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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06651281
Registration number
NCT06651281
Ethics application status
Date submitted
18/10/2024
Date registered
21/10/2024
Date last updated
10/09/2025
Titles & IDs
Public title
Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
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Scientific title
A Phase 3 Extension Study to Evaluate the Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis
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Secondary ID [1]
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2024-513533-20-00
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Secondary ID [2]
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7240-011
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn Disease
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Colitis, Ulcerative
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Condition category
Condition code
Oral and Gastrointestinal
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Inflammatory bowel disease
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Crohn's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tulisokibart
Treatment: Drugs - Placebo to tulisokibart
Experimental: Group 1: Low Dose Unblinded - Participants receive a low dose subcutaneous (SC) tulisokibart regimen.
Experimental: Group 2: High Dose Unblinded - Participants receive a high dose SC tulisokibart regimen.
Experimental: Group 3: High Dose Blinded - Participants receive a blinded high dose SC tulisokibart regimen.
Experimental: Group 4: Low Dose Blinded - Participants receive a blinded low dose SC tulisokibart regimen.
Treatment: Drugs: Tulisokibart
Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously
Treatment: Drugs: Placebo to tulisokibart
Placebo matching SC tulisokibart
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Intervention code [1]
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Treatment: Drugs
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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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Number of Participants Who Experience an Adverse Event (AE)
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Assessment method [1]
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An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
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Timepoint [1]
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Up to approximately 378 weeks
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Primary outcome [2]
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Number of Participants Who Discontinue Study Treatment Due to an AE
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Assessment method [2]
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An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
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Timepoint [2]
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Up to approximately 364 weeks
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Secondary outcome [1]
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Percentage of Participants with Crohn's Disease Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score
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Assessment method [1]
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The percentage of participants who enrolled in their parent study with Crohn's disease who achieve clinical remission, as defined by CDAI score \<150, at Week 364 will be presented.
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Timepoint [1]
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Week 364
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Secondary outcome [2]
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Percentage of Participants with Crohn's Disease Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score
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Assessment method [2]
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The percentage of participants who enrolled in their parent study with Crohn's disease achieving clinical remission at Week 364 per stool frequency/abdominal pain score (SF/APS), as defined by average daily SF =2.8 and average daily APS =1.0 and both not greater than baseline will be presented.
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Timepoint [2]
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Week 364
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Secondary outcome [3]
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Percentage of Participants with Crohn's Disease With Endoscopic Remission Per Simplified Endoscopic Score for Crohn's Disease (SES-CD)
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Assessment method [3]
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The Simplified Endoscopic Score for Crohn's Disease (SES-CD) measures ileocolonoscopic findings in Crohn's Disease. Each segment of the ileo-colon (terminal ileum; ascending, transverse, and descending colon; rectum) is scored from 0 (normal or inactive disease) to 12 (severe disease; no more than one segment can have a score of 12, in which case the other 4 segments must each be =11), and the scores summed to produce an SES-CD ranging from 0 (overall least severe disease) to 56 (overall most severe disease). Endoscopic remission is defined as an SES-CD =4 and at least 2-point reduction from baseline and no subscore \>1 in any individual variable, as scored by central reader.
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Timepoint [3]
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Week 364
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Secondary outcome [4]
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Percentage of Participants with Ulcerative Colitis Achieving Clinical Remission Per Modified Mayo Score (MMS)
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Assessment method [4]
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The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (=5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
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Timepoint [4]
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Week 364
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Eligibility
Key inclusion criteria
* Has participated in a qualifying tulisokibart Phase 2 or Phase 3 parent study for CD or UC
* The investigator determines that the participant derives clinical benefit from continued study intervention based upon clinical evaluations performed during their parent study
* A participant assigned female sex at birth is not breastfeeding during the study intervention period and for at least 14 weeks after the last dose of study intervention
* A participant of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention
* A POCBP uses an acceptable contraceptive method, or adheres to penile-vaginal intercourse abstinence as their preferred and usual lifestyle (abstinent on a long-term and persistent basis)
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Minimum age
No limit
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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
* Has prematurely discontinued study intervention in their parent study
* Has received any protocol-specified prohibited medications during their parent study
* Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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 administering the treatment/s
The people assessing the outcomes
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
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
25/11/2024
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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
17/12/2037
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Actual
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Sample size
Target
1380
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Royal Adelaide Hospital ( Site 4100) - Adelaide
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Connecticut
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United States of America
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State/province [2]
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Michigan
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United States of America
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Missouri
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United States of America
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New York
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Country [5]
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
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Washington
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Czechia
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Brno-mesto
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Czechia
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Hradec Králové
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France
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Alpes-Maritimes
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France
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Hauts-de-Seine
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France
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Meurthe-et-Moselle
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France
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Nord
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Georgia
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Tbilisi
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Hungary
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Bekes County
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Hungary
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Budapest
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Poland
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Greater Poland Voivodeship
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Poland
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Kuyavian-Pomeranian Voivodeship
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Poland
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Lesser Poland Voivodeship
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Poland
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Lower Silesian Voivodeship
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Poland
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Lublin Voivodeship
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Poland
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Masovian Voivodeship
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Poland
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Silesian Voivodeship
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Poland
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West Pomeranian Voivodeship
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Poland
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Lódz Voivodeship
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United Kingdom
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England
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United Kingdom
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State/province [27]
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Knowsley
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Merck Sharp & Dohme LLC
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
Researchers want to learn more about tulisokibart (also known as MK-7240) in an extension study. Tulisokibart is a medicine designed to treat active, moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). An extension study is a type of study where people who received tulisokibart in certain other studies for CD or UC (called a parent study) may be able to join this study. The goals of this study are to learn about the safety of tulisokibart over time in people with CD or UC, and if people tolerate it.
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Trial website
https://clinicaltrials.gov/study/NCT06651281
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Toll Free Number
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Address
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Country
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Phone
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1-888-577-8839
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Fax
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Email
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[email protected]
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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?
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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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://externaldatasharing-msd.com/
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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/NCT06651281
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