Prurigo nodularis (PN) is a chronic skin condition that causes intense itching. The itchy spots on your skin are often symmetrical — for example, you may have bumps in a similar location on both arms. PN can be debilitating, and it may be difficult to find treatments that work.^1,2 However, advances in clinical research are leading to new potential treatments for PN and other skin conditions.³ You may qualify to participate in clinical studies evaluating new drugs for PN.

See if You May Qualify for a Clinical Trial

Learnings from clinical studies have improved the outcomes and quality of life of people with many different skin conditions.³ Clinical research using volunteer participants is required to make sure a drug works to help with the condition. This is done by comparing the effects of an investigational drug with other drugs and/or a placebo. The placebo will look like the drug being studied, but it will not contain active ingredients. A placebo has no medical effect.^3,4 Every new drug must go through a clinical study process before it can be approved by the U.S. Food and Drug Administration (FDA) to treat PN or any other condition. This is an important step that couldn’t happen without people who volunteer to help advance research and bring new therapies to the market.⁵ There’s no guarantee that a clinical study will lead to an new medication that works, but the goal of each study is to give valuable data that can help researchers understand the disease better and, ultimately, improve health care and quality of life for people with PN or other diseases.³

One clinical study now recruiting participants who have PN is testing a drug called rocatinlimab. This clinical trial aims to find out if rocatinlimab is effective in reducing PN signs and bumps, whether it causes any side effects, and how the drug moves through the body, at two different dose levels.

Why Join a Clinical Study?

There are many reasons to participate in clinical research. During a clinical study, your health and your PN will be closely monitored. Study participants also play a part in bringing new treatments to market, which can benefit many people in the future who also have PN.⁶

The AMG451PN Study

AMG451PN is a phase 3 study. The researchers are looking for about 460 adult volunteers who have been diagnosed with PN that isn’t controlled by topical therapies (applied to the skin, like a cream or gel) or who can’t use topical therapies.

If you join the study, you will get either rocatinlimab (the study drug) or a placebo (a substance that looks like rocatinlimab but has no medical effect). Neither the researchers nor you will know which one you are getting. The study medication is given like the flu shot. After a prespecified period, some participants who were assigned placebo, and have not seen sufficient improvements in their condition, may opt to get the open label rocatinlimab treatment. Open label means that both you and the researchers will then know you are getting the investigational drug.

Qualification for Research Participation

The study will take place in study centers or clinics. Volunteers may qualify to participate if they:

• Are 18 years or older
• Have had a clinical diagnosis of PN for at least three months
• Have 20 or more PN nodules spread across both legs and/or both arms and/or their trunk (chest and back)
• Have tried topical corticosteroids of medium strength or stronger without experiencing much relief or can’t use topical corticosteroids
• Are willing and able to complete daily multiple choice questionnaires

You may not qualify to participate if:

• You have another health condition that has been active and has required treatment within the past three months.
• Your PN is considered to be caused by medications.
• Your PN is considered to be caused by a neurological or psychiatric condition.
• You are assigned female at birth, able to become pregnant, and unwilling to use a birth control method specified by the researchers.
• You are pregnant at the beginning of the study or plan to become pregnant within 16 weeks after completing the study.
• You are currently breastfeeding.

There are other criteria for participation in addition to those listed here. If you meet the initial requirements, a study representative may discuss the additional eligibility criteria with you.

Costs and Reimbursement

Qualified participants may be reimbursed for approved study-related travel, lodging, and meals. This may include bus/subway fare, Uber/Lyft, tolls, and gas. You can ask the study site office staff for more information.

See if You May Qualify for a Clinical Trial

Talk With Others Who Understand

MyPrurigoTeam is the social network for people with PN and their loved ones. On MyPrurigoTeam, thousands of members come together to ask questions, give advice, and share their stories with others who understand life with PN.

Do you or your loved one have PN and are interested in joining a clinical study? Have you participated in a clinical study before? Share your experience in the comments below, or start a conversation by posting on your Activities page.