근치 방광 절제술을 받을 자격이 없거나 받지 않기로 선택한 방광내 Bacillus Calmette-Guérin에 반응하지 않는 비근육 침습성 방광암(NMIBC) 참가자를 대상으로 한 TAR-200과 세트렐리맙, TAR-200 단독 또는 세트렐리맙 단독에 대한 연구 (SunRISe-1)
2026년 11월 2일 업데이트: Janssen Research & Development, LLC
BCG(Intravesical Bacillus Calmette-Guérin)에 반응하지 않는 고위험 비근육 침윤성 방광암(NMIBC) 환자에서 Cetrelimab, TAR-200 단독 또는 Cetrelimab 단독과 TAR-200의 효능 및 안전성을 평가하는 2b상 임상 연구 근치적 방광 절제술을 받을 자격이 없거나 받지 않기로 선택한 사람
The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease; and disease-free survival (DFS) in participants treated with TAR-200 alone with papillary disease only (Cohort 4).
연구 개요
연구 유형
중재적
등록 (실제)
220
단계
- 2 단계
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연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Cholargós, 그리스, 155 62
- Metropolitan General A E
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Marousi, 그리스, 151 25
- Athens Medical Center
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Thessaloniki, 그리스, 54645
- Euromedica General Clinic
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Thessaloniki, 그리스, 546 22
- Bioclinic - Thessaloniki
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Thessaloniki, 그리스, 54635
- General Hospital of Thessaloniki G. Gennimatas
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Thessaloniki, 그리스, TK 56403
- Papageorgiou General Hospital Of Thessaloniki
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-
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-
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Amsterdam, 네덜란드, 1066 CX
- Antoni van Leeuwenhoek
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Eindhoven, 네덜란드, 5623EJ
- Catharina Ziekenhuis
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Nijmegen, 네덜란드, 6532SZ
- Canisius-Wilhelmina Ziekenhuis
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Utrecht, 네덜란드, 3508 GA
- The Julius Center - Utrecht Science Park - Stratenum
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-
-
-
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Busan, 대한민국, 612-896
- Inje University Haeundae Paik Hospital
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Daegu, 대한민국, 41404
- Kyungpook National University Chilgok Hospital
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Daegu, 대한민국, 42601
- Keimyung University Dongsan Hospital
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Goyang-si, 대한민국, 10408
- National Cancer Center
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Gwangju, 대한민국, 61469
- Chonnam National University Hospital
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Seoul, 대한민국, 03080
- Seoul National University Hospital
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Seoul, 대한민국, 03722
- Severance Hospital
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Seoul, 대한민국, 06273
- Gangnam Severance Hospital
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Seoul, 대한민국, 06591
- The Catholic University of Korea Seoul St Mary s Hospital
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Yangsan, 대한민국, 50612
- Pusan National University Yangsan Hospital
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-
-
-
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Cologne, 독일, 50968
- Urologische Partnerschaft Koln UPK
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Duisburg, 독일, 47169
- Urologicum Duisburg
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Herne, 독일, 44625
- Klinikum Herne - Urologie
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Markkleeberg, 독일, 04416
- Matthias Schulze - Germany
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Mettmann, 독일, 40822
- Urologie Neandertal Praxis Mettmann
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Münster, 독일, 48149
- Universitatsklinikum Munster
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Nuremberg, 독일, 90491
- Schön Klinik Nürnberg Fürth
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Nürtingen, 독일, 72622
- Studienpraxis Urologie Nürtingen - Germany
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Würselen, 독일, 52146
- Urologische Praxis am Wasserturm - Germany
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Moscow, 러시아 제국, 125284
- Hertzen Oncology Research Institute
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Nizhny Novgorod, 러시아 제국, 603074
- Privolzhsky District Medical Centre
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Novosibirsk, 러시아 제국, 630099
- Avicenna Medical Center
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Obninsk, 러시아 제국, 249031
- A. Tsyb Medical Radiological Research Center
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Omsk, 러시아 제국, 644013
- BHI of Omsk region Clinical Oncology Dispensary
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Pyatigorsk, 러시아 제국, 357502
- Ultrasound Clinic 4D
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Saratov, 러시아 제국, 410054
- Saratov State Medical University
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Tyumen, 러시아 제국, 625041
- Multifunctional clinical medical center 'Medical city'
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Ufa, 러시아 제국, 450008
- Bashkir State Medical University
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Arizona
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Tucson, Arizona, 미국, 85715
- Del Sol Research Management, LLC
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California
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Los Angeles, California, 미국, 90033
- University of Southern California
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Sherman Oaks, California, 미국, 91411
- Genesis Healthcare Partners - Genesis Research Greater Los Angeles
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Colorado
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Denver, Colorado, 미국, 80211
- The Urology Center of Colorado
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Golden, Colorado, 미국, 80401
- Foothills Urology - Golden Off
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Illinois
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Lisle, Illinois, 미국, 60532
- DuPage Medical Group
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Indiana
-
Greenwood, Indiana, 미국, 46143
- Urology of Indiana
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Kansas
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Wichita, Kansas, 미국, 67226
- Wichita Urology Group
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Michigan
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Troy, Michigan, 미국, 48084
- Michigan Institute of Urology
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New York
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New York, New York, 미국, 10017
- NYU Langone Health
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Syracuse, New York, 미국, 13210
- Associated Medical Professionals
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Syracuse, New York, 미국, 13210-2375
- SUNY Upstate Medical University
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North Carolina
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Charlotte, North Carolina, 미국, 28204
- Levine Cancer Institute
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Ohio
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Cincinnati, Ohio, 미국, 45212
- The Urology Group
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Pennsylvania
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Bala-Cynwyd, Pennsylvania, 미국, 19004
- Urologic Consultants of Southeastern Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19107
- Thomas Jefferson University
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Tennessee
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Nashville, Tennessee, 미국, 37232
- Vanderbilt University Medical Center
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Nashville, Tennessee, 미국, 37209
- Urology Associates, PC
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Texas
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Austin, Texas, 미국, 78745
- Urology Austin
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Dallas, Texas, 미국, 75390
- University of Texas Southwestern Medical Center
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San Antonio, Texas, 미국, 78229
- Urology San Antonio Research
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Washington
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Spokane, Washington, 미국, 99202
- Spokane Urology
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Assebroek, 벨기에, 8310
- AZ Sint-Lucas Brugge
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Bruges, 벨기에, 8000
- AZ Sint-Jan Brugge
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Brussels, 벨기에, 1070
- Hopital Erasme
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Ghent, 벨기에, 9000
- Universitair Ziekenhuis Gent
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Ghent, 벨기에, 9000
- Algemeen ziekenhuis Maria Middelares
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Roeselare, 벨기에, 8800
- Algemeen Ziekenhuis Delta
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Sint-Niklaas, 벨기에, 9100
- AZ Nikolaas
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A Coruña, 스페인, 15006
- Hosp Univ A Coruna
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Badalona, 스페인, 08916
- Hosp. Univ. Germans Trias I Pujol
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Barcelona, 스페인, 08025
- Fund. Puigvert
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Cadiz, 스페인, 11009
- Hosp. Puerta Del Mar
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Granada, 스페인, 18014
- Hosp. Univ. Virgen de Las Nieves
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Jerez de la Frontera, 스페인, 11407
- Hosp. de Jerez de La Frontera
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Madrid, 스페인, 28041
- Hosp. Univ. 12 de Octubre
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Madrid, 스페인, 28034
- Hosp. Univ. Ramon Y Cajal
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Madrid, 스페인, 28046
- Hosp. Univ. La Paz
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Madrid, 스페인, 28050
- Hosp Univ Hm Sanchinarro
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Málaga, 스페인, 29010
- Hosp Virgen de La Victoria
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Sabadell, 스페인, 08208
- Corporacio Sanitari Parc Tauli
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Valencia, 스페인, 46009
- Instituto Valenciano de Oncologia
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Glasgow, 영국, G12 0YN
- NHS Greater Glasgow and Clyde
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Leeds, 영국, LS9 7TF
- Leeds Teaching Hospitals NHS Trust
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Chernihiv, 우크라이나, 14029
- Chernihivskyi oblasnyi onkolohichnyi dyspanser
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Kiev, 우크라이나, 08173
- Asklepion LLC
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Sumy, 우크라이나, 40022
- Sumy Regional Clinical Oncology Centre
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Bari, 이탈리아, 70120
- Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
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Bari, 이탈리아, 70124
- Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Satellite 1
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Florence, 이탈리아, 50135
- Azienda Ospedaliera Universitaria Careggi
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Genova, 이탈리아, 16132
- Ospedale San Martino 1
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Milan, 이탈리아, 20132
- Ospedale San Raffaele
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Pisa, 이탈리아, 56126
- Azienda Ospedaliero Universitaria Pisana
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Roma, 이탈리아, 00189
- Azienda Ospedaliera Sant Andrea
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Rome, 이탈리아, 00144
- Istituto Nazionale Tumori Regina Elena
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Torino, 이탈리아, 10126
- Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
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Varese, 이탈리아, 21100
- Ospedale di Circolo e Fondazione Macchi
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Vicenza, 이탈리아, 36100
- Ospedale San Bortolo
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Iizuka, 일본, 820-8501
- Aso Co.,Ltd Iizuka Hospital
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Kanagawa, 일본, 216 8511
- St Marianna University Hospital
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Kashihara-shi, 일본, 634-8522
- Nara Medical University Hospital
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Kisarazu-shi, 일본, 292-8535
- Kimitsu Chuo Hospital
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Nagasaki, 일본, 852-8501
- Nagasaki University Hospital
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Osaka, 일본, 591-8025
- JOHAS Osaka Rosai Hospital
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Tokyo, 일본, 105-8470
- Toranomon Hospital
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Toyama, 일본, 930-0194
- Toyama University Hospital
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Toyoake, 일본, 470-1192
- Fujita Health University Hospital
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Tsukuba, 일본, 305-8520
- University of Tsukuba Hospital
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Yokohama, 일본, 232 0024
- Yokohama City University Medical Center
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British Columbia
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Abbotsford British Columbia, British Columbia, 캐나다, V2S 3N5
- Exdeo Clinical Research Inc
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Ontario
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Brampton, Ontario, 캐나다, L6R 3J7
- William Osler Health System
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Toronto, Ontario, 캐나다, M5G 2M9
- Princess Margaret Hospital- UHN
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Quebec
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Montreal, Quebec, 캐나다, H4A 3J1
- McGill University Health Centre
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Sherbrooke, Quebec, 캐나다, J1H 5H3
- Universite de Sherbrooke
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Almada, 포르투갈, 2805-267
- Hospital Garcia de Orta
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Aveiro, 포르투갈, 3810-193
- Uls Regiao Aveiro - Hosp. Infante D. Pedro
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Guimarães, 포르투갈, 4835-044
- Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes
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Lisbon, 포르투갈, 1400-038
- Fund. Champalimaud
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Lisbon, 포르투갈, 1150-199
- Centro Hospitalar de Lisboa Central
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Loures, 포르투갈, 2674 514
- Uls Loures Odivelas - Hosp. Loures
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Porto, 포르투갈, 4200-072
- Instituto Portugues de Oncologia do Porto Francisco Gentil
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Vila Nova de Gaia, 포르투갈, 4434 502
- Centro Hospitalar de Vila Nova de Gaia Espinho E P E
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Vila Real, 포르투갈, 5000508
- Centro Hospitalar de Trás os Montes e Alto-Douro
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Bordeaux, 프랑스, 33076
- Hopital Pellegrin CHU Bordeaux
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Bordeaux, 프랑스, 33300
- Polyclinique Bordeaux Nord Acquitaine
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Grenoble, 프랑스, 38043
- CHU Grenoble
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Hyères, 프랑스, 83400
- Clinique Sainte Marguerite
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Limoges, 프랑스, 87000
- Polyclinique de Limoges - Francois Chenieux
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Lyon, 프랑스, 69437
- Hôpital Edouard Herriot
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Marseille, 프랑스, 13273
- Institut Paoli-Calmettes
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Montpellier, 프랑스, 34070
- Centre de Cancerologie du Grand Montpellier
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Nîmes, 프랑스, 30029
- CHU Nimes
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Paris, 프랑스, 75010
- Hopital Saint Louis
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Paris, 프랑스, 75013
- Hôpital Universitaire Pitié-Salpêtrière
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Paris, 프랑스, 75877
- Hopital Bichat Claude Bernard
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Paris, 프랑스, 75020
- Groupe Hospitalier Diaconesses Croix Saint Simon
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Paris, 프랑스, 75015
- Hopital Europeen Georges-Pompidou
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Quint-Fonsegrives, 프랑스, 31130
- Clinical La Croix Du Sud - Ramsay Santé
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Rennes, 프랑스, 35033
- Hopital Pontchaillou
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Saint-Grégoire, 프랑스, 35760
- CHP Saint Gregoire
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Strasbourg, 프랑스, 67200
- Institut de Cancerologie Strasbourg Europe ICANS
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Suresnes, 프랑스, 92151
- Hopital Foch
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Toulouse, 프랑스, 31059
- Hopital Rangueil
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Bedford Park, 호주, 5042
- Flinders Medical Centre
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Box Hill, 호주, 3128
- Eastern Health Research
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Sydney, 호주, 2109
- Macquarie University Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Histologically confirmed diagnosis of persistent or recurrent high-risk non-muscle invasive bladder cancer (HR-NMIBC), (carcinoma in situ [CIS] or tumor in situ [Tis]), with or without papillary disease (T1, high-grade Ta) or papillary disease only (high-grade Ta or any T1 and absence of CIS), within 12 months of completion of the last dose of Bacillus Calmette-Guerin (BCG) therapy, in participants who have received adequate BCG. Mixed histology tumors are allowed if urothelial differentiation (transitional cell histology) is predominant. However, the presence of neuroendocrine, micropapillary, signet ring cell, plasmacytoid, or sarcomatoid features will make a participant ineligible. For participants with lamina propria invasion (T1) on the screening biopsy/ transurethral resection of bladder tumor (TURBT), muscularis propria must be present in order to rule out Muscle Invasive Bladder Cancer (MIBC)
- All visible papillary disease must be fully resected (absent) prior to randomization (residual CIS is acceptable for participants eligible for Cohorts 1, 2, and 3 only) and documented in the electronic case report form (eCRF) at screening cystoscopy. For participants with papillary disease only (Cohort 4), local urine cytology at screening must be negative or atypical (for High-Grade Urothelial Carcinoma [HGUC])
- Participants must be ineligible for or have elected not to undergo radical cystectomy
- BCG-unresponsive high-risk NMIBC after treatment with adequate BCG therapy defined as a minimum of 5 of 6 full doses of an induction course (adequate induction) plus 2 of 3 doses of a maintenance course, or at least 2 of 6 doses of a second induction course
- Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
Exclusion Criteria:
- Presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, and/or Stage IV)
- Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder. Ta/T1/CIS of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to randomization
- Received a live virus vaccine within 30 days prior to the initiation of study treatment. Inactivated (non-live or non-replicating) vaccines approved or authorized for emergency use (for example, COVID-19) by local health authorities are allowed
- Active hepatitis B or C infection (for example, participants with history of hepatitis C infection but undetectable hepatitis C virus polymerase chain reaction (PCR) test and participants with history of hepatitis B infection with positive hepatitis B surface antigen (HBsAg) antibody and undetectable PCR are allowed)
- Prior therapy with an anti-programmed-cell death 1 (PD-1), anti-PD-ligand 2 (L2) agent, or with an agent directed to another co-inhibitory T-cell receptor
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Cohort 1: TAR-200 and Cetrelimab
TAR-200 is placed into the bladder through a urinary placement catheter in participants with carcinoma in situ (CIS), with or without papillary disease, on Day 0 and will be dosed every 3 weeks (Q3W) for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2). In addition, Cetrelimab will be dosed Q3W through Week 78 (18 months). |
TAR-200 will be administered transuretherally.
다른 이름들:
Cetrelimab will be administered.
다른 이름들:
|
|
실험적: Cohort 2: TAR-200
TAR-200 is placed into the bladder through a urinary placement catheter in participants with CIS, with or without papillary disease, on Day 0 and will be dosed Q3W for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2). |
TAR-200 will be administered transuretherally.
다른 이름들:
|
|
실험적: Cohort 3: Cetrelimab
Participants with CIS, with or without papillary disease, will receive Cetrelimab which will be dosed Q3W through Week 78 (18 months). |
Cetrelimab will be administered.
다른 이름들:
|
|
실험적: Cohort 4: TAR-200 (Participants with Papillary Disease only)
TAR-200 is placed into the bladder through a urinary placement catheter in participants with papillary disease only, on Day 0 and will be dosed Q3W for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2). |
TAR-200 will be administered transuretherally.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Cohorts 1, 2, and 3: Overall Complete Response (CR) Rate
기간: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
|
Overall CR rate was defined as the percentage of participants who met at least one of the following: negative cystoscopy and negative (including atypical) centrally read urine cytology, or positive cystoscopy with biopsy-proven benign or low-grade non-muscle invasive bladder cancer (NMIBC) and negative (including atypical) centrally read cytology at any time point. |
From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
|
|
Cohort 4: Disease-free Survival (DFS)
기간: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
|
DFS was defined as the time from the date of first dose of study treatment to the time of one of the following events, whichever occurred first: (1) The first recurrence of high-risk disease (high-grade Ta, any T1 or CIS), (2) progression to muscle invasive bladder cancer (MIBC) (T greater than or equal to [>=] 2) or to lymph node (N+) or to distant disease (M+), whichever occurred first, (3) Death due to any cause. |
From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall Survival (OS)
기간: From Week 0 up to 6 years 7 months
|
From Week 0 up to 6 years 7 months
|
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ) -C30 Scores
기간: From Week 0 up to 6 years 7 months
|
From Week 0 up to 6 years 7 months
|
|
|
Change From Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores
기간: From Week 0 up to 6 years 7 months
|
From Week 0 up to 6 years 7 months
|
|
|
Time to Symptom Deterioration as Assessed by European Organisation for Research and Treatment of Cancer Qualityof-life Questionnaire (EORTC QLQ) -C30 Scores
기간: From Week 0 up to 6 years 7 months
|
From Week 0 up to 6 years 7 months
|
|
|
Time to Symptom Deterioration as Assessed by EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores
기간: From Week 0 up to 6 years 7 months
|
From Week 0 up to 6 years 7 months
|
|
|
Number of Participants With Adverse Events (AEs) by Severity Grades
기간: From Week 0 up to 6 years 7 months
|
From Week 0 up to 6 years 7 months
|
|
|
Number of Participants With Clinical Laboratory Abnormalities by Severity Grades
기간: From Week 0 up to 6 years 7 months
|
From Week 0 up to 6 years 7 months
|
|
|
Cohorts 1, 2, and 3: Number of Participants With at Least 12 Months Duration of Response
기간: From onset of first CR up to clinical cut-off date 3rd July 2025 (up to 47.3 months)
|
DOR was defined as the date of first complete response (CR) achieved to the date of first evidence of recurrence or progression or death, using cystoscopy, centrally read bladder biopsy and urine cytology, and imaging, if available. Complete response was defined as having a negative cystoscopy and negative (including atypical) centrally assessed urine cytology, or positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative (including atypical) centrally assessed cytology at any time point. Number of participants with at least 12 months duration of response were reported. |
From onset of first CR up to clinical cut-off date 3rd July 2025 (up to 47.3 months)
|
|
Cohorts 1, 2, and 4: Plasma Concentrations of Gemcitabine and 2',2' Difluorodeoxyuridine (dFdU) (Metabolite)
기간: Predose at Week 0 and at any time between Days 2-7 during Weeks 3, 6, 9, 15, 18, and 21 postdose
|
Plasma concentrations of gemcitabine and dFdU were reported. |
Predose at Week 0 and at any time between Days 2-7 during Weeks 3, 6, 9, 15, 18, and 21 postdose
|
|
Cohorts 1 and 2: Maximum Observed Urine Concentration (Cmax) of Gemcitabine and dFdU (Metabolite)
기간: At Week 0
|
Cmax was defined as maximum observed urine concentration. |
At Week 0
|
|
Cohort 4: Urine Concentration of Gemcitabine and dFdU (Metabolite)
기간: At Weeks 3, 6, 9, 15, 18, and 21
|
Urine concentrations of gemcitabine and dFdU were reported. |
At Weeks 3, 6, 9, 15, 18, and 21
|
|
Cohort 1and 3: Serum Concentration of Cetrelimab
기간: At Weeks 0, 3, 12, 24, 48, 60, 84 (end of infusion) [EOI]
|
Serum concentration of cetrelimab were reported. |
At Weeks 0, 3, 12, 24, 48, 60, 84 (end of infusion) [EOI]
|
|
Cohort 3: Serum Concentration of Cetrelimab
기간: At Weeks 60 (EOI)
|
Serum concentration of cetrelimab were reported. |
At Weeks 60 (EOI)
|
|
Cohorts 1 and 3: Number of Participants With Anti-cetrelimab Antibodies
기간: From date of first dose up to clinical cut-off date 3rd July 2025 (54 months)
|
Number of participants positive to anti-cetrelimab antibodies was reported using validated immunoassay for anti-drug antibody (ADA) analysis. |
From date of first dose up to clinical cut-off date 3rd July 2025 (54 months)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2020년 12월 18일
기본 완료 (실제)
2025년 7월 3일
연구 완료 (추정된)
2027년 9월 30일
연구 등록 날짜
최초 제출
2020년 11월 20일
QC 기준을 충족하는 최초 제출
2020년 11월 20일
처음 게시됨 (실제)
2020년 11월 23일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 11월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 11월 2일
마지막으로 확인됨
2026년 11월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CR108921
- 2020-002646-16 (EudraCT 번호)
- 17000139BLC2001 (기타 식별자: Janssen Research & Development, LLC)
- 2023-506146-23-00 (레지스트리 식별자: EUCT number)
- 2023 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/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
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .