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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04232553




Registration number
NCT04232553
Ethics application status
Date submitted
15/01/2020
Date registered
18/01/2020
Date last updated
4/12/2020

Titles & IDs
Public title
A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
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
Secondary ID [1] 0 0
I6T-MC-AMAX
Secondary ID [2] 0 0
16628
Universal Trial Number (UTN)
Trial acronym
VIVID-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Endoscopic Response - Endoscopic response based on Simple Endoscopic Score for Crohn's Disease (SES-CD) total score
Timepoint [1] 0 0
Week 52
Secondary outcome [1] 0 0
Percentage of Participants Achieving Clinical Remission - Clinical remission by Patient Reported Outcome (PRO) based on stool frequency (SF) and abdominal pain (AP)
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Percentage of Participants Achieving Endoscopic Remission - Endoscopic remission based on SES-CD total score
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Percentage of Participants Achieving Clinical Response - Clinical response by PRO based on SF and AP
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Change from Baseline in C-Reactive Protein - Change from baseline in c-reactive protein
Timepoint [4] 0 0
Baseline, Week 12
Secondary outcome [5] 0 0
Change from Baseline in Fecal Calprotectin - Change from baseline in fecal calprotectin
Timepoint [5] 0 0
Baseline, Week 12
Secondary outcome [6] 0 0
Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) - Change from baseline on the IBDQ
Timepoint [6] 0 0
Baseline to Week 52

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants must not have developed a new condition, including cancer in the previous
study (I6T-MC-AMAG or I6T-MC-AMAM)

- 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

- Participants may not have received surgery for Crohn's disease in the originator study
or are likely to require surgery for treatment of Crohn's disease during the study

- Participants must not have developed adenomatous polyps during the originator study
that have not been removed prior to the start of this study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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Florida
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Georgia
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Idaho
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Indiana
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Kentucky
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Louisiana
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Michigan
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Minnesota
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Missouri
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New Jersey
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North Carolina
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Ohio
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Oklahoma
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Tennessee
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Texas
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Utah
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Washington
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Argentina
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Buenos Aires
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Austria
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Vienna
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Austria
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Innsbruck
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Austria
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Salzburg
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Austria
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Wien
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Belgium
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Brussel
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Belgium
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Gent
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Bahia
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Ceara
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Distrito Federal
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GO
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Parana
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Rio Grande Do Sul
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Sao Paulo
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SP
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São Paulo
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Rio de Janeiro
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Canada
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Ontario
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Olomouc
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Plzen
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Praha 4 - Krc
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Czechia
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Czechia
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Praha 8 - Karlin
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Czechia
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Zlin
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Germany
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Niedersachsen
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Germany
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North Rhine-Westphalia
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Germany
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Saarland
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Germany
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Sachsen Anhalt
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Germany
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Sachsen
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Germany
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Berlin
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Bekes
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EU
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Komarom-Esztergom
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Budapest
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Hungary
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Gyongyos
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Hungary
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Miskolc
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Mosonmagyarovar
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Szeged
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Vac
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Haifa
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Jerusalem
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Israel
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Nahariya
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Israel
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Rehovot
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Israel
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Zerifin
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Italy
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Milano
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Italy
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Catanzaro
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Japan
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Fukoka
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Japan
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Fukuoka-Ken
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Japan
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Hokkaido
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Japan
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Ibaraki
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Japan
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Kagoshima
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Japan
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Kanagawa
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Japan
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Miyagi-Ken
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Japan
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Tokyo
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Japan
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Toyama
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Japan
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Fukuoka
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Korea, Republic of
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Korea
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Korea, Republic of
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Busan
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Netherlands
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North Brabant
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Netherlands
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Amsterdam
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Bydgoszcz
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Rzeszow
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Szczecin
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Warszawa
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Wroclaw
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Zamosc
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Romania
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Bihor
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Romania
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Cluj
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Romania
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Bucharest
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Romania
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Bucuresti
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Romania
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Timisoara
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Russian Federation
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Barnaul
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Russian Federation
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Ekaterinburg
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Russian Federation
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Irkutsk
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Novosibirsk
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Samara
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Spain
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Alicante
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Turkey
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Antayla
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Kocaeli
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Mersin
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Ankara
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Bursa
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Edirne
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Gaziantep
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Istanbuk
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Istanbul
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Izmir
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Kayseri
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Ukraine
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Dnipro
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Ukraine
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Odesa
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Ukraine
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Uzhgorod
Country [121] 0 0
Ukraine
State/province [121] 0 0
Vinnytsia
Country [122] 0 0
Ukraine
State/province [122] 0 0
Zaporizhzhia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT04232553
Trial related presentations / publications
Public notes

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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
clinicaltrials.gov@lilly.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04232553