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

• Status: Completed
• Trial end date: 2021-04-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dermavant Sciences GmbH
• Collaborator: IQVIA Biotech

Criteria

Inclusion Criteria:

1. Completed the 12-week treatment period in 1 of the 2 parent studies (Study DMVT-505-3001 or Study DMVT-505-3002);

2. Male and female subjects

3. 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

4. Capable of giving written informed consent

Exclusion Criteria:

1. Used a prohibited concomitant product or procedure to treat psoriasis during parent study

2. 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

3. 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

4. Known hypersensitivity to tapinarof