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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04232553
Registration number
NCT04232553
Ethics application status
Date submitted
15/01/2020
Date registered
18/01/2020
Titles & IDs
Public title
A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
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Scientific title
A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients With Crohn's Disease
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Secondary ID [1]
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0
I6T-MC-AMAX
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Secondary ID [2]
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16628
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Universal Trial Number (UTN)
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Trial acronym
VIVID-2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease
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0
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Condition category
Condition code
Oral and Gastrointestinal
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0
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0
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Inflammatory bowel disease
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Inflammatory and Immune System
0
0
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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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Crohn's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Mirikizumab
Treatment: Drugs - Mirikizumab
Experimental: Mirikizumab SC - Mirikizumab given subcutaneously (SC).
Experimental: Mirikizumab IV and SC - Mirikizumab given intravenously (IV) and SC.
Treatment: Drugs: Mirikizumab
Administered IV
Treatment: Drugs: Mirikizumab
Administered SC
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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 Endoscopic Response
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Assessment method [1]
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Endoscopic response based on Simple Endoscopic Score for Crohn's Disease (SES-CD) total score
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Timepoint [1]
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Week 52
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Primary outcome [2]
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Percentage of Participants Achieving Clinical Remission
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Assessment method [2]
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Clinical remission based on Crohn's Disease Activity Index (CDAI)
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Timepoint [2]
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Week 52
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Secondary outcome [1]
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Percentage of Participants Achieving Endoscopic Remission
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Assessment method [1]
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Endoscopic remission based on SES-CD total score
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Timepoint [1]
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Week 52
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Secondary outcome [2]
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Percentage of Participants Achieving Clinical Response
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Assessment method [2]
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Clinical response by patient-reported outcomes (PRO) based on stool frequency (SF) and abdominal pain (AP)
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Timepoint [2]
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Week 52
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Secondary outcome [3]
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Change from Baseline in C-Reactive Protein
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Assessment method [3]
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Change from baseline in c-reactive protein
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Timepoint [3]
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Baseline, Week 12
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Secondary outcome [4]
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Change from Baseline in Fecal Calprotectin
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Assessment method [4]
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Change from baseline in fecal calprotectin
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Timepoint [4]
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Baseline, Week 12
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Secondary outcome [5]
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Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ)
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Assessment method [5]
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Change from baseline on the IBDQ
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Timepoint [5]
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Baseline to Week 52
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Eligibility
Key inclusion criteria
* Participants must have completed study I6T-MC-AMAG (NCT02891226) or study I6T-MC-AMAM (NCT03926130)
* If female, participant must meet the contraception requirements
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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
* Participants must not have developed a new condition, including cancer in the previous study (I6T-MC-AMAG or I6T-MC-AMAM) that would pose an unacceptable risk in the trial.
* Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either previous study.
Note: Participants with a history of active TB with documentation of treatment by the Centers for Disease Control (CDC) and/or World Health Organization (WHO) criteria prior to the originator study are not excluded from the study.
* Participants must not have a known hypersensitivity to any component of mirikizumab or have experienced acute systemic hypersensitivity event with previous study drug administration in the originating study that precludes mirikizumab therapy.
* Participation must not be pregnant, lactating, or planning to become pregnant while enrolled in the study or 16 weeks after receiving the last dose of study drug.
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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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
22/06/2020
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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
1/12/2026
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Actual
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Sample size
Target
778
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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St Vincent's Hospital - Sydney
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Royal Brisbane and Women's Hospital - Brisbane
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Coastal Digestive Health - Maroochydore
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Royal Adelaide Hospital - Adelaide
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The Royal Melbourne Hospital - Parkville
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Recruitment hospital [7]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
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2139 - Concord
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Recruitment postcode(s) [2]
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2010 - Sydney
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Recruitment postcode(s) [3]
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4029 - Brisbane
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4558 - Maroochydore
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5000 - Adelaide
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Recruitment postcode(s) [6]
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3050 - Parkville
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Recruitment postcode(s) [7]
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6150 - Murdoch
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Korea, Republic of
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Seoul-teukbyeolsi [Seoul]
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Korea, Republic of
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Taegu-Kwangyokshi
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Korea, Republic of
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Taegu-Kwan
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Korea, Republic of
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Taejon-Kwangyokshi
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Latvia
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Riga
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Lithuania
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Kaunas
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Mexico
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Nuevo León
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Mexico
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San Luis Potosí
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Mexico
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Chihuahua
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Netherlands
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Noord-Brabant
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Netherlands
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Noord-Holland
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Poland
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Dolnoslaskie
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Poland
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Kujawsko-pomorskie
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Poland
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Lubelskie
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Poland
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Mazowieckie
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Poland
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Malopolskie
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Poland
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Podkarpackie
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Poland
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Podlaskie
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Poland
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Pomorskie
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Poland
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Silesian
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Poland
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Warminsko-mazurskie
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Poland
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Poland
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Zachodniopomorskie
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Poland
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Slaskie
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Romania
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Bucure?ti
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Romania
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Timi?
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Romania
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Constan?a
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Russian Federation
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Altayskiy Kray
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Russian Federation
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Irkutskaya Oblast'
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Russian Federation
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Kareliya, Respublika
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Russian Federation
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Kemerovskaya Oblast'
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Russian Federation
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Moskva
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Russian Federation
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Nizhegorodskaya Oblast'
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Russian Federation
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Novosibirskaya Oblast'
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Russian Federation
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Omskaya Oblast'
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Russian Federation
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Rostovskaya Oblast'
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Russian Federation
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Samarskaya Oblast'
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Russian Federation
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Sankt-Peterburg
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Russian Federation
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Sverdlovskaya Oblast'
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Serbia
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Beograd
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Serbia
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Vojvodina
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Slovakia
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Banskobystrický Kraj
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Slovakia
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Bratislavs
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Slovakia
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Nitriansky Kraj
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Slovakia
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PreÅ¡ovský Kraj
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Switzerland
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Berne
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Switzerland
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Sankt Gallen
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Turkey
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Balçova
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Turkey
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Eskisehir
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Turkey
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Istanbul
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Turkey
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Kocaeli
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Turkey
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Ankara
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Turkey
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Antalya
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Turkey
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Bursa
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Turkey
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Edirne
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Turkey
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Hatay
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Turkey
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Mersin
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Ukraine
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Dnipropetrovska Oblast
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Ukraine
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Ivano-Frankivska Oblast
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Ukraine
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Kharkivska Oblast
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Ukraine
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Kyivska Oblast
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Ukraine
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Lvivska Oblast
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Ukraine
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Odeska Oblast
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Ukraine
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Vinnytska Oblast
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Ukraine
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Zakarpatska Oblast
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Ukraine
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Zaporizka Oblast
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Ukraine
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Chernivtsi
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Ukraine
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Kyiv
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United Kingdom
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Cambridgeshire
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United Kingdom
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England
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United Kingdom
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Cardiff
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Eli Lilly and Company
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.
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Trial website
https://clinicaltrials.gov/study/NCT04232553
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM -5 PM Eastern time (UTC/GMT - 5 hours, EST)
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Address
0
0
Eli Lilly and Company
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0
0
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Phone
0
0
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Fax
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0
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Email
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0
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Contact person for public queries
Name
0
0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
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Address
0
0
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Country
0
0
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Phone
0
0
1-317-615-4559
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Fax
0
0
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Email
0
0
[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?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
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Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/
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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/NCT04232553