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Un estudio para evaluar la eficacia y seguridad de la crema de ruxolitinib en participantes con prurigo nodularis (PN) (TRuE-PN2)

15 de octubre de 2026 actualizado por: Incyte Corporation

Un estudio de fase 3, doble ciego, aleatorizado, controlado con vehículo, de eficacia y seguridad de la crema de ruxolitinib en participantes con prurigo nodularis

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

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

190

Fase

  • Fase 3

Acceso ampliado

Aprobado en venta al público. Ver registro de acceso ampliado.

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Bielefeld, Alemania, 33647
        • Klinikum Bielefeld Rosenhohe Dermatologie
      • Frankfurt am Main, Alemania, 60590
        • Universitatsklinikum Frankfurt
      • Göttingen, Alemania, 37075
        • Universitatsmedizin Goettingen
      • Mahlow, Alemania, 15831
        • Dermatologische Gemeinschaftspraxis Mahlow
      • Münster, Alemania, 48149
        • Universitatsklinikum Munster
  • Australia
      • Phillip, Australia, 02606
        • Paratus Clinical Research, Woden
    • New South Wales
      • Kogarah, New South Wales, Australia, 02217
        • Premier Specialists Pty Ltd
      • Liverpool, New South Wales, Australia, 02170
        • Liverpool Hospital
      • Sydney, New South Wales, Australia, 02010
        • Holdsworth House Medical Practice
      • Sydney, New South Wales, Australia, 02145
        • Westmead Hospital
    • Queensland
      • Woolloongabba, Queensland, Australia, 04102
        • Veracity Clinical Research
    • Victoria
      • Melbourne, Victoria, Australia, 03004
        • The Alfred Hospital
  • Austria
      • Graz, Austria, 08036
        • Landeskrankenhaus Universitatsklinikum Graz
      • Linz, Austria, 04020
        • Ordensklinikum Linz Gmbh Elisabethinen
      • Vienna, Austria, 01220
        • Sozialmedizinisches Zentrum Ost-Donauspital
  • Bulgaria
      • Pleven, Bulgaria, 05800
        • Medical Center Medconsult Pleven Ood
      • Rousse, Bulgaria, 07000
        • Medical Center- Prolet Ltd
      • Sevlievo, Bulgaria, 05400
        • Medical Center Unimed Eood
      • Sofia, Bulgaria, 01431
        • Dcc 'Alexandrovska', Eood
      • Sofia, Bulgaria, 01510
        • Medical Center Hera Eood
      • Stara Zagora, Bulgaria, 06000
        • Umhat Prof. Dr. Stoyan Kirkovich Ad
  • Canadá
    • Ontario
      • Etobicoke, Ontario, Canadá, M8X 1Y9
        • Kingsway Clinical Research
      • Markham, Ontario, Canadá, L3P 1X3
        • Lynderm Research Inc
      • North YORK, Ontario, Canadá, M2M 4J5
        • North York Research Inc.
      • Peterborough, Ontario, Canadá, K9J 5K2
        • Skin Centre For Dermatology
    • Quebec
      • Québec, Quebec, Canadá, G1V 4T3
        • Diex Recherche Quebec Inc.
  • Corea del Sur
      • Seoul, Corea del Sur, 03080
        • Seoul National University Hospital
      • Seoul, Corea del Sur, 05505
        • Asan Medical Center
      • Seoul, Corea del Sur, 02841
        • Korea University Anam Hospital
      • Seoul, Corea del Sur, 08308
        • Korea University Guro Hospital
      • Seoul, Corea del Sur, 06591
        • The Catholic University of Korea Seoul St. Mary'S Hospital
      • Suwon, Corea del Sur, 16499
        • Ajou University Hospital
  • Dinamarca
      • Hellerup, Dinamarca, 02900
        • Herlev Og Gentofte Hospital
      • Roskilde, Dinamarca, 04000
        • Sjaellands Universitetshospital
  • España
      • Badalona, España, 08916
        • Ceim Hospital Universitari Germans Trias I Pujol
      • Las Palmas de Gran Canaria, España, 35010
        • Hospital Universitario de Gran Canaria Doctor Negrin
      • Madrid, España, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, España, 28034
        • Hospital Universitario Ramon Y Cajal
      • Santiago de Compostela, España, 15002
        • Clinica Gaias Santiago
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35233
        • University of Alabama At Birmingham
    • Arkansas
      • Arkansas City, Arkansas, Estados Unidos, 72758
        • Northwest Arkansas Clinical Trials Center
    • California
      • Los Angeles, California, Estados Unidos, 90045
        • Dermatology Research Associates
      • Santa Monica, California, Estados Unidos, 90404
        • Clinical Science Institute Clinical Research Specialists Inc
      • Sherman Oaks, California, Estados Unidos, 91403
        • Cura Clinical Research
    • Florida
      • Orlando, Florida, Estados Unidos, 32819
        • Ars - Maitland Clinical Research Unit
    • Georgia
      • Marietta, Georgia, Estados Unidos, 30060-1047
        • Marietta Dermatology the Skin Cancer Center Marietta
    • Indiana
      • South Bend, Indiana, Estados Unidos, 46617
        • The South Bend Clinic Main Campus
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21237
        • Axon Clinical Research
    • Massachusetts
      • Beverly, Massachusetts, Estados Unidos, 01915
        • Activmed Practices Research, Llc Beverly
    • Ohio
      • Athens, Ohio, Estados Unidos, 45701
        • Oakview Dermatology
      • Dublin, Ohio, Estados Unidos, 43016
        • Aventiv Research Inc-Dublin
      • Fairborn, Ohio, Estados Unidos, 45324
        • Wright State Physicians, Inc.
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15232
        • University of Pittsburgh Medical Center Upmc Dermatology Clinic Oakland Falk Medical Building
      • Sugarloaf, Pennsylvania, Estados Unidos, 18249
        • Dermdox Center For Dermatology
    • Texas
      • Austin, Texas, Estados Unidos, 78759
        • Dermresearch, Inc.
  • Francia
      • Bordeaux, Francia, 33000
        • Bordeaux Chu Hopital Saint - Andre
      • Dijon, Francia, 21000
        • Chu Dijon-Bourgogne
      • Lyon, Francia, 69003
        • Hopital Edouard Herrio
      • Nice, Francia, 06200
        • Chu de Nice - Hospital L Archet
      • Poitiers, Francia, 86021
        • Centre Hospitalier Universitaire de Poitiers
      • Salouël, Francia, 80480
        • Chu Amiens - Hopital Sud
  • Italia
      • Milan, Italia, 20122
        • Fondazione Irccs Ca Granda Ospedale Maggiore
      • Naples, Italia, 80131
        • Universita Degli Studi Della Campania Luigi Vanvitelli
      • Perugia, Italia, 06132
        • Azienda Ospedaliera Di Perugia - Ospedale Santa Maria Della Misericordia
      • Pisa, Italia, 56126
        • Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara
      • Rome, Italia, 00133
        • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
  • Polonia
      • Krakow, Polonia, 31-559
        • Diamond Clinic Specjalistyczne Poradnie Lekarskie
      • Lodz, Polonia, 90-436
        • Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak
      • Lublin, Polonia, 20-362
        • Luxderm Specjalistyczny Gabinet Dermatologiczny
      • Malbork, Polonia, 82-200
        • Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.
      • Poznan, Polonia, 60-529
        • Solumed Centrum Medyczne
      • Wroclaw, Polonia, 50-414
        • Dermaceum Centrum Badan Klinicznych
      • Wroclaw, Polonia, 51-318
        • Dermmedica Sp. Z O.O.
  • Suiza
      • Buochs, Suiza, 06374
        • Dermatology & Skin Care Clinic
      • Lausanne, Suiza, 01011
        • Centre Hospitalier Universitaire Vaudois (Chuv)
      • Zurich-flughafen, Suiza, 08058
        • Universitatsspital Zurich

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 99 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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 enter the open label extension (OLE) period for up to 40 weeks.
Droga: Ruxolitinib Cream

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

Otros nombres:
  • INCB018424 crema de fosfato
  • Opzelura
Comparador de placebos: Vehicle Cream

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.
Droga: Vehicle Cream

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
WI-NRS4 Response at Week 12
Periodo de tiempo: Baseline; 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). 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
WI-NRS4 Response at Week 4
Periodo de tiempo: Baseline; 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). 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
Periodo de tiempo: Baseline; 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
Periodo de tiempo: Baseline; 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 at Day 7
Periodo de tiempo: Baseline; 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). 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
WI-NRS4 Response at Each Post-baseline Visit
Periodo de tiempo: Baseline; up to Week 52

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). 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: Change From Baseline in WI-NRS Score at Each Post-baseline Visit
Periodo de tiempo: Baseline; up to Week 12

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). 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
Periodo de tiempo: Baseline; up to Week 52

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). 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
Periodo de tiempo: Baseline; up to Week 12

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). 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
Time to ≥4-point Improvement From Baseline in WI-NRS Score
Periodo de tiempo: Baseline; up to Week 12

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). 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
DBVC Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline
Periodo de tiempo: Baseline; up to Week 12

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). 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
Periodo de tiempo: Baseline; up to Week 52

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). 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
Periodo de tiempo: Baseline; up to Week 12

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). 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
Periodo de tiempo: Baseline; up to Week 52

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). 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
Periodo de tiempo: Baseline; up to Week 52

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]).
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
Periodo de tiempo: Baseline; up to Week 52

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
Periodo de tiempo: Baseline; up to Week 12

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
Periodo de tiempo: Baseline; up to Week 52

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
Periodo de tiempo: Baseline; up to Week 12

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
Periodo de tiempo: Baseline; up to Week 52

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
Periodo de tiempo: Baseline; up to Week 12

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
Periodo de tiempo: Baseline; up to Week 52

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
Periodo de tiempo: Baseline; up to Week 12

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
Periodo de tiempo: Baseline; up to Week 52

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)
Periodo de tiempo: up to Week 12

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
Periodo de tiempo: up to Week 12

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
Periodo de tiempo: from beginning of Week 13 up to Week 56

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
Periodo de tiempo: from beginning of Week 13 up to Week 56

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Incyte Corporation

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

12 de junio de 2023

Finalización primaria (Actual)

30 de diciembre de 2024

Finalización del estudio (Actual)

4 de noviembre de 2025

Fechas de registro del estudio

Enviado por primera vez

1 de marzo de 2023

Primero enviado que cumplió con los criterios de control de calidad

1 de marzo de 2023

Publicado por primera vez (Actual)

10 de marzo de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

15 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • INCB18424-320
  • 2022-502461-23-00 (Identificador de registro: EU CT Number)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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

Marco de tiempo para compartir IPD

Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.

Criterios de acceso compartido de IPD

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.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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