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治験 NCT06516965（対象：結節性痒疹）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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インサイトA Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2) 第III相・フェーズ3 330
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06516965 は 結節性痒疹 に関する 治療 の研究で、第III相・フェーズ3 介入研究 臨床試験 です。現在は 募集中 で、2024年10月10日 から開始しています。330 名の参加者 の募集が計画されています。この試験は インサイト によって主導され、2027年5月3日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年3月16日 です。
概要
The purpose of this study is to evaluate effect of povorcitinib on itch and skin lesions in participants with prurigo nodularis.
公式タイトル
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis
疾患名
結節性痒疹その他の研究識別子
- INCB54707-306
- 2024-511881-35-00 (登録識別子) (EU CT Number)
NCT番号
開始日
2024-10-10
最終更新日
2026-03-16
終了予定日
2027-05-03
目標参加者数
330
試験の種類
介入研究
治験の相・段階
第III相・フェーズ3
状況
募集中
キーワード
Prurigo nodularis
PN
INCB054707
chronic pruritus
PN
INCB054707
chronic pruritus
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
四重盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Povorcitinib Dose 1 Povorcitinib at the protocol-defined dose. | Povorcitinib Oral Tablet |
実験的Povorcitinib Dose 2 Povorcitinib at the protocol-defined dose. | Povorcitinib Oral Tablet |
プラセボ対照薬Placebo Placebo at the protocol-defined dose. | プラセボ Oral Tablet |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at Week 24 | Defined as proportion of participants achieving a ≥ 4-point improvement \[reduction\] in Itch NRS score from baseline (Itch NRS4) and an IGA CPG-S score of 0 or 1 with a ≥ 2-grade improvement from baseline (IGA-CPG-S-TS). | Week 24 |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Proportion of participants achieving Itch NRS4 at Week 24 | Defined as percentage of participants that achieve a ≥ 4-point improvement (reduction) in Itch NRS score from baseline. | Week 24 |
Proportion of participants achieving IGA-CPG-S-TS at Week 24 | Defined as percentage of participants that achieve IGA-CPG-S score of 0 or 1 with a ≥ 2 grade improvement from baseline. | Week 24 |
Proportion of participants achieving Itch NRS4 at Week 4 | Defined as percentage of participants that achieve a ≥ 4-point improvement (reduction) in Itch NRS score from baseline. | Week 4 |
Time to Itch NRS4 | Defined as time taken for the participant to achieve a ≥4 improvement in Itch NRS score from baseline. | Up to 52 Weeks |
Change from baseline in Itch NRS score at each postbaseline visit | Itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable". | Up to 52 weeks |
Percent change from baseline in NRS score at each postbaseline visit | Itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable". | Up to 52 weeks |
Proportion of participants achieving Itch NRS4 at each postbaseline visit | Defined as percentage of participants that achieve a ≥ 4-point improvement in Itch NRS score from baseline. | Up to 52 weeks |
Proportion of participants achieving IGA-CPG-S-TS at each postbaseline visit | Defined as percentage of participants that achieve an IGA-CPG-S score of 0 or 1 with a ≥ 2 grade improvement from baseline. | Up to 52 weeks |
Proportion of participants achieving Investigator's Global Assessment - Chronic Prurigo Activity (IGA-CPG-A) at each postbaseline visit | Defined as percentage of participants that achieve an IGA-CPG-A score of 0 or 1 with a ≥ 2 grade improvement (reduction) from baseline. | Up to 52 weeks |
Proportion of participants achieving ≥ 75% healed lesions in Prurigo Activity Score (PAS) at each postbaseline visit | The modified PAS will be used in this study as defined by the protocol. | Up to 52 weeks |
Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at each postbaseline visit | Defined as percentage of participants that achieve a ≥ 4-point improvement (reduction) in Itch NRS score and IGA-CPG-S score of 0 or 1 with a ≥ 2-grade improvement from baseline. | Up to 52 weeks |
Change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit. | The DLQI is a simple, 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. | Up to 52 weeks |
Percent change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit. | The DLQI is a simple, 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. | Up to 52 weeks |
Proportion of participants with at least a 4-point decrease in DLQI score from baseline at each postbaseline visit for participants with DLQI score ≥ 4 at baseline | Defined as percentage of participants with at least a 4-point decrease in DLQI score from baseline at each postbaseline visit for participants with DLQI score ≥ 4 at baseline. | Up to 52 weeks |
Change from baseline in Skin Pain NRS score at each postbaseline visit | Skin Pain NRS is an 11-point scale (0 to10) where 0 is "no pain" and 10 is the "worst pain imaginable". | Up to 52 weeks |
Percent change from baseline in Skin Pain NRS score at each postbaseline visit | Skin Pain NRS is an 11-point scale (0 to10) where 0 is "no pain" and 10 is the "worst pain imaginable". | Up to 52 weeks |
Change from baseline in the Hospital Anxiety and Depression Scale (HADS) score at each postbasline visit | HADS is a 14-item questionnaire that assesses the levels of anxiety and depression that a participant is currently experiencing. There are 7 questions each for measuring anxiety and for measuring depression, with 4 possible responses to each question (responses are scored as 0, 1, 2, or 3). | Up to 52 weeks |
Percent change from baseline in the HADS score at each postbaseline visit | HADS is a 14-item questionnaire that assesses the levels of anxiety and depression that a participant is currently experiencing. There are 7 questions each for measuring anxiety and for measuring depression, with 4 possible responses to each question (responses are scored as 0, 1, 2, or 3). | Up to 52 weeks |
Change from baseline in EQ-5D-5L score at each postbaseline visit | The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome. | Up to 52 weeks |
Percent change from baseline in EQ-5D-5L score at each postbaseline visit | The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome. | Up to 52 weeks |
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score at each postbaseline visit | The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days. | Up to 52 weeks |
Percent change in FACIT-F score at each postbaseline visit | The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days. | Up to 52 weeks |
Proportion of participants with at least a ≥ 4-point increase in FACIT-F score at each postbaseline visit for participants with FACIT-F score ≤ 48 at baseline | The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days. | Up to 52 weeks |
Number of Participants with Treatment Emergent Adverse Events (TEAE) | Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. | Up to 52 weeks |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- Male and female participants 18 to 75 years of age.
- Clinical diagnosis of PN for at least 3 months prior to Screening visit.
- Pruritus, defined as an average Itch NRS score ≥ 7 during the 7 days prior to Day 1/Baseline.
- Total of ≥ 20 pruriginous lesions on ≥ 2 different body regions (both legs, and/or both arms, and/or trunk) at Screening and Day 1/Baseline.
- Documented history of treatment failure, demonstrated intolerance, or contraindication to a previous PN treatment.
- Willingness to avoid pregnancy or fathering children.
- Chronic pruritus due to a condition other than PN or neuropathic and psychogenic pruritus.
- Diagnosis of PN secondary to medications.
- Active AD lesions (signs and symptoms other than dry skin) within 3 months prior to Screening visit.
- Women who are pregnant (or are considering pregnancy) or breastfeeding.
- Medical history including thrombocytopenia, coagulopathy or platelet dysfunction; venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure, cerebrovascular accident, myocardial infarction, or other significant cardiovascular diseases; Q-wave interval abnormalities; disseminated herpes zoster or dermatomal herpes zoster; disseminated herpes simplex; chronic/recurrent infections; malignancies.
- Evidence of infection with TB, HBV, HCV or HIV.
- History of failure to any topical or systemic JAK or TYK2 inhibitor as treatment of PN or any inflammatory disease.
- Laboratory values outside of the protocol-defined ranges.
Other protocol-defined Inclusion/Exclusion Criteria apply.
インサイト149 件のアクティブな治験を探索試験中央連絡先
連絡先: Incyte Corporation Call Center (US), 1.855.463.3463, [email protected]
連絡先: Incyte Corporation Call Center (ex-US), +800 00027423, [email protected]
121 11カ国の場所
Tokyo Medical and Dental University Hospital, Faculty of Medicine, Bunkyō City, 113-8519, Japan
募集中
Tokyo Medical University Ibaraki Medical Center - Kasumigaura Campus (Tokyo Medical University Kasum, Inashiki-gun, Japan
募集中
Noguchi Dermatology Clinic, Kamimashiki-gun, 861-3101, Japan
募集中
Nippon Medical School Musashikosugi Hospital, Kawasaki-shi, 211-8533, Japan
募集中
University of Occupational and Environmental Health, Japan, Kitakyushu, 807-8555, Japan
募集中
Shimizu Dermatology Clinic, Kobe, 657-0846, Japan
募集中
Aoi Dermatology Clinic, Kumamoto, 861-2236, Japan
募集中
Dokkyo Medical University Saitama Medical Center, Minamikoshigaya, 343-8555, Japan
募集中
Central Japan International Medical Center, Minokamo, 505-8510, Japan
募集中
Niigata University Medical & Dental Hospital, Niigata, 951-8520, Japan
募集中
Medical Corporation Jun Dermatology Clinic, Osaka, 558-0003, Japan
募集中
Tanpopo Dermatology Clinic, Ōta-ku, 143-0023, Japan
募集中
Kume Derma Clinic, Sakai, 593-8324, Japan
募集中
Sapporo Skin Clinic, Sapporo, 600063, Japan
募集中
Tohoku University Hospital, Sendai, 980-8574, Japan
募集中
Tokyo Medical University Hospital, Shinjuku-ku, 160-0023, Japan
募集中
National Defence Medical College Hospital, Tokorozawa-shi, 359-8513, Japan
募集中
Queen'S Square Medical Facilities, Yokohama, 220-6208, Japan
募集中
Nomura Dermatology Clinic, Yokohama, 221-0825, Japan
募集中
Arizona
Medical Dermatology Specialists Phoenix, Phoenix, Arizona, 85006, United States
募集中
Investigate Md, Scottsdale, Arizona, 85255, United States
完了
California
First Oc Dermatology Research Inc, Fountain Valley, California, 92708-3701, United States
募集中
Clinical Science Institute Clinical Research Specialists Inc, Santa Monica, California, 90404, United States
募集中
Florida
Center For Clinical and Cosmetic Research, Aventura, Florida, 33180, United States
完了
Schweiger Dermatology, Boca Raton, Florida, 33428, United States
募集中
Direct Helpers Research Center, Hialeah, Florida, 33012, United States
募集中
Skin Care Research, Llc, Hollywood, Florida, 33201, United States
募集中
Ziaderm Research, Llc, Miami, Florida, 33162, United States
募集中
Nodal Medical Center, Llc, Tampa, Florida, 33607, United States
募集中
Trueblue Clinical Research Moore Clinical Research, Inc McR Tampa Clinic Location, Tampa, Florida, 33609, United States
完了
Kentucky
Dermatology Specialists Research, Louisville, Kentucky, 40241, United States
完了
Maryland
University of Maryland School of Medicine, Baltimore, Maryland, 21201, United States
募集中
Dermatology Associates Pc, Rockville, Maryland, 20850, United States
完了
Massachusetts
Metro Boston Clinical Partners, Brighton, Massachusetts, 02135-3511, United States
完了
Michigan
Fivenson Dermatology, Ann Arbor, Michigan, 48103, United States
募集中
Henry Ford Health System, Detroit, Michigan, 48202, United States
募集中
Michigan Dermatology Institute, Waterford, Michigan, 48328, United States
募集中
New Hampshire
Allcutis Research, Llc, Portsmouth, New Hampshire, 03801, United States
完了
New Jersey
Schweiger Dermatology, Hackensack, New Jersey, 07601, United States
完了
New York
OPTISKIN, New York, New York, 10128, United States
募集中
Ohio
University of Cincinnati Cancer Institute, Cincinnati, Ohio, 45267, United States
募集中
Oklahoma
Central Sooner Research, Oklahoma City, Oklahoma, 73118, United States
募集中
Pennsylvania
Paddington Testing Co Inc, Philadelphia, Pennsylvania, 19103, United States
募集中
Yardley Dermatology Associates, Yardley, Pennsylvania, 19067, United States
完了
Texas
Modern Research Associates Pllc, Dallas, Texas, 75231, United States
完了
Utah
University of Utah Midvalley Dermatology, Murray, Utah, 84107, United States
完了
Washington
Aesthetic General Dermatology of Seattle, Burien, Washington, 98168, United States
募集中
New South Wales
Novatrials, Charlestown, New South Wales, 02290, Australia
募集中
Premier Specialists Pty Ltd, Kogarah, New South Wales, 02217, Australia
募集中
Skin & Cancer Foundation Australia, Sydney, New South Wales, 02010, Australia
募集中
Westmead Hospital, Westmead, New South Wales, 02145, Australia
募集中
Queensland
Veracity Clinical Research Pty Ltd, Woolloongabba, Queensland, 04102, Australia
募集中
Victoria
The Alfred Hospital, Melbourne, Victoria, 03004, Australia
募集中
Fremantle Dermatology, Fremantle, 06160, Australia
募集中
Az Sint-Jan Brugge Av, Bruges, 08000, Belgium
募集中
Universitair Ziekenhuis Gent (Uz Gent), Ghent, 09000, Belgium
募集中
Grand Hopital de Charleroi - Site Imtr, Gilly, 06060, Belgium
募集中
Centre Hospitalier Universitaire (Chu) de Liege - Domaine Universitaire Du Sart Tilman, Liège, 04000, Belgium
募集中
Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc, Woluwe-Saint-Lambert, 01200, Belgium
募集中
Alberta
Skin Physicians, Edmonton, Alberta, T6W 4V4, Canada
募集中
Alpha Research-Lucere Dermatology and Laser Clinic, Edmonton, Alberta, T6X 0N9, Canada
完了
Ontario
Simcoderm Medical and Surgical Dermatology Centre, Barrie, Ontario, L4M 7G1, Canada
募集中
Dermeffects, London, Ontario, N6H 5L5, Canada
募集中
North York Research Inc., Toronto, Ontario, M2N 3A6, Canada
募集中
Toronto Research Centre, Toronto, Ontario, M3H 5Y8, Canada
完了
Quebec
Centre de Recherche Saint-Louis, Québec, Quebec, G1W 4R4, Canada
募集中
Saskatchewan
Skinsense Medical Research, Saskatoon, Saskatchewan, S7K 2C1, Canada
募集中
Centro Medico Skinmed Limitada, Santiago, 7580206, Chile
募集中
Centro Internacional de Estudios Clinicos, Santiago, 8420383, Chile
募集中
Clinical Research Chile Spa., Valdivia, 5090000, Chile
募集中
Clintrial S.R.O., Prague, 100 00, Czechia
募集中
Sanatorium Profesora Arenbergera, Prague, 110 00, Czechia
募集中
Sanixtra Prague, Prague, 158 00, Czechia
募集中
University Hospital Rwth Aachen, Aachen, 52074, Germany
募集中
Elbe Kliniken Buxtehude, Buxtehude, 21614, Germany
募集中
Drk Krankenhaus Chemnitz-Rabenstein, Chemnitz, 09117, Germany
募集中
Klinikum Darmstadt, Darmstadt, 64283, Germany
募集中
Rosenpark Research Gmbh, Darmstadt, 64283, Germany
募集中
University Hospital Carl Gustav Carus, Dresden, 01307, Germany
募集中
Klinikum Der Johann Wolfgang Goethe-Universitaet, Frankfurt am Main, 60590, Germany
募集中
Universitaetsmedizin Goettingen, Göttingen, 37075, Germany
募集中
Magdeburger Company For Medical Studies and Services Gmbh, Magdeburg, 39104, Germany
募集中
Dermatologische Gemeinschaftspraxis Dres. Quist, Mainz, 55128, Germany
募集中
Technischen Universitaet Muenchen, München, 80802, Germany
募集中
University Hospital Muenster, Münster, 48149, Germany
募集中
Klinikum Oldenburg Aor, Oldenburg, 26133, Germany
募集中
Hautarztpraxis Dr. Hoffmann, Witten, 58453, Germany
募集中
Akk Medical Sp. Z O.O. - Centrum Medyczne Tu Sie Leczy, Gdansk, 80-280, Poland
募集中
Care Clinic Sp. Z O.O., Katowice, 40-568, Poland
募集中
Santa Familia Ptg Lodz, Lodz, 90-302, Poland
募集中
Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak, Lodz, 90-436, Poland
募集中
Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Dr. Hab. N. Med. Dorota Krasowska, Lublin, 20-573, Poland
募集中
Dermedic Jacek Zdybski, Ostrowiec Świętokrzyski, 27-400, Poland
募集準備中
Clinical Research Center Spolka Z Ograniczona Odpowiedzialnoscia Medic-R Spolka Komandytowa, Poznan, 61-731, Poland
募集中
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie, Rzeszów, 35-055, Poland
募集中
Alergo-Med Osrodek Badan Klinicznych Sp. Z O.O., Tarnów, 33-100, Poland
撤回
Mics Centrum Medyczne Torun, Torun, 87-100, Poland
募集中
High-Med. Przychodnia Specjalistyczna, Warsaw, 01-817, Poland
募集中
Panstwowy Instytut Medyczny Mswia, Warsaw, 02-507, Poland
募集中
Royalderm Agnieszka Nawrocka, Warsaw, 02-692, Poland
募集中
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska, Wroclaw, 50566, Poland
募集中
Hospital General Universitario Dr Balmis, Alicante, 03010, Spain
募集中
Hospital Universitari Germans Trias I Pujol (Hugtp), Badalona, 08916, Spain
募集中
Hospital de La Santa Creu I Sant Pau, Barcelona, 08041, Spain
完了
Hospital Universitario Reina Sofia, Córdoba, 14004, Spain
募集中
Hospital Clinico Universitario San Cecilio, Granada, 18016, Spain
募集中
Hospital Universitario Ramon Y Cajal, Madrid, 28034, Spain
募集中
Hospital Universitario 12 de Octubre, Madrid, 28041, Spain
募集中
Hospital Universitario La Paz, Madrid, 28046, Spain
募集中
Hospital Universitario Puerta de Hierro de Majadahonda, Majadahonda, 28222, Spain
完了
Hospital de Manises, Manises, 46940, Spain
募集中
Area Sanitaria de Santiago de Compostela Y Barbanza - Complejo Hospitalario Universitario de Santiag, Santiago de Compostela, 15706, Spain
募集中
Hospital Universitario Virgen Del Rocio, Seville, 41013, Spain
募集中
Universitat de Valencia - Hospital Universitari I Politecnic La Fe de Valencia (Hospital La Fe Bulev, Valencia, 46026, Spain
募集中
The Dudley Group Nhs Foundation Trust, Dudley, DY1 2HQ, United Kingdom
募集中
Ipswich Hospital, East Suffolk and North Essex Nhs Foundation Trust, Ipswich, IP4 5PD, United Kingdom
募集中
Broadgreen Hospital - Liverpool University Hospitals Nhs Foundation Trust, Liverpool, L14 3LB, United Kingdom
募集中
The Royal London Hospital - Barts Health Nhs Trust, London, E1 1FR, United Kingdom
募集中
Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust, London, SE1 9RT, United Kingdom
募集中
Poole Hospital - University Hospitals Dorset Nhs Foundation Trust, Poole, BH15 2JB, United Kingdom
募集中
Surrey and Sussex Healthcare Nhs Trust - East Surrey Hospital, Redhill, United Kingdom
募集中