此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

一项评估 Ruxolitinib 乳膏在结节性痒疹 (PN) 参与者中的疗效和安全性的研究 (TRuE-PN2)

2026年10月15日 更新者：Incyte Corporation

Ruxolitinib 乳膏在结节性痒疹参与者中的第 3 期、双盲、随机、车辆对照、疗效和安全性研究

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

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

190

阶段

  • 第三阶段

扩展访问

得到正式认可的 出售给公众。 查看扩展访问记录。

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 99年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
药品：Ruxolitinib Cream

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

其他名称：
  • INCB018424 磷酸盐霜
  • 奥普泽鲁拉
安慰剂比较：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.
药品：Vehicle Cream

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

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
WI-NRS4 Response at Week 12
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
WI-NRS4 Response at Week 4
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Incyte Corporation

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年6月12日

初级完成 (实际的)

2024年12月30日

研究完成 (实际的)

2025年11月4日

研究注册日期

首次提交

2023年3月1日

首先提交符合 QC 标准的

2023年3月1日

首次发布 (实际的)

2023年3月10日

研究记录更新

最后更新发布 (实际的)

2026年11月6日

上次提交的符合 QC 标准的更新

2026年10月15日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • INCB18424-320
  • 2022-502461-23-00 (注册表标识符：EU CT Number)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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 共享时间框架

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

IPD 共享访问标准

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 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅