Prurigo Nodularis Research Study

Do you suffer from intensely itching bumps on the arms, legs or trunk? We are looking for patients to take part in a clinical study for the chronic inflammatory skin condition Prurigo Nodularis.
Benefits of Joining a Clinical Trial
  • Study-related care and medical exams at no cost
  • Study-related medical supervision
  • Compensation for study-related time and reimbursement for travel
  • Health insurance is not required
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Patient with symptoms who may qualify for a prurigo nodularis research study
Gender
Male and Female
Ages
18+
Status
Enrolling

Overview

Struggling with Prurigo Nodularis?

Join a Prurigo Nodularis research study!

Prurigo Nodularis is a chronic inflammatory skin disease that persistently causes intense itching and skin papules or nodules on certain areas of the skin - especially on arms, legs, or trunk.

Prurigo Nodularis is a chronic disease with a significant impact on quality of life and everyday life. The disease at any age but is more commonly observed in middle-aged to elderly individuals and people with colored skin.

Prurigo Nodularis is not contagious.

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About the Study

We are looking for participants for our prurigo nodularis research study who suffer from the symptoms listed. The aim of the study is to evaluate the effect of the investigational study drug to be tested on Prurigo Nodularis and the change in quality of life for you as a patient.

The patients are randomly divided into three groups. There are two different dosage forms.

  • Group 1 receives low dose
  • Group 2 receives high dose
  • There is also a placebo group. The patients of the placebo group will receive the active substance during the extension period of the treatment phase.

The active substance and placebo is administered orally as a tablet.

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Who Can Join the Study

You are suitable if you:

  • Are at least 18 years old
  • Have been suffering from Prurigo Nodularis for at least 3 months
  • Have at least 20 lesions on the entire body
  • Have already been pre-treated with topical corticosteroids (without sufficient effect or with intolerance)

Excluded from participation are persons who:

  • Have a documented atopic dermatitis (AD) severity moderate to severe recently
  • Are infected with hepatitis B, hepatitis C or the human immunodeficiency virus (HIV)
  • Have other uncontrolled or serious disease
  • Are currently pregnant, breastfeeding or planning to become pregnant in the near future

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

You may also qualify for other studies.

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Why Join the Study

The prurigo nodularis research study offers access to an innovative investigational therapy and the opportunity to contribute to medical research – with professional support and regular study-related medical care.

During the course of the study, you will receive comprehensive and study-related treatment from our medical specialists.

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What to Expect

Study Duration:

The total duration of the prurigo nodularis research study is approximately 12 months (48 weeks).

The study will be conducted in three phases:

  • Preliminary examination: up to 4 weeks before the start of treatment (1 visit to the study site)
  • Treatment phase: core period of 16 weeks (6 visits) and extension period of 24 weeks (7 visits)
  • Follow-up care: 4 weeks (1 visits)

Study Visits:

It includes 15 visits to the study site.

Study Procedure:

  • Oral intake of three tablets daily
  • All participants are monitored by medical professionals throughout the course of the study and are examined at regular intervals.

Need More Details?

The study team or your study doctor will explain all procedures and other requirements in detail before you decide to participate in the prurigo nodularis research study. Participation is voluntary and you can withdraw from the study anytime.

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See if You Qualify.

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

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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 specific requirements for participants based on factors such as age, medical history, and current health status. The eligibility criteria in each study protocol are used to identify the volunteers best qualified to participate.
No. Study-related medications, lab tests, and medical visits are provided at no cost to you. Participating in a clinical trial should never require you to pay for study-related care.
Many studies provide compensation for your time and travel. Compensation amounts vary by study and will be fully explained before you decide to enroll.
Health insurance is not required for most clinical trials. All study-related care, procedures, and doctor visits are typically provided at no cost to you.
Participation is completely voluntary. You may choose to leave a clinical trial at any time, for any reason. Your decision will not affect your regular medical care or relationship with your doctor.
Each study has specific eligibility criteria. The best way to find out if you qualify is to complete our online eligibility form or speak directly with a member of our research team.
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