A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)
SunRISe-3
A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and Safety of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer
4 other identifiers
interventional
1,135
21 countries
240
Brief Summary
The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2023
Longer than P75 for phase_3
240 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2023
CompletedFirst Posted
Study publicly available on registry
February 6, 2023
CompletedStudy Start
First participant enrolled
March 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 18, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 18, 2029
April 13, 2026
April 1, 2026
6.5 years
January 27, 2023
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Event-free Survival (EFS)
EFS is defined as the time from randomization to either the time of the first recurrence of high-risk disease, progression, or death due to any cause, whichever occurs first. For participants with carcinoma In-situ (CIS), persistent disease at 6 months (Week 24) is also considered an EFS event. Progression is defined as: an increase of stage from Ta to T1 or from CIS to T1 or 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 occurs first.
Up to 5 years 2 months
Secondary Outcomes (12)
Overall Complete Response (CR) Rate
Up to 5 years 2 months
Duration of CR
Up to 5 years 2 months
Recurrence-Free Survival (RFS)
Up to 5 years 2 months
Time to Progression (TTP)
Up to 5 years 2 months
Overall Survival (OS)
Up to 5 years 2 months
- +7 more secondary outcomes
Study Arms (3)
Treatment Group A: TAR-200 + Cetrelimab
EXPERIMENTALParticipants will receive intravesical TAR-200 once every 3 weeks (Q3W) and cetrelimab.
Treatment Group B: Bacillus Calmette-Guerin (BCG) Vesiculture
ACTIVE COMPARATORParticipants will receive intravesical BCG once every week for 6 weeks (induction) and then followed by once every week for 3 weeks starting at Weeks 12, 24, 48, 72, and 96 (maintenance).
Treatment Group C: TAR-200 Alone
EXPERIMENTALParticipants will receive intravesical TAR-200 alone once Q3W.
Interventions
TAR-200 will be administered intravesically.
Cetrelimab will be administered.
BCG will be administered intravesically.
Eligibility Criteria
You may qualify if:
- Histologically confirmed initial diagnosis by local pathology (within 90 days of the most recent signed informed consent) of high grade non-muscle invasive bladder cancer (HR-NMIBC) (high-grade Ta, any T1 or carcinoma in-situ \[CIS\]), in participants who are Bacillus Calmette Guérin (BCG)-naïve
- BCG-naïve (participants who have not received prior intravesical BCG or who previously received but stopped BCG more than 3 years before date of randomization are eligible)
- All visible papillary disease must be fully resected (absent) prior to date of randomization and documented at baseline cystoscopy. Local urine cytology at screening must be negative or atypical (for high-grade urothelial carcinoma \[HGUC\]) for patients with papillary only disease (without CIS)
- Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
- All adverse events associated with any prior surgery and/or intravesical therapy must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade less than (\<) 2 prior to date of randomization
- Participants must be willing to undergo all study procedures
You may not qualify if:
- Presence or history of histologically confirmed, muscle invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, greater than and equal to \[\>=\] T2)
- Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder (that is, urethra, ureter, or renal pelvis). Ta/any 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
- Presence of any bladder or urethral anatomic feature (example, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of TAR-200 or administration of intravesical BCG. Participants with tumors involving the prostatic urethra in men will be excluded
- A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (mL)
- Indwelling catheters are not permitted; however, intermittent catheterization is acceptable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (240)
Mayo Clinic
Scottsdale, Arizona, 85259, United States
Arkansas Urology
Little Rock, Arkansas, 72211, United States
VA Long Beach Health Care System
Long Beach, California, 90822, United States
Genesis Research, LLC - West Coast Urology
Los Alamitos, California, 90720, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, 95630, United States
Genesis Research
San Diego, California, 92123, United States
Providence Saint Johns Cancer Institute
Santa Monica, California, 90404, United States
Providence Medical Foundation
Santa Rosa, California, 95403, United States
Colorado Clinical Research
Lakewood, Colorado, 80228, United States
Urological Research Network
Hialeah, Florida, 33016, United States
Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
The Emory Clinic Department of Urology
Atlanta, Georgia, 30322, United States
Northwestern University
Chicago, Illinois, 60611, United States
Duly Health and Care
Lisle, Illinois, 60532, United States
Blessing Hospital
Quincy, Illinois, 62301, United States
Urology of Indiana
Carmel, Indiana, 46032, United States
First Urology
Jeffersonville, Indiana, 47130, United States
AMR Kansas City Oncology
Merriam, Kansas, 66204, United States
Wichita Urology Group
Wichita, Kansas, 67226, United States
Chesapeake Urology Research Associates
Hanover, Maryland, 21076, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
University Of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
The Urology Center, PC
Omaha, Nebraska, 68114, United States
Cooper Health System MD Anderson Cancer Center at Cooper
Camden, New Jersey, 08103, United States
VA NY Harbor Healthcare System
New York, New York, 10010, United States
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029, United States
Associated Medical Professionals of Ny
Syracuse, New York, 13210, United States
SUNY Upstate Med Univ
Syracuse, New York, 13210, United States
Vidant Urology - Greenville
Greenville, North Carolina, 27834, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Central Ohio Urology Group
Gahanna, Ohio, 43230, United States
Centers for Advanced Urology LLC d b a MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, 15232, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Urology Associates
Nashville, Tennessee, 37209, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Urology Austin
Austin, Texas, 78745, United States
Urology Clinics of North Texas
Dallas, Texas, 75231, United States
Houston Metro Urology
Houston, Texas, 77027, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Urology San Antonio Research
San Antonio, Texas, 78229, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
George E. Wahlen VAMC
Salt Lake City, Utah, 84148, United States
Urology Of Virginia, Pllc
Virginia Beach, Virginia, 23462, United States
Spokane Urology
Spokane, Washington, 99202, United States
Hospital Italiano de Buenos Aires
Buenos Aires, C1199, Argentina
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
Buenos Aires, C1417, Argentina
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Córdoba, 5000, Argentina
Centro Urologico Profesor Bengio
Córdoba, X5000KPH, Argentina
Hospital Privado Centro Medico de Cordoba
Córdoba, X5016KEH, Argentina
Hospital Privado de la Comunidad
Mar del Plata, B7602CBM, Argentina
Instituto Medico Rio Cuarto
Río Cuarto, 5800, Argentina
Austin Health
Heidelberg, 3084, Australia
Macquarie University Hospital
Macquarie University, 2109, Australia
Hollywood Private Hospital
Nedlands, 6009, Australia
Mater Hospital Brisbane
South Brisbane, 4101, Australia
ZNA Middelheim
Antwerp, 2020, Belgium
AZ Sint-Jan
Bruges, 8000, Belgium
AZ Sint-Lucas
Bruges, 8310, Belgium
AZ Maria Middelares
Ghent, 9000, Belgium
UZ Gent
Ghent, 9000, Belgium
Centre Hospitalier de l'Ardenne
Libramont-Chevigny, 6800, Belgium
AZ Delta
Roeselare, 8800, Belgium
Vitaz
Sint-Niklaas, 9100, Belgium
GZA Ziekenhuizen- Campus St Augustinus
Wilrijk, 2610, Belgium
Fundacao Pio XII
Barretos, 14784-400, Brazil
NAIC Nair Antunes Instituto do Cancer
Bauru, 17033-495, Brazil
Universidade Estadual De Campinas
Campinas, 13083-888, Brazil
Liga Paranaense de Combate ao Cancer
Curitiba, 81520 060, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, 59075-740, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90050-170, Brazil
Hospital Regional do Cancer - Hospital de Esperança
Presidente Prudente, 19013-050, Brazil
Hospital Sao Rafael
Salvador, 41253 190, Brazil
Hospital Ana Nery Santa Cruz do Sul
Santa Cruz do Sul, 96835-090, Brazil
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
Santo André, 09060-870, Brazil
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
São Paulo, 01246 000, Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, 01508-010, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, 05652 900, Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo, 1321 001, Brazil
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 2Y9, Canada
St Josephs Healthcare Hamilton
Hamilton, Ontario, L8N 4A6, Canada
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario, M5G 1Z5, Canada
CHUM - Centre hospitalier universitaire de Montreal
Montreal, Quebec, H2X 3E4, Canada
CHU de Quebec Universite Laval Hopital de l Enfant Jesus
Québec, Quebec, G1J1Z4, Canada
Unite de Recherche Clinique du CISSS des Laurentides
Saint Jerome Quebec, Quebec, J7Z 2V4, Canada
Peking University First Hospital
Beijing, 100034, China
Beijing Hospital
Beijing, 100730, China
Beijing Luhe Hospital, Capital Medical University
Beijing, 101100, China
The First Bethune Hospital of Jilin University
Changchun, 130499, China
Hunan Province Cancer Hospital
Changsha, 410013, China
West China Hospital Sichuan University
Chengdu, 610044, China
Chongqing University Cancer Hospital
Chongqing, 400000, China
People's Hospital of Deyang City
Deyang, 618000, China
Sun Yat Sen University Cancer Center
Guangzhou, 430030, China
Zhejiang Provincial People's Hospital
Hangzhou, 310000, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, 310016, China
Nanjing Drum Tower Hospital
Nanjing, 210008, China
The First Affiliated Hospital of Ningbo University
Ningbo, 315010, China
Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine
Shanghai, 200025, China
Huadong Hospital Affiliated to Fudan University
Shanghai, 200400, China
Shengjing Hospital Of China Medical University
Shenyang, 110004, China
The Second Hospital Of Tianjin Medical University
Tianjin, 300211, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000, China
TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
Wuhan, 430030, China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, 710061, China
Yantai Yuhuangding Hospital
Yantai, 264000, China
Henan Cancer Hospital
Zhengzhou, 450008, China
Fakultni nemocnice u sv. Anny v Brne
Brno, 65691, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Krajská nemocnice Liberec a.s.
Liberec, 460 01, Czechia
Fakultni nemocnice Olomouc
Olomouc, 779 00, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
Thomayerova nemocnice, Onkologicka klinika
Prague, 140 59, Czechia
Fakultni nemocnice v Motole
Prague, 15006, Czechia
Polyclinique Bordeaux Nord Acquitaine
Bordeaux, 33000, France
CHU Gabriel-Montpied
Clermont-Ferrand, 63003, France
CHU Grenoble
Grenoble, 38043, France
Polyclinique de Limoges - Francois Chenieux
Limoges, 87000, France
Hôpital Edouard Herriot
Lyon, 69437, France
CHU de Nantes hotel Dieu
Nantes, 44093, France
CHU Nimes
Nîmes, 30029, France
Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source
Orléans, 45067, France
Hôpital Universitaire Pitié-Salpêtrière
Paris, 75013, France
Hopital Europeen Georges-Pompidou
Paris, 75015, France
APHP - Hopital Bichat - Claude Bernard
Paris, 75018, France
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, 75960, France
Clinical La Croix Du Sud - Ramsay Santé
Quint-Fonsegrives, 31130, France
Chu Rennes Hopital Pontchaillou
Rennes, 35000, France
Institut de Cancerologie Strasbourg Europe ICANS
Strasbourg, 67200, France
CHU Rangueil
Toulouse, 31059, France
Urologische Partnerschaft Koln UPK
Cologne, 50968, Germany
Urologicum Duisburg
Duisburg, 47169, Germany
Universitatsklinikum Erlangen
Erlangen, 91054, Germany
Universitatsklinikum Essen
Essen, 45147, Germany
Universitaetsklinikum Frankfurt
Frankfurt am Main, 60590, Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Matthias Schulze - Germany
Markkleeberg, 04416, Germany
Urologie Neandertal Praxis Mettmann
Mettmann, 40822, Germany
Klinikum rechts der Isar an der Technischen Universitat Munchen
München, 81675, Germany
Universitatsklinikum Munster
Münster, 48149, Germany
Klinikum Nurnberg Nord
Nuremberg, 90419, Germany
Medizinisches Versorgungszentrum - Urologie
Nuremberg, 90491, Germany
Studienpraxis Urologie Nurtingen
Nürtingen, 72622, Germany
Caritas-Krankenhaus St. Josef
Regensburg, 93053, Germany
Universitat Tubingen
Tübingen, 72076, Germany
Health Care Global Enterprises pvt Ltd
Bangalore, 560027, India
Post Graduate Institute of Medical Education And Research PGIMER
Chandigarh, 160012, India
Artemis Hospital
Gurugram, 122001, India
Netaji Subhas chandra Bose Cancer Research Institute
Kolkata, 700094, India
Tata Memorial Hospital
Mumbai, 400012, India
CIMET s Inamdar Multispeciality Hospital
Pune, 411040, India
Generale Regionale F. Miulli
Acquaviva delle Fonti, 70021, Italy
Ospedale Cardinal Massaia
Asti, 14100, Italy
Ospedale San Giuseppe Moscati di Avellino
Avellino, 83100, Italy
Ospedale San Giacomo Apostolo, Guardia pediatrica territoriale
Castelfranco Veneto, 31033, Italy
Ospedale San Raffaele di Milano
Milan, 20132, Italy
Istituto Europeo di Oncologia
Milan, 20141, Italy
Fondazione G Pascale Istituto Nazionale Tumori IRCCS
Naples, 80138, Italy
Ospedale S. Maria Delle Croci
Ravenna, 48121, Italy
Istituto Nazionale Tumori Regina Elena
Rome, 00128, Italy
Fuji City General Hospital
Fuji-shi, 417-8567, Japan
Kanazawa University Hospital
Kanazawa, 920 8641, Japan
Nara Medical University Hospital
Kashihara-shi, 634-8522, Japan
Kimitsu Chuo Hospital
Kisarazu-shi, 292-8535, Japan
Kobe City Medical Center General Hospital
Kobe, 650 0047, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, 860-0008, Japan
Nagano Municipal Hospital
Nagano, 381-8551, Japan
Nagasaki University Hospital
Nagasaki, 852-8501, Japan
JRC Nagasaki Genbaku Hospital
Nagasaki, 852-8511, Japan
Saiseikai Narashino Hospital
Narashino-shi, 275-8580, Japan
Ehime University Hospital
Toon-shi, 791-0295, Japan
Toyama University Hospital
Toyama, 930 0194, Japan
Yamaguchi University Hospital
Ube, 755-8505, Japan
Yokohama City University Medical Center
Yokohama, 232 0024, Japan
Consultorio Medico dentro del Hospital Angeles Acoxpa
Mexico City, 14308, Mexico
Eme Red Hospitalaria
Mérida, 97000, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, 64460, Mexico
Avix Investigacion Clinica S C
Monterrey, 64710, Mexico
Oncologico Potosino
San Luis Potosí City, 78260, Mexico
Spaarne Gasthuis
Hoofddorp, 2134 TM, Netherlands
Canisius-Wilhelmina Ziekenhuis
Nijmegen, 6524 KD, Netherlands
Radboud Umcn
Nijmegen, 6525 GA, Netherlands
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15 276, Poland
IN VIVO Sp. z o.o
Bydgoszcz, 85 048, Poland
Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego SPZOZ
Lublin, 20 708, Poland
Centrum Medyczne
Piotrkow Trybunalski, 97 300, Poland
Clinical Research Center sp z o o MEDIC R s k
Poznan, 61 731, Poland
Wojewodzki Szpital Specjalistyczny im Janusza Korczaka
Słupsk, 76-200, Poland
Provita Poliklinika
Warsaw, 02-647, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, 02-781, Poland
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw, 50 556, Poland
Ipo Coimbra
Coimbra, 3000-075, Portugal
Uls Santa Maria - Hosp. Santa Maria
Lisbon, 1769 001, Portugal
Uls Gaia Espinho
Vila Nova de Gaia, 4434 502, Portugal
Pusan National University Hospital
Busan, 49241, South Korea
Chungbuk National University Hospital
Cheongju-si, 28644, South Korea
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
Keimyung University Dongsan Hospital
Daegu, 42601, South Korea
National Cancer Center
Gyeonggi-do, 10408, South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591, South Korea
Hosp Univ A Coruna
A Coruña, 15006, Spain
Hosp. Punta de Europa
Algeciras, 11207, Spain
Fund. Puigvert
Barcelona, 08025, Spain
Hosp. Puerta Del Mar
Cadiz, 11009, Spain
Hosp. Gral. Univ. de Castellon
Castellon, 12004, Spain
Hosp. Univ. de Bellvitge
L'Hospitalet de Llobregat, 08907, Spain
Hosp. Univ. Lucus Augusti
Lugo, 27003, Spain
Clinica Univ. de Navarra
Madrid, 28027, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Hosp. Univ. La Paz
Madrid, 28046, Spain
Hosp Virgen de La Victoria
Málaga, 29010, Spain
Hosp. Univ. Marques de Valdecilla
Santander, 39008, Spain
Hosp. Clinico Univ. de Valencia
Valencia, 46010, Spain
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Chang Kung Memorial Hospital
Kaohsiung City, 833, Taiwan
China Medical University Hospital
Taichung, 404, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, 33382, Taiwan
Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
St Bartholomews Hospital
London, EC1A 7BE, United Kingdom
The Royal Marsden NHS Trust
London, SW3 6JJ, United Kingdom
Charing Cross Hospital
London, W6 8RF, United Kingdom
Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
Scunthorpe General Hospital
Scunthorpe, DN15 7BH, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2JF, United Kingdom
Lister Hospital
Stevenage, SG1 4AB, United Kingdom
Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
Truro, TR1 3LJ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
January 27, 2023
First Posted
February 6, 2023
Study Start
March 23, 2023
Primary Completion (Estimated)
September 18, 2029
Study Completion (Estimated)
September 18, 2029
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& 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