According to the National Institutes of Health, Prurigo Nodularis (PN) is a skin disease that causes hard, itchy bumps (nodules) to form on the skin. The itching can be intense, causing people to scratch themselves to the point of bleeding or pain.
Scratching can cause more nodules to appear. The nodules can range in size from very small to about half an inch in diameter and often have a rough, dry top. Nodules most commonly form on the outer arms, legs, shoulders, and can also form on the neck and torso.
People who have PN may become very concerned about the appearance of the nodules, and the intensely itchy skin may interfere with sleep or everyday activities. This can cause people with PN to develop stress and depression.
When people with PN have a skin biopsy, it can be seen that the nerves in the skin are thickened. It is thought that these thickened nerves may send stronger signals to the brain that the skin is itchy. This can cause scratching, which causes more nodules to form and the nerves to become even more thickened. This cycle, called the itch-scratch cycle, is thought to cause an increase in the number of nodules associated with PN.
There is currently no approved treatment specifically for PN, so it is important that research studies, like this one, are conducted that may find new medications to treat this condition.
Before new medications can be approved for public use, they must be tested in research studies like the PRISM research study.
The purpose of the PRISM research study is to evaluate the effectiveness and safety of an investigational medication for people with itching from Prurigo Nodularis. The investigational medication will be evaluated for effectiveness on itchiness, itch-related quality of life, and sleep quality.
The investigational medication are tablets that are taken orally.
This research study is being conducted at approximately 60 study centers throughout the United States and Europe.
If you qualify and during the first visit to the PRISM study clinic, the study requirements as well as the potential risks of participation will be explained in detail. People wishing to participate after this explanation will be asked to sign a written consent form. Study staff experienced in research studies will monitor the health of study participants throughout the study.
Those who sign the consent form will enter the screening portion of the study. During the screening period, the study team will verify that those wishing to participate in the study satisfy all applicable requirements.
If qualified, participants will begin the treatment part of the study, which will last approximately 1 year. The study has 2 parts, a double-blind period and an open-label period.
During the double-blind period, which lasts 14 weeks, neither you nor the study doctor will know if you are taking the study medication or placebo, a tablet that looks like the study drug but has no active ingredients. The assignment to either study drug or placebo is made randomly, and the chances of receiving either the study drug or placebo during the double-blind period is 50%, like flipping a coin.
During the open-label period, which will last up to 38 additional weeks, all participants will receive the study medication and the doctor and participants will be aware of this. After the open-label period ends at week 52, there will be a safety follow-up visit 2 weeks later, and 2 weeks after that the study will end with a final telephone call with the clinic to ask about your level of itch.
The total duration of participation will be approximately 60 weeks, including a screening period that may last up to 6 weeks.
All medical examinations and assigned study treatments are provided to qualified participants at no cost. Financial compensation may also be provided to cover travel and other expenses related to the research study. The amount of available compensation will be discussed with you by the staff at the study center.
Health insurance is not required to participate.