Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03926130




Registration number
NCT03926130
Ethics application status
Date submitted
23/04/2019
Date registered
24/04/2019

Titles & IDs
Public title
A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
Scientific title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's Disease
Secondary ID [1] 0 0
I6T-MC-AMAM
Secondary ID [2] 0 0
16590
Universal Trial Number (UTN)
Trial acronym
VIVID-1
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
Treatment: Drugs - Ustekinumab
Treatment: Drugs - Ustekinumab
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo

Experimental: Mirikizumab - Mirikizumab given intravenously (IV) and subcutaneously (SC).

Participants in the open-label adolescent addendum will be given mirikizumab IV and SC.

Active comparator: Ustekinumab - Ustekinumab given IV and SC.

Placebo comparator: Placebo - Placebo given IV and SC.


Treatment: Drugs: Mirikizumab
Administered IV

Treatment: Drugs: Mirikizumab
Administered SC

Treatment: Drugs: Ustekinumab
Administered IV

Treatment: Drugs: Ustekinumab
Administered SC

Treatment: Drugs: Placebo
Administered IV

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

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Clinical Response at Week 12 and Endoscopic Response at Week 52
Timepoint [1] 0 0
Baseline to Week 52
Primary outcome [2] 0 0
Percentage of Participants Achieving Clinical Response at Week 12 and Clinical Remission at Week 52
Timepoint [2] 0 0
Baseline to Week 52
Secondary outcome [1] 0 0
Percentage of Participants Achieving Endoscopic Response
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Percentage of Participants Achieving Clinical Remission
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Percentage of Participants Achieving Endoscopic Response
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Percentage of Participants Achieving Endoscopic Remission
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Percentage of Participants Achieving Clinical Remission
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Change from Baseline in Urgency Numeric Rating Score (NRS)
Timepoint [6] 0 0
Baseline, Week 12
Secondary outcome [7] 0 0
Change from Baseline in Urgency NRS
Timepoint [7] 0 0
Baseline, Week 52
Secondary outcome [8] 0 0
Percentage of Participants Achieving Clinical Response at Week 12 and Clinical Remission by PRO at Week 52
Timepoint [8] 0 0
Baseline to Week 52
Secondary outcome [9] 0 0
Percentage of Participants Achieving Clinical Response at Week 12 and Endoscopic Remission at Week 52
Timepoint [9] 0 0
Baseline to Week 52
Secondary outcome [10] 0 0
Percentage of Participants Achieving Clinical Response at Week 12 and Corticosteroid-free AND either in Clinical Remission or Endoscopic Remission at Week 52
Timepoint [10] 0 0
Baseline to Week 52
Secondary outcome [11] 0 0
Change from Baseline in C-Reactive Protein
Timepoint [11] 0 0
Baseline, Week 52
Secondary outcome [12] 0 0
Change from Baseline in Fecal Calprotectin
Timepoint [12] 0 0
Baseline, Week 52
Secondary outcome [13] 0 0
Percentage of Participants with Extraintestinal Manifestations (EIMs) of Crohn's Disease
Timepoint [13] 0 0
Week 52
Secondary outcome [14] 0 0
Percentage of Participants with Fistulae Response
Timepoint [14] 0 0
Week 52
Secondary outcome [15] 0 0
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Mirikizumab
Timepoint [15] 0 0
Baseline through Week 52
Secondary outcome [16] 0 0
Change from Baseline in Health Related Quality of Life
Timepoint [16] 0 0
Baseline, Week 52

Eligibility
Key inclusion criteria
* Diagnosis of CD for at least 3 months prior to baseline
* Confirmed diagnosis of moderate to severe CD as assessed by SF, AP score, and SES-CD
* Demonstrated intolerance, loss of response or inadequate response to conventional or to biologic therapy for CD
* If female, subject must meet the contraception recommendations
Minimum age
15 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have a current diagnosis of ulcerative colitis, inflammatory bowel disease-unclassified (IBD-U) (formerly known as indeterminate colitis) or short bowel syndrome
* Currently have or are suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained, adequately treated and resolved at least 3 weeks prior to baseline or 8 weeks prior to baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery
* Have a stoma, ileoanal pouch or ostomy
* Have had a bowel resection within 6 months, or any kind of intra-abdominal or extra abdominal surgery within 3 months of baseline
* Have ever received any monoclonal antibodies binding IL-23

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/10/2023
Sample size
Target
Accrual to date
Final
1158
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
St. Vincents Hospital Sydney - Darlinghurst
Recruitment hospital [3] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [4] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [5] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [6] 0 0
Coastal Digestive Health - Maroochydore
Recruitment hospital [7] 0 0
Coral Sea Clinical Research Institute - North Mackay
Recruitment hospital [8] 0 0
Emeritus Research - Camberwell
Recruitment hospital [9] 0 0
Northern Hospital - Epping
Recruitment hospital [10] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [11] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2747 - Kingswood
Recruitment postcode(s) [4] 0 0
2170 - Liverpool
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
4558 - Maroochydore
Recruitment postcode(s) [7] 0 0
4740 - North Mackay
Recruitment postcode(s) [8] 0 0
3124 - Camberwell
Recruitment postcode(s) [9] 0 0
3076 - Epping
Recruitment postcode(s) [10] 0 0
3050 - Parkville
Recruitment postcode(s) [11] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Mississippi
Country [18] 0 0
United States of America
State/province [18] 0 0
Missouri
Country [19] 0 0
United States of America
State/province [19] 0 0
Nevada
Country [20] 0 0
United States of America
State/province [20] 0 0
New Mexico
Country [21] 0 0
United States of America
State/province [21] 0 0
New York
Country [22] 0 0
United States of America
State/province [22] 0 0
North Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Ohio
Country [24] 0 0
United States of America
State/province [24] 0 0
Oklahoma
Country [25] 0 0
United States of America
State/province [25] 0 0
Pennsylvania
Country [26] 0 0
United States of America
State/province [26] 0 0
Rhode Island
Country [27] 0 0
United States of America
State/province [27] 0 0
South Carolina
Country [28] 0 0
United States of America
State/province [28] 0 0
Tennessee
Country [29] 0 0
United States of America
State/province [29] 0 0
Texas
Country [30] 0 0
United States of America
State/province [30] 0 0
Utah
Country [31] 0 0
United States of America
State/province [31] 0 0
Virginia
Country [32] 0 0
United States of America
State/province [32] 0 0
Washington
Country [33] 0 0
United States of America
State/province [33] 0 0
West Virginia
Country [34] 0 0
United States of America
State/province [34] 0 0
Wyoming
Country [35] 0 0
Argentina
State/province [35] 0 0
Buenos Aires
Country [36] 0 0
Argentina
State/province [36] 0 0
Ciudad Autónoma De Buenos Aire
Country [37] 0 0
Argentina
State/province [37] 0 0
Tucumán
Country [38] 0 0
Austria
State/province [38] 0 0
Innsbruck
Country [39] 0 0
Austria
State/province [39] 0 0
Salzburg
Country [40] 0 0
Austria
State/province [40] 0 0
Wien
Country [41] 0 0
Belgium
State/province [41] 0 0
Antwerpen
Country [42] 0 0
Belgium
State/province [42] 0 0
Brussel
Country [43] 0 0
Belgium
State/province [43] 0 0
Kortrijk
Country [44] 0 0
Belgium
State/province [44] 0 0
Leuven
Country [45] 0 0
Brazil
State/province [45] 0 0
Bahia
Country [46] 0 0
Brazil
State/province [46] 0 0
Ceara
Country [47] 0 0
Brazil
State/province [47] 0 0
Distrito Federal
Country [48] 0 0
Brazil
State/province [48] 0 0
GO
Country [49] 0 0
Brazil
State/province [49] 0 0
MG
Country [50] 0 0
Brazil
State/province [50] 0 0
Minas Gerais
Country [51] 0 0
Brazil
State/province [51] 0 0
Parana
Country [52] 0 0
Brazil
State/province [52] 0 0
Rio Grande Do Sul
Country [53] 0 0
Brazil
State/province [53] 0 0
Sao Paulo
Country [54] 0 0
Brazil
State/province [54] 0 0
SP
Country [55] 0 0
Brazil
State/province [55] 0 0
São Paulo
Country [56] 0 0
Brazil
State/province [56] 0 0
Rio de Janeiro
Country [57] 0 0
Canada
State/province [57] 0 0
Alberta
Country [58] 0 0
Canada
State/province [58] 0 0
British Columbia
Country [59] 0 0
Canada
State/province [59] 0 0
Nova Scotia
Country [60] 0 0
Canada
State/province [60] 0 0
Ontario
Country [61] 0 0
Canada
State/province [61] 0 0
Quebec
Country [62] 0 0
China
State/province [62] 0 0
Anhui
Country [63] 0 0
China
State/province [63] 0 0
Beijing
Country [64] 0 0
China
State/province [64] 0 0
Chongqing
Country [65] 0 0
China
State/province [65] 0 0
Fuzhou
Country [66] 0 0
China
State/province [66] 0 0
Guangdong
Country [67] 0 0
China
State/province [67] 0 0
Hainan
Country [68] 0 0
China
State/province [68] 0 0
Hubei
Country [69] 0 0
China
State/province [69] 0 0
Hunan
Country [70] 0 0
China
State/province [70] 0 0
Jiangsu
Country [71] 0 0
China
State/province [71] 0 0
Jiangxi
Country [72] 0 0
China
State/province [72] 0 0
Liaoning
Country [73] 0 0
China
State/province [73] 0 0
Pudong District
Country [74] 0 0
China
State/province [74] 0 0
Shanghai
Country [75] 0 0
China
State/province [75] 0 0
Sichuan
Country [76] 0 0
China
State/province [76] 0 0
Tianjin
Country [77] 0 0
China
State/province [77] 0 0
Yunnan
Country [78] 0 0
China
State/province [78] 0 0
Zhejiang
Country [79] 0 0
China
State/province [79] 0 0
Xiamen
Country [80] 0 0
Croatia
State/province [80] 0 0
Osijek
Country [81] 0 0
Croatia
State/province [81] 0 0
Zagreb
Country [82] 0 0
Czechia
State/province [82] 0 0
Brno-mesto
Country [83] 0 0
Czechia
State/province [83] 0 0
Czech Republic
Country [84] 0 0
Czechia
State/province [84] 0 0
Hradec Králové
Country [85] 0 0
Czechia
State/province [85] 0 0
Olomoucký Kraj
Country [86] 0 0
Czechia
State/province [86] 0 0
Prague
Country [87] 0 0
Czechia
State/province [87] 0 0
Praha 2
Country [88] 0 0
Czechia
State/province [88] 0 0
Praha 4
Country [89] 0 0
Czechia
State/province [89] 0 0
Zlínský Kraj
Country [90] 0 0
Czechia
State/province [90] 0 0
Brno
Country [91] 0 0
Czechia
State/province [91] 0 0
Nachod
Country [92] 0 0
Czechia
State/province [92] 0 0
Olomouc
Country [93] 0 0
Czechia
State/province [93] 0 0
Ostrava - Muglinov
Country [94] 0 0
Czechia
State/province [94] 0 0
Plzen
Country [95] 0 0
Czechia
State/province [95] 0 0
Praha 5
Country [96] 0 0
Czechia
State/province [96] 0 0
Praha 8
Country [97] 0 0
Czechia
State/province [97] 0 0
Praha 9
Country [98] 0 0
Denmark
State/province [98] 0 0
Midtjylland
Country [99] 0 0
Denmark
State/province [99] 0 0
Aalborg
Country [100] 0 0
France
State/province [100] 0 0
Bas Rhin
Country [101] 0 0
France
State/province [101] 0 0
Cedex 12
Country [102] 0 0
France
State/province [102] 0 0
Paris
Country [103] 0 0
France
State/province [103] 0 0
Rhone
Country [104] 0 0
France
State/province [104] 0 0
Amiens
Country [105] 0 0
France
State/province [105] 0 0
Le Mans
Country [106] 0 0
France
State/province [106] 0 0
Montpellier Cedex 5
Country [107] 0 0
France
State/province [107] 0 0
Pessac Cedex
Country [108] 0 0
France
State/province [108] 0 0
Poitiers Cedex
Country [109] 0 0
France
State/province [109] 0 0
Rouen cedex
Country [110] 0 0
France
State/province [110] 0 0
Saint Etienne Cedex 2
Country [111] 0 0
France
State/province [111] 0 0
Vand?uvre-lès-Nancy
Country [112] 0 0
Germany
State/province [112] 0 0
Baden-Württemberg
Country [113] 0 0
Germany
State/province [113] 0 0
Bayern
Country [114] 0 0
Germany
State/province [114] 0 0
Hessen
Country [115] 0 0
Germany
State/province [115] 0 0
Niedersachsen
Country [116] 0 0
Germany
State/province [116] 0 0
Nordrhein Westfalen
Country [117] 0 0
Germany
State/province [117] 0 0
North Rhine-Westphalia
Country [118] 0 0
Germany
State/province [118] 0 0
Rhineland-Palatinate
Country [119] 0 0
Germany
State/province [119] 0 0
Saarland
Country [120] 0 0
Germany
State/province [120] 0 0
Sachsen Anhalt
Country [121] 0 0
Germany
State/province [121] 0 0
Saxony-Anhalt
Country [122] 0 0
Germany
State/province [122] 0 0
Schleswig-Holstein
Country [123] 0 0
Germany
State/province [123] 0 0
Berlin
Country [124] 0 0
Germany
State/province [124] 0 0
Düsseldorf
Country [125] 0 0
Germany
State/province [125] 0 0
Hamburg
Country [126] 0 0
Germany
State/province [126] 0 0
Mainz
Country [127] 0 0
Germany
State/province [127] 0 0
Uslar
Country [128] 0 0
Hungary
State/province [128] 0 0
Bekes
Country [129] 0 0
Hungary
State/province [129] 0 0
Csongrad
Country [130] 0 0
Hungary
State/province [130] 0 0
EU
Country [131] 0 0
Hungary
State/province [131] 0 0
Komárom-Esztergom
Country [132] 0 0
Hungary
State/province [132] 0 0
Budapest
Country [133] 0 0
Hungary
State/province [133] 0 0
Békéscsaba
Country [134] 0 0
Hungary
State/province [134] 0 0
Gyöngyös
Country [135] 0 0
Hungary
State/province [135] 0 0
Miskolc
Country [136] 0 0
Hungary
State/province [136] 0 0
Szekszard
Country [137] 0 0
India
State/province [137] 0 0
Delhi
Country [138] 0 0
India
State/province [138] 0 0
Gujarat
Country [139] 0 0
India
State/province [139] 0 0
Maharashtra
Country [140] 0 0
India
State/province [140] 0 0
Punjab
Country [141] 0 0
India
State/province [141] 0 0
Rajasthan
Country [142] 0 0
India
State/province [142] 0 0
Tamil Nadu
Country [143] 0 0
India
State/province [143] 0 0
Telangana
Country [144] 0 0
India
State/province [144] 0 0
Chandigarh
Country [145] 0 0
India
State/province [145] 0 0
New Delhi
Country [146] 0 0
Israel
State/province [146] 0 0
Beer Sheva
Country [147] 0 0
Israel
State/province [147] 0 0
Haifa
Country [148] 0 0
Israel
State/province [148] 0 0
Holon
Country [149] 0 0
Israel
State/province [149] 0 0
Jerusalem
Country [150] 0 0
Israel
State/province [150] 0 0
Nahariya
Country [151] 0 0
Israel
State/province [151] 0 0
Ramat Gan
Country [152] 0 0
Israel
State/province [152] 0 0
Rehovot
Country [153] 0 0
Israel
State/province [153] 0 0
Zerifin
Country [154] 0 0
Italy
State/province [154] 0 0
Bari
Country [155] 0 0
Italy
State/province [155] 0 0
Cagliari
Country [156] 0 0
Italy
State/province [156] 0 0
Catanzaro
Country [157] 0 0
Italy
State/province [157] 0 0
Lazio
Country [158] 0 0
Italy
State/province [158] 0 0
Milano
Country [159] 0 0
Italy
State/province [159] 0 0
Milan
Country [160] 0 0
Italy
State/province [160] 0 0
MI
Country [161] 0 0
Italy
State/province [161] 0 0
Brescia
Country [162] 0 0
Italy
State/province [162] 0 0
Modena
Country [163] 0 0
Italy
State/province [163] 0 0
Napoli
Country [164] 0 0
Italy
State/province [164] 0 0
Reggio Emilia
Country [165] 0 0
Italy
State/province [165] 0 0
Roma
Country [166] 0 0
Italy
State/province [166] 0 0
Udine
Country [167] 0 0
Japan
State/province [167] 0 0
Aichi
Country [168] 0 0
Japan
State/province [168] 0 0
Aomori
Country [169] 0 0
Japan
State/province [169] 0 0
Chiba
Country [170] 0 0
Japan
State/province [170] 0 0
Fukuoka
Country [171] 0 0
Japan
State/province [171] 0 0
Fukushima
Country [172] 0 0
Japan
State/province [172] 0 0
Gunma
Country [173] 0 0
Japan
State/province [173] 0 0
Hiroshima
Country [174] 0 0
Japan
State/province [174] 0 0
Hokkaido
Country [175] 0 0
Japan
State/province [175] 0 0
Hyogo
Country [176] 0 0
Japan
State/province [176] 0 0
Ibaraki
Country [177] 0 0
Japan
State/province [177] 0 0
Ishikawa
Country [178] 0 0
Japan
State/province [178] 0 0
Kagawa
Country [179] 0 0
Japan
State/province [179] 0 0
Kanagawa
Country [180] 0 0
Japan
State/province [180] 0 0
Mie
Country [181] 0 0
Japan
State/province [181] 0 0
Miyagi
Country [182] 0 0
Japan
State/province [182] 0 0
Nagasaki
Country [183] 0 0
Japan
State/province [183] 0 0
Osaka-Fu
Country [184] 0 0
Japan
State/province [184] 0 0
Saga
Country [185] 0 0
Japan
State/province [185] 0 0
Shizuoka-Ken
Country [186] 0 0
Japan
State/province [186] 0 0
Tochigi
Country [187] 0 0
Japan
State/province [187] 0 0
Tokyo
Country [188] 0 0
Japan
State/province [188] 0 0
Tottori
Country [189] 0 0
Japan
State/province [189] 0 0
Kagoshima
Country [190] 0 0
Japan
State/province [190] 0 0
Kumamoto
Country [191] 0 0
Japan
State/province [191] 0 0
Kyoto
Country [192] 0 0
Japan
State/province [192] 0 0
Okayama
Country [193] 0 0
Japan
State/province [193] 0 0
Saitama
Country [194] 0 0
Japan
State/province [194] 0 0
Toyama
Country [195] 0 0
Japan
State/province [195] 0 0
Yamagata
Country [196] 0 0
Korea, Republic of
State/province [196] 0 0
Gyeonggi-do
Country [197] 0 0
Korea, Republic of
State/province [197] 0 0
Gyeonggido
Country [198] 0 0
Korea, Republic of
State/province [198] 0 0
Korea
Country [199] 0 0
Korea, Republic of
State/province [199] 0 0
Kyongsangbuk-do
Country [200] 0 0
Korea, Republic of
State/province [200] 0 0
Seoul, Korea
Country [201] 0 0
Korea, Republic of
State/province [201] 0 0
Seoul-teukbyeolsi [Seoul]
Country [202] 0 0
Korea, Republic of
State/province [202] 0 0
Taejon-Kwangyokshi
Country [203] 0 0
Korea, Republic of
State/province [203] 0 0
Busan
Country [204] 0 0
Korea, Republic of
State/province [204] 0 0
Daegu
Country [205] 0 0
Korea, Republic of
State/province [205] 0 0
Gangwon-do
Country [206] 0 0
Korea, Republic of
State/province [206] 0 0
Seoul
Country [207] 0 0
Latvia
State/province [207] 0 0
Riga
Country [208] 0 0
Lithuania
State/province [208] 0 0
Kaunas
Country [209] 0 0
Mexico
State/province [209] 0 0
Distrito Federal
Country [210] 0 0
Mexico
State/province [210] 0 0
JA
Country [211] 0 0
Mexico
State/province [211] 0 0
Nuevo Leon
Country [212] 0 0
Mexico
State/province [212] 0 0
Queretaro
Country [213] 0 0
Mexico
State/province [213] 0 0
Chihuahua
Country [214] 0 0
Mexico
State/province [214] 0 0
Durango
Country [215] 0 0
Mexico
State/province [215] 0 0
San Luis Potosi
Country [216] 0 0
Mexico
State/province [216] 0 0
Veracruz
Country [217] 0 0
Netherlands
State/province [217] 0 0
North Brabant
Country [218] 0 0
Netherlands
State/province [218] 0 0
Uden
Country [219] 0 0
Poland
State/province [219] 0 0
Dolnoslaskie
Country [220] 0 0
Poland
State/province [220] 0 0
Lower Silesian
Country [221] 0 0
Poland
State/province [221] 0 0
Lubelskie
Country [222] 0 0
Poland
State/province [222] 0 0
Mazowieckie
Country [223] 0 0
Poland
State/province [223] 0 0
Malopolskie
Country [224] 0 0
Poland
State/province [224] 0 0
Podkarpackie
Country [225] 0 0
Poland
State/province [225] 0 0
Podlaskie
Country [226] 0 0
Poland
State/province [226] 0 0
Pomorskie
Country [227] 0 0
Poland
State/province [227] 0 0
Silesian
Country [228] 0 0
Poland
State/province [228] 0 0
Subcarpathian
Country [229] 0 0
Poland
State/province [229] 0 0
West Pomeranian
Country [230] 0 0
Poland
State/province [230] 0 0
Wielkopolskie
Country [231] 0 0
Poland
State/province [231] 0 0
Woj Mazowieckie
Country [232] 0 0
Poland
State/province [232] 0 0
Bydgoszcz
Country [233] 0 0
Poland
State/province [233] 0 0
Elblag
Country [234] 0 0
Poland
State/province [234] 0 0
Knurow
Country [235] 0 0
Poland
State/province [235] 0 0
Lodz
Country [236] 0 0
Poland
State/province [236] 0 0
Szczecin
Country [237] 0 0
Poland
State/province [237] 0 0
Warszawa
Country [238] 0 0
Poland
State/province [238] 0 0
Zamosc
Country [239] 0 0
Poland
State/province [239] 0 0
Slaskie
Country [240] 0 0
Puerto Rico
State/province [240] 0 0
Caguas
Country [241] 0 0
Puerto Rico
State/province [241] 0 0
Rio Piedras
Country [242] 0 0
Puerto Rico
State/province [242] 0 0
San Juan
Country [243] 0 0
Puerto Rico
State/province [243] 0 0
Vega Baja
Country [244] 0 0
Romania
State/province [244] 0 0
Bihor
Country [245] 0 0
Romania
State/province [245] 0 0
Bucure?ti
Country [246] 0 0
Romania
State/province [246] 0 0
Cluj
Country [247] 0 0
Romania
State/province [247] 0 0
Bucuresti
Country [248] 0 0
Romania
State/province [248] 0 0
Constanta
Country [249] 0 0
Romania
State/province [249] 0 0
Targu Mures
Country [250] 0 0
Romania
State/province [250] 0 0
Timisoara
Country [251] 0 0
Russian Federation
State/province [251] 0 0
Irkutskaya Oblast'
Country [252] 0 0
Russian Federation
State/province [252] 0 0
Kareliya, Respublika
Country [253] 0 0
Russian Federation
State/province [253] 0 0
Moskva
Country [254] 0 0
Russian Federation
State/province [254] 0 0
Nizhegorodskaya Oblast'
Country [255] 0 0
Russian Federation
State/province [255] 0 0
Novosibirskaya Oblast'
Country [256] 0 0
Russian Federation
State/province [256] 0 0
Rostovskaya Oblast'
Country [257] 0 0
Russian Federation
State/province [257] 0 0
Sankt-Peterburg
Country [258] 0 0
Russian Federation
State/province [258] 0 0
Barnaul
Country [259] 0 0
Russian Federation
State/province [259] 0 0
Chelyabinsk
Country [260] 0 0
Russian Federation
State/province [260] 0 0
Cherepovets
Country [261] 0 0
Russian Federation
State/province [261] 0 0
Ekaterinburg
Country [262] 0 0
Russian Federation
State/province [262] 0 0
Kaliningrad
Country [263] 0 0
Russian Federation
State/province [263] 0 0
Kazan
Country [264] 0 0
Russian Federation
State/province [264] 0 0
Kemerovo
Country [265] 0 0
Russian Federation
State/province [265] 0 0
Moscow
Country [266] 0 0
Russian Federation
State/province [266] 0 0
Novosibirsk
Country [267] 0 0
Russian Federation
State/province [267] 0 0
Omsk
Country [268] 0 0
Russian Federation
State/province [268] 0 0
Saint Petersburg
Country [269] 0 0
Russian Federation
State/province [269] 0 0
Saint-Petersburg
Country [270] 0 0
Russian Federation
State/province [270] 0 0
Samara
Country [271] 0 0
Russian Federation
State/province [271] 0 0
St-Petersburg
Country [272] 0 0
Serbia
State/province [272] 0 0
Beograd
Country [273] 0 0
Serbia
State/province [273] 0 0
NAP
Country [274] 0 0
Serbia
State/province [274] 0 0
Nišavski Okrug
Country [275] 0 0
Serbia
State/province [275] 0 0
Vojvodina
Country [276] 0 0
Serbia
State/province [276] 0 0
Belgrade
Country [277] 0 0
Serbia
State/province [277] 0 0
Kragujevac
Country [278] 0 0
Slovakia
State/province [278] 0 0
Prešovský Kraj
Country [279] 0 0
Slovakia
State/province [279] 0 0
Banska Bystrica
Country [280] 0 0
Slovakia
State/province [280] 0 0
Bratislava
Country [281] 0 0
Slovakia
State/province [281] 0 0
Nove Zamky
Country [282] 0 0
Slovakia
State/province [282] 0 0
Presov
Country [283] 0 0
Spain
State/province [283] 0 0
A Coruña [La Coruña]
Country [284] 0 0
Spain
State/province [284] 0 0
Asturias
Country [285] 0 0
Spain
State/province [285] 0 0
Barcelona
Country [286] 0 0
Spain
State/province [286] 0 0
Navarra
Country [287] 0 0
Spain
State/province [287] 0 0
Alicante
Country [288] 0 0
Spain
State/province [288] 0 0
Cordoba
Country [289] 0 0
Spain
State/province [289] 0 0
La Coruña
Country [290] 0 0
Spain
State/province [290] 0 0
Las Palmas de Gran Canaria
Country [291] 0 0
Spain
State/province [291] 0 0
Madrid
Country [292] 0 0
Spain
State/province [292] 0 0
Santa Cruz de Tenerife
Country [293] 0 0
Switzerland
State/province [293] 0 0
Sankt Gallen
Country [294] 0 0
Switzerland
State/province [294] 0 0
Bern
Country [295] 0 0
Turkey
State/province [295] 0 0
Antalya
Country [296] 0 0
Turkey
State/province [296] 0 0
Istanbul
Country [297] 0 0
Turkey
State/province [297] 0 0
Mersin
Country [298] 0 0
Turkey
State/province [298] 0 0
Ankara
Country [299] 0 0
Turkey
State/province [299] 0 0
Bursa
Country [300] 0 0
Turkey
State/province [300] 0 0
Edirne
Country [301] 0 0
Turkey
State/province [301] 0 0
Eskisehir
Country [302] 0 0
Turkey
State/province [302] 0 0
Gaziantep
Country [303] 0 0
Turkey
State/province [303] 0 0
Hatay
Country [304] 0 0
Turkey
State/province [304] 0 0
Izmir
Country [305] 0 0
Turkey
State/province [305] 0 0
Izmit
Country [306] 0 0
Turkey
State/province [306] 0 0
Kayseri
Country [307] 0 0
Turkey
State/province [307] 0 0
Konya
Country [308] 0 0
Turkey
State/province [308] 0 0
Malatya
Country [309] 0 0
Ukraine
State/province [309] 0 0
Kharkivska Oblast
Country [310] 0 0
Ukraine
State/province [310] 0 0
Kyiv
Country [311] 0 0
Ukraine
State/province [311] 0 0
Lvivska Oblast
Country [312] 0 0
Ukraine
State/province [312] 0 0
Chernivtsi
Country [313] 0 0
Ukraine
State/province [313] 0 0
Dnipro
Country [314] 0 0
Ukraine
State/province [314] 0 0
Ivano-Frankivsk
Country [315] 0 0
Ukraine
State/province [315] 0 0
Kharkiv
Country [316] 0 0
Ukraine
State/province [316] 0 0
Odesa
Country [317] 0 0
Ukraine
State/province [317] 0 0
Uzhgorod
Country [318] 0 0
Ukraine
State/province [318] 0 0
Vinnitsa
Country [319] 0 0
Ukraine
State/province [319] 0 0
Vinnytsia
Country [320] 0 0
Ukraine
State/province [320] 0 0
Vinnytsya
Country [321] 0 0
Ukraine
State/province [321] 0 0
Zaporizhzhia
Country [322] 0 0
United Kingdom
State/province [322] 0 0
Cambridgeshire
Country [323] 0 0
United Kingdom
State/province [323] 0 0
England
Country [324] 0 0
United Kingdom
State/province [324] 0 0
Greater Manchester
Country [325] 0 0
United Kingdom
State/province [325] 0 0
London
Country [326] 0 0
United Kingdom
State/province [326] 0 0
South Glamorgan
Country [327] 0 0
United Kingdom
State/province [327] 0 0
Wstmid
Country [328] 0 0
United Kingdom
State/province [328] 0 0
Doncaster
Country [329] 0 0
United Kingdom
State/province [329] 0 0
Edinburgh
Country [330] 0 0
United Kingdom
State/province [330] 0 0
Hexham

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
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.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


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/NCT03926130