For people with Palmoplantar Pustulosis (PPP), every day can be challenging.
The purpose of the RIST4721-202 PPP research study is to evaluate if RIST4721, the investigational medication, is a safe and effective treatment for Palmoplantar Pustulosis.
During this research study, medical professionals will provide study-related care and monitoring of your Palmoplantar Pustulosis (PPP).
About the RIST4721-202 PPP study
Doctors at research centers are looking for volunteers for the RIST4721-202 PPP study.
This research study is evaluating an investigational medication (RIST4721) taken by mouth for the treatment of PPP.
People who are qualified and choose to take part will receive study-related care at no cost. Your overall health will be monitored by a team of doctors and their staff throughout the study.
Who can participate in the study?
To qualify* for this study, you must:
Be between the ages of 18 and 74 years old
Have had PPP for at least 6 months
*Please note that there are other eligibility criteria that you must meet to participate in the study.
Short Study Summary
Subjects will receive RIST4721 or placebo for 12 weeks. The placebo will look like RIST4721, but it will not contain active medication. You will be randomly assigned to RIST4721 or placebo. This is called the Part A study treatment period.
After 12 weeks, eligible subjects will be invited to participate in an optional extension period that lasts for up to 72 weeks. All eligible subjects will be assigned to receive RIST4721 during Part B. This is called the Part B study treatment period.
What happens if I Participate?
The first step is to see if you
pre-qualify. If you do, and want to learn more, your information will be sent to the research center that you select.
If you qualify for the study the research staff will talk to you about the potential benefits and possible risks of participation and what will happen during the study. After you understand and have asked all of your questions you will sign a consent form.
During the study the research staff will talk to you about each visit and ask you how you are feeling.
the study at any time and for any reason.
Step 1: Screening
This is the time when the study doctor and staff determine if you are eligible, and you decide if you want to participate. This step will take place up to 4 weeks prior to the start of the Part A study treatment period.
Step 2: Treatment (Part A & Part B)
If you are eligible, you will take the Part A study treatment as directed by the study doctor and visit the research center for appointments. You will receive either a lower dose of RIST 4721, a higher dose of RIST4721, or placebo.
If you complete 12 weeks of the study and are eligible to continue into part B, you may elect to continue into Part B. If you decide to continue, you will take the higher dose of RIST4721 as directed by the study doctor and visit the research center for appointments.
Step 3: Follow Up
You will visit the research center for the last time 4 weeks after you have had your last dose of study treatment.
What is Palmoplantar Pustulosis (PPP)?
Over time the blisters turn brown, peel off, and can form a crust with redness and burning in the hands and feet. Once developed, PPP is a chronic disease that may persist for decades. PPP is not contagious and cannot be spread from person to person.
The disease is also referred to as Chronic palmoplantar pustular psoriasis, Pustulosis palmaris et plantaris, or Persistent palmoplantar pustulosis.