Has the study medication been used before? What phase is this study?
Yes, the study medication (called RPT193) has been used in previous clinical studies for people with eczema (atopic dermatitis). This study is a phase 2 study.
How many people will participate in the study?
The study will enroll up to 265 men and women with eczema at approximately 60 U.S. study centers.
Will I have to pay for anything if I choose to join the study? No, participants in the study will receive all study-related care and study medication at no cost. Health insurance is not required to participate.
Does everyone in the study receive the investigational medication?
No, as part of the study participants will be randomly assigned (by chance) to take either the investigational medication (75% chance) or a placebo medication (25% chance). The placebo looks just like the investigational medication but has no active ingredient. Neither you nor your study doctor will know which medication you receive. This is a common technique in clinical studies, as it helps researchers understand the effects of the investigational medication without bias.
How long does the study last?
The study lasts up to 7 months. During this time, you will meet with your study doctor a total of 10 times. These visits are an important part of the study, as they allow your study doctor to closely monitor your eczema symptoms, and also discuss your overall experience. You may also be compensated for your time and travel to attend these study visits.
What happens during the visits?
At your first visit (the Screening Visit), your study doctor and staff will review your medical history and eczema symptoms to confirm if you are eligible to join the study. You will also receive a routine physical exam, and electrocardiogram (ECG), and will have blood and urine samples collected to assess your general health.
If you are eligible and choose to participate, you will return for a Baseline Visit (Visit 2) where you will be provided with study medication and instructions. You will return to your study doctor’s office 8 more times over the next 6 months to evaluate your progress and monitor your health. Before you decide to participate, your study team will provide you with a detailed summary of what will happen at each visit so that you can make an informed decision about joining the study.
What if I join the study and decide I do not want to participate anymore?
As with all clinical studies, your participation is completely voluntary. You may leave the study at any time without any effect on your future medical care.
I am interested in possibly moving forward. What is the next step?
Please contact your local study center, and they will work with you to schedule a convenient time for your initial visit.