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New cream offers hope for unbearable itch

NCT ID NCT05755438

Symptom relief Sponsor: Incyte Corporation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 13, 2026 · Updated 3 times

Summary

This Phase 3 trial tested a cream containing ruxolitinib in 204 adults with prurigo nodularis, a skin condition causing intense itching and hard bumps. Participants applied the cream twice daily for 12 weeks. The main goal was to see if it reduced itch by at least 4 points on a 0-10 scale. Results showed significant improvement compared to a placebo cream.

What this could mean

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

Active substance
Ruxolitinib cream (1.5%)
What this could lead to
If successful, this cream could provide a new, non-steroid option to ease severe itching in people with prurigo nodularis.
What could go wrong
This is a completed Phase 3 trial, but results may not apply to all patients. The cream only treats symptoms, not the underlying cause, and long-term safety is still being studied.

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

204 people

The number who actually took part.

Started

Mar 2023

Finished

Aug 2025

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 99 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: * Clinical diagnosis of PN ≥ 3 months before screening. * ≥ 6 pruriginous lesions on ≥ 2 different body areas (such as right and left leg) at screening and baseline having a treatment area \<20% BSA. * IGA-CPG-S score of ≥ 2 at screening and baseline. * Baseline PN-related WI-NRS score ≥ 7. * Willingness to avoid pregnancy or fathering children. Exclusion Criteria: * Chronic pruritus due to a condition other than PN * Total estimated BSA treatment area (excluding the scalp) \> 20%. * Neuropathic and psychogenic pruritus * Active atopic dermatitis lesions within 3 months of screening and baseline. * Uncontrolled thyroid function * Concurrent skin or other serious or unstable medical conditions which may interfere with the evaluation of PN such as immunocompromised status, acute/chronic infections, active malignancy, history of TB, history of DVT/VTE, etc Protocol defined abnormal laboratory results. * Use of any protocol-defined prohibited medication unless a washout is completed or use of medication known to cause itching. * Psoralen and ultraviolet A or ultraviolet B therapy within 4 weeks before baseline or Ultraviolet light therapy or prolonged exposure to natural or artificial sources of ultraviolet radiation (within 2 weeks before baseline * Pregnant or lactating, or considering pregnancy. * History of alcoholism or drug addiction within 1 year * Known allergy or reaction to any of the components of the study drug. * Committed to a mental health institution by virtue of an order issued either by the judicial or the administrative authorities. * Employees of the sponsor or investigator or otherwise dependents of them. * The following participants are excluded in France: 1. Vulnerable populations according to article L.1121-6 of the French Public Health Code. 2. Adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code. 3. Individuals not affiliated with the social security system.

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Conditions

The condition(s) this trial relates to.

dermatitis prurigo prurigo nodularis skin disorder

As listed by the trial registrant

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

Prurigo

Contacts and locations

Locations

  • Amsterdam University Medical Centre

    Amsterdam, 1105 AZ, Netherlands

  • Asl 1 Avezzano L'Aquila Sulmona- Ospedale Regionale San Salvatore

    Coppito, 67100, Italy

  • Austin Institute For Clinical Research Aicr Pflugerville

    Pflugerville, Texas, 78660, United States

  • Az Sint-Lucas

    Ghent, 09000, Belgium

  • Azienda Ospedaliera Universitaria Policlinico 'Federico Ii'

    Naples, 80131, Italy

  • Azienda Ospedaliero Universitaria Policlinico G.Rodolico San Marco

    Catania, 95123, Italy

  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Spedali Civili)

    Brescia, 25123, Italy

  • Beacon Dermatology

    Calgary, Alberta, T3E 0B2, Canada

  • Bravis Ziekenhuis

    Bergen op Zoom, 4624 VT, Netherlands

  • Buenos Aires Skin

    Ciudad Autonoma Buenos Aires, C1055AAO, Argentina

  • Cedic Centro de Investigaciones Clinicas

    Ciudad Autonoma Buenos Aires, 01125, Argentina

  • Center For Clinical Studies

    Webster, Texas, 77598, United States

  • Central Sooner Research

    Norman, Oklahoma, 73071, United States

  • Centralny Szpital Kliniczny Mswia

    Warsaw, 02-507, Poland

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liège, 04000, Belgium

  • Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

    Nantes, 44093, France

  • Centre de Recherche Saint-Louis

    Québec, Quebec, G1W 4R4, Canada

  • Centro Medico Skinmed

    Las Condes, 7580206, Chile

  • Centro de Investigaciones Medicas Mar Del Plata

    Mar del Plata, B7600FYK, Argentina

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, T4000AXL, Argentina

  • Chu Ucl Namur de Saint Elisabeth

    Namur, 05000, Belgium

  • Ciec - Centro Internacional de Estudios Cli-Nicos

    Santiago, 8420383, Chile

  • Clarkston Medical Group

    Clarkston, Michigan, 48346, United States

  • Clinical Research Chile Spa.

    Valdivia, 5090000, Chile

  • Clinical Research Group Sp. Z.O.O

    Warsaw, 01-142, Poland

  • Cliniques Universitaires Ucl Saint-Luc

    Brussels, 01200, Belgium

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, 15706, Spain

  • Conexa Investigacion Clinica S.A.

    Buenos Aires, 01012, Argentina

  • Dermatology Associates Pc

    Rockville, Maryland, 20850, United States

  • Dermatology Associates of Plymouth Meeting

    Plymouth Meeting, Pennsylvania, 19462, United States

  • Dermeffects

    London, Ontario, N6H 5L4, Canada

  • ETG LODZ

    Lodz, 90-302, Poland

  • Fachklinik Bad Bentheim Dermatologie

    Bad Bentheim, 48455, Germany

  • First Oc Dermatology

    Fountain Valley, California, 92708, United States

  • Fondazione Policlinico Universitario Agostino Gemelli Irccs

    Roma, 00137, Italy

  • Fundacion Scherbovsky

    Mendoza, 05500, Argentina

  • Hautarztpraxis Dr. Med. Matthias Hoffmann

    Witten, 58453, Germany

  • High-Med Przychodnia Specjalistycza

    Warsaw, 01-817, Poland

  • Hospital General Unviersitario de Alicante

    Alicante, 03010, Spain

  • Hospital Morvan

    Brest, 29609, France

  • Hospital Prive D'Antony

    Antony, 92160, France

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, 28223, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, 14004, Spain

  • Hospital de Manises

    Manises, 46940, Spain

  • Instituto de Especialidades de La Salud Rosario

    Rosario, S2000KPG, Argentina

  • International Clinical Research Tennessee Llc

    Murfreesboro, Tennessee, 37130, United States

  • Johnson Dermatology

    Fort Smith, Arkansas, 72916, United States

  • Kliniczny Szpital Wojewodzki Nr 1

    Rzeszów, 35-055, Poland

  • Medical Dermatology Specialists Phoenix

    Phoenix, Arizona, 85006, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Medisearch Clinical Trials

    Saint Joseph, Missouri, 64506, United States

  • North Texas Center For Clinical Research Ntccr

    Frisco, Texas, 75034, United States

  • Ospedali Riuniti Di Ancona

    Torrette, 60123, Italy

  • Pratia McM Krakow

    Krakow, 30-510, Poland

  • Premier Clinical Research

    Spokane, Washington, 99204, United States

  • Psoriahue-Medicina Interdisciplinar

    Ciudad Autonoma Buenos Aires, C1425DKG, Argentina

  • Research Toronto

    Toronto, Ontario, M3H 5Y8, Canada

  • Revival Research Institute, Llc Troy

    Troy, Michigan, 48084, United States

  • Simcomed Health Ltd

    Barrie, Ontario, L4M 1G7, Canada

  • UC Health, Llc

    Cincinnati, Ohio, 45219, United States

  • Ulb Hospital Erasme

    Brussels, 01070, Belgium

  • Universitaetsklinikum Carl Gustav Carus Tu Dresden

    Dresden, 01307, Germany

  • Universitair Ziekenhuis (Uz) Leuven

    Leuven, 03000, Belgium

  • Universitair Ziekenhuis Gent

    Ghent, 09000, Belgium

  • Universitats-Hautklink Tubingen

    Tübingen, 72076, Germany

  • Universitatsklinikum Schleswig Holstein

    Kiel, 24105, Germany

  • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

    Mainz, 55131, Germany

  • University Hospital of Saint Etienne

    Saint-Etienne, 42270, France

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University Medical Center Rwth Aachen

    Aachen, 52074, Germany

  • Wake Forest University

    Winston-Salem, North Carolina, 27157, United States

More trials for these conditions

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