Status:
COMPLETED
Long Term Extension Study of Tapinarof for Plaque Psoriasis in Adults (3003)
Lead Sponsor:
Organon and Co
Collaborating Sponsors:
IQVIA Biotech
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
At the completion of the Week-12 visit of the pivotal study (Baseline \[Day 1\] in this study), all eligible subjects will be offered enrollment in the long-term extension study. Study visits during t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2021
Estimated Enrollment :
763 Patients enrolled
Trial Details
Trial ID
NCT04053387
Start Date
August 13 2019
End Date
April 6 2021
Last Update
August 6 2025
Active Locations (104)
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1
Dermavant Investigative Site
Birmingham, Alabama, United States, 35205
2
Dermavant Investigative Site
Phoenix, Arizona, United States, 85032
3
Dermavant Investigative Site
Bryant, Arkansas, United States, 72022
4
Dermavant Investigative Site
Fort Smith, Arkansas, United States, 72916