Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could dupixent help kids with chronic itchy skin disease?

NCT ID NCT06293053

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests the drug dupilumab (Dupixent) in 18 children aged 6 months to 18 years with prurigo nodularis, a condition causing very itchy skin bumps. The main goals are to measure how the drug moves through the body and to check for side effects. Participants receive injections over 24 weeks and are followed for 16 more weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dupilumab (Dupixent)
What this could lead to
If it works, this could provide a treatment option for children with prurigo nodularis, a chronic itchy skin condition.
What could go wrong
This is a small, early-phase study focused on safety and drug levels, not yet on how well it works. Side effects or lack of effectiveness in kids are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 18 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants must be ≥6 months to \<18 years of age, at the time of signing the informed consent. * A clinical diagnosis of prurigo nodularis (PN) at least 3 months prior to screening, an Investigator's global assessment for prurigo nodularis stage (IGA PN-S) score of ≥2 with presence of ≥6 pruriginous lesions at Baseline. The lesions should be present on ≥2 different body surface areas at Baseline. * On the worst itch numerical rating scale (WI-NRS) (for participants aged ≥6 years to \<18 years old at the screening visit) or worst-scratch/itch NRS (for participants aged ≥6 months to \<6 years at the screening visit) ranging from 0 to 10, participants must have an average worst itch score of ≥7 in the 7 days prior to Day 1. NOTE: Baseline pruritus NRS average score for maximum itch intensity will be determined based on the average of daily NRS scores for maximum intensity (the daily score ranges from 0 to 10) during the 7 days immediately preceding the Day 1/Baseline visit. A minimum of 4 daily scores out of the 7 days is required to calculate the baseline average score. * Participants/Caregivers must be willing and able to complete a daily symptom e-Diary for the duration of the study. * Contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Presence of active moderate to severe lesions of atopic dermatitis (AD), and/or other skin conditions that may interfere with the PN diagnosis including but not limited to the following: scabies, psoriasis, lymphomatoid papulosis, habitual picking, dermatitis herpetiformis, sporotrichosis, and bullous disease. * Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the screening visit or during the screening period. NOTE: Participants may be rescreened after infection resolves. * Known or suspected immunodeficiency, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting an immune compromised status, as judged by the Investigator. * Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study. * Planned or anticipated major surgical procedure during the participant's participation in this clinical trial. * Participants who has taken biologic therapy/systemic immunosuppressant/ immunomodulator within 4 weeks before the screening visit or 5 half-lives, whichever is longer. * Current participation to any clinical trial of an investigational drug or device or participation within 3 months before the screening visit or 5 half-lives of the investigational compound, whichever is longer. * Participation in prior dupilumab clinical study or have been treated with commercially available dupilumab.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Prurigo nodularis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

prurigo nodularis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prurigo nodularis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    14 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AXIS Clinicals - Fargo- Site Number : 8400013

    RECRUITING

    Fargo, North Dakota, 58103, United States

  • Dell Children's Medical Center- Site Number : 8400007

    RECRUITING

    Austin, Texas, 78723, United States

  • Direct Helpers Research Center- Site Number : 8400015

    RECRUITING

    Hialeah, Florida, 33012, United States

  • Driscoll Children's Hospital- Site Number : 8400017

    RECRUITING

    Corpus Christi, Texas, 78411, United States

  • Life Clinical Trials - Coral Springs- Site Number : 8400018

    RECRUITING

    Coral Springs, Florida, 33071, United States

  • MediSearch Clinical Trials- Site Number : 8400004

    RECRUITING

    Saint Joseph, Missouri, 64506, United States

  • Mission Dermatology Center- Site Number : 8400011

    RECRUITING

    Rancho Santa Margarita, California, 92688, United States

  • Pediatric Center of Excellence (PCE) - Miami Pediatric Endocrinology- Site Number : 8400005

    RECRUITING

    Coral Gables, Florida, 33146, United States

  • Stanford University Medical Center CTRU - 800 Welch Road- Site Number : 8400021

    RECRUITING

    Palo Alto, California, 94304, United States

  • SunCoast Skin Solutions - Lutz- Site Number : 8400008

    RECRUITING

    Lutz, Florida, 33558, United States

  • Tareen Dermatology - Eagan- Site Number : 8400022

    RECRUITING

    Eagan, Minnesota, 55123, United States

  • Texas Dermatology and Laser Specialists - San Antonio - Oakwell Court- Site Number : 8400020

    RECRUITING

    San Antonio, Texas, 78218, United States

  • USF Health- Site Number : 8400003

    RECRUITING

    Tampa, Florida, 33606, United States

  • Vital Prospects Clinical Research Institute - Tulsa- Site Number : 8400002

    RECRUITING

    Tulsa, Oklahoma, 74136, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.