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

Completed · Phase 3

Conditions studied: Plaque Psoriasis

In brief

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.

Key facts

Study ID

NCT04053387

Run by

Organon and Co

People needed

763

Starts

2019-08-13

Expected to finish

2021-04-06

Last updated by the study team

2025-08-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dermavant Investigative Site — Phoenix, Arizona, United States
• Dermavant Investigative Site — Bryant, Arkansas, United States
• Dermavant Investigative Site — Fort Smith, Arkansas, United States
• Dermavant Investigative Site — Fountain Valley, California, United States
• Dermavant Investigative Site — Fremont, California, United States
• Dermavant Investigative Site — Fresno, California, United States
• Dermavant Investigative Site — Los Angeles, California, United States
• Dermavant Investigative Site — Los Angeles, California, United States
• Dermavant Investigative Site — Northridge, California, United States
• Dermavant Investigative Site — Oceanside, California, United States
• Dermavant Investigative Site — San Diego, California, United States
• Dermavant Investigative Site — Santa Ana, California, United States
• Dermavant Investigative Site — Santa Monica, California, United States
• Dermavant Investigative Site — Denver, Colorado, United States
• Dermavant Investigative Site — Cromwell, Connecticut, United States
• Dermavant Investigative Site — Boca Raton, Florida, United States
• Dermavant Investigative Site — Boynton Beach, Florida, United States
• Dermavant Investigative Site — Hialeah, Florida, United States
• Dermavant Investigative Site — Margate, Florida, United States
• Dermavant Investigative Site — Miami, Florida, United States
• Dermavant Investigative Site — Miramar, Florida, United States
• Dermavant Investigative Site — Boise, Idaho, United States
• Dermavant Investigative Site — Rolling Meadows, Illinois, United States
• Dermavant Investigative Site — Evansville, Indiana, United States
• Dermavant Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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