Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Organon and Co
With
IQVIA Biotech
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 the treatment period for all subjects will occur every 4 weeks (± 3 days). The total duration of study participation will be approximately 44 weeks.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Long Term Extension Study of Tapinarof for Plaque Psoriasis in Adults (3003)