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New hope for mystery itch: drug targets chronic pruritus

NCT ID NCT05263206

Symptom relief 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This study tests if dupilumab can reduce severe itching in adults with chronic pruritus of unknown origin (CPUO) — a condition where people itch for months without a clear cause. About 284 adults aged 18 to 90 will receive either dupilumab or a placebo for 24 weeks, alongside standard itch treatments. The main goal is to see if dupilumab leads to a meaningful drop in itch intensity.

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 284 people

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

Started

Feb 2022

Expected to finish

Aug 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

18 to 90 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: * Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 90 years of age inclusive, at the time of signing the informed consent. * Participants with chronic pruritus for at least 6 months before the screening visit. * Chronic pruritus considered of unknown origin as assessed by the investigator at baseline (excluding chronic pruritus secondary to dermatological or systemic conditions, of neuropathic or psychogenic origin or secondary to drugs). * Chronic pruritus must affect at least 2 of the following body areas: legs, arms, or trunk. * History of insufficient control of the chronic pruritus with prior treatment. * Participants should receive optimal treatment for concomitant conditions that could impact pruritus (eg, diabetes, iron deficiency). * Participants must have a history of severe itch and a worst itch score of ≥7 at screening on the WI-NRS (score scale ranges from 0 to 10; higher score indicates worse itch) and Patient Global Impression of Severity (PGIS) of pruritus scored "severe" at screening. * Participants must have an average worst itch score of ≥7 in the 7 days prior to run-in visit and in the 7 days prior to Day 1 on the WI-NRS. * Participants scored "severe" in the PGIS of pruritus on Day 1. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the patient's participation in the study. * Patients with active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis, unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent. * Diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drug within 2 weeks before the screening visit. * HIV infection. * Severe renal failure (dialysis). * Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the run-in visit. * 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 and completely treated and resolved non metastatic squamous or basal cell carcinoma of the skin. * History of hypersensitivity or intolerance to non-sedative antihistamines. * Participation in prior dupilumab clinical study or have been treated with commercially available dupilumab. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

Pruritus

As listed by the trial registrant

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

Pruritus

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

    81 sites in 13 countries. 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

  • AUSL Toscana Centro - Presidio Ospedaliero "Piero Palagi-"Site Number : 3800005

    RECRUITING

    Florence, Firenze, 50125, Italy

  • AXIS Clinicals - Fargo- Site Number : 8400037

    RECRUITING

    Fargo, North Dakota, 58103, United States

  • Aeroallergy Research Laboratory- Site Number : 8400036

    RECRUITING

    Savannah, Georgia, 31406, United States

  • Azienda Ospedaliero Universitaria delle Marche-Site Number : 3800004

    RECRUITING

    Ancona, 60126, Italy

  • Azienda Ospedaliero-Universitaria di Ferrara-Site Number : 3800007

    RECRUITING

    Cona, Ferrara, 44124, Italy

  • Columbia Dermatology & Aesthetics- Site Number : 8400047

    RECRUITING

    Columbia, South Carolina, 29212, United States

  • Complete Dermatology - Sugar Land- Site Number : 8400046

    RECRUITING

    Sugar Land, Texas, 77479, United States

  • Dawes Fretzin Clinical Research- Site Number : 8400007

    RECRUITING

    Indianapolis, Indiana, 46256, United States

  • Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400031

    RECRUITING

    Louisville, Kentucky, 40241, United States

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-Site Number : 3800003

    RECRUITING

    Milan, Milano, 20122, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Site Number : 3800001

    RECRUITING

    Rome, Roma, 00168, Italy

  • FoxHall Dermatology- Site Number : 8400042

    RECRUITING

    Washington D.C., District of Columbia, 20016, United States

  • Investigational Site Number : 0320001

    COMPLETED

    Buenos Aires, 1023, Argentina

  • Investigational Site Number : 0320002

    RECRUITING

    Buenos Aires, 1121, Argentina

  • Investigational Site Number : 0320003

    RECRUITING

    Buenos Aires, 1414, Argentina

  • Investigational Site Number : 0320004

    COMPLETED

    Rosario, Santa Fe Province, 2000, Argentina

  • Investigational Site Number : 0320005

    RECRUITING

    Buenos Aires, 1012, Argentina

  • Investigational Site Number : 0320006

    RECRUITING

    Buenos Aires, 1055, Argentina

  • Investigational Site Number : 0320007

    RECRUITING

    Buenos Aires, 1061, Argentina

  • Investigational Site Number : 0320008

    RECRUITING

    Rosario, Santa Fe Province, 2000, Argentina

  • Investigational Site Number : 1240001

    RECRUITING

    Calgary, Alberta, T2G 1B1, Canada

  • Investigational Site Number : 1240002

    RECRUITING

    London, Ontario, L6A 2C2, Canada

  • Investigational Site Number : 1240003

    COMPLETED

    Markham, Ontario, L3P 1X2, Canada

  • Investigational Site Number : 1240004

    RECRUITING

    Verdun, Quebec, H4G 2L8, Canada

  • Investigational Site Number : 1240005

    COMPLETED

    Montreal, Quebec, H4A 3T2, Canada

  • Investigational Site Number : 1240006

    RECRUITING

    Toronto, Ontario, M4C 1L1, Canada

  • Investigational Site Number : 1240008

    COMPLETED

    Edmonton, Alberta, T6G 1C3, Canada

  • Investigational Site Number : 1560001

    RECRUITING

    Shanghai, 200040, China

  • Investigational Site Number : 1560002

    RECRUITING

    Hangzhou, 310006, China

  • Investigational Site Number : 1560003

    RECRUITING

    Beijing, 100191, China

  • Investigational Site Number : 1560004

    RECRUITING

    Chengdu, 610041, China

  • Investigational Site Number : 1560005

    RECRUITING

    Guangzhou, 510080, China

  • Investigational Site Number : 1560006

    RECRUITING

    Guangzhou, 510018, China

  • Investigational Site Number : 1560008

    RECRUITING

    Wuhan, 430022, China

  • Investigational Site Number : 1560009

    RECRUITING

    Chongqing, 400016, China

  • Investigational Site Number : 1560011

    RECRUITING

    Suzhou, 215006, China

  • Investigational Site Number : 1580001

    RECRUITING

    Taipei, 100, Taiwan

  • Investigational Site Number : 1580002

    RECRUITING

    Taoyuan City, 333, Taiwan

  • Investigational Site Number : 1580003

    RECRUITING

    Kaohsiung City, 833, Taiwan

  • Investigational Site Number : 1580004

    RECRUITING

    New Taipei City, 235, Taiwan

  • Investigational Site Number : 2500001

    RECRUITING

    Brest, 29200, France

  • Investigational Site Number : 2500003

    RECRUITING

    Nice, 06202, France

  • Investigational Site Number : 2500004

    RECRUITING

    Reims, 51100, France

  • Investigational Site Number : 2760001

    RECRUITING

    Münster, 48149, Germany

  • Investigational Site Number : 2760002

    RECRUITING

    Berlin, 12203, Germany

  • Investigational Site Number : 2760003

    RECRUITING

    Mainz, 55131, Germany

  • Investigational Site Number : 2760004

    RECRUITING

    Frankfurt, 60590, Germany

  • Investigational Site Number : 2760005

    RECRUITING

    Bad Bentheim, 48455, Germany

  • Investigational Site Number : 3480001

    RECRUITING

    Budapest, 1036, Hungary

  • Investigational Site Number : 3480002

    RECRUITING

    Zalaegerszeg, 8900, Hungary

  • Investigational Site Number : 3480003

    RECRUITING

    Szeged, 6720, Hungary

  • Investigational Site Number : 3480005

    RECRUITING

    Debrecen, 4031, Hungary

  • Investigational Site Number : 3480009

    RECRUITING

    Budapest, 1066, Hungary

  • Investigational Site Number : 3480010

    RECRUITING

    Gyula, 5700, Hungary

  • Investigational Site Number : 3480011

    RECRUITING

    Székesfehérvár, 8000, Hungary

  • Investigational Site Number : 3800002

    RECRUITING

    Rozzano, Milano, 20089, Italy

  • Investigational Site Number : 3800006

    RECRUITING

    Naples, Napoli, 80131, Italy

  • Investigational Site Number : 3920001

    RECRUITING

    Tachikawa, Tokyo, 190-0023, Japan

  • Investigational Site Number : 3920002

    RECRUITING

    Sakai, Osaka, 593-8324, Japan

  • Investigational Site Number : 3920003

    RECRUITING

    Obihiro, Hokkaido, 080-0013, Japan

  • Investigational Site Number : 3920004

    RECRUITING

    Habikino, Osaka, 583-8588, Japan

  • Investigational Site Number : 3920005

    RECRUITING

    Izumo, Shimane, 693-8501, Japan

  • Investigational Site Number : 3920006

    RECRUITING

    Sapporo, Hokkaido, 060-0063, Japan

  • Investigational Site Number : 3920007

    RECRUITING

    Urayasu, Chiba, 279-0011, Japan

  • Investigational Site Number : 4100001

    COMPLETED

    Seoul, Seoul-teukbyeolsi, 07441, South Korea

  • Investigational Site Number : 4100002

    COMPLETED

    Seoul, Seoul-teukbyeolsi, 03722, South Korea

  • Investigational Site Number : 4100003

    COMPLETED

    Busan, Busan, 49241, South Korea

  • Investigational Site Number : 4100004

    COMPLETED

    Ansan-si, Gyeonggi-do, 15355, South Korea

  • Investigational Site Number : 4100005

    COMPLETED

    Seoul, Seoul-teukbyeolsi, 03080, South Korea

  • Investigational Site Number : 4100006

    RECRUITING

    Seoul, Seoul-teukbyeolsi, 05030, South Korea

  • Investigational Site Number : 4100007

    RECRUITING

    Seoul, Seoul-teukbyeolsi, 07804, South Korea

  • Investigational Site Number : 6160001

    RECRUITING

    Krakow, Lesser Poland Voivodeship, 30-033, Poland

  • Investigational Site Number : 6160003

    ACTIVE_NOT_RECRUITING

    Wroclaw, Lower Silesian Voivodeship, 51-318, Poland

  • Investigational Site Number : 6160003

    RECRUITING

    Wroclaw, Lower Silesian Voivodeship, 51-503, Poland

  • Investigational Site Number : 6160005

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-172, Poland

  • Investigational Site Number : 6160007

    RECRUITING

    Wroclaw, Lower Silesian Voivodeship, 50-566, Poland

  • Investigational Site Number : 6160008

    RECRUITING

    Warsaw, Masovian Voivodeship, 01-142, Poland

  • Investigational Site Number : 7240001

    RECRUITING

    Pontevedra, Pontevedra [Pontevedra], 36002, Spain

  • Investigational Site Number : 7240003

    RECRUITING

    Barcelona, Barcelona [Barcelona], 08003, Spain

  • Investigational Site Number : 7240004

    RECRUITING

    Córdoba, 14004, Spain

  • Investigational Site Number : 7240005

    RECRUITING

    Alicante, 03010, Spain

  • Investigational Site Number : 7240006

    RECRUITING

    Barcelona, Catalunya [Cataluña], 08041, Spain

  • Johns Hopkins Hospital- Site Number : 8400020

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Kern Allergy and Medical Research- Site Number : 8400016

    COMPLETED

    Bakersfield, California, 93301, United States

  • Modena Allergy + Asthma- Site Number : 8400038

    RECRUITING

    La Jolla, California, 92037, United States

  • Mount Sinai - Union Square- Site Number : 8400034

    RECRUITING

    New York, New York, 10003, United States

  • National Allergy and Asthma - North Charleston - Northside Drive- Site Number : 8400032

    RECRUITING

    North Charleston, South Carolina, 29420, United States

  • Optima Research - Boardman- Site Number : 8400039

    RECRUITING

    Boardman, Ohio, 44512, United States

  • Palm Harbor Dermatology- Site Number : 8400024

    RECRUITING

    Belleair, Florida, 32756, United States

  • Skin Care Physicians of Georgia - Macon- Site Number : 8400030

    RECRUITING

    Macon, Georgia, 31217, United States

  • The Asthma and Allergy Center- Site Number : 8400014

    RECRUITING

    Bellevue, Nebraska, 68123, United States

  • Tulane University School of Medicine- Site Number : 8400045

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • University of Miami Hospital- Site Number : 8400011

    RECRUITING

    Miami, Florida, 33136, United States

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