Phase 3 N=763 Treatment

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

Plaque Psoriasis

Bottom Line

View on ClinicalTrials.gov: NCT04053387 ↗

Enrolled (actual)

763

Serious AEs

2.5%

Results posted

Aug 2022

Primary outcome: Primary: Number of Subjects With Adverse Events and Serious Adverse Events — 474; 19 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: tapinarof cream, 1% (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: Apr 2021

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	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04053387). 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.