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: Completed
• 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 (Actual): 204
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 01012
    • CONEXA Investigacion Clinica S.A.
  • Ciudad Autonoma Buenos Aires, Argentina, 01125
    • CEDIC Centro de Investigaciones Clinicas
  • Ciudad Autonoma Buenos Aires, Argentina, C1055AAO
    • Buenos Aires Skin
  • Ciudad Autonoma Buenos Aires, Argentina, C1425DKG
    • PSORIAHUE-Medicina Interdisciplinar
  • Mar del Plata, Argentina, B7600FYK
    • Centro de Investigaciones Medicas Mar Del Plata
  • Mendoza, Argentina, 05500
    • Fundacion Scherbovsky
  • Rosario, Argentina, S2000KPG
    • Instituto de Especialidades de la Salud Rosario
  • San Miguel de Tucumán, Argentina, T4000AXL
    • Centro de Investigaciones Medicas Tucuman
• Belgium
  • Brussels, Belgium, 01200
    • Cliniques Universitaires Ucl Saint-Luc
  • Brussels, Belgium, 01070
    • Ulb Hospital Erasme
  • Ghent, Belgium, 09000
    • Universitair Ziekenhuis Gent
  • Ghent, Belgium, 09000
    • AZ Sint-Lucas
  • Leuven, Belgium, 03000
    • Universitair Ziekenhuis (Uz) Leuven
  • Liège, Belgium, 04000
    • Centre Hospitalier Universitaire de Liege - Sart Tilman
  • Namur, Belgium, 05000
    • Chu Ucl Namur de Saint Elisabeth
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3E 0B2
      • Beacon Dermatology
  • Ontario
    • Barrie, Ontario, Canada, L4M 1G7
      • Simcomed Health Ltd
    • London, Ontario, Canada, N6H 5L4
      • DermEffects
    • Toronto, Ontario, Canada, M3H 5Y8
      • Research Toronto
  • Quebec
    • Québec, Quebec, Canada, G1W 4R4
      • Centre de Recherche Saint-Louis
• Chile
  • Las Condes, Chile, 7580206
    • Centro Medico SkinMed
  • Santiago, Chile, 8420383
    • Ciec - Centro Internacional de Estudios Cli-Nicos
  • Valdivia, Chile, 5090000
    • Clinical Research Chile SpA.
• France
  • Antony, France, 92160
    • Hospital Prive D'Antony
  • Brest, France, 29609
    • Hospital Morvan
  • Nantes, France, 44093
    • Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
  • Saint-Etienne, France, 42270
    • University Hospital of Saint Etienne
• Germany
  • Aachen, Germany, 52074
    • University Medical Center Rwth Aachen
  • Bad Bentheim, Germany, 48455
    • Fachklinik Bad Bentheim Dermatologie
  • Dresden, Germany, 01307
    • Universitaetsklinikum Carl Gustav Carus TU Dresden
  • Kiel, Germany, 24105
    • Universitatsklinikum Schleswig Holstein
  • Mainz, Germany, 55131
    • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
  • Tübingen, Germany, 72076
    • Universitats-Hautklink Tubingen
  • Witten, Germany, 58453
    • Hautarztpraxis Dr. Med. Matthias Hoffmann
• Italy
  • Brescia, Italy, 25123
    • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
  • Catania, Italy, 95123
    • Azienda Ospedaliero Universitaria Policlinico G.Rodolico San Marco
  • Coppito, Italy, 67100
    • Asl 1 Avezzano L'Aquila Sulmona- Ospedale Regionale San Salvatore
  • Napoli, Italy, 80131
    • Azienda Ospedaliera Universitaria Policlinico 'Federico II'
  • Roma, Italy, 00137
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Torrette, Italy, 60123
    • Ospedali Riuniti Di Ancona
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Amsterdam University Medical Centre
  • Bergen op Zoom, Netherlands, 4624 VT
    • Bravis ziekenhuis
• Poland
  • Krakow, Poland, 30-510
    • Pratia MCM Krakow
  • Lodz, Poland, 90-302
    • ETG Lodz
  • Rzeszów, Poland, 35-055
    • Kliniczny Szpital Wojewodzki Nr 1
  • Warsaw, Poland, 02-507
    • Centralny Szpital Kliniczny Mswia
  • Warsaw, Poland, 01-817
    • High-Med Przychodnia Specjalistycza
  • Warsaw, Poland, 01-142
    • Clinical Research Group Sp. Z.O.O
• Spain
  • Alicante, Spain, 03010
    • Hospital General Unviersitario de Alicante
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • Manises, Spain, 46940
    • Hospital de Manises
  • Pozuelo de Alarcón, Spain, 28223
    • Hospital Universitario Quirónsalud Madrid
  • Santiago de Compostela, Spain, 15706
    • Complejo Hospitalario Universitario de Santiago
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Medical Dermatology Specialists Phoenix
  • Arkansas
    • Fort Smith, Arkansas, United States, 72916
      • Johnson Dermatology
  • California
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Dermatology Associates Pc
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • Clarkston Medical Group
    • Troy, Michigan, United States, 48084
      • Revival Research Institute, Llc Troy
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • MediSearch Clinical Trials
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • UC Health, Llc
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • Central Sooner Research
  • Pennsylvania
    • Plymouth Meeting, Pennsylvania, United States, 19462
      • Dermatology Associates of Plymouth Meeting
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37130
      • International Clinical Research Tennessee Llc
  • Texas
    • Frisco, Texas, United States, 75034
      • North Texas Center For Clinical Research Ntccr
    • Pflugerville, Texas, United States, 78660
      • Austin Institute For Clinical Research Aicr Pflugerville
    • Webster, Texas, United States, 77598
      • Center for Clinical Studies
  • Washington
    • Spokane, Washington, United States, 99204
      • 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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
WI-NRS4 Response at Week 4	WI-NRS4 was defined as the percentage of participants achieving a ≥4-point improvement (reduction) in 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.	Baseline; Week 4
Percentage of Participants With Overall-Treatment Success at Week 12	Overall-Treatment Success was defined as both a WI-NRS4 response and Investigator's Global Assessment for Stage of Chronic Prurigo Treatment Success (IGA-CPG-S-TS). IGA-CPG-S-TS was defined as an IGA-CPG-S score of 0 or 1 with a ≥2 grade improvement from baseline. The IGA-CPG-S is an overall severity rating of chronic prurigo on a scale of 0 to 4: 0, clear (no pruriginous lesions); 1, almost clear (rare palpable pruriginous lesions [approximately 1-5 lesions]); 2, mild (few palpable pruriginous lesions [approximately 6-19 lesions]); 3, moderate (many palpable pruriginous lesions [approximately 20-100 lesions]); 4, severe (abundant palpable pruriginous lesions [over 100 lesions]).	Baseline; Week 12
Percentage of Participants With IGA-CPG-S-TS at Week 12	IGA-CPG-S-TS was defined as an IGA-CPG-S score of 0 or 1 with a ≥2 grade improvement from baseline. The IGA-CPG-S is an overall severity rating of chronic prurigo on a scale of 0 to 4: 0, clear (no lesions); 1, almost clear (rare palpable pruriginous lesions [approximately 1-5 lesions]); 2, mild (few palpable pruriginous lesions [approximately 6-19 lesions]); 3, moderate (many palpable pruriginous lesions [approximately 20-100 lesions]); 4, severe (abundant palpable pruriginous lesions [over 100 lesions]).	Baseline; Week 12
WI-NRS4 Response on Day 7	WI-NRS4 was defined as the percentage of participants achieving a ≥4-point improvement (reduction) in 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.	Baseline; Day 7
DBVC Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit	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.	Baseline; up to Week 12
OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit	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.	Baseline; up to Week 52
WI-NRS4 Response at Each Post-baseline Visit	WI-NRS4 was defined as the percentage of participants achieving a ≥4-point improvement (reduction) in 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.	Baseline; up to Week 52
Time to ≥2-point Improvement From Baseline in WI-NRS Score	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.	Baseline; up to Week 52
Time to ≥4-point Improvement From Baseline in WI-NRS Score	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.	Baseline; up to Week 52
DBVC Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline	Participants assessed their worst level of prurigo nodularis-related skin pain during the past 24 hours on a scale of 0 ("no pain") to 10 ("worse imaginable pain"). The Skin Pain NRS score for baseline was determined by averaging the 7 daily NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit Skin Pain NRS score for post-baseline visits was determined by averaging the 7 daily NRS scores before the visit day.	Baseline; up to Week 12
OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline	Participants assessed their worst level of prurigo nodularis-related skin pain during the past 24 hours on a scale of 0 ("no pain") to 10 ("worse imaginable pain"). The Skin Pain NRS score for baseline was determined by averaging the 7 daily NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit Skin Pain NRS score for post-baseline visits was determined by averaging the 7 daily NRS scores before the visit day.	Baseline; up to Week 52
DBVC Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit	Participants assessed their worst level of prurigo nodularis-related skin pain during the past 24 hours on a scale of 0 ("no pain") to 10 ("worse imaginable pain"). The Skin Pain NRS score for baseline was determined by averaging the 7 daily NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit Skin Pain NRS score for post-baseline visits was determined by averaging the 7 daily NRS scores before the visit day. Change from baseline was calculated as the post-baseline value minus the baseline value.	Baseline; up to Week 12
OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit	Participants assessed their worst level of prurigo nodularis-related skin pain during the past 24 hours on a scale of 0 ("no pain") to 10 ("worse imaginable pain"). The Skin Pain NRS score for baseline was determined by averaging the 7 daily NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit Skin Pain NRS score for post-baseline visits was determined by averaging the 7 daily NRS scores before the visit day. Change from baseline was calculated as the post-baseline value minus the baseline value.	Baseline; up to Week 52
Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit	IGA-CPG-S-TS was defined as an IGA-CPG-S score of 0 or 1 with a ≥2 grade improvement from baseline. The IGA-CPG-S is an overall severity rating of chronic prurigo nodularis on a scale of 0 to 4: 0, clear (no lesions); 1, almost clear (rare palpable pruriginous lesions [approximately 1-5 lesions]); 2, mild (few palpable pruriginous lesions [approximately 6-19 lesions]); 3, moderate (many palpable pruriginous lesions [approximately 20-100 lesions]); 4, severe (abundant palpable pruriginous lesions [over 100 lesions]). 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; up to Week 52
Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit	The Investigator Global Assessment for Activity of Chronic Prurigo (IGA-CPG-A) is an overall severity rating of chronic prurigo nodularis on a scale of 0 to 4: 0, clear (no pruriginous lesions have excoriations or crusts); 1, almost clear (very small proportion of pruriginous lesions have excoriations or crusts [up to approximately 10% of all pruriginous lesions]); 2, mild (minority of pruriginous lesions have excoriations or crusts [approximately 11%-25% of all pruriginous lesions]); 3, moderate (many pruriginous lesions have excoriations or crusts [approximately 26%-75% of all pruriginous lesions]); 4, severe (majority of pruriginous lesions have excoriations or crusts [approximately 76%-100% of all pruriginous lesions]).	Baseline; up to Week 52
DBVC Period: Percentage of Participants With >75% Healed Lesions From Prurigo Activity Score (PAS) at Each Postbaseline Visit	The extent and severity of prurigo nodularis was assessed via the PAS (version 1.2). The first 3 items are descriptive of the type, predominant type, distribution, and quantity of pruriginous lesions. The remaining 2 items of the PAS assess disease activity in terms of percentage (i.e., 0%, 1%-25%, 26%-50%, 51%-75%, and 76%-100%) of pruriginous lesions with excoriations/crusts on top (to reflect active scratching) and the percentage (i.e., 100%, 76%-99%, 51%-75%, 26%-50%, and 0%-25%) of healed pruriginous lesions in order to quantify change of prurigo nodularis skin lesions.	Baseline; up to Week 12
OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit	The extent and severity of prurigo nodularis was assessed via the PAS (version 1.2). The first 3 items are descriptive of the type, predominant type, distribution, and quantity of pruriginous lesions. The remaining 2 items of the PAS assess disease activity in terms of percentage (i.e., 0%, 1%-25%, 26%-50%, 51%-75%, and 76%-100%) of pruriginous lesions with excoriations/crusts on top (to reflect active scratching) and the percentage (i.e., 100%, 76%-99%, 51%-75%, 26%-50%, and 0%-25%) of healed pruriginous lesions in order to quantify change of prurigo nodularis skin lesions.	Baseline; up to Week 52
DBVC Period: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Each Post-baseline 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. Each question was scored as: 3 (very much), 2 (a lot), 1 (a little), 0 (not at all or not relevant). The DLQI total score was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more the quality of life was impaired. Total DLQI scores were categorized as follows: 0 to 1 (no effect), 2 to 5 (small effect), 6 to 10 (moderate effect), 11 to 20 (very large effect), and 21 to 30 (extremely large effect). Change from Baseline was calculated as the post-baseline visit minus the baseline visit.	Baseline; up to Week 12
OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline 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. Each question was scored as: 3 (very much), 2 (a lot), 1 (a little), 0 (not at all or not relevant). The DLQI total score was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more the quality of life was impaired. Total DLQI scores were categorized as follows: 0 to 1 (no effect), 2 to 5 (small effect), 6 to 10 (moderate effect), 11 to 20 (very large effect), and 21 to 30 (extremely large effect). Change from Baseline was calculated as the post-baseline visit minus the baseline visit.	Baseline; up to Week 52
DBVC Period: Change From Baseline in European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) Visual Analog Scale (VAS) Score at Each Postbaseline Visit	The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L consists of 2 sections: the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ VAS records the participant's self-rated health on a vertical VAS (0-100), on which the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). Change from Baseline was calculated as the post-baseline value minus the baseline value.	Baseline; up to Week 12
OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit	The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L consists of 2 sections: the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ VAS records the participant's self-rated health on a vertical VAS (0-100), on which the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). Change from Baseline was calculated as the post-baseline value minus the baseline value.	Baseline; up to Week 52
DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit	The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L consists of 2 sections: the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ VAS records the participant's self-rated health on a vertical VAS (0-100), on which the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). Change from Baseline was calculated as the post-baseline value minus the baseline value.	Baseline; up to Week 12
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit	The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L consists of 2 sections: the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ VAS records the participant's self-rated health on a vertical VAS (0-100), on which the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). Change from Baseline was calculated as the post-baseline value minus the baseline value.	Baseline; up to Week 52
DBVC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug.	up to Week 12
DBVC Period: Number of Participants With Any ≥Grade 3 TEAE	An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of TEAEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grades 1 through 5. The investigator made an assessment of intensity for each TEAE and assigned it to one of the following categories: Grade 1, mild; Grade 2, moderate; Grade 3, severe or medically significant but not immediately life threatening; Grade 4, life-threatening consequences; Grade 5, fatal.	up to Week 12
OLE Period: Number of Participants With Any TEAE	An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug.	from beginning of Week 13 up to Week 56
OLE Period: Number of Participants With Any ≥Grade 3 TEAE	An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of TEAEs was assessed using CTCAE version 5.0 Grades 1 through 5. The investigator made an assessment of intensity for each TEAE and assigned it to one of the following categories: Grade 1, mild; Grade 2, moderate; Grade 3, severe or medically significant but not immediately life threatening; Grade 4, life-threatening consequences; Grade 5, fatal.	from beginning of Week 13 up to Week 56

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 (Actual): October 7, 2024
• Study Completion (Actual): August 13, 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 (Estimated): November 14, 2025
• Last Update Submitted That Met QC Criteria: October 30, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Skin Diseases; Dermatitis; ruxolitinib; PN; Prurigo Nodularis; Prurigo; Eczematous; INCB 18424
• Additional Relevant MeSH Terms: Skin and Connective Tissue Diseases; Dermatitis; Skin Diseases; Prurigo
• Other Study ID Numbers: INCB 18424-319; 2022-501621-20-00 (Registry Identifier: EU CT Number)

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