A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)

NCT05755438 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: INCB 18424-3192022-501621-20-00
• Study Type: interventional
• Target: 204
• Locations: 11 countries
• Sites: 71

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).

Conditions

Prurigo

Keywords

Prurigo; Prurigo Nodularis; PN; Skin Diseases; Dermatitis; Eczematous; ruxolitinib; INCB 18424

Outcome Measures

Primary Outcomes (1)

• WI-NRS4 Response at Week 12

  WI-NRS4 was defined as the percentage of participants achieving a ≥4-point improvement (reduction) in Worst-Itch Numeric Rating Scale (WI-NRS) score from baseline. The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day. Participants with missing Week 12 data for any reason, including treatment discontinuation (due to development of atopic dermatitis lesions or any other cause), were defined as nonresponders.

  Baseline; Week 12

Secondary Outcomes (27)

• WI-NRS4 Response at Week 4

  Baseline; Week 4

• Percentage of Participants With Overall-Treatment Success at Week 12

  Baseline; Week 12

• Percentage of Participants With IGA-CPG-S-TS at Week 12

  Baseline; Week 12

• WI-NRS4 Response on Day 7

  Baseline; Day 7

• DBVC Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit

  Baseline; up to Week 12

Study Arms (2)

Vehicle Cream BID

PLACEBO COMPARATOR

Participants apply ruxolitinib matching vehicle cream topically to the affected areas as a thin film twice daily (BID) for 12 weeks during the DBVC period. Participants who have completed the treatment during DBVC period will apply ruxolitinib 1.5% cream topically during the open label extension (OLE) period for up to 40 weeks.

Drug: Vehicle Cream

Ruxolitinib 1.5% Cream

EXPERIMENTAL

Participants apply ruxolitinib 1.5% cream topically to the affected areas as a thin film BID for 12 weeks during the DBVC period. Participants who have completed the treatment during DBVC period will apply ruxolitinib 1.5% cream the open label extension (OLE) period for up to 40 weeks.

Drug: Ruxolitinib Cream

Interventions

Ruxolitinib Cream DRUG

Ruxolitinib cream 1.5% twice daily (BID) during the vehicle controlled (DBVC)and open label treatment period (OLE).

Also known as: INCB018424 phosphate cream

Ruxolitinib 1.5% Cream

Vehicle Cream DRUG

Ruxolitinib matching vehicle cream 1.5% twice daily (BID) during the vehicle controlled period (DBVC).

Vehicle Cream BID

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Vulnerable populations according to article L.1121-6 of the French Public Health Code.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (71)

Medical Dermatology Specialists Phoenix

Phoenix, Arizona, 85006, United States

Location

Johnson Dermatology

Fort Smith, Arkansas, 72916, United States

Location

First Oc Dermatology

Fountain Valley, California, 92708, United States

Location

Dermatology Associates Pc

Rockville, Maryland, 20850, United States

Location

Clarkston Medical Group

Clarkston, Michigan, 48346, United States

Location

Revival Research Institute, Llc Troy

Troy, Michigan, 48084, United States

Location

Medisearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

UC Health, Llc

Cincinnati, Ohio, 45219, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Central Sooner Research

Norman, Oklahoma, 73071, United States

Location

Dermatology Associates of Plymouth Meeting

Plymouth Meeting, Pennsylvania, 19462, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

International Clinical Research Tennessee Llc

Murfreesboro, Tennessee, 37130, United States

Location

North Texas Center For Clinical Research Ntccr

Frisco, Texas, 75034, United States

Location

Austin Institute For Clinical Research Aicr Pflugerville

Pflugerville, Texas, 78660, United States

Location

Center For Clinical Studies

Webster, Texas, 77598, United States

Location

Premier Clinical Research

Spokane, Washington, 99204, United States

Location

Conexa Investigacion Clinica S.A.

Buenos Aires, 01012, Argentina

Location

Cedic Centro de Investigaciones Clinicas

Ciudad Autonoma Buenos Aires, 01125, Argentina

Location

Buenos Aires Skin

Ciudad Autonoma Buenos Aires, C1055AAO, Argentina

Location

Psoriahue-Medicina Interdisciplinar

Ciudad Autonoma Buenos Aires, C1425DKG, Argentina

Location

Centro de Investigaciones Medicas Mar Del Plata

Mar del Plata, B7600FYK, Argentina

Location

Fundacion Scherbovsky

Mendoza, 05500, Argentina

Location

Instituto de Especialidades de La Salud Rosario

Rosario, S2000KPG, Argentina

Location

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, T4000AXL, Argentina

Location

Ulb Hospital Erasme

Brussels, 01070, Belgium

Location

Cliniques Universitaires Ucl Saint-Luc

Brussels, 01200, Belgium

Location

Az Sint-Lucas

Ghent, 09000, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 09000, Belgium

Location

Universitair Ziekenhuis (Uz) Leuven

Leuven, 03000, Belgium

Location

Centre Hospitalier Universitaire de Liege - Sart Tilman

Liège, 04000, Belgium

Location

Chu Ucl Namur de Saint Elisabeth

Namur, 05000, Belgium

Location

Beacon Dermatology

Calgary, Alberta, T3E 0B2, Canada

Location

Simcomed Health Ltd

Barrie, Ontario, L4M 1G7, Canada

Location

Dermeffects

London, Ontario, N6H 5L4, Canada

Location

Research Toronto

Toronto, Ontario, M3H 5Y8, Canada

Location

Centre de Recherche Saint-Louis

Québec, Quebec, G1W 4R4, Canada

Location

Centro Medico Skinmed

Las Condes, 7580206, Chile

Location

Ciec - Centro Internacional de Estudios Cli-Nicos

Santiago, 8420383, Chile

Location

Clinical Research Chile Spa.

Valdivia, 5090000, Chile

Location

Hospital Prive D'Antony

Antony, 92160, France

Location

Hospital Morvan

Brest, 29609, France

Location

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

Nantes, 44093, France

Location

University Hospital of Saint Etienne

Saint-Etienne, 42270, France

Location

University Medical Center Rwth Aachen

Aachen, 52074, Germany

Location

Fachklinik Bad Bentheim Dermatologie

Bad Bentheim, 48455, Germany

Location

Universitaetsklinikum Carl Gustav Carus Tu Dresden

Dresden, 01307, Germany

Location

Universitatsklinikum Schleswig Holstein

Kiel, 24105, Germany

Location

Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

Mainz, 55131, Germany

Location

Universitats-Hautklink Tubingen

Tübingen, 72076, Germany

Location

Hautarztpraxis Dr. Med. Matthias Hoffmann

Witten, 58453, Germany

Location

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

Brescia, 25123, Italy

Location

Azienda Ospedaliero Universitaria Policlinico G.Rodolico San Marco

Catania, 95123, Italy

Location

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

Coppito, 67100, Italy

Location

Azienda Ospedaliera Universitaria Policlinico 'Federico Ii'

Napoli, 80131, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli Irccs

Roma, 00137, Italy

Location

Ospedali Riuniti Di Ancona

Torrette, 60123, Italy

Location

Amsterdam University Medical Centre

Amsterdam, 1105 AZ, Netherlands

Location

Bravis Ziekenhuis

Bergen op Zoom, 4624 VT, Netherlands

Location

Pratia McM Krakow

Krakow, 30-510, Poland

Location

ETG LODZ

Lodz, 90-302, Poland

Location

Kliniczny Szpital Wojewodzki Nr 1

Rzeszów, 35-055, Poland

Location

Clinical Research Group Sp. Z.O.O

Warsaw, 01-142, Poland

Location

High-Med Przychodnia Specjalistycza

Warsaw, 01-817, Poland

Location

Centralny Szpital Kliniczny Mswia

Warsaw, 02-507, Poland

Location

Hospital General Unviersitario de Alicante

Alicante, 03010, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Hospital de Manises

Manises, 46940, Spain

Location

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, 28223, Spain

Location

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, 15706, Spain

Location

MeSH Terms

Conditions

Prurigo; Skin Diseases; Dermatitis

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Haq Nawaz, md

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: March 6, 2023
• Study Start: March 10, 2023
• Primary Completion: October 7, 2024
• Study Completion: August 13, 2025
• Last Updated: November 14, 2025
• Results First Posted: November 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

Locations

AR (8); BE (7); FR (4); ES (5); CA (5); PL (6); US (18); NL (2); DE (7); CL (3); IT (6)