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New shot could tame uncontrollable itch of prurigo nodularis

NCT ID NCT04183335

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested the drug dupilumab in 151 adults with prurigo nodularis, a condition causing intense itching and raised skin bumps. Participants had severe itch that creams could not control. They received either dupilumab injections or a placebo for 24 weeks. The main goal was to see if dupilumab could reduce itch by at least 4 points on a 0-10 scale.

What this could mean

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

Active substance
Dupilumab (injection)
What this could lead to
If it works, this could provide a new treatment option for people with prurigo nodularis whose severe itch and skin bumps are not controlled by creams.
What could go wrong
This is a single Phase 3 trial with 151 participants. Results may not apply to everyone, and side effects like injection reactions or infections 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

151 people

The number who actually took part.

Started

Dec 2019

Finished

Feb 2022

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

18 to 80 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: Must be 18 to 80 years of age, at the time of signing the informed consent. With a clinical diagnosis of PN defined by all of the following: * Diagnosed by a dermatologist for at least 3 months before the screening visit. * On the worst-Itch Numeric Rating Scale (WI-NRS) ranged from 0 to 10, participants who had an average worst itch score of greater than or equal to (\>=) 7 in the 7 days prior to Day 1. * Participants who had a minimum of 20 PN lesions in total on both legs, and/or both arms and/or trunk, at screening visit and Day 1. * History of failing a 2-week course of medium-to-superpotent TCS or when TCS were not medically advisable. * Had applied a stable dose of topical emollient (moisturizer) once or twice daily for at least 5 out of the 7 consecutive days immediately before Day 1. * Was willing and abled to complete a daily symptom electronic-diary for the duration of the study. Exclusion Criteria: Participants were excluded from the study if any of the following criteria apply: * Presence of skin morbidities other than PN and mild atopic dermatitis (AD) that interfered with the assessment of the study outcomes. * PN secondary to medications. * PN secondary to medical conditions such as neuropathy or psychiatric disease. * Within 6 months before the screening visit, or documented diagnosis of moderate to severe AD from screening visit to randomization visit. * Severe concomitant illness(es) under poor control that, in the investigator's judgment, would adversely affect the participant's participation in the study. * Severe renal conditions (eg, participants with uremia and/or on dialysis). * Participants with uncontrolled thyroid disease. * Active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis unless documented adequately treated. * Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection, unless clinical and (if necessary) laboratory assessment had ruled out active infection before randomization. * Active chronic or acute infection (except human immunodeficiency virus infection) required treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the screening visit or during the screening period. * Known or suspected immunodeficiency. * Active malignancy or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

neurodermatitis prurigo nodularis

As listed by the trial registrant

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

Neurodermatitis

Contacts and locations

Locations

  • Investigational Site Number :0320001

    Buenos Aires, C1121ABE, Argentina

  • Investigational Site Number :0320002

    CABA, Buenos Aires, C1425BEN, Argentina

  • Investigational Site Number :0320003

    San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

  • Investigational Site Number :0320004

    CABA, Buenos Aires F.D., C1425BEA, Argentina

  • Investigational Site Number :0320005

    CABA, Buenos Aires, C1055AAO, Argentina

  • Investigational Site Number :0320006

    Caba, 1425DES, Argentina

  • Investigational Site Number :0320007

    CABA, Buenos Aires F.D., C1431EKK, Argentina

  • Investigational Site Number :0320008

    CABA, Buenos Aires, C1023AAB, Argentina

  • Investigational Site Number :0320009

    Mendoza, M5500, Argentina

  • Investigational Site Number :1560001

    Chengdu, 610041, China

  • Investigational Site Number :1560002

    Hangzhou, 310006, China

  • Investigational Site Number :1560003

    Wuxi, 214002, China

  • Investigational Site Number :1560004

    Beijing, 100050, China

  • Investigational Site Number :2500005

    Reims, 51100, France

  • Investigational Site Number :3920001

    Shinagawa-Ku, Tokyo, 141-8625, Japan

  • Investigational Site Number :3920002

    Nagoya, 454-8509, Japan

  • Investigational Site Number :3920003

    Tokorozawa-shi, Saitama, 359-8513, Japan

  • Investigational Site Number :3920004

    Bunkyo-ku, Tokyo, 113-8519, Japan

  • Investigational Site Number :3920005

    Kyoto, Kyoto, 606-8507, Japan

  • Investigational Site Number :3920006

    Itabashi-ku, Tokyo, 173-8610, Japan

  • Investigational Site Number :3920007

    Nagasaki, Nagasaki, 852-8501, Japan

  • Investigational Site Number :3920009

    Yokohama, Kanagawa, 236-0004, Japan

  • Investigational Site Number :3920010

    Izumo-shi, Shimane, 693-8501, Japan

  • Investigational Site Number :4100001

    Incheon, 21565, South Korea

  • Investigational Site Number :4100002

    Seoul, Seoul-teukbyeolsi, 03080, South Korea

  • Investigational Site Number :4100003

    Seoul, Seoul-teukbyeolsi, 03722, South Korea

  • Investigational Site Number :4100004

    Seoul, Seoul-teukbyeolsi, 07441, South Korea

  • Investigational Site Number :4100005

    Incheon, Incheon-gwangyeoksi, 21431, South Korea

  • Investigational Site Number :4100007

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Investigational Site Number :4840001

    Monterrey, Nuevo León, 64460, Mexico

  • Investigational Site Number :4840002

    Guadalajara, Jalisco, 44100, Mexico

  • Investigational Site Number :4840003

    Veracruz, 91910, Mexico

  • Investigational Site Number :4840005

    Monterrey, Nuevo León, 64718, Mexico

  • Investigational Site Number :4840006

    Guadalajara, 44210, Mexico

  • Investigational Site Number :6430001

    Stavropol, 355030, Russia

  • Investigational Site Number :6430002

    Saint Petersburg, 197022, Russia

  • Investigational Site Number :6430005

    Moscow, 107076, Russia

  • Investigational Site Number :6430006

    Moscow, 125993, Russia

  • Investigational Site Number :6430007

    Krasnodar, 350020, Russia

  • Investigational Site Number :6430008

    Chelyabinsk, 454048, Russia

  • Investigational Site Number :6430009

    Saratov, 410026, Russia

  • Investigational Site Number :6430010

    Moscow, 115522, Russia

  • Investigational Site Number :8400001

    Dublin, Ohio, 43016, United States

  • Investigational Site Number :8400002

    Pflugerville, Texas, 78660, United States

  • Investigational Site Number :8400003

    Newnan, Georgia, 30263, United States

  • Investigational Site Number :8400004

    Columbus, Georgia, 31904, United States

  • Investigational Site Number :8400005

    Norfolk, Virginia, 23502, United States

  • Investigational Site Number :8400006

    Bellaire, Texas, 77401, United States

  • Investigational Site Number :8400007

    Tulsa, Oklahoma, 74136, United States

  • Investigational Site Number :8400009

    Athens, Ohio, 45701, United States

  • Investigational Site Number :8400010

    Philadelphia, Pennsylvania, 19104, United States

  • Investigational Site Number :8400011

    Gilbert, Arizona, 85234, United States

  • Investigational Site Number :8400013

    St Louis, Missouri, 63110, United States

  • Investigational Site Number :8400014

    Miami, Florida, 33136, United States

  • Investigational Site Number :8400015

    Charleston, South Carolina, 29414, United States

  • Investigational Site Number :8400016

    Indianapolis, Indiana, 46250, United States

  • Investigational Site Number :8400017

    Sandy Springs, Georgia, 30328, United States

  • Investigational Site Number :8400018

    Clarkston, Michigan, 48346, United States

  • Investigational Site Number :8400019

    San Antonio, Texas, 78249, United States

  • Investigational Site Number :8400022

    Fort Smith, Arkansas, 72916, United States

  • Investigational Site Number :8400024

    East Windsor, New Jersey, 08520, United States

  • Investigational Site Number :8400025

    Houston, Texas, 77058, United States

  • Investigational Site Number :8400026

    Sacramento, California, 95816, United States

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