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New hope for chronic itch: dupilumab tackles prurigo nodularis

NCT ID NCT04202679

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 160 adults with prurigo nodularis, a skin condition causing intense itching and bumps. Participants received either dupilumab injections or a placebo for up to 24 weeks. The main goal was to see if dupilumab could reduce itch by at least 4 points on a 0-10 scale by week 12.

What this could mean

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

Active substance
dupilumab (an injectable drug that blocks inflammation)
What this could lead to
If it works, this could provide a new treatment option for people with prurigo nodularis who have severe itching and skin bumps that don't improve with creams.
What could go wrong
This is a completed Phase 3 trial, but results are not yet widely available. The drug may not work for 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

160 people

The number who actually took part.

Started

Jan 2020

Finished

Nov 2021

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) ranging from 0 to 10, participants must have an average worst itch score of \>=7 in the 7 days prior to Day1. * Participants must have 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 topical corticosteroids (TCS) or when TCS are not medically advisable * Have 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. Must be willing and able to complete a daily symptom eDiary 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 that may interfere 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 atopic dermatitis 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 have ruled out active infection before randomization. * Active chronic or acute infection (except HIV) requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the screening visit and 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 :1240001

    Toronto, Ontario, M5A 3R6, Canada

  • Investigational Site Number :1240002

    Calgary, Alberta, T2G 1B1, Canada

  • Investigational Site Number :1240006

    Surrey, British Columbia, V3R 6A7, Canada

  • Investigational Site Number :1240007

    Markham, Ontario, L3P 1X3, Canada

  • Investigational Site Number :1240008

    Newmarket, Ontario, L3Y 5G8, Canada

  • Investigational Site Number :1240009

    Saskatoon, Saskatchewan, S7K 0H6, Canada

  • Investigational Site Number :1520001

    Santiago, Reg Metropolitana de Santiago, 7640881, Chile

  • Investigational Site Number :1520002

    Santiago, Chile

  • Investigational Site Number :1520003

    Santiago, Reg Metropolitana de Santiago, 7580206, Chile

  • Investigational Site Number :1520004

    Santiago, Reg Metropolitana de Santiago, 80004005, Chile

  • Investigational Site Number :1520005

    Valdivia, Los Ríos Region, 5110683, Chile

  • Investigational Site Number :1520006

    Osorno, Reg Metropolitana de Santiago, 5311523, Chile

  • Investigational Site Number :1580001

    Taipei, 10002, Taiwan

  • Investigational Site Number :1580002

    Taipei, 10449, Taiwan

  • Investigational Site Number :1580005

    Hsinchu, 30059, Taiwan

  • Investigational Site Number :1580006

    Kaohsiung City, 833, Taiwan

  • Investigational Site Number :1580008

    Taichung, Taiwan

  • Investigational Site Number :2500001

    Brest, 29200, France

  • Investigational Site Number :2500002

    Lille, 59037, France

  • Investigational Site Number :2500003

    Toulouse, 31059, France

  • Investigational Site Number :2500004

    Paris, 75010, France

  • Investigational Site Number :2500005

    Reims, 51100, France

  • Investigational Site Number :2500006

    Lyon, 69003, France

  • Investigational Site Number :2500007

    Bordeaux, 33075, France

  • Investigational Site Number :2500008

    Le Mans, 72037, France

  • Investigational Site Number :3480002

    Orosháza, 5900, Hungary

  • Investigational Site Number :3480003

    Szeged, 6720, Hungary

  • Investigational Site Number :3480004

    Debrecen, 4032, Hungary

  • Investigational Site Number :3480005

    Pécs, 7632, Hungary

  • Investigational Site Number :3800001

    Rozzano, Milano, 20089, Italy

  • Investigational Site Number :3800002

    Milan, 20122, Italy

  • Investigational Site Number :3800003

    Catanzaro, 88100, Italy

  • Investigational Site Number :3800004

    Ancona, 60032, Italy

  • Investigational Site Number :4100001

    Seoul, Seoul-teukbyeolsi, 06973, South Korea

  • Investigational Site Number :4100002

    Busan, Busan, 49241, South Korea

  • Investigational Site Number :4100003

    Bucheon-si, Gyeonggi-do, 14584, South Korea

  • Investigational Site Number :4100005

    Seoul, Seoul-teukbyeolsi, 03722, South Korea

  • Investigational Site Number :4100006

    Seoul, Seoul-teukbyeolsi, 07441, South Korea

  • Investigational Site Number :4100007

    Incheon, Incheon-gwangyeoksi, 21431, South Korea

  • Investigational Site Number :6200001

    Coimbra, 3000-075, Portugal

  • Investigational Site Number :6200002

    Lisbon, 1998-018, Portugal

  • Investigational Site Number :6200003

    Porto, 4099-001, Portugal

  • Investigational Site Number :7240001

    Pontevedra, Galicia [Galicia], 36071, Spain

  • Investigational Site Number :7240002

    Zaragoza, 50009, Spain

  • Investigational Site Number :7240003

    Valencia, 46026, Spain

  • Investigational Site Number :7240004

    Córdoba, 14004, Spain

  • Investigational Site Number :7240007

    Madrid, 28034, Spain

  • Investigational Site Number :7240008

    Santullano, Principality of Asturias, 33619, Spain

  • Investigational Site Number :7240009

    Badalona, Barcelona [Barcelona], 08916, Spain

  • Investigational Site Number :8260001

    Redhill, Surrey, RH1 5RH, United Kingdom

  • Investigational Site Number :8400001

    Sugar Land, Texas, 77479, United States

  • Investigational Site Number :8400002

    Plainfield, Indiana, 46168, United States

  • Investigational Site Number :8400003

    Baltimore, Maryland, 21205, United States

  • Investigational Site Number :8400005

    Pembroke Pines, Florida, 33028, United States

  • Investigational Site Number :8400006

    East Windsor, New Jersey, 08520, United States

  • Investigational Site Number :8400008

    Sacramento, California, 95816, United States

  • Investigational Site Number :8400054

    Fort Smith, Arkansas, 72916, United States

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