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

NCT05764161 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: INCB18424-3202022-502461-23-00
• Study Type: interventional
• Target: 190
• Locations: 12 countries
• Sites: 69

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 Nodularis

Keywords

PN; INCB18424-320; INCB18424; Prurigo; Prurigo Nodularis; Skin Diseases; Dermatitis; ruxolitinib

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 at Day 7

  Baseline; Day 7

• WI-NRS4 Response at Each Post-baseline Visit

  Baseline; up to Week 52

Study Arms (2)

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 enter the open label extension (OLE) period for up to 40 weeks.

Drug: Ruxolitinib Cream

Vehicle Cream

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 enter the open label extension (OLE) period for up to 40 weeks.

Drug: Vehicle Cream

Interventions

Ruxolitinib Cream DRUG

Ruxolitinib cream 1.5% twice daily (BID) during the continuous and open label treatment period.

Also known as: Opzelura, INCB018424 phosphate cream

Ruxolitinib 1.5% Cream

Vehicle Cream DRUG

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

Vehicle Cream

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 (76)

University of Alabama At Birmingham

Birmingham, Alabama, 35233, United States

Location

Northwest Arkansas Clinical Trials Center

Arkansas City, Arkansas, 72758, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Clinical Science Institute Clinical Research Specialists Inc

Santa Monica, California, 90404, United States

Location

Cura Clinical Research

Sherman Oaks, California, 91403, United States

Location

Ars - Maitland Clinical Research Unit

Orlando, Florida, 32819, United States

Location

Marietta Dermatology the Skin Cancer Center Marietta

Marietta, Georgia, 30060-1047, United States

Location

The South Bend Clinic Main Campus

South Bend, Indiana, 46617, United States

Location

Axon Clinical Research

Baltimore, Maryland, 21237, United States

Location

Activmed Practices Research, Llc Beverly

Beverly, Massachusetts, 01915, United States

Location

Oakview Dermatology

Athens, Ohio, 45701, United States

Location

Aventiv Research Inc-Dublin

Dublin, Ohio, 43016, United States

Location

Wright State Physicians, Inc.

Fairborn, Ohio, 45324, United States

Location

University of Pittsburgh Medical Center Upmc Dermatology Clinic Oakland Falk Medical Building

Pittsburgh, Pennsylvania, 15232, United States

Location

Dermdox Center For Dermatology

Sugarloaf, Pennsylvania, 18249, United States

Location

Dermresearch, Inc.

Austin, Texas, 78759, United States

Location

Premier Specialists Pty Ltd

Kogarah, New South Wales, 02217, Australia

Location

Liverpool Hospital

Liverpool, New South Wales, 02170, Australia

Location

Holdsworth House Medical Practice

Sydney, New South Wales, 02010, Australia

Location

Westmead Hospital

Sydney, New South Wales, 02145, Australia

Location

Veracity Clinical Research

Woolloongabba, Queensland, 04102, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 03004, Australia

Location

Paratus Clinical Research, Woden

Phillip, 02606, Australia

Location

Landeskrankenhaus Universitatsklinikum Graz

Graz, 08036, Austria

Location

Ordensklinikum Linz Gmbh Elisabethinen

Linz, 04020, Austria

Location

Sozialmedizinisches Zentrum Ost-Donauspital

Vienna, 01220, Austria

Location

Medical Center Medconsult Pleven Ood

Pleven, 05800, Bulgaria

Location

Medical Center- Prolet Ltd

Rousse, 07000, Bulgaria

Location

Medical Center Unimed Eood

Sevlievo, 05400, Bulgaria

Location

Dcc 'Alexandrovska', Eood

Sofia, 01431, Bulgaria

Location

Medical Center Hera Eood

Sofia, 01510, Bulgaria

Location

Umhat Prof. Dr. Stoyan Kirkovich Ad

Stara Zagora, 06000, Bulgaria

Location

Kingsway Clinical Research

Etobicoke, Ontario, M8X 1Y9, Canada

Location

Lynderm Research Inc

Markham, Ontario, L3P 1X3, Canada

Location

North York Research Inc.

North YORK, Ontario, M2M 4J5, Canada

Location

Skin Centre For Dermatology

Peterborough, Ontario, K9J 5K2, Canada

Location

Diex Recherche Quebec Inc.

Québec, Quebec, G1V 4T3, Canada

Location

Herlev Og Gentofte Hospital

Hellerup, 02900, Denmark

Location

Sjaellands Universitetshospital

Roskilde, 04000, Denmark

Location

Bordeaux Chu Hopital Saint - Andre

Bordeaux, 33000, France

Location

Chu Dijon-Bourgogne

Dijon, 21000, France

Location

Hopital Edouard Herrio

Lyon, 69003, France

Location

Chu de Nice - Hospital L Archet

Nice, 06200, France

Location

Centre Hospitalier Universitaire de Poitiers

Poitiers, 86021, France

Location

Chu Amiens - Hopital Sud

Salouël, 80480, France

Location

Klinikum Bielefeld Rosenhohe Dermatologie

Bielefeld, 33647, Germany

Location

Universitatsklinikum Frankfurt

Frankfurt am Main, 60590, Germany

Location

Universitatsmedizin Goettingen

Göttingen, 37075, Germany

Location

Dermatologische Gemeinschaftspraxis Mahlow

Mahlow, 15831, Germany

Location

Universitatsklinikum Munster

Münster, 48149, Germany

Location

Fondazione Irccs Ca Granda Ospedale Maggiore

Milan, 20122, Italy

Location

Universita Degli Studi Della Campania Luigi Vanvitelli

Naples, 80131, Italy

Location

Azienda Ospedaliera Di Perugia - Ospedale Santa Maria Della Misericordia

Perugia, 06132, Italy

Location

Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara

Pisa, 56126, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Rome, 00133, Italy

Location

Diamond Clinic Specjalistyczne Poradnie Lekarskie

Krakow, 31-559, Poland

Location

Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak

Lodz, 90-436, Poland

Location

Luxderm Specjalistyczny Gabinet Dermatologiczny

Lublin, 20-362, Poland

Location

Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.

Malbork, 82-200, Poland

Location

Solumed Centrum Medyczne

Poznan, 60-529, Poland

Location

Dermaceum Centrum Badan Klinicznych

Wroclaw, 50-414, Poland

Location

Dermmedica Sp. Z O.O.

Wroclaw, 51-318, Poland

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

The Catholic University of Korea Seoul St. Mary'S Hospital

Seoul, 06591, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Ajou University Hospital

Suwon, 16499, South Korea

Location

Ceim Hospital Universitari Germans Trias I Pujol

Badalona, 08916, Spain

Location

Hospital Universitario de Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria, 35010, Spain

Location

Hospital Universitario Ramon Y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Clinica Gaias Santiago

Santiago de Compostela, 15002, Spain

Location

Dermatology & Skin Care Clinic

Buochs, 06374, Switzerland

Location

Centre Hospitalier Universitaire Vaudois (Chuv)

Lausanne, 01011, Switzerland

Location

Universitatsspital Zurich

Zurich-flughafen, 08058, Switzerland

Location

MeSH Terms

Conditions

Prurigo; Skin Diseases; Dermatitis

Interventions

ruxolitinib

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

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
• Expanded Access: Yes

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 10, 2023
• Study Start: June 12, 2023
• Primary Completion: December 30, 2024
• Study Completion: November 4, 2025
• Last Updated: December 18, 2025
• Results First Posted: November 24, 2025

Record last verified: 2025-12

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

DK (2); US (16); ES (5); PL (7); CH (3); IT (5); BU (6); FR (6); CA (5); AU (3); DE (5); KR (6)