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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06956235
Registration number
NCT06956235
Ethics application status
Date submitted
30/04/2025
Date registered
4/05/2025
Date last updated
10/09/2025
Titles & IDs
Public title
Study to Evaluate Tulisokibart for Hidradenitis Suppurativa (MK-7240-012)
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Scientific title
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderate to Severe Hidradenitis Suppurativa
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Secondary ID [1]
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U1111-1316-5263
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Secondary ID [2]
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7240-012
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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:
Hidradenitis Suppurativa
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tulisokibart
Treatment: Drugs - Placebo
Experimental: Arm 1: High Dose - Participants receive a high dose tulisokibart regimen.
Experimental: Arm 2: Medium Dose - Participants receive a medium dose tulisokibart regimen.
Experimental: Arm 3: Low Dose - Participants receive a low dose tulisokibart regimen.
Placebo comparator: Arm 4: Placebo - Participants receive a placebo regimen, and are then allocated to a medium or high tulisokibart dose regimen after Week 16.
Treatment: Drugs: Tulisokibart
Solution in autoinjector for subcutaneous (SC) injection
Treatment: Drugs: Placebo
Solution in autoinjector for SC injection
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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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Percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 50 at Week 16
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Assessment method [1]
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The percentage of participants with =50% reduction in total abscesses and inflammatory nodules (AN) count with no increase in abscess count, and no increase in draining tunnels (ie, HiSCR50) will be reported.
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Timepoint [1]
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Week 16
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Secondary outcome [1]
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Percentage of participants achieving HiSCR75 at Week 16
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Assessment method [1]
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The percentage of participants with =75% reduction in total abscesses and inflammatory nodules (AN) count with no increase in abscess count, and no increase in draining tunnels (ie, HiSCR75) will be reported.
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Timepoint [1]
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Week 16
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Secondary outcome [2]
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Mean Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16
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Assessment method [2]
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The DLQI is a validated dermatology-specific instrument that measures the HRQoL in adult patients with skin diseases. The DLQI consists of 10 questions and provides a total HRQoL score, as well as scores for 6 aspects of QoL: symptoms and feelings; daily activities; leisure; work/school; personal relationships; and treatment. The recall period is over the last week. Question responses are assessed using a 4-point Likert rating scale ranging from "not at all" (scored 0) to "very much" (scored 3). The final score ranges from 0 (no impact on QOL) to 30 (maximum impairment). The mean change from baseline in DLQI at Week 16 will be reported.
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Timepoint [2]
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Week 16
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Secondary outcome [3]
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Percentage of Participants Who Experience One or More Adverse Events (AEs)
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Assessment method [3]
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An AE is defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of participants with any AE will be reported.
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Timepoint [3]
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Up to ~130 weeks
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Secondary outcome [4]
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Percentage of Participants Who Discontinue Study Intervention Due to an AE
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Assessment method [4]
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An AE is defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of participants discontinuing from study intervention due to AE will be reported.
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Timepoint [4]
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Up to ~116 weeks
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Eligibility
Key inclusion criteria
* Has signs and symptoms of hidradenitis suppurativa (HS) for = 6 months and a clinical diagnosis of HS at screening
* Has moderate or severe HS
* Has a history of inadequate response to a course of systemic antibiotics for treatment of HS or intolerance to or has a contraindication to systemic antibiotics for treatment of HS
* Has =20 draining tunnel count at Screening and Randomization
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Minimum age
18
Years
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Maximum age
75
Years
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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 other active skin conditions that may interfere with the assessment of HS
* Has any immune-mediated inflammatory condition that is not well controlled and which may potentially require biologic therapy
* Has a transplanted organ and requires continued systemic immunosuppression
* Has a history of cancer (except fully treated non-melanoma skin cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years
* 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
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 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 2
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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
9/06/2025
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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
22/01/2029
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Actual
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Sample size
Target
147
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Liverpool Hospital ( Site 1403) - Liverpool
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Recruitment hospital [2]
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The Alfred Hospital ( Site 1401) - Melbourne
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Recruitment hospital [3]
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Fremantle Dermatology ( Site 1402) - Fremantle
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Recruitment postcode(s) [1]
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1871 - Liverpool
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment postcode(s) [3]
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6160 - Fremantle
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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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Alabama
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United States of America
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Arizona
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Arkansas
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United States of America
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California
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United States of America
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Florida
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Georgia
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Indiana
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Michigan
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New York
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North Carolina
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Ohio
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South Carolina
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Texas
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Argentina
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CABA
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Canada
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Ontario
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China
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Guangdong
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China
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Hunan
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China
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Jilin
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China
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Shanghai Municipality
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China
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Xinjiang
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Colombia
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Antioquia
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France
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Paris
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Japan
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Aichi-ken
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Japan
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Hokkaido
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Japan
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Okinawa
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Japan
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Tokyo
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Japan
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Kyoto
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Netherlands
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South Holland
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Spain
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Valencia
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Spain
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State/province [30]
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Barcelona
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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
This is a phase 2b randomized, double-blind, placebo-controlled study of the safety and efficacy of tulisokibart in participants with moderate to severe hidradenitis suppurativa. The primary hypothesis is that at least 1 dose of tulisokibart is superior to placebo with respect to the proportion of participants achieving a 50% reduction in Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 16 (ie, at end of double-blind treatment).
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Trial website
https://clinicaltrials.gov/study/NCT06956235
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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 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/NCT06956235
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