prurigo nodularis research study participant

Prurigo Nodularis Research Study

A Study of the Efficacy and Safety of an Investigational Medication for Participants with Prurigo Nodularis.
Benefits of Joining a Clinical Trial
  • Receive study-related medical care and the investigational medication at no cost
  • Be closely monitored by a team of medical professionals
  • Contributes to the advancement of medical knowledge and the potential development of new treatments for individuals living with prurigo nodularis
  • The study sponsor provides insurance coverage for participants as required by clinical trial regulations.
Gender
Male and Female
Ages
18-75
Status
Coming Soon
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Overview

Prurigo Nodularis Research Study

Prurigo nodularis (PN) is a chronic skin condition that causes firm, itchy bumps on the skin. The itching can be intense and ongoing, often affecting sleep, daily activities, and overall quality of life.

This clinical research study is evaluating an investigational medication to see if it may help reduce itching and improve skin symptoms in people living with PN. Researchers are also studying how safe the treatment is and how well it is tolerated over time.

Some participants in this study may receive a placebo, which looks like the study medication but does not contain active medicine. This helps researchers better understand how the treatment works.

The goal of this prurigo nodularis research study is to explore a potential new treatment option that may help people better manage the symptoms of Prurigo Nodularis.

Table of Contents

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About the Study

A Prurigo Nodularis Research Study is being conducted to evaluate the efficacy and safety of an investigational drug for participants with . This Phase 2 study is a randomized, double-blind, placebo-controlled, dose-ranging trial. The study consists of a 4-week screening period, a 16-week core treatment period, and an optional 24-week extension period.

The primary objective of the study is to evaluate the efficacy of said PN medication compared to a placebo in participants with moderate-to-severe prurigo nodularis.

This Prurigo Nodularis Research Study focuses on an investigational product being tested for its potential to reduce the symptoms associated with this condition. Participants will be randomly assigned to receive either the study drug or a placebo during the core period.

The study aims to determine the proportion of participants achieving a significant reduction in itch and a clear or almost clear skin assessment. Safety and tolerability of various doses will also be closely monitored throughout the trial.

The study team or your study doctor will explain what this means for you in detail.

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Who Can Join

You may be able to participate in this Prurigo Nodularis Research Study if you:

  • Are between 18 and 75 years old
  • Have been diagnosed with Prurigo Nodularis by a dermatologist for at least 3 months
  • Have multiple itchy bumps (lesions); 20 or more nodules on the body
  • Have not had enough relief from topical treatments

You may not be eligible if you:

  • Are currently using certain medications that affect the immune system or treat nerve-related itching
  • Have recently received certain skin treatments, such as steroid injections, light therapy, or similar procedures within a specified timeframe before the first dose
  • Are taking medications that may interfere with study results
  • Have other active skin conditions that could interfere with the study assessments
  • Have history of significant cardiovascular disease or thromboembolism
  • Have active bleeding or history of bleeding disorders
  • Have a history of organ transplant or significant renal impairment.
  • Have imminent risk of self-harm

*Other conditions may apply

Not sure if you qualify?
A member of our study team will review your medical history and medications with you to determine if this Prurigo Nodularis research study may be a good fit for you.

You may also qualify for other studies.

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What to Expect

If you qualify for the Prurigo Nodularis Research Study, your participation will involve the following:

Study Duration and Number of Visits

The study will last about 44 weeks.

The total duration of the study includes a screening period of up to 28 days. The core treatment period lasts 16 weeks. Following this, eligible participants may choose to enter an optional extension period for an additional 24 weeks of treatment.

Study Visits

Participants will attend approximately 16 study visits throughout the study.

Participants will attend regular clinic visits for health assessments, blood tests, and skin examinations. These visits occur at Week 0 (Day 1), Week 2, Week 4, Week 8, Week 12, and Week 16. If enrolled in the extension period, additional visits will be scheduled through Week 40.

Procedures During the Study

Participants will:

  • Receive and take the study medication or placebo as directed by the study team.
  • Have their skin condition and symptoms monitored regularly
    • Complete questionnaires about itching and quality of life
    • Completing daily electronic diaries to track itch intensity.
  • Attend scheduled clinic visits for evaluations and safety checks

Compensation

Participants may receive compensation for time and travel. Details will be discussed with the study team.

More Details

If you have any other questions about what to expect from this Prurigo Nodularis research study, feel free to ask the study team or your study doctor.

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See if You Qualify.

To see if you qualify or to learn more, please complete the form

Frequently Asked Questions.

What is a Clinical Trial?

A clinical trial is a research study that evaluates new medications, devices, or treatment approaches to determine if they are safe and effective. Clinical trials help doctors and researchers develop better treatments for current and future patients. All studies follow strict safety guidelines and are carefully monitored.
Each clinical study has requirements for participants based on specific factors such as age, medical history and current health. The eligibility criteria in each study protocol are used to identify the volunteers best qualified to participate.
No. Study-related medications, tests, and medical visits are provided at no cost to you. Participation in a clinical trial should not require you to pay for study-related care.
Many studies provide compensation for time and travel. Compensation varies by study and will be explained before you decide to participate.
Health insurance is not required for most clinical trials. Study-related care is typically provided at no cost to you.
Participation is completely voluntary. You may choose to leave the study at any time, for any reason. Your decision will not affect your regular medical care or benefits.
Each study has specific eligibility criteria based on age, medical history, and other factors. The best way to find out if you qualify is to complete the eligibility form or speak with a research team member.
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