Phase 3
Completed N=763
Long Term Extension Study of Tapinarof for Plaque Psoriasis in Adults (3003)
Source: ClinicalTrials.gov NCT04053387 ↗Enrolled (actual)
763
Serious AEs
2.5%
Results posted
Aug 2022
Primary outcomePrimary: Number of Subjects With Adverse Events and Serious Adverse Events — 474; 19 Participants
◆ Published Evidence
Emerging
10citations · ~3 / year
Tapinarof Cream 1% Once Daily for the Treatment of Plaque Psoriasis: Case Photography of Clinical Outcomes from Three Phase 3 Trials.
Summary
This is a long-term, open-label, multicenter, study to evaluate the safety and efficacy of topical tapinarof cream, 1% in adults with plaque psoriasis. Subjects in this study completed treatment in 1 of 2 Phase 3 pivotal efficacy and safety studies (Study DMVT-505-3001 or Study DMVT-505-3002). This study will consist of up to 40 weeks of treatment and a 4-week safety follow-up period.
Linked Publications (2)
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Tapinarof Cream 1% Once Daily for the Treatment of Plaque Psoriasis: Case Photography of Clinical Outcomes from Three Phase 3 Trials.
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Characteristics and management of follicular events and contact dermatitis in patients using tapinarof cream for the treatment of atopic dermatitis or plaque psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Adverse Events and Serious Adverse Events |
474; 19 | — |
| PRIMARY Frequency of Adverse Events and Serious Adverse Events |
1190; 21 | — |
| PRIMARY Number of Subjects With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values and Vital Signs |
0; 0; 0; 7; 6; 16 | — |
| PRIMARY Remittive Effect of Treatment Success in Pivotal: Median Time to First Worsening (PGA ≥ 2) While Off Therapy for Subjects Who Entered LTE PGA = 0 (Clear) |
115 | — |
| PRIMARY Complete Disease Clearance During LTE: Number of Subjects Achieving Disease Clearance PGA =0 (Clear) While on Therapy for Subjects Entered LTE PGA ≥ 1 (Almost Clear) |
233 | — |
| PRIMARY Response During LTE: Number of Subjects Achieving PGA =0 or 1 (Clear or Almost Clear) While on Therapy for Subjects Who Entered LTE With PGA ≥ 2 (Mild) |
302 | — |
| PRIMARY Remittive Effect of Treatment Success: Number of Subjects Experiencing Worsening (PGA ≥ 2) While Off Therapy for Subjects Who Entered LTE With a PGA = 0 (Clear) |
60; 19 | — |
| PRIMARY Change From Baseline in %BSA Affected |
-2.03 | — |
| PRIMARY Percent Change From Baseline in %BSA Affected |
-18.48 | — |
| PRIMARY Mean Duration (Days) of Treatment Course |
172.9 | — |
| PRIMARY Change From Baseline in Psoriasis Area and Severity Index (PASI) Score |
-1.80 | — |
| PRIMARY Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score |
-11.90 | — |
| PRIMARY Change From Baseline in Disease Impact on Daily Activities, as Measured by the Dermatology Life Quality Index (DLQI) |
-2.0 | — |
| PRIMARY Percent Change From Baseline in Disease Impact on Daily Activities, as Measured by the Dermatology Life Quality Index (DLQI) |
-37.1 | — |
Eligibility Criteria
Inclusion Criteria
- Completed the 12-week treatment period in 1 of the 2 parent studies (Study DMVT-505-3001 or Study DMVT-505-3002);
- Male and female subjects
- Females of child bearing potential and male subjects who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance while on the study, and for at least 4 weeks after the last exposure to study treatment
- Capable of giving written informed consent
Exclusion Criteria
- Used a prohibited concomitant product or procedure to treat psoriasis during parent study
- Had a serious adverse event (SAE) that was potentially related to treatment or experienced an adverse event (AE) that led to permanent discontinuation of treatment in the parent study
- History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion, may interfere with the subject's completion of the study
- Known hypersensitivity to tapinarof
Data sourced from ClinicalTrials.gov (NCT04053387) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.