Trial Outcomes & Findings for Long Term Extension Study of Tapinarof for Plaque Psoriasis in Adults (3003) (NCT NCT04053387)

NCT ID: NCT04053387

Last Updated: 2025-08-06

Results Overview

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%.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 763 participants
• Primary outcome timeframe: Baseline to 44 weeks
• Results posted on: 2025-08-06

Participant Flow

Participant milestones

Measure	Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score 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 received treatment with tapinarof cream, 1% until they achieve a PGA = 0, at which time treatment was discontinued and subjects were monitored for durability of response (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. 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
Overall Study STARTED	763
Overall Study COMPLETED	531
Overall Study NOT COMPLETED	232

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score n=763 Participants 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 received treatment with tapinarof cream, 1% until they achieved a PGA = 0, at which time treatment was discontinued and subjects were monitored for durability of response (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. 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.
Age, Continuous	50.7 years STANDARD_DEVIATION 12.88 • n=93 Participants
Sex: Female, Male Female	315 Participants n=93 Participants
Sex: Female, Male Male	448 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	117 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	641 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=93 Participants
Race (NIH/OMB) Asian	51 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=93 Participants
Race (NIH/OMB) Black or African American	39 Participants n=93 Participants
Race (NIH/OMB) White	643 Participants n=93 Participants
Race (NIH/OMB) More than one race	18 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline to 44 weeks

Population: 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.

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%.

Outcome measures

Measure	Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score n=763 Participants 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 received treatment with tapinarof cream, 1% until they achieve a PGA = 0, at which time treatment was discontinued and subjects were monitored for durability of response (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. 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.
Number of Subjects With Adverse Events and Serious Adverse Events Adverse Events	474 Participants
Number of Subjects With Adverse Events and Serious Adverse Events Serious Adverse Events	19 Participants

PRIMARY outcome

Timeframe: Baseline to 44 weeks

Population: 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.

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%.

Outcome measures

Measure	Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score n=763 Participants 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 received treatment with tapinarof cream, 1% until they achieve a PGA = 0, at which time treatment was discontinued and subjects were monitored for durability of response (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. 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.
Frequency of Adverse Events and Serious Adverse Events Adverse Events	1190 events
Frequency of Adverse Events and Serious Adverse Events Serious Adverse Events	21 events

PRIMARY outcome

Timeframe: Baseline to 40 weeks

Population: 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.

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.

Outcome measures

Measure	Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score n=763 Participants 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 received treatment with tapinarof cream, 1% until they achieve a PGA = 0, at which time treatment was discontinued and subjects were monitored for durability of response (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. 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.
Number of Subjects With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values and Vital Signs Clinically meaningful changes in chemistry	0 Participants
Number of Subjects With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values and Vital Signs Clinically meaningful changes in pulse rate	7 Participants
Number of Subjects With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values and Vital Signs Clinically Meaningful changes in hematology	0 Participants
Number of Subjects With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values and Vital Signs Clinically meaningful changes in urinalysis	0 Participants
Number of Subjects With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values and Vital Signs 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 Clinically meaningful changes in diastolic blood pressure	16 Participants

PRIMARY outcome

Timeframe: Baseline to 44 weeks

Population: 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.

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.

Outcome measures

Measure

Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score n=79 Participants 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 received treatment with tapinarof cream, 1% until they achieve a PGA = 0, at which time treatment was discontinued and subjects were monitored for durability of response (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. 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.

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)

115 days from baseline visit Interval 85.0 to 168.0

PRIMARY outcome

Timeframe: Baseline to 44 weeks

Population: 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.

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.

Outcome measures

Measure

Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score n=680 Participants 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 received treatment with tapinarof cream, 1% until they achieve a PGA = 0, at which time treatment was discontinued and subjects were monitored for durability of response (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. 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.

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)

233 Participants

PRIMARY outcome

Timeframe: Baseline to 44 weeks

Population: 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.

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.

Outcome measures

Measure

Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score n=519 Participants 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 received treatment with tapinarof cream, 1% until they achieve a PGA = 0, at which time treatment was discontinued and subjects were monitored for durability of response (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. 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.

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)

302 Participants

PRIMARY outcome

Timeframe: Baseline to 44 weeks

Population: 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.

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.

Outcome measures

Measure	Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score n=79 Participants 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 received treatment with tapinarof cream, 1% until they achieve a PGA = 0, at which time treatment was discontinued and subjects were monitored for durability of response (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. 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.
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) Number of subjects entering with PGA=0 who experienced PGA ≥ 2 at least 1 time during the study	60 Participants
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) Number of subjects entering with PGA=0 who never experienced PGA ≥ 2 throughout the study	19 Participants

PRIMARY outcome

Timeframe: Baseline to 40 weeks

Population: 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.

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

Outcome measures

Measure

Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score n=742 Participants 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 received treatment with tapinarof cream, 1% until they achieve a PGA = 0, at which time treatment was discontinued and subjects were monitored for durability of response (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. 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.

Change From Baseline in %BSA Affected

-2.03 percentage of BSA affected Standard Deviation 4.848

PRIMARY outcome

Timeframe: Baseline to 40 weeks

Population: 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.

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

Outcome measures

Measure

Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score n=665 Participants 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 received treatment with tapinarof cream, 1% until they achieve a PGA = 0, at which time treatment was discontinued and subjects were monitored for durability of response (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. 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.

Percent Change From Baseline in %BSA Affected

-18.48 percentage change Standard Deviation 149.908

PRIMARY outcome

Timeframe: Baseline to 40 weeks

Population: 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.

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.

Outcome measures

Measure

Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score n=735 Participants 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 received treatment with tapinarof cream, 1% until they achieve a PGA = 0, at which time treatment was discontinued and subjects were monitored for durability of response (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. 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.

Mean Duration (Days) of Treatment Course

172.9 days Standard Deviation 102.17

PRIMARY outcome

Timeframe: Baseline to 40 weeks

Population: 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

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 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%). Overall PASI = the sum of (individual scores x by a weighted factor for each body region).

Outcome measures

Measure

Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score n=741 Participants 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 received treatment with tapinarof cream, 1% until they achieve a PGA = 0, at which time treatment was discontinued and subjects were monitored for durability of response (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. 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.

Change From Baseline in Psoriasis Area and Severity Index (PASI) Score

-1.80 scores on a scale Standard Deviation 4.334

PRIMARY outcome

Timeframe: Baseline to 40 weeks

Population: 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

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 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%). Overall PASI = the sum of (individual scores x by a weighted factor for each body region).

Outcome measures

Measure

Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score n=663 Participants 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 received treatment with tapinarof cream, 1% until they achieve a PGA = 0, at which time treatment was discontinued and subjects were monitored for durability of response (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. 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.

Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score

-11.90 percentage change Standard Deviation 151.684

PRIMARY outcome

Timeframe: Baseline to 40 weeks

Population: 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.

Subjects received treatment with tapinarof intermittently guided by disease severity. This outcome measure assesses change from baseline in disease impact on daily activities, as measured by the DLQI, in all subjects including those on and those off therapy.

The DLQI is a 10-item PRO measure that assesses the extent to which the skin condition has affected the subject's quality of life over the past week, including 6 domains (daily activities, personal relationships, symptoms and feelings, leisure, work/school, and treatment). The total score (0-30) is the sum of 10 questions with each ranging from 0 to 3. The scoring of each question is as follows: Very much= 3, A lot=2, A little = 1, Not at all = 0, Not relevant = 0, Question unanswered = 0.

DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life.

Outcome measures

Measure

Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score n=538 Participants 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 received treatment with tapinarof cream, 1% until they achieve a PGA = 0, at which time treatment was discontinued and subjects were monitored for durability of response (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. 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.

Change From Baseline in Disease Impact on Daily Activities, as Measured by the Dermatology Life Quality Index (DLQI)

-2.0 scores on a scale Standard Deviation 4.31

PRIMARY outcome

Timeframe: Baseline to 40 weeks

Population: 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.

Subjects received treatment with tapinarof intermittently guided by disease severity. This outcome measure assesses % change from baseline in disease impact on daily activities, as measured by the DLQI, in all subjects including those on and those off therapy.

The DLQI is a 10-item PRO measure that assesses the extent to which the skin condition has affected the subject's quality of life over the past week, including 6 domains (daily activities, personal relationships, symptoms and feelings, leisure, work/school, and treatment). The total score (0-30) is the sum of 10 questions with each ranging from 0 to 3. The scoring of each question is as follows: Very much= 3, A lot=2, A little = 1, Not at all = 0, Not relevant = 0, Question unanswered = 0.

Outcome measures

Measure

Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score n=420 Participants 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 received treatment with tapinarof cream, 1% until they achieve a PGA = 0, at which time treatment was discontinued and subjects were monitored for durability of response (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. 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.

Percent Change From Baseline in Disease Impact on Daily Activities, as Measured by the Dermatology Life Quality Index (DLQI)

-37.1 percentage change Standard Deviation 121.35

Adverse Events

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

Serious events: 19 serious events

Other events: 204 other events

Deaths: 1 deaths

Serious adverse events

Measure	Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score n=763 participants at risk 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 received treatment with tapinarof cream, 1% until they achieve a PGA = 0, at which time treatment was discontinued and subjects were monitored for durability of response (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. 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. All SAEs were deemed unrelated to treatment with tapinarof cream, 1%.
Cardiac disorders Arrhythmia	0.13% 1/763 • subject duration: 40 weeks of treatment and a 4 week, safety follow up period Overall duration of study: 16 months
Cardiac disorders Myocardial Infarction	0.13% 1/763 • subject duration: 40 weeks of treatment and a 4 week, safety follow up period Overall duration of study: 16 months
Cardiac disorders Pericardial effusion	0.13% 1/763 • subject duration: 40 weeks of treatment and a 4 week, safety follow up period Overall duration of study: 16 months
Gastrointestinal disorders Pancreatitis	0.26% 2/763 • subject duration: 40 weeks of treatment and a 4 week, safety follow up period Overall duration of study: 16 months
Infections and infestations Appendicitis	0.13% 1/763 • subject duration: 40 weeks of treatment and a 4 week, safety follow up period Overall duration of study: 16 months
Infections and infestations Diverticulitis	0.13% 1/763 • subject duration: 40 weeks of treatment and a 4 week, safety follow up period Overall duration of study: 16 months
Infections and infestations Pelvic inflammatory disease	0.13% 1/763 • subject duration: 40 weeks of treatment and a 4 week, safety follow up period Overall duration of study: 16 months
Infections and infestations Pneumonia	0.13% 1/763 • subject duration: 40 weeks of treatment and a 4 week, safety follow up period Overall duration of study: 16 months
Infections and infestations Tooth abscess	0.13% 1/763 • subject duration: 40 weeks of treatment and a 4 week, safety follow up period Overall duration of study: 16 months
Injury, poisoning and procedural complications Road Traffic Accident	0.26% 2/763 • subject duration: 40 weeks of treatment and a 4 week, safety follow up period Overall duration of study: 16 months
Injury, poisoning and procedural complications Ankle fracture	0.13% 1/763 • subject duration: 40 weeks of treatment and a 4 week, safety follow up period Overall duration of study: 16 months
Injury, poisoning and procedural complications Head injury	0.13% 1/763 • subject duration: 40 weeks of treatment and a 4 week, safety follow up period Overall duration of study: 16 months
Injury, poisoning and procedural complications Patella fracture	0.13% 1/763 • subject duration: 40 weeks of treatment and a 4 week, safety follow up period Overall duration of study: 16 months
Musculoskeletal and connective tissue disorders Osteoarthritis	0.13% 1/763 • subject duration: 40 weeks of treatment and a 4 week, safety follow up period Overall duration of study: 16 months
Nervous system disorders Cerebrovascular accident	0.13% 1/763 • subject duration: 40 weeks of treatment and a 4 week, safety follow up period Overall duration of study: 16 months
Nervous system disorders Intracranial aneurysm	0.13% 1/763 • subject duration: 40 weeks of treatment and a 4 week, safety follow up period Overall duration of study: 16 months
Renal and urinary disorders Nephrolithiasis	0.13% 1/763 • subject duration: 40 weeks of treatment and a 4 week, safety follow up period Overall duration of study: 16 months
Renal and urinary disorders Pelvi-ureteric obstruction	0.13% 1/763 • subject duration: 40 weeks of treatment and a 4 week, safety follow up period Overall duration of study: 16 months
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.13% 1/763 • subject duration: 40 weeks of treatment and a 4 week, safety follow up period Overall duration of study: 16 months

Other adverse events

Measure	Continuous or Intermittent Use of Tapinarof (DMVT-505) Cream According to PGA Score n=763 participants at risk 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 received treatment with tapinarof cream, 1% until they achieve a PGA = 0, at which time treatment was discontinued and subjects were monitored for durability of response (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. 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. All SAEs were deemed unrelated to treatment with tapinarof cream, 1%.
Infections and infestations Folliculitis	22.7% 173/763 • subject duration: 40 weeks of treatment and a 4 week, safety follow up period Overall duration of study: 16 months
Skin and subcutaneous tissue disorders Dermatitis contact	5.5% 42/763 • subject duration: 40 weeks of treatment and a 4 week, safety follow up period Overall duration of study: 16 months

Additional Information

Clinical Lead, Late-Stage Clinical Development

Organon and Co

Phone: 551-430-6000

Email: pdrl@organon.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place