Prurigo Nodularis

Prurigo Nodularis (PN) is a chronic inflammatory skin disease that results in an extremely itchy, symmetrically distributed rash comprised of hard bumps (also called nodules). Itching can be so intense that people will scratch themselves to the point of pain or bleeding. If your child is experiencing a rash, participating in a PN study may be right for them. Learn more about this study below and complete the pre-screener today.

Prurigo Nodularis Clinical Study

The purpose of this clinical study is to learn more about the medication dupilumab for treating Prurigo Nodularis (PN) in children and adolescents.

  • The medication has been approved for use in adults but is investigational for Prurigo Nodularis in children and adolescents.
  • The medication is authorized in multiple countries for children with asthma, atopic dermatitis, and eosinophilic esophagitis.
  • If enrolled, your child will receive the investigational medication as an injection, up to 6 or 12 times depending on the weight of the child, over the course of approximately 6 months.
  • Study procedures will include blood draws, physical examinations, and laboratory tests. Participants will receive trial-related procedures and study medication at no cost.

See If You Qualify

Eligibility Requirements

Participants must be:

Ages

Between the ages of 6 months
and less than 18 years.

Diagnosed

Diagnosed with Prurigo Nodularis
for at least 3 months.

All participants will receive the investigational medication.

Benefits of Participation

Doctor's Visits

As simple as a doctor’s visit

Get seen by top doctors in their field at no cost to you. Follow-up visits may be required.

Financial Compensation

Earn money for your time

Financial compensation varies by study, you can earn compensation for your time and travel.

No-cost Study-related Medical Care

No-cost study-related medical care

Participants can receive new and advanced medical treatment by leading doctors and hospitals.

What to Expect

  • Step 1

    Prescreening

  • Step 2

    Study Enrollment

  • Step 3

    Trial Participation

The first step towards enrollment is to see if you pre-qualify for this study. If your medical condition and symptoms match the study criteria, you will be contacted by a study coordinator for further evaluation. If you do not qualify for this specific trial, you can submit your contact information and we will contact you if you match to new trials in the future.

After pre-qualification, the next step is to have an in-person appointment at a local study site to enroll in the research study. Study sites are medical facilities (like hospitals, clinics and universities) where study-related activities will occur. At your first visit, you will receive additional information about the trial. You may be required to complete further screening at the study site to confirm your eligibility.

Before fully enrolling in the study, participants will read and sign an informed consent document that gives a full explanation of all activities that will happen during the study. This consent document is not a contract, and participants can withdraw their consent from the study at any time.

Participation will last between 42 to 44 Weeks. During the study, you and your child will be asked to come to the study site approximately 6 times, including an initial screening visit to see if your child is eligible for the study. You will also have the option to administer the investigational medication to your child at home after appropriate training by the investigator. Your child will need to comply with blood draws and physical examinations during clinic visits. Parents/caregivers will complete e-diary entries throughout the study to note their child’s daily symptoms and any adverse reactions to medication will be reported in the paper home dosing diary.

To Get Started, Take the Private Online Pre-screener Questionnaire

See If You Qualify

Frequently Asked Questions

Who is sponsoring this trial?

This trial is being paid for by Sanofi, a pharmaceutical company. Sanofi is one of the developers of the investigational medication in this study.

Will I receive the investigational medication/study drug if I participate in this trial?

All enrolled participants will receive the investigational medication.

Will I receive a placebo if I participate in this trial?

No, there is no placebo in this study.

Will I have health checks?

All participants will be monitored for adverse reactions to the investigational medication and attend regularly scheduled follow-up visits during the study per the protocol.

Why should I join this study?

The patients who will participate in this study may have the potential benefit of receiving a novel treatment targeting underlying type 2 inflammation in PN and it is anticipated that use of dupilumab will lead to reduced symptomatology associated with PN and improved quality of life for these patients.

If I participate, can I continue my current medications?

If your child is using topical corticosteroids or topical calcineurin inhibitors, they may be allowed to continue daily use of these medications during the study. The study doctor will review any medications your child is currently taking and determine which medications can be continued, adjusted, or need to be discontinued prior to the study.

What phase of the trial is being conducted?

This is a Phase 3 clinical trial.