to Week 8. Analyses Were Done Using Multiple Imputation. Baseline to Week 8 | Tapinarof Cream | 46.4 Percentage of participants |
| Vehicle Cream | 18.0 Percentage of participants | |||
| NCT05142774 | Dermatitis, Atopic | Absolute Change From Baseline in %BSA Affected Baseline to Week 48 | Tapinarof Cream | -7.14 percentage of BSA (±12.881 Standard Deviation) |
| NCT05142774 | Dermatitis, Atopic | Change From Baseline in Clinical Laboratory Values (%) Baseline to Week 48 | Tapinarof Cream | -0.73 % of cells (±10.440 Standard Deviation) |
| Tapinarof Cream | -0.06 % of cells (±0.402 Standard Deviation) | |||
| Tapinarof Cream | -0.39 % of cells (±3.427 Standard Deviation) | |||
| Tapinarof Cream | 0.03 % of cells (±0.272 Standard Deviation) | |||
| Tapinarof Cream | 1.18 % of cells (±11.436 Standard Deviation) | |||
| Tapinarof Cream | -0.09 % of cells (±2.592 Standard Deviation) | |||
| NCT05142774 | Dermatitis, Atopic | Change From Baseline in Clinical Laboratory Values (10^12 Cells/L) Baseline to Week 48 | Tapinarof Cream | 0.038 10^12 cells/L (±0.2905 Standard Deviation) |
| NCT05142774 | Dermatitis, Atopic | Change From Baseline in Clinical Laboratory Values (10^9 Cells/L) Baseline to Week 48 | Tapinarof Cream | 0.01 10^9 cells/L (±0.051 Standard Deviation) |
| Tapinarof Cream | -0.02 10^9 cells/L (±0.909 Standard Deviation) | |||
| Tapinarof Cream | 0.00 10^9 cells/L (±0.192 Standard Deviation) | |||
| Tapinarof Cream | -4.0 10^9 cells/L (±59.57 Standard Deviation) | |||
| Tapinarof Cream | 0.18 10^9 cells/L (±2.474 Standard Deviation) | |||
| Tapinarof Cream | -.03 10^9 cells/L (±0.308 Standard Deviation) | |||
| Tapinarof Cream | 0.22 10^9 cells/L (±2.079 Standard Deviation) | |||
| NCT05142774 | Dermatitis, Atopic | Change From Baseline in Clinical Laboratory Values (fl) Baseline to Week 48 | Tapinarof Cream | 0.37 fl (±2.364 Standard Deviation) |
| NCT05142774 | Dermatitis, Atopic | Change From Baseline in Clinical Laboratory Values (g/L) Baseline to Week 48 | Tapinarof Cream | 0.0 g/L (±3.95 Standard Deviation) |
| Tapinarof Cream | -0.5 g/L (±2.43 Standard Deviation) | |||
| Tapinarof Cream | 1.7 g/L (±8.45 Standard Deviation) | |||
| Tapinarof Cream | 0.0 g/L (±7.61 Standard Deviation) | |||
| NCT05142774 | Dermatitis, Atopic | Change From Baseline in Clinical Laboratory Values (L/L) Baseline to Week 48 | Tapinarof Cream | 0.005 L/L (±0.0263 Standard Deviation) |
| NCT05142774 | Dermatitis, Atopic | Change From Baseline in Clinical Laboratory Values (mmol/L) Baseline to Week 48 | Tapinarof Cream | -0.03 mmol/L (±0.493 Standard Deviation) |
| Tapinarof Cream | -0.2 mmol/L (±2.31 Standard Deviation) | |||
| Tapinarof Cream | 0.04 mmol/L (±1.428 Standard Deviation) | |||
| Tapinarof Cream | 0.13 mmol/L (±1.462 Standard Deviation) | |||
| Tapinarof Cream | -0.1 mmol/L (±2.14 Standard Deviation) | |||
| Tapinarof Cream | -0.019 mmol/L (±0.0926 Standard Deviation) | |||
| Tapinarof Cream | -0.3 mmol/L (±2.43 Standard Deviation) | |||
| NCT05142774 | Dermatitis, Atopic | Change From Baseline in Clinical Laboratory Values (pg) Baseline to Week 48 | Tapinarof Cream | 0.13 pg (±0.823 Standard Deviation) |
| NCT05142774 | Dermatitis, Atopic | Change From Baseline in Clinical Laboratory Values (U/L) Baseline to Week 48 | Tapinarof Cream | -14.9 U/L (±69.45 Standard Deviation) |
| Tapinarof Cream | -2.6 U/L (±16.13 Standard Deviation) | |||
| Tapinarof Cream | -1.5 U/L (±11.96 Standard Deviation) | |||
| NCT05142774 | Dermatitis, Atopic | Change From Baseline in Clinical Laboratory Values (Umol/L) Baseline to Week 48 | Tapinarof Cream | 2.7 umol/L (±12.06 Standard Deviation) |
| Tapinarof Cream | 2.1 umol/L (±7.92 Standard Deviation) | |||
| Tapinarof Cream | 0.40 umol/L (±3.434 Standard Deviation) | |||
| Tapinarof Cream | 0.9 umol/L (±52.32 Standard Deviation) | |||
| NCT05142774 | Dermatitis, Atopic | Change From Baseline in Vital Signs - Blood Pressure (Systolic and Diastolic) Baseline to Week 48 | Tapinarof Cream | 1.0 mmHg (±10.72 Standard Deviation) |
| Tapinarof Cream | 0.7 mmHg (±9.78 Standard Deviation) | |||
| NCT05142774 | Dermatitis, Atopic | Change From Baseline in Vital Signs - Pulse Baseline to Week 48 | Tapinarof Cream | -0.9 beats per minute (bpm) (±12.61 Standard Deviation) |
| NCT05142774 | Dermatitis, Atopic | Change From Baseline in Vital Signs - Temperature Baseline to Week 48 | Tapinarof Cream | 0.02 degrees C (±0.437 Standard Deviation) |
| NCT05142774 | Dermatitis, Atopic | Complete Disease Clearance During LTE: Number of Subjects Achieving Disease Clearance vIGA-AD =0 (Clear) While on Therapy for Subjects Entered LTE vIGA-AD ≥ 1 (Almost Clear ) Baseline to Week 48 | Tapinarof Cream | 320 Participants |
| NCT05142774 | Dermatitis, Atopic | Frequency of Adverse Events and Serious Adverse Events Baseline to Week 49 | Tapinarof Cream | 1226 Events |
| Tapinarof Cream | 45 Events | |||
| NCT05142774 | Dermatitis, Atopic | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score Baseline to Week 48 | Tapinarof Cream | -4.19 Units on a scale (±7.248 Standard Deviation) |
| NCT05142774 | Dermatitis, Atopic | Mean Change in Peak Pruritis-Numeric Rating Scale (PP-NRS) From Baseline Baseline to Week 48 | Tapinarof Cream | -1.618 Units on a scale (±2.7756 Standard Deviation) |
| NCT05142774 | Dermatitis, Atopic | Number of Subjects With a Baseline Peak Pruritis-Numeric Rating Scale (PP-NRS) Score ≥ 4 Who Achieve ≥ 4-point Reduction in the PP-NRS From Baseline Baseline to Week 48 | Tapinarof Cream | 94 Participants |
| NCT05142774 | Dermatitis, Atopic | Number of Subjects With Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events Baseline to Week 49 | Tapinarof Cream | 451 Participants |
| Tapinarof Cream | 34 Participants | |||
| NCT05142774 | Dermatitis, Atopic | Percent Change From Baseline in %BSA Affected Baseline to Week 48 | Tapinarof Cream | -37.45 percent change from baseline in % total (±189.905 Standard Deviation) |
| NCT05142774 | Dermatitis, Atopic | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Baseline to Week 48 | Tapinarof Cream | -33.70 Units on a scale (±139.557 Standard Deviation) |
| NCT05142774 | Dermatitis, Atopic | Percent of Subjects With ≥ 50% Improvement in Eczema Area and Severity Index (EASI) From Baseline at Week 48. Baseline to Week 48 | Tapinarof Cream | 325 Participants |
| NCT05142774 | Dermatitis, Atopic | Percent of Subjects With ≥ 75% Improvement in Eczema Area and Severity Index (EASI) From Baseline at Week 48. Baseline to Week 48 | Tapinarof Cream | 256 Participants |
| NCT05142774 | Dermatitis, Atopic | Percent of Subjects With ≥ 90% Improvement in Eczema Area and Severity Index (EASI) From Baseline at Week 48. Baseline to Week 48 | Tapinarof Cream | 178 Participants |
| NCT05142774 | Dermatitis, Atopic | Response During LTE: Number of Subjects Achieving vIGA-AD =0 or 1 (Clear or Almost Clear) While on Therapy for Subjects Who Entered LTE With vIGA-AD ≥ 2 (Mild) Baseline to Week 48 | Tapinarof Cream | 347 Participants |