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結節性痒疹（PN）の参加者におけるルキソリチニブクリームの有効性と安全性を評価する研究 (TRuE-PN2)

2026年10月15日 更新者：Incyte Corporation

結節性痒疹の参加者におけるルキソリチニブクリームの第3相、二重盲検、無作為化、溶媒制御、有効性および安全性研究

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

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

190

段階

  • フェーズ 3

アクセスの拡大

承認済み 一般販売用。 拡張アクセス記録をご覧ください。

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～99年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：Ruxolitinib Cream

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

他の名前：
  • INCB018424 リン酸クリーム
  • オプゼルラ
プラセボコンパレーター：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.
薬：Vehicle Cream

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

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
WI-NRS4 Response at Week 12
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
WI-NRS4 Response at Week 4
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Incyte Corporation

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2023年6月12日

一次修了 (実際)

2024年12月30日

研究の完了 (実際)

2025年11月4日

試験登録日

最初に提出

2023年3月1日

QC基準を満たした最初の提出物

2023年3月1日

最初の投稿 (実際)

2023年3月10日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月6日

QC基準を満たした最後の更新が送信されました

2026年10月15日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • INCB18424-320
  • 2022-502461-23-00 (レジストリ識別子：EU CT Number)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

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

IPD 共有アクセス基準

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 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

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