A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease (DUET ENCORE-CD)
2026年8月27日 更新者：Janssen Research & Development, LLC
A Phase 3, Randomized, Double-blind, and Active-controlled Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active Crohn's disease (a long-term, progressive [worsens with time] and life-threatening disease of the intestine).
調査の概要
研究の種類
介入
入学 (推定)
460
段階
- フェーズ 3
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。
研究連絡先
- 名前：Study Contact
- 電話番号：844-434-4210
- メール：Participate-In-This-Study1@its.jnj.com
研究場所
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California
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Anaheim、California、アメリカ、92805
- 募集
- Clinnova Research
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Chula Vista、California、アメリカ、91910
- 募集
- Gastro SB Clinic
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Los Alamitos、California、アメリカ、90720
- 募集
- United Medical Doctors
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San Diego、California、アメリカ、92123
- 募集
- Medical Associates Research Group, Inc.
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Colorado
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Colorado Springs、Colorado、アメリカ、80907
- 募集
- Peak Gastroenterology Associates
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Florida
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Lakewood Rch、Florida、アメリカ、34211
- 募集
- Florida Research Center Inc.
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Miami、Florida、アメリカ、33157-6575
- 募集
- Sanchez Clinical Research, Inc
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Tampa、Florida、アメリカ、33609
- 募集
- GCP Clinical Research
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Georgia
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Suwanee、Georgia、アメリカ、30024
- 募集
- Atlanta Gastroenterology Specialists
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Kentucky
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Crestview Hills、Kentucky、アメリカ、41017
- 募集
- Tri-State Gastroenterology Assoc
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Louisiana
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Lafayette、Louisiana、アメリカ、70503
- 募集
- Gastroenterology Clinic of Acadiana
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Michigan
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Farmington Hills、Michigan、アメリカ、48334
- 募集
- Michigan Center of Medical Research
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New York
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New York、New York、アメリカ、10075
- 募集
- New York Gastroenterology Associates
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North Carolina
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Chapel Hill、North Carolina、アメリカ、27599
- 募集
- University of North Carolina Hospital
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Ohio
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Mentor、Ohio、アメリカ、44060
- 募集
- Great Lakes Gastroenterology Research, LLC
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ、73114
- 募集
- Digestive Disease Specialists Inc
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Oregon
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Portland、Oregon、アメリカ、97220
- 募集
- The Oregon Clinic
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Tennessee
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Cordova、Tennessee、アメリカ、38018
- 募集
- Gastro One
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Texas
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Tyler、Texas、アメリカ、75701
- 募集
- Tyler Research Institute, LLC
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Washington
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Tacoma、Washington、アメリカ、98405
- 募集
- GI Alliance Tacoma
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AAI、アルゼンチン、C1425BGC
- 募集
- GEDYT
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La Plata、アルゼンチン、1896
- 募集
- Globalpsy
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Mendoza、アルゼンチン、M5500DPS
- 募集
- HIGEA
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Quilmes、アルゼンチン、B1878DVB
- 募集
- Cer Instituto Medico
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-
-
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Ashdod、イスラエル、7747629
- 募集
- Assuta Medical Center
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Haifa、イスラエル、3109601
- 募集
- Rambam Medical Center
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Haifa、イスラエル、31048
- 募集
- Bnai Zion Medical Center
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Holon、イスラエル、5822012
- 募集
- Wolfson Medical Center
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Jerusalem、イスラエル、9103102
- 募集
- Shaare Zedek Medical Center
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Kfar Saba、イスラエル、44281
- 募集
- Meir Medical Center
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Nahariya、イスラエル、2210001
- 募集
- Galilee Medical Center
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Petah Tikva、イスラエル、4941492
- 募集
- Rabin Medical Center
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Ramat Gan、イスラエル、52621
- 募集
- Sheba Medical Center
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Tel Aviv、イスラエル、64239
- 募集
- Tel Aviv Sourasky Medical Center
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-
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Hubballi、インド、580021
- 募集
- Sushruta Multispecialty Hospital and Research Centre
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Hyderabad、インド、500032
- 募集
- Asian Institute of Gastroenterology
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Jaipur、インド、302006
- 募集
- S. R. Kalla Memorial General Hospital
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Kochi、インド、682018
- 募集
- Lisie Hospital
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Secunderabad、インド、500003
- 募集
- Yashoda Super Speciality Hospitals
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Surat、インド、395002
- 募集
- SIDS (Surat Institute of Digestive Sciences) Hospital and Research Centre
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Surat、インド、395009
- 募集
- Gujarat Gastro and Vascular Hospital
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Nijmegen、オランダ、6525 GA
- 募集
- Radboud Umcn
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Adelaide、オーストラリア、5000
- 募集
- Banksia Trials SA
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Camperdown、オーストラリア、2050
- 募集
- Royal Prince Alfred Hospital
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Clayton、オーストラリア、3168
- 募集
- Monash Medical Centre
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East Melbourne、オーストラリア、3002
- 募集
- The Melbourne Gut Clinic Epworth Hospital
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Kurralta Park、オーストラリア、5037
- 募集
- IBD SA
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New Lambton Heights、オーストラリア、2305
- 募集
- John Hunter Hospital
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South Brisbane、オーストラリア、4101
- 募集
- Mater Misericordiae Hospital
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Alberta
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Edmonton、Alberta、カナダ、T5R 1W2
- 募集
- Gastroenterology and Internal Medicine Research Institute (GIRI)
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Edmonton、Alberta、カナダ、Code: T6K 4B2
- 募集
- South Edmonton Gastroenterology Research Clinic
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British Columbia
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Vancouver、British Columbia、カナダ、V6Z 2K5
- 募集
- GI Research Institute (G.I.R.I.)
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Nova Scotia
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Kentville、Nova Scotia、カナダ、B4N 0A3
- 募集
- Viable Clinical Research
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Ontario
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London、Ontario、カナダ、N6K 1M6
- 募集
- London Digestive Disease Institute
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Mississauga、Ontario、カナダ、L5M 2S4
- 募集
- West GTA Research Inc
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Toronto、Ontario、カナダ、M6A 3B4
- 募集
- Toronto Immune and Digestive Health Institute Inc
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Quebec
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Montreal、Quebec、カナダ、H2X 0C1
- 募集
- CHUM - Centre hospitalier universitaire de Montreal
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Montreal、Quebec、カナダ、H3H1E3
- 募集
- Clinique IMD
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Madrid、スペイン、28031
- 募集
- Hosp. Univ. Infanta Leonor
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Vigo、スペイン、36312
- 募集
- Hosp. Alvaro Cunqueiro
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Banská Bystrica、スロバキア、975 17
- 募集
- FNsP F. D. Roosevelta Banska Bystrica
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Bratislava、スロバキア、811 09
- 募集
- Cliniq s.r.o.
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Košice、スロバキア、040 13
- 募集
- ENDOMED s.r.o
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Nitra、スロバキア、949 01
- 募集
- KM Management spol. s r.o.
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Prešov、スロバキア、080 01
- 募集
- GASTRO I. s.r.o.
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Prešov、スロバキア、080 01
- 募集
- Gastro LM s.r.o.
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Hradec Králové、チェコ、500 12
- 募集
- Hepato-gastroenterologie HK, s.r.o.
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Prague、チェコ、190 00
- 募集
- ISCARE a.s.
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Prague、チェコ、14000
- 募集
- Fakultni Thomayerova nemocnice
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Antalya、トルコ（Türkiye）、07100
- 募集
- Antalya Training and Research Hospital
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Istanbul、トルコ（Türkiye）、34899
- 募集
- Marmara University Pendik Training Hospital
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Istanbul、トルコ（Türkiye）、34093
- 募集
- Bezmialem University Medical Faculty
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Izmir、トルコ（Türkiye）、35540
- 募集
- Izmir Şehir Hastanesi
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Kocaeli、トルコ（Türkiye）、41001
- 募集
- Kocaeli University Medical Faculty
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Mersin、トルコ（Türkiye）、33343
- 募集
- Mersin University Medical Faculty
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Berlin、ドイツ、14163
- 募集
- Krankenhaus Waldfriede Mitte
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Dresden、ドイツ、01307
- 募集
- Universitätsklinikum Carl Gustav Carus Dresden
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Hanover、ドイツ、30625
- 募集
- Medizinische Hochschule Hannover
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Kiel、ドイツ、24105
- 募集
- Universitatsklinikum Schleswig Holstein Kiel
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Leipzig、ドイツ、04103
- 募集
- EUGASTRO GmbH
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Mannheim、ドイツ、68167
- 募集
- Universitaetsklinikum Mannheim
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Rostock、ドイツ、18057
- 募集
- Universitaetsmedizin Rostock
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-
-
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Tromsø、ノルウェー、9038
- 募集
- Universitetssykehuset Nord-Norge HF
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Trondheim、ノルウェー、7030
- 募集
- St. Olavs Hospital
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Ålesund、ノルウェー、6017
- 募集
- Alesund sjukehus
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-
-
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Nantes、フランス、44000
- 募集
- CHU de Nantes hotel Dieu
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Reims、フランス、51100
- 募集
- CHU de Reims
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-
-
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Curitiba、ブラジル、80430 180
- 募集
- CDC - Centro Digestivo de Curitiba
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Macaé、ブラジル、27910-020
- 募集
- Cliged
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Porto Alegre、ブラジル、90035 903
- 募集
- Hospital de Clínicas de Porto Alegre
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Porto Alegre、ブラジル、90160 093
- 募集
- Hospital Ernesto Dornelles
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Santo André、ブラジル、09080-110
- 募集
- Pesquisare Saúde
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São Paulo、ブラジル、01236 030
- 募集
- BR Trials
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São Paulo、ブラジル、04077-020
- 募集
- Rocco And Nazato Servicos Medicos Ltda
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Votuporanga、ブラジル、15500-269
- 募集
- Integral Pesquisa e Ensino
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-
-
-
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Edegem、ベルギー、2650
- 募集
- Universitair Ziekenhuis Antwerpen
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Ghent、ベルギー、9000
- 募集
- Ghent University Hospital
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Leuven、ベルギー、3000
- 募集
- Universitair Ziekenhuis Leuven
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Roeselare、ベルギー、8800
- 募集
- Algemeen Ziekenhuis Delta
-
-
-
-
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Braga、ポルトガル、4710 243
- 募集
- Uls Braga - Hosp. Braga
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Viana do Castelo、ポルトガル、4900-408
- 募集
- Ulsam - Hosp. Santa Luzia
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-
-
-
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Bydgoszcz、ポーランド、85 229
- 募集
- Centrum Medyczne Medis ManerMed Sp Z O O
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Krakow、ポーランド、31-513
- 募集
- Centrum Medyczne PROMED
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Lublin、ポーランド、20 582
- 募集
- Medrise Sp. z o.o.
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Rzeszów、ポーランド、35-055
- 募集
- Centrum Medyczne 'Medyk' Sp. z o.o. K.
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Szczecin、ポーランド、71-434
- 募集
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
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Zamość、ポーランド、22 400
- 募集
- ETG Zamosc
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-
-
-
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Ampang、マレーシア、68000
- 募集
- Hospital Ampang
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Kajang、マレーシア、43000
- 募集
- Sultan Idris Shah Hospital
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Kota Kinabalu、マレーシア、88586
- 募集
- Hospital Queen Elizabeth
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Kuala、マレーシア、20400
- 募集
- Hospital Sultanah Nur Zahirah
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Petaling Jaya、マレーシア、50603
- 募集
- University Malaya Medical Centre
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-
-
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Beijing、中国、100191
- 募集
- Peking University Third Hospital
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Changzhou、中国、213004
- 募集
- Changzhou No 2 Peoples Hospital
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Chongqing、中国、400014
- 募集
- Chongqing General Hospital
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Guangzhou、中国、510655
- 募集
- Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital
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Hangzhou、中国、310000
- 募集
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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Huai'an、中国、223300
- 募集
- Huai'an 1st Hospital
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Ningbo、中国、315041
- 募集
- Ningbo Medical Center Lihuili Hospital
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Zhuzhou、中国、412007
- 募集
- Zhuzhou Central Hospital
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-
-
-
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Taoyuan、台湾、333
- 募集
- Linkou Chang Gung Memorial Hospital
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-
-
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Hamamatsu、日本、431-3192
- 募集
- Hamamatsu University Hospital
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Hirosaki、日本、036-8545
- 募集
- National Hospital Organization Hirosaki National Hospital
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Kagoshima、日本、892-0843
- 募集
- Kagoshima IBD Gastroenterology Clinic
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Kashiwa、日本、277-0871
- 募集
- Tsujinaka Hospital Kashiwanoha
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Kobe、日本、650 0017
- 募集
- Kobe University Hospital
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Kumamoto、日本、860-8556
- 募集
- Kumamoto University Hospital
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Kumamoto、日本、861-8520
- 募集
- Japanese Red Cross Kumamoto Hospital
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Kumamoto、日本、862-0971
- 募集
- Takano Hospital
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Minatoku、日本、108-8642
- 募集
- Kitasato University Kitasato Institute Hospital
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Nagoya、日本、467-8602
- 募集
- Nagoya City University Hospital
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Osaka、日本、540-0006
- 募集
- National Hospital Organization Osaka National Hospital
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Osaka、日本、543-8555
- 募集
- Japanese Red Cross Osaka Hospital
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Sapporo、日本、065-0033
- 募集
- Sapporo Higashi Tokushukai Hospital
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Sapporo、日本、060-0033
- 募集
- Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
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Shimizu、日本、411-8611
- 募集
- National Hospital Organization Shizuoka Medical Center
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Takamatsu、日本、760-0017
- 募集
- Takamatsu Red Cross Hospital
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Yamanashi、日本、400-8506
- 募集
- Yamanashi Prefectural Central Hospital
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-
-
-
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Busan、韓国、48108
- 募集
- Inje University Haeundae Paik Hospital
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Daejeon、韓国、34943
- 募集
- The Catholic University of Korea Daejeon St Mary's Hospital
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Gangnam Gu、韓国、06351
- 募集
- Samsung Medical Center
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Seoul、韓国、05505
- 募集
- Asan Medical Center
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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
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion criteria:
- Have a diagnosis of Crohn's disease (CD) or fistulizing CD established greater than or equal to (>=) 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD
- Have moderately to severely active CD based on crohn's disease activity index (CDAI) criteria defined as a baseline CDAI score >= 220 but less than or equal to (<=) 450 and either: a. Mean daily stool frequency (SF) count >= 4.0, based on the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily AP score >= 2.0, based on the unweighted CDAI component of abdominal pain (AP)
- Have moderately to severely active ileal and/or colonic CD as assessed by central review of the screening video ileocolonoscopy based on simple endoscopic score for crohn's disease (SES-CD) criteria
- Have had an inadequate initial response, loss of response, or intolerance to previously approved systemic therapies
Exclusion criteria:
- Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, ulcerative colitis (UC) or clinical findings highly suggestive of UC
- Complications of CD such as symptomatic bowel strictures or stenoses, or any other manifestation that may require intestinal surgery while enrolled in the study
- Presence of draining (that is, functioning) stoma or ostomy
- Has a history of short bowel syndrome, is missing greater than (>) 2 of the 5 ileocolonic segments, or has any other medical condition that could preclude or confound the ability to use efficacy assessment tools (such as CDAI) to assess response to study intervention
- Currently has or is suspected of having an abscess
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：JNJ-78934804
Participants will receive JNJ-78934804 induction dose, at Weeks 0, 4, and 8 followed by JNJ-78934804 maintenance dose, once every 4 weeks (q4w) starting at Week 12.
All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28.
Participants who complete double-blind treatment phase (Week 48) and who may benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the long-term extension (LTE) phase.
|
JNJ-78934804 will be administered subcutaneously.
他の名前：
|
|
アクティブコンパレータ：Guselkumab
Participants will receive guselkumab induction dose at Weeks 0, 4, and 8 followed by guselkumab maintenance dose q4w starting at Week 12.
All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28.
Participants who complete double-blind treatment phase (Week 48) and who may benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the LTE phase.
|
グセルクマブは皮下投与されます。
他の名前：
JNJ-78934804 will be administered subcutaneously.
他の名前：
|
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 |
|---|---|---|
|
Co-Primary: Percentage of Participants with Clinical Remission at Week 48
時間枠：At Week 48
|
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score less than (<) 150.
CDAI scores range from 0 to approximately 600.
Higher score indicates higher disease activity.
|
At Week 48
|
|
Co-Primary: Percentage of Participants with Endoscopic Remission at Week 48
時間枠：At Week 48
|
Endoscopic remission is defined as a Simple Endoscopic Score for Crohn's Disease (SES-CD) score of less than or equal to (<=) 4 with at least a 2-point reduction from baseline and no subscore greater than (>) 1 in any individual component.
The SES-CD is based on the evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments.
SES-CD score can range from 0 to 56.
Higher scores indicating more severe disease.
|
At Week 48
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of Participants with Deep Remission at Week 48
時間枠：At Week 48
|
Deep remission (composite endpoint) is defined as achieving both clinical remission and endoscopic remission at Week 48 at the participant level.
Clinical remission is defined as a CDAI score of <150 and Endoscopic remission is defined as a SES-CD score of <= 4 with at least a 2-point reduction from baseline and no subscore >1 in any individual component.
CDAI scores range from 0 to approximately 600.
Higher score indicates higher disease activity.
SES-CD score can range from 0 to 56.
Higher scores indicating more severe disease.
|
At Week 48
|
|
Percentage of Participants with Corticosteroid-Free (90-Day) Clinical Remission at Week 48
時間枠：At Week 48
|
Corticosteroid-free (90-day) clinical remission at Week 48 is defined as clinical remission at Week 48 and not receiving corticosteroids for at least 90 days prior to Week 48.
Clinical remission is defined as a CDAI score of <150.
CDAI scores range from 0 to approximately 600.
Higher score indicates higher disease activity.
|
At Week 48
|
|
Percentage of Participants with Corticosteroid-Free (90-day) PRO-2 Remission at Week 48
時間枠：At Week 48
|
Corticosteroid-free (90-day) patient-reported outcome(s) (PRO-2) remission at Week 48 is defined as an abdominal plan (AP) mean daily score less than or equal to (<=) 1 and stool frequency (SF) mean daily score <= 2.8, and no worsening of AP or SF from baseline, and not receiving corticosteroids for at least 90 days prior to Week 48.
|
At Week 48
|
|
Percentage of Participants with Sustained Clinical Remission
時間枠：At Weeks 12 and 48
|
Sustained clinical remission is defined as clinical remission at Week 12 and Week 48.
Clinical remission is defined as CDAI score of <150.
CDAI scores range from 0 to approximately 600.
Higher score indicates higher disease activity.
|
At Weeks 12 and 48
|
|
Percentage of Participants with Histologic-Endoscopic Remission at Week 48
時間枠：At Week 48
|
Histologic-endoscopic remission at week 48 is defined as achieving a combination of histologic remission and endoscopic remission at Week 48.
Histologic remission is defined as absence of neutrophils from the mucosa (both lamina propria and epithelium), no crypt destruction, and no erosions, or ulcerations or granulation tissue as assessed by the Robarts Histopathology Index.
Endoscopic remission is defined as a SES-CD score of <= 4 with at least a 2-point reduction from baseline and no subscore > 1 in any individual component.
|
At Week 48
|
|
Percentage of Participants with Inflammatory Bowel Disease Questionnaire (IBDQ) Response at Week 48
時間枠：At Week 48
|
IBDQ response at Week 48 is defined as an improvement of at least 16 points in the IBDQ total score from baseline at Week 48.
IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD that will be used to evaluate disease-specific health related quality of life (HRQoL) across 4 dimensional scores: bowel symptoms (loose stools, AP), systemic function (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability).
Scores range from 32 to 224, with higher scores indicating better outcomes.
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At Week 48
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Percentage of Participants with Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) Mental Component Summary Score (MCS) Response at Week 48
時間枠：At Week 48
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PROMIS-29 MCS response at Week 48 is defined as an improvement of at least 7 points in PROMIS-29 MCS score from baseline at Week 48.
The PROMIS-29 is a collection of short forms containing 4 items for each of 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities).
PROMIS-29 also includes an overall average pain intensity 0-10 numeric rating scale.
The PROMIS-29 MCS will be assessed, which is primarily informed by domains of emotional distress (depression/anxiety) and fatigue as well as sleep disturbance where higher MCS scores reflect better mental health.
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At Week 48
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Percentage of Participants with Clinical Remission at Week 12
時間枠：At Week 12
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Clinical remission at Week 12 is defined as CDAI score <150 at Week 12. CDAI scores range from 0 to approximately 600.
Higher score indicates higher disease activity.
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At Week 12
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Percentage of Participants with Endoscopic Response at Week 12
時間枠：At Week 12
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Endoscopic response at Week 12 is defined as greater than (>) 50 percent (%) improvement from baseline in SES-CD score at Week 12 or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease.
SES-CD score can range from 0 to 56.
Higher scores indicating more severe disease.
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At Week 12
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Number of Participants with Adverse Events (AE) and Serious AEs (SAEs)
時間枠：Up to approximately 3 years
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An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product.
An AE does not necessarily have a causal relationship with the intervention.
An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, and is medically important.
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Up to approximately 3 years
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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。
捜査官
- スタディディレクター：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC
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)
2026年5月22日
一次修了 (推定)
2028年6月12日
研究の完了 (推定)
2030年7月12日
試験登録日
最初に提出
2026年5月5日
QC基準を満たした最初の提出物
2026年5月5日
最初の投稿 (実際)
2026年5月11日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月28日
QC基準を満たした最後の更新が送信されました
2026年8月27日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
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
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。