A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN) (TRuE-PN1)

A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Prurigo Nodularis

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

Study Overview

• Status: Recruiting
• Conditions: Prurigo
• Intervention / Treatment: Drug: Vehicle Cream; Drug: Ruxolitinib Cream

Detailed Description

The study comprises of a 12 week double-blind, vehicle-controlled (DBVC) treatment period, followed by a 40 week open label extension period, and 30 day safety follow-up period During the double blind period, all PN-affected areas identified at baseline will be treated, and during the open label period, only active PN-affected areas will be treated.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Incyte Corporation Call Center (US); Phone Number: 1.855.463.3463; Email: medinfo@incyte.com
• Study Contact Backup: Name: Incyte Corporation Call Center (ex-US); Phone Number: +800 00027423; Email: eumedinfo@incyte.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, 01012
    • Recruiting
    • Conexa Investigacion Clinica S.A.
  • Ciudad Autonoma Buenos Aires, Argentina, C1425DKG
    • Recruiting
    • Psoriahue-Medicina Interdisciplinar
  • Ciudad Autonoma Buenos Aires, Argentina, 01125
    • Recruiting
    • Cedic Centro de Investigaciones Clinicas
  • Ciudad Autonoma Buenos Aires, Argentina, C1055AAO
    • Recruiting
    • Buenos Aires Skin
  • Mar Del Plata, Argentina, B7600FYK
    • Recruiting
    • Centro de Investigaciones Medicas Mar del Plata
  • Mendoza, Argentina, 05500
    • Recruiting
    • Fundacion Scherbovsky
  • Rosario, Argentina, S2000KPG
    • Recruiting
    • Instituto de Especialidades de la Salud Rosario
  • San Miguel de Tucuman, Argentina, T4000AXL
    • Recruiting
    • Centro de Investigaciones Médicas Tucuman
• Belgium
  • Brussels, Belgium, 01200
    • Recruiting
    • Cliniques Universitaires Ucl Saint-Luc
  • Bruxelles, Belgium, 01070
    • Not yet recruiting
    • Ulb Hospital Erasme
  • Gent, Belgium, 09000
    • Recruiting
    • AZ Sint-Lucas
  • Ghent, Belgium, 09000
    • Recruiting
    • Universitair Ziekenhuis Gent
  • Leuven, Belgium, 03000
    • Recruiting
    • Universitair Ziekenhuis (Uz) Leuven
  • Liege, Belgium, 04000
    • Recruiting
    • Centre Hospitalier Universitaire de Liege - Sart Tilman
  • Namur, Belgium, 05000
    • Not yet recruiting
    • Chu Ucl Namur de Saint Elisabeth
• Brazil
  • Santo André, Brazil, 09080-110
    • Withdrawn
    • Pesquisare Saúde
• Canada
  • Quebec, Canada, G1W 4R4
    • Recruiting
    • Centre de Recherche Saint-Louis
  • Alberta
    • Calgary, Alberta, Canada, T3E 0B2
      • Recruiting
      • Beacon Dermatology
  • Ontario
    • Barrie, Ontario, Canada, L4M 1G7
      • Recruiting
      • Simcomed Health Ltd
    • London, Ontario, Canada, N6H 5L4
      • Recruiting
      • Dermeffects
    • Toronto, Ontario, Canada, M3H 5Y8
      • Recruiting
      • Research Toronto
• Chile
  • Las Condes, Chile, 7580206
    • Recruiting
    • Centro Medico Skinmed
  • Santiago, Chile, 8420383
    • Recruiting
    • Ciec - Centro Internacional de Estudios Cli-Nicos
  • Valdivia, Chile, 5090000
    • Recruiting
    • Clinical Research Chile Spa.
• France
  • Antony, France, 92160
    • Recruiting
    • Hospital Prive D'Antony
  • Brest Cedex 2, France, 29609
    • Recruiting
    • Hospital Morvan
  • Nantes, France, 44093
    • Recruiting
    • Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
  • Saint-etienne Cedex 2, France, 42270
    • Recruiting
    • University Hospital of Saint Etienne
• Germany
  • Aachen, Germany, 52074
    • Recruiting
    • University Medical Center Rwth Aachen
  • Bad Bentheim, Germany, 48455
    • Recruiting
    • Fachklinik Bad Bentheim Dermatologie
  • Dresden, Germany, 01307
    • Recruiting
    • Universitaetsklinikum Carl Gustav Carus TU Dresden
  • Kiel, Germany, 24105
    • Recruiting
    • Universitatsklinikum Schleswig Holstein
  • Mainz, Germany, 55131
    • Recruiting
    • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
  • Tuebingen, Germany, 72076
    • Recruiting
    • Universitats-Hautklink Tubingen
  • Witten, Germany, 58453
    • Recruiting
    • Hautarztpraxis Dr. Med. Matthias Hoffmann
• Italy
  • Brescia, Italy, 25123
    • Recruiting
    • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
  • Catania, Italy, 95123
    • Recruiting
    • Azienda Ospedaliero Universitaria Policlinico G.Rodolico San Marco
  • Coppito, Italy, 67100
    • Recruiting
    • Asl 1 Avezzano L'Aquila Sulmona- Ospedale Regionale San Salvatore
  • Napoli, Italy, 80131
    • Recruiting
    • Azienda Ospedaliera Universitaria Policlinico 'Federico Ii'
  • Roma, Italy, 00137
    • Recruiting
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Rozzano, Italy, 20089
    • Withdrawn
    • Irccs Istituto Clinico Humanitas
  • Torrette, Italy, 60123
    • Recruiting
    • Ospedali Riuniti di Ancona
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Recruiting
    • Amsterdam University Medical Centre
  • Bergen Op Zoom, Netherlands, 4624 VT
    • Recruiting
    • Bravis Ziekenhuis
• Poland
  • Krakow, Poland, 30-510
    • Recruiting
    • Pratia MCM Krakow
  • Lodz, Poland, 90-302
    • Recruiting
    • ETG Lodz
  • Rzeszow, Poland, 35-055
    • Recruiting
    • Kliniczny Szpital Wojewodzki Nr 1
  • Warszawa, Poland, 02-507
    • Recruiting
    • Centralny Szpital Kliniczny MSWiA
  • Warszawa, Poland, 01-142
    • Recruiting
    • Clinical Research Group Sp. Z.O.O
  • Warszawa, Poland, 01-817
    • Recruiting
    • High-Med Przychodnia Specjalistycza
• Spain
  • Alicante, Spain, 03010
    • Recruiting
    • Hospital General Unviersitario de Alicante
  • Cordoba, Spain, 14004
    • Recruiting
    • Hospital Universitario Reina Sofia
  • Manises, Spain, 46940
    • Recruiting
    • Hospital de Manises
  • Pozuelo de Alarcon, Spain, 28223
    • Recruiting
    • Hospital Universitario Quironsalud Madrid
  • Santiago de Compostela, Spain, 15706
    • Recruiting
    • Complejo Hospitalario Universitario de Santiago
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Recruiting
      • Medical Dermatology Specialists Phoenix
  • Arkansas
    • Fort Smith, Arkansas, United States, 72916
      • Recruiting
      • Johnson Dermatology
  • California
    • Fountain Valley, California, United States, 92708
      • Recruiting
      • First OC Dermatology
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Recruiting
      • Dermatology Associates Pc
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • Recruiting
      • Clarkston Medical Group
    • Troy, Michigan, United States, 48084
      • Recruiting
      • Revival Research Institute, Llc Troy
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Recruiting
      • Medisearch Clinical Trials
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • UC Health, Llc
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • Recruiting
      • Central Sooner Research
  • Pennsylvania
    • Plymouth Meeting, Pennsylvania, United States, 19462
      • Recruiting
      • Dermatology Associates of Plymouth Meeting
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37130
      • Recruiting
      • International Clinical Research Tennessee Llc
  • Texas
    • Frisco, Texas, United States, 75034
      • Not yet recruiting
      • North Texas Center For Clinical Research Ntccr
    • Pflugerville, Texas, United States, 78660
      • Recruiting
      • Austin Institute For Clinical Research Aicr Pflugerville
    • Webster, Texas, United States, 77598
      • Recruiting
      • Center For Clinical Studies
  • Washington
    • Spokane, Washington, United States, 99204
      • Recruiting
      • Premier Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle Cream BID; 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 matching vehicle cream 1.5% twice daily (BID) during the vehicle controlled period (DBVC).
Experimental: Ruxolitinib 1.5% Cream; 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; Ruxolitinib cream 1.5% twice daily (BID) during the vehicle controlled (DBVC)and open label treatment period (OLE).; Other Names: INCB018424 phosphate cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Worst-Itch Numeric Rating Scale (WI-NRS) ≥ 4-point improvement in WI-NRS score Response	Defined as achieving a ≥ 4-point improvement (reduction) in Worst Itch Numeric Rating Scale (WI-NRS) score from baseline.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WI-NRS4 Response	Defined as achieving a ≥ 4-point improvement (reduction) in WI-NRS score from baseline.	Week 4
Overall Treatment Success (TS)	Defined as achieving both a WI-NRS4 response and an Investigator's Global Assessment for Stage of Chronic Prurigo Treatment Success (IGA-CPG-S-TS).	Week 12
IGA-CPG-S-TS	Defined as an IGA-CPG-S score of 0 or 1 with a ≥ 2 grade improvement from baseline	Week 12
WI-NRS4 Response	Defined as achieving a ≥ 4-point improvement (reduction) in WI-NRS score from baseline.	Day 7
Proportion of participants with WI-NRS4 at each postbaseline visit.	Defined as percentage of participants that achieve a ≥ 4-point improvement in WI-NRS score	Up to 52 weeks
Change from baseline in WI-NRS score	Defined as change in Intensity of itch. Itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable".	Up to 52 weeks
Time to ≥ 2-point improvement from baseline in WI-NRS score	Participants rate pruritus daily on Worst Itch [pruritis] Numerical Rating Scale (0=no pruritus; 10=worst imaginable pruritus)	Up to 52 weeks
Time to ≥ 4-point improvement from baseline in WI-NRS score	Defined as time taken for the participant to achieve a ≥4 improvement in NRS scale compared to baseline	Up to 52 weeks
Skin pain response, defined as a ≥ 2-point improvement in Skin Pain NRS score	Itch NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable".	Up to 52 weeks
Change from baseline in Skin Pain NRS score	Itch NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable".	Up to 52 weeks
IGA-TS response, defined as achieving IGA TS at each postbaseline visit.	The IGA for chronic prurigo nodularis considers the number of nodules, also referred to as lesions, and uses them to determine an overall severity rating on on a 5-point scale ranging from 0 (clear skin) to 4 (severe).	Up to 56 weeks
IGA-CPG-A 0 or 1 response, defined as achieving an IGA score of 0 or 1 at each postbaseline visit.	The IGA-CPG-A is an overall PN severity rating on a 5-point scale ranging from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, induration/papulation, and oozing/crusting.	Up to 56 weeks
> 75% healed lesions from baseline in PAS at each postbaseline visit.	PAS includes 5 items; descriptive of the type, predominant type, distribution, and quantity of pruriginous lesions, and disease activity in terms of percentage of pruriginous lesions with excoriations/crusts on top.	Up to 56 weeks
Number of Treatment-emergent adverse events (TEAEs)	TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.	Up to 56 weeks
Change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit.	The DLQI is a simple, 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days	Up to 56 weeks
Change from baseline in EQ-5D-5L score at each postbaseline visit.	The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome	Up to 56 weeks

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Haq Nawaz, md, Incyte Corporation

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2023
• Primary Completion (Estimated): August 7, 2024
• Study Completion (Estimated): December 3, 2025

Study Registration Dates

• First Submitted: January 25, 2023
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Skin Diseases; Dermatitis; ruxolitinib; PN; Prurigo Nodularis; Prurigo; Eczematous; INCB 18424
• Additional Relevant MeSH Terms: Skin Diseases; Prurigo
• Other Study ID Numbers: INCB 18424-319

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
• IPD Sharing Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No