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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05528510
Registration number
NCT05528510
Ethics application status
Date submitted
19/08/2022
Date registered
6/09/2022
Titles & IDs
Public title
A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
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Scientific title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
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Secondary ID [1]
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0
2022-000365-41
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Secondary ID [2]
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0
CR109228
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Universal Trial Number (UTN)
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Trial acronym
ASTRO
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colitis, Ulcerative
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0
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Condition category
Condition code
Oral and Gastrointestinal
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0
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
0
0
0
0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
0
0
0
0
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Guselkumab Dose 1
Treatment: Drugs - Guselkumab Dose 2
Treatment: Drugs - Guselkumab Dose 3
Other interventions - Placebo
Experimental: Group 1: Guselkumab - Participants will receive guselkumab (Dose 1) subcutaneous (SC) injection followed by guselkumab (Dose 2) SC injection.
Experimental: Group 2: Guselkumab - Participants will receive guselkumab (Dose 1) SC injection followed by guselkumab (Dose 3) SC injection.
Placebo comparator: Group 3: Placebo - Participants will receive matching placebo SC injection.
Treatment: Drugs: Guselkumab Dose 1
Guselkumab (Dose 1) will be administered as SC injection.
Treatment: Drugs: Guselkumab Dose 2
Guselkumab (Dose 2) will be administered as SC injection.
Treatment: Drugs: Guselkumab Dose 3
Guselkumab (Dose 3) will be administered as SC injection.
Other interventions: Placebo
Placebo will be administered as SC injection.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Clinical Remission
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Assessment method [1]
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Clinical remission per modified Mayo score.
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Timepoint [1]
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Week 12
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Secondary outcome [1]
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Symptomatic Remission
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Assessment method [1]
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Symptomatic remission per Mayo score is defined as a stool frequency subscore of 0 (normal number of stools) or 1 (1 to 2 stools more than normal) and a rectal bleeding subscore of 0 (no blood seen).
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Timepoint [1]
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Weeks 12 and 24
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Secondary outcome [2]
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Endoscopic Improvement
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Assessment method [2]
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Endoscopic improvement per Mayo endoscopy subscore.
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Timepoint [2]
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Weeks 12 and 24
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Secondary outcome [3]
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Clinical Response
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Assessment method [3]
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Clinical response per modified Mayo score.
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Timepoint [3]
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Weeks 12 and 24
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Secondary outcome [4]
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Clinical Remission
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Assessment method [4]
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Clinical remission per modified Mayo score.
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Timepoint [4]
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Week 24
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Secondary outcome [5]
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Histologic-Endoscopic Mucosal Improvement
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Assessment method [5]
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Histologic-endoscopic mucosal improvement is defined as a combination of histologic improvement according to the Geboes grading system and endoscopic improvement (Mayo endoscopy subscore of 0 or 1 without friability).
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Timepoint [5]
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Week 12
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Secondary outcome [6]
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Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation of Study Intervention
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Assessment method [6]
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Percentage of participants with AEs, SAEs and AEs leading to discontinuation of study intervention will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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Timepoint [6]
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Up to Week 112
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Eligibility
Key inclusion criteria
* Signed informed consent form
* 18 years of age or older
* Documented diagnosis of ulcerative colitis (UC) at least 12 weeks prior to screening
* Moderately to severely active UC as per the modified Mayo score
* Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease
* Surgery within 8 weeks before screening or planned surgery during the study that may confound the evaluation of benefit from study intervention
* Receiving prohibited medications and treatments
* UC limited to the rectum only
* Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) corona virus disease (COVID-19) infection
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/09/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
10/10/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
418
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Royal Prince Alfred Hospital - Camperdown
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Monash Health - Clayton
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Royal Brisbane and Women's Hospital - Herston
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Fiona Stanley Hospital - Murdoch
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Royal Melbourne Hospital - Parkville
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IBD Clinical Trials Mater Research - South Brisbane
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The Queen Elizabeth Hospital - Woodville South
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Princess Alexandra Hospital - Woolloongabba
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5000 - Adelaide
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2050 - Camperdown
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3168 - Clayton
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4029 - Herston
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6150 - Murdoch
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3050 - Parkville
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4101 - South Brisbane
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5011 - Woodville South
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Recruitment postcode(s) [9]
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4102 - Woolloongabba
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Recruitment outside Australia
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Sumida ku
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Tokyo
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Urayasu
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Jordan
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Amman
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Jordan
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Aydoun
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Jordan
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Irbid
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Busan
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Suwon si
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Malaysia
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Batu Caves
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Kuching
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Merida
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Monterrey
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Saltillo
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Mexico
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San Pedro Garza Garcia
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Boulcott
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Grafton
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Hamilton
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Poland
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Bialystok
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Bydgoszcz
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Chojnice
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Grudziadz
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Krakow
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Lublin
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Torun
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Zamosc
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Kosice
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Nitra
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Badalona
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Sevilla
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Spain
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Villajoyosa
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Spain
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Taichung
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Taipei
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Istambul
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Izmir
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Turkey
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Mersin
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).
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Trial website
https://clinicaltrials.gov/study/NCT05528510
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Janssen Research & Development, LLC Clinical trial
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Address
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Janssen Research & Development, LLC
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05528510