A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer (MoonRISe-3)

A Phase 3, Randomized, Open-label, Multicenter Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Investigator's Choice of Intravesical Chemotherapy in Participants With High-risk Non-muscle-invasive Bladder Cancer With Susceptible FGFR Alterations Who Had Received Intravesical Bacillus Calmette-Guérin (BCG)

The main purpose of this study is to compare the disease-free survival (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of high-risk non-muscle-invasive bladder cancer (HR-NMIBC).

Study Overview

• Status: Recruiting
• Conditions: Non-Muscle Invasive Bladder Neoplasms
• Intervention / Treatment: Drug: Gemcitabine; Drug: TAR-210; Drug: Mitomycin C

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1426ANZ
    • Recruiting
    • Instituto Alexander Fleming
  • Buenos Aires, Argentina, C1419AHN
    • Recruiting
    • Hospital Sirio Libanes
  • Caba, Argentina, C1425
    • Recruiting
    • Investigaciones Clinico Moleculares (ICM)
  • Córdoba, Argentina, X5000KPH
    • Recruiting
    • Centro Urologico Profesor Bengio
  • Rosario, Argentina, 2000
    • Recruiting
    • Sanatorio de la Mujer
• Belgium
  • Brussels, Belgium, 1070
    • Recruiting
    • Hopital Erasme
  • Genk, Belgium, 3600
    • Recruiting
    • Ziekenhuis Oost-Limburg
  • Ghent, Belgium, 9000
    • Recruiting
    • AZ Maria Middelares
  • Leuven, Belgium, 3000
    • Recruiting
    • Universitair Ziekenhuis Leuven
  • Roeselare, Belgium, 8800
    • Recruiting
    • Algemeen Ziekenhuis Delta
• Brazil
  • Natal, Brazil, 59062 000
    • Recruiting
    • Liga Norte Riograndense Contra O Cancer
  • Presidente Prudente, Brazil, 19013-050
    • Recruiting
    • Hospital Regional do Cancer - Hospital de Esperança
  • São José do Rio Preto, Brazil, 15090 000
    • Recruiting
    • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
  • São Paulo, Brazil, 01246 000
    • Recruiting
    • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
  • São Paulo, Brazil, 01323 010
    • Recruiting
    • Real e Benemerita Associacao Portuguesa de Beneficencia
• China
  • Beijing, China, 100034
    • Recruiting
    • Peking University First Hospital
  • Chengdu, China, 610093
    • Recruiting
    • West China Hospital Sichuan University
  • Chengdu, China, 610014
    • Recruiting
    • The Third People's Hospital of Chengdu
  • Guangzhou, China, 510260
    • Recruiting
    • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
  • Nanjing, China, 210008
    • Recruiting
    • Nanjing Drum Tower Hospital
  • Ningbo, China, 315020
    • Recruiting
    • The First Affiliated Hospital of Ningbo University
  • Tianjin, China, 300211
    • Recruiting
    • The Second Hospital Of Tianjin Medical University
  • Wenzhou, China, 325000
    • Recruiting
    • The First Affiliated Hospital of Wenzhou Medical University
  • Wuhan, China, 430030
    • Recruiting
    • TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
• France
  • Marseille, France, 13009
    • Recruiting
    • Institut Paoli Calmettes
  • Paris, France, 75010
    • Recruiting
    • Hopital Saint Louis
  • Paris, France, 75013
    • Recruiting
    • CHU Pitie Salpetriere
  • Paris, France, 75014
    • Recruiting
    • Hopital Saint Joseph
  • Quint-Fonsegrives, France, 31130
    • Recruiting
    • Clinique de la Croix du Sud
  • Saint-Grégoire, France, 35768
    • Recruiting
    • CHP Saint Gregoire
  • Villejuif, France, 94800
    • Recruiting
    • Gustave Roussy
• Germany
  • Cologne, Germany, 50937
    • Recruiting
    • Universitaetsklinikum Koeln
  • Herne, Germany, 44625
    • Recruiting
    • Marien Hospital Herne
  • Leverkusen, Germany, 51375
    • Recruiting
    • Klinikum Leverkusen gGmbH
  • Mannheim, Germany, 68167
    • Recruiting
    • Universitaetsklinikum Mannheim
  • Nürtingen, Germany, 72622
    • Recruiting
    • Studienpraxis Urologie Nurtingen
  • Regensburg, Germany, 93053
    • Recruiting
    • Caritas-Krankenhaus St. Josef
• Greece
  • Athens, Greece, 115 27
    • Recruiting
    • Laiko General Hospital of Athens
  • Athens, Greece, 115 27
    • Recruiting
    • General Hospital of Athens G Gennimatas
  • Athens, Greece, 15126
    • Recruiting
    • Sismanogleio General Hospital
  • Thessaloniki, Greece, 56429
    • Recruiting
    • General Hospital Of Thessaloniki Papageorgiou
  • Thessaloniki, Greece, 57001
    • Recruiting
    • Athens Medical Center S A Interbalkan Medical Center of Thessaloniki
• Israel
  • Haifa, Israel, 3109601
    • Recruiting
    • Rambam Medical Center
  • Haifa, Israel, 3436212
    • Recruiting
    • Carmel Medical Center
  • Kfar Saba, Israel, 44281
    • Recruiting
    • Meir Medical Center
  • Petah Tikva, Israel, 4941492
    • Recruiting
    • Rabin Medical Center
  • Ramat Gan, Israel, 52621
    • Recruiting
    • Sheba Medical Center
  • Tel Aviv, Israel, 64239
    • Recruiting
    • Tel Aviv Sourasky Medical Center
• Italy
  • Bergamo, Italy, 24125
    • Recruiting
    • Cliniche Humanitas Gavazzeni
  • Brescia, Italy, 25123
    • Recruiting
    • ASST Spedali Civili Brescia
  • Genova, Italy, 16149
    • Recruiting
    • SPDC Villa Scassi
  • Milan, Italy, 20132
    • Recruiting
    • Ospedale San Raffaele
  • Naples, Italy, 80131
    • Recruiting
    • Fondazione G Pascale Istituto Nazionale Tumori IRCCS
  • Roma, Italy, 00144
    • Recruiting
    • Istituto Nazionale Tumori Regina Elena
  • Sanatorio San Luigi, Italy, 10043
    • Recruiting
    • Aou San Luigi Gonzaga
  • Udine, Italy, 33100
    • Recruiting
    • Ospedale S. Maria Della Misericordia
• Japan
  • Bunkyō City, Japan, 113 8431
    • Recruiting
    • Juntendo University Hospital
  • Funabashi Shi, Japan, 273 8588
    • Recruiting
    • Funabashi Municipal Medical Center
  • Hakodate, Japan, 040 8611
    • Recruiting
    • Hakodate Goryoukaku Hospital
  • Kawasaki, Japan, 216 8511
    • Recruiting
    • St Marianna University Hospital
  • Minatoku, Japan, 105 8471
    • Recruiting
    • The Jikei University Hospital
  • Sakura, Japan, 285-8741
    • Recruiting
    • Toho University Sakura Medical Center
  • Yokohama, Japan, 221 0855
    • Recruiting
    • Yokohama Municipal Citizen's Hospital
  • Yokohama, Japan, 232 0024
    • Recruiting
    • Yokohama City University Medical Center
• Netherlands
  • Nijmegen, Netherlands, 6525 GA
    • Recruiting
    • Radboud Umcn
  • Nijmegen, Netherlands, 6532 SZ
    • Recruiting
    • Canisius-Wilhelmina ZH
  • Rotterdam, Netherlands, 3015
    • Recruiting
    • Erasmus MC
  • Utrecht, Netherlands, 3584 CX
    • Recruiting
    • UMC Utrecht
• South Korea
  • Cheongju-si, South Korea, 28644
    • Recruiting
    • Chungbuk National University Hospital
  • Gangnam Gu, South Korea, 06351
    • Recruiting
    • Samsung Medical Center
  • Seongnam-si, South Korea, 13620
    • Recruiting
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 03080
    • Recruiting
    • Seoul National University Hospital
  • Seoul, South Korea, 03722
    • Recruiting
    • Severance Hospital Yonsei University Health System
• Spain
  • A Coruña, Spain, 15006
    • Recruiting
    • Hosp Univ A Coruna
  • Barcelona, Spain, 08036
    • Recruiting
    • Hosp. Clinic de Barcelona
  • Cadiz, Spain, 11009
    • Recruiting
    • Hosp. Puerta Del Mar
  • Castellon, Spain, 12004
    • Recruiting
    • Hosp. Gral. Univ. de Castellon
  • Ferrol, Spain, 15405
    • Recruiting
    • Hosp. Arquitecto Marcide
  • Jerez de la Frontera, Spain, 11407
    • Recruiting
    • Hosp. de Jerez de La Frontera
  • Madrid, Spain, 28041
    • Recruiting
    • Hosp. Univ. 12 de Octubre
  • Málaga, Spain, 29010
    • Recruiting
    • Hosp Virgen de La Victoria
  • Sabadell, Spain, 08208
    • Recruiting
    • Hosp.Univ.Parc Tauli
• United Kingdom
  • Cottingham, United Kingdom, HU16 5JQ
    • Recruiting
    • Hull University Teaching Hospitals NHS Trust
  • London, United Kingdom, EC1A 7BE
    • Recruiting
    • St Bartholomews Hospital
  • Southampton, United Kingdom, SO16 6HU
    • Recruiting
    • Southampton University Hospital
  • Stevenage, United Kingdom, SG1 4AB
    • Recruiting
    • Lister Hospital
  • Surrey, United Kingdom, SM2 5PT
    • Recruiting
    • Royal Marsden Hospital
• United States
  • Arizona
    • Sun City, Arizona, United States, 85351
      • Recruiting
      • Academic Urology and Urogynecology of Arizona
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Recruiting
      • Colorado Clinical Research
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Recruiting
      • Georgia Urology
  • Illinois
    • Chicago Ridge, Illinois, United States, 60415
      • Recruiting
      • Associated Urological Specialists
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Recruiting
      • Urology of Indiana
  • Massachusetts
    • Plymouth, Massachusetts, United States, 02360
      • Recruiting
      • Greater Boston Urology
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Recruiting
      • Comprehensive Urology
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Completed
      • UroHealth Partners
  • New Jersey
    • Voorhees Township, New Jersey, United States, 08043
      • Recruiting
      • New Jersey Urology LLC
  • New York
    • Syracuse, New York, United States, 13210
      • Recruiting
      • Associated Medical Professionals
  • Ohio
    • Centerville, Ohio, United States, 45459
      • Recruiting
      • Dayton Physicians Network Urology
    • Cincinnati, Ohio, United States, 45212
      • Recruiting
      • The Urology Group
    • Middleburg Heights, Ohio, United States, 44130
      • Recruiting
      • Helios Clinical Research, LLC
  • Oregon
    • Springfield, Oregon, United States, 97477
      • Recruiting
      • Oregon Urology Institute
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Recruiting
      • MidLantic Urology
    • Lancaster, Pennsylvania, United States, 17604
      • Recruiting
      • Keystone Urology Specialists
    • Pittsburgh, Pennsylvania, United States, 15232
      • Recruiting
      • University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Recruiting
      • Carolina Urologic Research Center
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Recruiting
      • The Conrad Pearson Clinic
  • Texas
    • Austin, Texas, United States, 78731
      • Recruiting
      • Texas Oncology-Austin
    • Austin, Texas, United States, 78745
      • Recruiting
      • Urology Austin
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Urology San Antonio PA dba USA Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• Histologically confirmed diagnosis by local pathology of papillary-only HR-NMIBC (defined as high-grade Ta or any T1, no CIS). Mixed histology tumors are allowed if urothelial differentiation is predominant. However, neuroendocrine, and small cell variants will be excluded
• Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue) as determined by central or local testing
• All visible tumor completely resected prior to randomization. Urine cytology must not be positive or suspicious for high grade UC before randomization. For participants with lamina propria invasion (T1) on the screening biopsy/TURBT, muscularis propria must be present to rule out MIBC
• Participants must have had either: a. Adequate Induction (5 of 6 doses) and either 2 of 3 doses of Maintenance or 2 of 6 doses of second Induction of BCG with high-grade T1 disease at first disease assessment after induction or high-grade Ta/any T1 disease within 6 months after last BCG (BCG-unresponsive population); b. had adequate induction (5 or 6 doses) with or without maintenance BCG with high-grade Ta/any T1 disease within 12 months after last BCG excluding BCG-unresponsive (BCG-experienced population); or c. been unable to complete an induction course of BCG with at least 5 doses due to grade >= 2 toxicity requiring BCG discontinuation (BCG intolerant population)
• Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2
• Must be ineligible for or refusing radical cystectomy (RC)

Exclusion criteria:

• Presence of CIS at any point from time of diagnosis of papillary-only HR-NMIBC recurrence to randomization. Additionally, presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is [i.e.], T2, T3, T4, N+, and/or M+)
• Active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. Allowed recent second or prior malignancies: a. Any malignancy that was not progressing nor requiring treatment change in the last 12 months; b. Malignancies treated within the last 12 months and considered at very low risk for recurrence for example (e.g.): non-melanoma skin cancers (treated with curative therapy or localized melanoma treated with curative surgical resection alone), non-invasive cervical cancer, breast cancer (adequately treated lobular CIS or ductal CIS, localized breast cancer and receiving antihormonal agents), localized prostate cancer ([N0, M0] with a Gleason score less than or equal to [<=] 7a, treated locally only [radical prostatectomy/radiation therapy/focal treatment]) and other malignancy that is considered at minimal risk of recurrence
• Presence of any bladder or urethral anatomic feature that, in the opinion of the investigator, may prevent the safe placement, indwelling use, or removal of TAR 210
• A history of clinically significant polyuria with recorded 24 hour urine volumes greater than (>) 4,000 milliliters (mL)
• Indwelling catheters are not permitted; however, intermittent catheterization is acceptable

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: TAR-210; Participants in Group A will have TAR-210 inserted in the bladder on Day 1. TAR-210 will be inserted over a treatment duration of approximately 2 years.	Drug: TAR-210; TAR-210 will be administered intravesically.; Other Names: JNJ-42756493
Active Comparator: Group B: Mitomycin C (MMC) or Gemcitabine; Participants in Group B will receive intravesical mitomycin C (MMC) or gemcitabine (investigator's choice) once weekly for 4 to 6 induction doses followed by maintenance dosing once monthly for up to 1 year. An optional second year of additional maintenance can be added at the investigator's discretion.	Drug: Gemcitabine; Gemcitabine will be administered intravesically.; Drug: Mitomycin C; MMC will be administered intravesically.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free Survival (DFS)	DFS is measured as the time from randomization to the date of the first recurrence of HR-NMIBC (high-grade Ta, any T1 or carcinoma in situ [CIS]), progression, or death due to any cause, whichever occurs first.	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence-Free Survival (RFS)	RFS is measured as the time from randomization to the date of the first recurrence of HR-NMIBC (high-grade Ta, any T1, or CIS), or death due to any cause, whichever occurs first.	Up to 5 years
Time to Next Intervention (TTNI)	TTNI (i.e., transurethral resection of bladder tumor [TURBT], radical cystectomy [RC], radiation therapy [RT], or chemotherapy) is measured as the time from randomization to the date of next intervention (localized or systemic) for the treatment of urothelial carcinoma (UC).	Up to 5 years
Time to Disease Worsening (TTDW)	TTDW is measured as the time from randomization to the date of cystectomy, systemic therapy, or radiation therapy, whichever occurs first.	Up to 5 years
Time to Progression (TTP)	TTP is measured as the time from randomization to the date of first documented evidence of disease progression (i.e., progression to muscle-invasive bladder cancer [MIBC] [T greater than or equal to {>=} 2], lymph node [N+], or distant disease [M+]), or death due to disease progression, whichever occurs first.	Up to 5 years
Overall Survival (OS)	OS is defined as the time from randomization to death due to any cause.	Up to 5 years
Number of Participants with Adverse Events (AEs) According to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0	Number of participants with AEs by severity grade as assessed by CTCAE version 5.0 will be reported. Grade refers to the severity of AE as follows: Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5- Death related to adverse event.	Up to 5 years
Number of Participants With Change from Baseline in Laboratory Abnormalities	Number of participants with change from baseline in laboratory abnormalities (hematology, serum chemistry and urine analysis) will be reported.	Up to 5 years
Number of Participants With Change from Baseline in Vital Signs Abnormalities	Number of participants with change from baseline in vital signs (temperature, pulse/heart rate, respiratory rate and blood pressure) will be reported.	Up to 5 years
Change from Baseline in European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-C30 Scores	EORTC QLQ-C30 is a 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. It includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea or vomiting), a global health status or HRQoL scale and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicate greater functioning, better global health status, or more severe symptoms.	Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and 96
Change from Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores	EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with NMIBC. The questionnaire is designed to supplement the QLQ-C30 and incorporates 6 multi-item scales (urinary symptoms, malaise, future worries, bloating and flatulence, sexual function and male sexual problems) and 5 single items (intravesical treatment issues, sexual intimacy, worries about risk of contaminating partner, sexual enjoyment, and female sexual problems). Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores represent a high level of symptoms or problems, except for sexual function and sexual enjoyment, where a higher score represents a higher level of functioning.	Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and 96
Percentage of Participants With Meaningful Change From Baseline in EORTC-QLQ-C30 Scores	EORTC QLQ-C30 is a 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. It includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea or vomiting), a global health status or HRQoL scale and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicate greater functioning, better global health status, or more severe symptoms.	Weeks 12, 24, 36, 48, 60, 72, 84 and 96
Percentage of Participants With Meaningful Change From Baseline in EORTC-QLQ-NMIBC24 Scores	EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with NMIBC. The questionnaire is designed to supplement the QLQ-C30 and incorporates 6 multi-item scales (urinary symptoms, malaise, future worries, bloating and flatulence, sexual function and male sexual problems) and 5 single items (intravesical treatment issues, sexual intimacy, worries about risk of contaminating partner, sexual enjoyment, and female sexual problems). Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores represent a high level of symptoms or problems, except for sexual function and sexual enjoyment, where a higher score represents a higher level of functioning.	Weeks 12, 24, 36, 48, 60, 72, 84 and 96
Number of Participants with Overall Side Effects Measured by EORTC Question 168 (Q168)	EORTC Q168 is a single item from the EORTC item library used to measure the overall impact of treatment side effects. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Higher score indicates greater impact.	Up to Week 96

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2025
• Primary Completion (Estimated): April 6, 2028
• Study Completion (Estimated): March 16, 2032

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Urologic Neoplasms; Carcinoma; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Quinones; Azirines; Mitomycins; Indolequinones; Gemcitabine; Mitomycin; erdafitinib
• Other Study ID Numbers: 42756493BLC3005 (Other Identifier: Janssen Research & Development, LLC); 2024-519493-39-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No