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Tapinarof for the Treatment of Plaque Psoriasis in Adults (3002)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03983980
Recruitment Status : Completed
First Posted : June 12, 2019
Results First Posted : October 13, 2022
Last Update Posted : October 13, 2022
Sponsor:
Collaborator:
IQVIA Biotech
Information provided by (Responsible Party):
Dermavant Sciences, Inc. ( Dermavant Sciences GmbH )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Interventions Drug: Tapinarof
Drug: Vehicle Cream
Enrollment 515
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tapinarof (DMVT-505) Cream Group Vehicle Cream Group
Hide Arm/Group Description

Tapinarof cream, 1%, applied once daily

Tapinarof: Tapinarof cream, 1%, applied once daily

Vehicle cream applied once daily

Vehicle Cream: Vehicle cream applied once daily
Period Title: Overall Study
Started 343 172
Completed 282 142
Not Completed 61 30
Arm/Group Title Tapinarof (DMVT-505) Cream Group Vehicle Cream Group Total
Hide Arm/Group Description

Tapinarof cream, 1%, applied once daily

Tapinarof: Tapinarof cream, 1%, applied once daily

Vehicle cream applied once daily

Vehicle Cream: Vehicle cream applied once daily

 Total of all reporting groups
Overall Number of Baseline Participants 343 172 515
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 343 participants 172 participants 515 participants
50.0  (13.07) 50.0  (13.67) 50.0  (13.26)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 343 participants 172 participants 515 participants
Female
155
  45.2%
70
  40.7%
225
  43.7%
Male
188
  54.8%
102
  59.3%
290
  56.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 343 participants 172 participants 515 participants
Hispanic or Latino
43
  12.5%
23
  13.4%
66
  12.8%
Not Hispanic or Latino
300
  87.5%
148
  86.0%
448
  87.0%
Unknown or Not Reported
0
   0.0%
1
   0.6%
1
   0.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 343 participants 172 participants 515 participants
American Indian or Alaska Native
2
   0.6%
2
   1.2%
4
   0.8%
Asian
25
   7.3%
21
  12.2%
46
   8.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.6%
1
   0.2%
Black or African American
12
   3.5%
6
   3.5%
18
   3.5%
White
300
  87.5%
138
  80.2%
438
  85.0%
More than one race
3
   0.9%
3
   1.7%
6
   1.2%
Unknown or Not Reported
1
   0.3%
1
   0.6%
2
   0.4%
Physicians Global Assessment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 343 participants 172 participants 515 participants
0 - Clear
0
   0.0%
0
   0.0%
0
   0.0%
1 - Almost Clear
0
   0.0%
0
   0.0%
0
   0.0%
2 - Mild
28
   8.2%
15
   8.7%
43
   8.3%
3 - Moderate
288
  84.0%
144
  83.7%
432
  83.9%
4 - severe
27
   7.9%
13
   7.6%
40
   7.8%
[1]
Measure Description: 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.
Psoriasis Area and Severity Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 343 participants 172 participants 515 participants
9.05  (3.676) 9.27  (4.016) 9.12  (3.791)
[1]
Measure Description: The Psoriasis Area and Severity Index (PASI) scoring system combines lesion severity and extent of affected area into 1 score: 0 (no disease) to 72 (maximal disease). 4 areas (head, arms, trunk, and legs) are each assessed for 3 signs: erythema (redness), induration (plaque thickness), and scale using a 5-point scale, where 0=none, 1=slight, 2=mild, 3=moderate, 4=severe and percent of skin involved using a 6-point scale were 6 is worse. Scores are multiplied by a weighted factor for each region; the sum of these scores gives the overall PASI score. Higher scores indicate more severe disease.
Percent Body Surface Area   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 343 participants 172 participants 515 participants
7.8  (4.39) 7.3  (4.14) 7.6  (4.31)
[1]
Measure Description: The handprint method was used to assess BSA with psoriasis, where the full palmar hand of the participant 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.
1.Primary Outcome
Title 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
Hide Description 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
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tapinarof (DMVT-505) Cream Group Vehicle Cream Group
Hide Arm/Group Description:

Tapinarof cream, 1%, applied once daily

Tapinarof: Tapinarof cream, 1%, applied once daily

Vehicle cream applied once daily

Vehicle Cream: Vehicle cream applied once daily
Overall Number of Participants Analyzed 343 172
Mean (Standard Error)
Unit of Measure: percentage of subjects
40.2  (2.82) 6.3  (1.99)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tapinarof (DMVT-505) Cream Group, Vehicle Cream Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 6.10
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percent of Subjects With ≥ 75% Improvement in Psoriasis Area and Severity Index (PASI) From Baseline at Week 12. Analyses Were Done Using Multiple Imputation.
Hide Description 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.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tapinarof (DMVT-505) Cream Group Vehicle Cream Group
Hide Arm/Group Description:

Tapinarof cream, 1%, applied once daily

Tapinarof: Tapinarof cream, 1%, applied once daily

Vehicle cream applied once daily

Vehicle Cream: Vehicle cream applied once daily
Overall Number of Participants Analyzed 343 172
Mean (Standard Error)
Unit of Measure: percentage of subjects
47.6  (2.81) 6.9  (2.01)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tapinarof (DMVT-505) Cream Group, Vehicle Cream Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 6.53
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percent of Subjects With a PGA Score of 0 or 1 at Week 12. Analyses Were Done Using Multiple Imputation.
Hide Description 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.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tapinarof (DMVT-505) Cream Group Vehicle Cream Group
Hide Arm/Group Description:

Tapinarof cream, 1%, applied once daily

Tapinarof: Tapinarof cream, 1%, applied once daily

Vehicle cream applied once daily

Vehicle Cream: Vehicle cream applied once daily
Overall Number of Participants Analyzed 343 172
Mean (Standard Error)
Unit of Measure: percentage of subjects
43.6  (2.85) 8.1  (2.21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tapinarof (DMVT-505) Cream Group, Vehicle Cream Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 4.55
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Mean Change in Percent of Total Body Surface Area (%BSA) Affected From Baseline to Week 12
Hide Description 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.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tapinarof (DMVT-505) Cream Group Vehicle Cream Group
Hide Arm/Group Description:

Tapinarof cream, 1%, applied once daily

Tapinarof: Tapinarof cream, 1%, applied once daily

Vehicle cream applied once daily

Vehicle Cream: Vehicle cream applied once daily
Overall Number of Participants Analyzed 343 172
Mean (Standard Error)
Unit of Measure: Mean change from Baseline
-4.22  (0.367) 0.10  (0.448)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tapinarof (DMVT-505) Cream Group, Vehicle Cream Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -4.32
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percent of Subjects With ≥90% Improvement in PASI Score From Baseline to Week 12. Analyses Were Done Using Multiple Imputation.
Hide Description 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.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tapinarof (DMVT-505) Cream Group Vehicle Cream Group
Hide Arm/Group Description:

Tapinarof cream, 1%, applied once daily

Tapinarof: Tapinarof cream, 1%, applied once daily

Vehicle cream applied once daily

Vehicle Cream: Vehicle cream applied once daily
Overall Number of Participants Analyzed 343 172
Mean (Standard Error)
Unit of Measure: percentage of subjects
20.9  (2.28) 2.5  (1.21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tapinarof (DMVT-505) Cream Group, Vehicle Cream Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 7.25
Estimation Comments [Not Specified]
Time Frame Subject duration: 12 weeks of treatment and 4 week follow-up for subjects not enrolled in the long-term extension study (DMVT-505-3003)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tapinarof (DMVT-505) Cream Group Vehicle Cream Group
Hide Arm/Group Description

Tapinarof cream, 1%, applied once daily

Tapinarof: Tapinarof cream, 1%, applied once daily.

All SAEs were deemed unrelated to treatment with tapinarof cream, 1%.

Vehicle cream applied once daily

Vehicle Cream: Vehicle cream applied once daily.

All SAEs were deemed unrelated to treatment with tapinarof cream, 1%.
All-Cause Mortality
Tapinarof (DMVT-505) Cream Group Vehicle Cream Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/343 (0.00%)   0/172 (0.00%) 
Hide Serious Adverse Events
Tapinarof (DMVT-505) Cream Group Vehicle Cream Group
Affected / at Risk (%) Affected / at Risk (%)
Total   7/343 (2.04%)   0/172 (0.00%) 
Cardiac disorders     
Coronary artery stenosis †  1/343 (0.29%)  0/172 (0.00%) 
Gastrointestinal disorders     
Pancreatitis †  1/343 (0.29%)  0/172 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis †  1/343 (0.29%)  0/172 (0.00%) 
Infections and infestations     
Appendicitis †  1/343 (0.29%)  0/172 (0.00%) 
Nervous system disorders     
Headache †  1/343 (0.29%)  0/172 (0.00%) 
Nerve compression †  1/343 (0.29%)  0/172 (0.00%) 
Renal and urinary disorders     
Nephrolithiasis †  1/343 (0.29%)  0/172 (0.00%) 
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Tapinarof (DMVT-505) Cream Group Vehicle Cream Group
Affected / at Risk (%) Affected / at Risk (%)
Total   123/343 (35.86%)   28/172 (16.28%) 
Gastrointestinal disorders     
Diarrhoea †  4/343 (1.17%)  0/172 (0.00%) 
General disorders     
Application site pruritus †  4/343 (1.17%)  0/172 (0.00%) 
Infections and infestations     
Folliculitis †  59/343 (17.20%)  1/172 (0.58%) 
Upper respiratory tract infection †  12/343 (3.50%)  8/172 (4.65%) 
Nasopharyngitis †  14/343 (4.08%)  5/172 (2.91%) 
Bronchitis †  6/343 (1.75%)  1/172 (0.58%) 
Sinusitis †  6/343 (1.75%)  1/172 (0.58%) 
Urinary tract infection †  5/343 (1.46%)  2/172 (1.16%) 
Influenza †  5/343 (1.46%)  1/172 (0.58%) 
Metabolism and nutrition disorders     
Glucose tolerance impaired †  0/343 (0.00%)  2/172 (1.16%) 
Musculoskeletal and connective tissue disorders     
Back pain †  2/343 (0.58%)  3/172 (1.74%) 
Nervous system disorders     
Headache †  13/343 (3.79%)  1/172 (0.58%) 
Respiratory, thoracic and mediastinal disorders     
Cough †  5/343 (1.46%)  1/172 (0.58%) 
Skin and subcutaneous tissue disorders     
Dermatitis contact †  18/343 (5.25%)  0/172 (0.00%) 
Pruritus †  7/343 (2.04%)  2/172 (1.16%) 
Dermatitis †  5/343 (1.46%)  1/172 (0.58%) 
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Investigator will submit any proposed publication or presentation along with the respective scientific journal or presentation forum at least 30 days before submission of the publication or presentation. Investigator will comply with DMVT request to delete references to its confidential information (other than the study results) in any paper or presentation and agrees to withhold publication or presentation for an additional 60 days in order to obtain patent protection if deemed necessary.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dermavant Sciences Medical Information Call Center
Organization: Dermavant Sciences
Phone: 1-833-762-8268
EMail: medinfo@dermavant.com
Publications:
Layout table for additonal information
Responsible Party: Dermavant Sciences, Inc. ( Dermavant Sciences GmbH )
ClinicalTrials.gov Identifier: NCT03983980    
Other Study ID Numbers: DMVT-505-3002
First Submitted: June 10, 2019
First Posted: June 12, 2019
Results First Submitted: June 21, 2022
Results First Posted: October 13, 2022
Last Update Posted: October 13, 2022