Are you itching to find a solution for Prurigo Nodularis?
A clinical research study may be the answer!
*There is no cost to you or your private medical insurance for the study drug or study procedures and you may be eligible for compensation for completing the study, and/or reimbursement for any travel-related expenses.
Would you like to participate in a clinical research study for prurigo nodularis?
We are inviting you to take part in a clinical research study for men and women who have prurigo nodularis. There is no cost to you or your private medical insurance for the study drug or study procedures. In addition, you may be eligible for compensation for completing the study and/or reimbursement for any travel-related expenses. No health insurance is required.
The researchers of the late phase Prurigo Nodularis Study are developing a study drug called KPL-716 for the treatment of chronic pruritic (itchy) diseases, like prurigo nodularis (a phase 2a study was completed for this compound).
You may qualify for the Prurigo Nodularis Study if you:
- Are over the age of 18
- Have a diagnosis of prurigo nodularis
- Have at least 20 nodules between 0.5 to 2cm (a cherry is approximately 2cm) present on your arms, legs, torso, or back.
Sign Up
What happens if I sign up? We will match you to a clinical research study location in your area that needs participants with prurigo nodularis or notify you when one becomes available. The study team will then contact you and you may have the opportunity to participate if qualified.
If you think you might like to participate in the Prurigo Nodularis Study or would like more information, please enter your information below so we can see if you may qualify and can contact you about the study. Keep in mind that participation is entirely voluntary. If you do decide to take part in a study, you may change your mind about participating at any time.
About Prurigo Nodularis
Prurigo nodularis is a chronic skin disease characterized by symmetrically distributed, intensively itchy nodules most frequently affecting the legs, arms, torso, and back. The itching can be accompanied by burning, stinging, pain, and other sensations.1
Prurigo nodularis can start from a small red bump that becomes itchy and intensifies over time. Once the nodule forms, many people experience more bumps that are:
- Hard
- Crusty
- Scaly
- Scabby
- Range from flesh tones to red, black, brown, or pink2
There are no approved therapies for prurigo nodularis. Topical therapies such as steroids along with other therapies are often tried with limited success, and in some cases with unfavorable risk-to-benefit ratio, meaning that it is usually better for some people to not use treatment at all.3
As a result, prurigo nodularis has significant unmet medical need as the intense itching, scratching, and associated skin lesions lead to sleep loss, embarrassment, anxiety and depression, and can diminish quality of life.4
The researchers of the Prurigo Nodularis Study are developing a study drug called KPL-716 for the treatment of chronic pruritic (itchy) diseases, like prurigo nodularis.
Frequently Asked Questions
What is a clinical research study?
A clinical research study (also called a clinical trial) helps to answer important questions about a study drug – these may include how well a study drug works for a certain condition. All medications must be tested in clinical research studies before they can be approved and prescribed to patients.
Why are clinical research studies important?
A clinical research study is the process by which new and innovative medications, interventions, and treatments are approved and brought to market, so people can live happier and healthier lives. Even over-the-counter medications, such as ibuprofen that you may have used to counteract a headache, have gone through the clinical research study process before they became available at your local pharmacy.
What is the purpose of the Prurigo Nodularis Study?
The researchers of the Prurigo Nodularis Study are developing a study drug called KPL-716 for the treatment of chronic pruritic (itchy) diseases, like prurigo nodularis.
KPL-716 is a “monoclonal antibody.” Antibodies are a type of protein that the body makes (a natural process) to block bacteria or viruses and prevent them from causing a disease. KPL-716 is an artificial (not natural) antibody, which is similar to the antibodies that the body makes, but it was specifically made to block a particular protein in the body that may be involved in causing the symptoms and signs of prurigo nodularis.
KPL-716 may stop the itching, inflammation (where part of the body becomes reddened, swollen, hot, and often painful), skin thickening and/or fibrosis (scarring) caused by prurigo nodularis.
What will the Prurigo Nodularis Study involve?
This study will enroll about 180 men and women, from ages 18 to 80, with prurigo nodularis to assess the study drug (KPL-716) when administered once every 4 weeks. This study will compare KPL-716 to a placebo (a liquid that looks like the study drug but has no medication in it).
All participants will be invited to participate in the Open-Label Extension study. Open-Label means that the participant will receive active drug.
Your participation in the study will last about 20 weeks (5 months). If you choose to participate in the Open-Label Extension of the study, where the study drug is administered once every 2 weeks, you will participate for an additional 36 weeks (about 8 months).
Will I be reimbursed?
Participants who qualify to take part in the study will receive reimbursement for time and travel. Please discuss this with the study team when they contact you.
Is there a cost to participate?
There is no cost to participate in the Prurigo Nodularis Study. If you decide to take part:
- You will receive study-related care throughout the study from a team of doctors, health care professionals, and research staff.
- There is no cost to you or your private medical insurance for the study drug or study procedures.
What else do I need to consider?
The research team will be able to explain more about what the Prurigo Nodularis Study will involve, and it is up to you to decide if you want to take part. Participation in this study is voluntary. Whether or not you decide to participate in this study will not affect your current or future relationships with your doctors. If you decide to participate, you are free to withdraw at any time without affecting those relationships.
How far is the study center?
We match you to a study center within a close travel distance from your home. If we are not running the study in your area currently, with your permission, we will keep you in our database and reach out once a study in your area becomes available. If, at any time, you decide you no longer want your information stored, you can opt-out and we will delete your details.
About the Prurigo Nodularis Study
The Prurigo Nodularis Study will enroll about 180 men and women with prurigo nodularis at approximately 75 study centers, globally.
Your participation in the study will last approximately 20 weeks, however, if you choose to participate in the Open-Label Extension of the study, your participation will continue for an additional 36 weeks.
There is no cost to you or your private medical insurance for the study drug or study procedures.
Participants who qualify to take part in the study will receive reimbursement for time and travel.
Who can take part in the Prurigo Nodularis Study?
You may qualify for the Prurigo Nodularis Study if you:
- Are over the age of 18
- Have a diagnosis of prurigo nodularis
- Have at least 20 nodules between 0.5 to 2cm (a cherry is approximately 2cm) present on your arms, legs, torso, or back.
All study-related care is provided by doctors and health care professionals
In this study, researchers are developing a study drug called KPL-716 for the treatment of chronic pruritic (itchy) diseases, like prurigo nodularis.