A trial to learn more about ruxolitinib cream, an investigational treatment for a skin condition called prurigo nodularis

Trial ID: NCT05764161

About the Trial

This trial is being done to see if ruxolitinib cream can help adults with prurigo nodularis (PN). The trial will be carried out in 2 parts:

Part 1: Participants will be randomly assigned to use either ruxolitinib cream or a “vehicle cream” (a cream that looks like ruxolitinib but does not have any active medicine in it). None of the participants, the trial doctors, or trial staff will know during the trial which treatment the participants are getting. This method will help the trial doctors to properly measure the effects of ruxolitinib cream. Part 1 lasts about 3 months.

Part 2: After completing 12 weeks of treatment with ruxolitinib or vehicle cream, participants will join the extension of the study unless there is a safety concern. This will last 40 weeks and involve the same activities as in Part 1. All participants will use ruxolitinib cream during this part. Part 2 will help the trial doctors to learn about the long-term effects of ruxolitinib cream.

The main goal of the trial is to see if ruxolitinib cream can help lessen skin itching due to PN and heal the nodules. One of the secondary goals is to learn about potential decrease in the number of nodules.

Estimated Enrollment

180 Participants

Phase

3

Key Eligibility Criteria

Participants must:

Be at least 18 years old.
Have PN for at least 3 months.
Have nodules in at least 2 different areas of the body.
Have at least 6 nodules.

Participants must not:

Have a condition other than PN that causes skin itching.
Have certain medical conditions, such as a weakened immune system (immunocompromised), hepatitis B or C, HIV, heart disease, stroke, or tuberculosis.
Have a recent history (within 1 year) of alcohol or drug abuse.
Be pregnant or breastfeeding.

Trial Sites

Sites are located in the cities/states identified with the red pin:

What Will Happen in This Trial

If you are interested in joining this trial, you will need to visit a trial site. A trial doctor will explain the trial to you. If you agree to join, the trial doctors and other trial staff will give you an examination, check your nodules and other PN symptoms, check your heart health using a test called “electrocardiogram” (or ECG), collect blood samples, and ask you questions about your medical history and medicines you are taking to make sure you are eligible to take part in the trial.

If you decide to join the trial, you will enter Part 1. You will use either ruxolitinib cream or a vehicle cream twice daily for 12 weeks. You will be asked to visit a site regularly (every 2 to 4 weeks) throughout this part. During these visits, the trial doctors may:

Give you a physical examination.
Check your nodules and PN symptoms.
Collect blood and urine samples.
Ask questions about how PN affects your daily life.
Ask about any new or worsening medical problems you might be having or any new medications you are taking.

You will also be asked to keep a record (like a diary) of your PN symptoms, such as itching and skin pain, and your daily use of either ruxolitinib or vehicle cream. You will track this every single day on a device, and it is necessary to accurately understand the effects of either ruxolitinib or vehicle cream.

After completing 12 weeks of treatment with ruxolitinib or vehicle cream, you will move into Part 2. This will last 40 weeks and involve the same activities as in Part 1. All participants will use ruxolitinib cream in Part 2.

After that, you will be asked to visit a trial site 1 last time after about a month.

In total, the participants will have 18 trial site visits over a period of about 60 weeks (about 14 months).

About the Condition/Disease Overview

Prurigo nodularis (PN) is a long-term skin condition that causes itchy bumps called “nodules” on the skin. These nodules can appear in any part of the body, but most often appear in areas where you can scratch such as the arms, legs, and trunk. Aside from severe itching, people with PN may also feel painful stinging and burning. These symptoms can affect a person’s quality of life.

In this trial, researchers are investigating “ruxolitinib” cream. Ruxolitinib cream is a medication applied to the affected areas of the skin, to determine if it is effective in relieving itch and healing the nodules.

Frequently Asked Questions (FAQs)

What is a clinical trial?

Through clinical research, scientists and doctors can determine whether a new medical strategy, drug, or device is safe and effective for people. New treatments cannot be discovered without clinical trials, which rely on potential trial participants like you to evaluate the safety and effectiveness of these treatments. Participation in a clinical trial is voluntary. Trial participants should have the intention to complete the trial, but they may leave the trial at any time after they join.

What does a typical clinical trial look like?

Clinical trials help determine the safety and effectiveness of treatments. A research plan, also called a protocol, is created before the trial starts. The protocol describes who can join the trial, what treatments the participants will receive, what questions the researchers will seek to answer, how long the trial will last, and how participant privacy and safety will be protected during the trial.

A clinical trial may compare a new treatment to a standard treatment option that is already available to a placebo (an identical-looking treatment with no active ingredient), or to no intervention at all. Before you decide to join a clinical trial, the trial team will explain all of the trial details.

What is a Phase 3 clinical trial?

When new drugs are being studied as a possible treatment for patients with a disease, they are tested in stages, or “phases.” If a drug is successful in Phase 1, it moves to Phase 2. If it is successful in Phase 2, it moves to Phase 3.

Drugs that enter Phase 3 trials have already been studied in other clinical trials. Researchers have gathered information about the safety of the drug already, usually in up to several hundred people. Phase 3 trials usually include large numbers of participants. Some Phase 3 trials are conducted in multiple countries and include thousands of people. Phase 3 trials are used to collect even more information about how safe a drug is and how well it works.

How can I check to see if I’m eligible for this trial?

Having completed a series of questions to arrive on this page, it appears you may be eligible to participate in this trial. Initiate the process of sending your contact details to a site by clicking the “Send My Information to a Site” button.

Can I quit the trial at any time?

Trial volunteers have the right to drop out of the trial at any time for any reason or no reason at all. The trial doctor or sponsor also has the right to discontinue a trial volunteer at any time for the participant’s safety or if the participant no longer meets the trial requirements.

What personal information is collected about me for the trial?

The trial doctor and other site staff will collect your personal information. This may include:

Your name, address, and telephone number
Your age, sex, and ethnic and racial background
Your lifestyle information
Your medical history details
Your trial treatment and your response to this treatment
Data resulting from testing your biological samples

This trial is not actively recruiting.