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

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Long-Term, Open-Label, Extension Study to Evaluate the Safety and Efficacy of Tapinarof Cream, 1% for the Treatment of Plaque Psoriasis in Adults

ClinicalTrials.gov ID

NCT04053387

Acronym / sponsor ID

DMVT-505-3003

Conditions

Plaque Psoriasis

Keywords

Tapinarof, plaque psoriasis,, adult, phase 3, topical, open-label, efficacy, safety

Phase

Phase 3

Study type

Interventional

Recruitment status

Completed

Enrolment

763 participants (actual)

Lead sponsor

Organon and CoIndustry (pharma, biotech, devices)

Collaborators

IQVIA Biotech

Study start

13 Aug 2019 (actual)

Primary completion

6 Apr 2021 (actual)

Study completion

6 Apr 2021 (actual)

First posted

12 Aug 2019 (actual)

Results

Posted 8 Aug 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Not applicable

Intervention model

Single group

Masking

None (open label)

Number of arms

1

Model description

Subjects in this study completed treatment with tapinarof or vehicle in 1 of 2 parent Phase 3 pivotal efficacy and safety studies (Study DMVT-505-3001 or Study DMVT-505-3002). The study will consist of up to 40 weeks of tapinarof cream, 1%, and a 4-week safety follow-up period.

Who may qualify

Ages

18 to 75 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Number of Subjects With Adverse Events and Serious Adverse Events

   Time frame: 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%.

2. Frequency of Adverse Events and Serious Adverse Events

   Time frame: 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%.

3. Number of Subjects With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values and Vital Signs

   Time frame: 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.

4. 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)

   Time frame: 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.

5. 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)

   Time frame: 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.

6. 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)

   Time frame: 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.

7. 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)

   Time frame: 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.

8. Change From Baseline in %BSA Affected

   Time frame: 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

9. Percent Change From Baseline in %BSA Affected

   Time frame: 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

10. Mean Duration (Days) of Treatment Course

    Time frame: 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.

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

    Time frame: Baseline to 40 weeks

    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).

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

    Time frame: Baseline to 40 weeks

    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).

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

    Time frame: Baseline to 40 weeks

    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.

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

    Time frame: Baseline to 40 weeks

    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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 40600584Gold LS, Bruno MJ, Lewitt GM, Hebert AA. Characteristics and management of follicular events and contact dermatitis in patients using tapinarof cream for the treatment of atopic dermatitis or plaque psoriasis. J Dermatolog Treat. 2025 Dec;36(1):2517388. doi: 10.1080/09546634.2025.2517388. Epub 2025 Jul 2.
• Derived from this study: PubMed 37697121Desai SR, Stein Gold L, Cameron MC, Golant A, Lewitt GM, Bruno MJ, Martin G, Brown PM, Rubenstein DS, Butners V, Tallman AM. Tapinarof Cream 1% Once Daily for the Treatment of Plaque Psoriasis: Case Photography of Clinical Outcomes from Three Phase 3 Trials. Dermatol Ther (Heidelb). 2023 Oct;13(10):2443-2460. doi: 10.1007/s13555-023-01008-9. Epub 2023 Sep 11.
• Derived from this study: PubMed 37076998Grossmann MC, Pixley JN, Feldman SR. A Review of Topical Tapinarof for the Treatment of Plaque Psoriasis. Ann Pharmacother. 2024 Jan;58(1):76-85. doi: 10.1177/10600280231164775. Epub 2023 Apr 19.
• Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

104 sites in 2 countries: see every site and its status.