Clinical Study on

Prurigo Nodularis

Do You Suffer From Intensely Itching Bumps on Your Arms, Legs, or Trunk?

Curly-haired woman in an orange shirt looks distressed while examining her wrist for pain
Woman in an orange shirt examines her forearm, looking concerned or pained near a window.
We are looking for patients to take part in a clinical study for the chronic inflammatory skin condition Prurigo Nodularis. Potential participants must fulfil certain requirements in order to take part in the study.
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What is Prurigo Nodularis?

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. 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.

Forearm with several small red circular skin lesions or spots among hair, possibly insect bites or irritated bumps.
Doctor in a white coat with a stethoscope greets a patient, placing a reassuring hand on her shoulder as they smile at each other in a clinic.

Why the study is being conducted?

We are looking for participants for our 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. During the course of the study, you will receive comprehensive and study-related treatment from our medical specialists.

How Prurigo Nodularis Can Affect Daily Life

Living with Prurigo Nodularis can impact much more than your skin.

Many people experience:

  • Chronic itching
  • Burning pain of the skin
  • Disturbed sleep
  • Emotional stress and mental health challenges
  • Reduced quality of life

If these symptoms sound familiar, you may qualify to participate in this clinical research study.

Woman in a pink shirt sits at a desk, touching her elbow in apparent pain during a medical appointment with a clinician in gloves.

Register for the Study

Complete the short form on this page or call 205-778-1564 to speak with our research team.

CALL (205) 778-1564
Sign Up Today

Study Information

  • Study Phase: Phase 2
  • Age Requirement: Adults 18 years and older Study
  • Medication: Oral tablets taken three times daily

Possible Symptoms of Prurigo Nodularis

Prurigo Nodularis is a chronic inflammatory skin disease that commonly causes:

  • Multiple symmetrical nodules, papules, or plaques distributed on the surface of limbs
  • Severe, relentless itching and burning pain

Important information

Study treatment and time required

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

Group 1 receives low dose; group 2 receives high dose and 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.

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)

The total duration of the study is approximately 12 months (48 weeks) and includes 15 visits to the study site. All participants are monitored by medical professionals throughout the course of the study and are examined at regular intervals.

Requirements for participation ​

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
  • have other uncontrolled or serious disease
  • are currently pregnant, breastfeeding or planning to become pregnant in the near future

Signing Up is Simple and Beneficial

Cahaba Clinical Research needs good, reliable participants like you for our Prurigo Nodularis Clinical Research Trial, so that advanced investigational medicines can be developed and introduced for public use. Look how easy we make it for you to join our team.

Here is all that’s required:

1. Fill Out the Short Form

You will be asked to answer a few basic questions.

2. Receive Our Phone Call

One of our recruiters will call you to discuss your specific skin condition.

3. Come in for an Appointment

At this in-person meeting, we will determine whether you qualify.

4. Join Our Clinical Study

You and your co-volunteers will receive innovative treatments and more.

5. Receive Generous Compensation

For your important participation, you will be well compensated.

FAQ's

This Phase 2 clinical study is evaluating an investigational oral medication for adults with Prurigo Nodularis to better understand its safety and effectiveness.
No. Participants are randomly assigned to receive either one of two investigational dose levels or placebo during the initial treatment period. Participants in the placebo group may receive the investigational medication during the extension phase.
No. ICP-332 is an investigational medication that has not yet been approved by the U.S. Food and Drug Administration for general use.
No. Medical insurance is not required to participate.
No. Proof of residency is not required.
No. Study-related visits, evaluations, laboratory testing, and study medication are provided at no cost.
Qualified participants may receive up to $1,400 for time and travel. Compensation varies based on study participation and completed visits.
Yes. Our research staff will review your current treatments and discuss which medications may be continued during the study.
Yes. Your personal and medical information is protected in accordance with HIPAA privacy regulations.
Yes. Participation is completely voluntary, and you may withdraw from the study at any time for any reason.
After you submit the form, a member of our research team will typically contact you within 1–2 business days to complete a confidential phone screening.

Cahaba Clinical Trials -
Your Trusted Source for
"Tomorrow’s Medicines Today“

Cahaba Clinical Research is a recognized leader in dermatology studies in Birmingham. Our team is experienced and dedicated. We adhere to FDA regulations and prioritize your privacy. Our Principal Investigator, Dr. Vlada Groysman, is a board-certified dermatologist with over 20 years of clinical experience. We specialize in challenging skin conditions and employ meticulous, science-driven methodologies.

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If you are interested and would like more information, please enter your postcode and
contact your nearest study site. Thank you for your interest.