Register a trial

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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/NCT03518086




Registration number
NCT03518086
Ethics application status
Date submitted
4/05/2018
Date registered
8/05/2018

Titles & IDs
Public title
An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
Scientific title
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
Secondary ID [1] 0 0
I6T-MC-AMAN
Secondary ID [2] 0 0
16591
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Mirikizumab
Treatment: Drugs - Placebo

Placebo comparator: Placebo Intravenous (IV) Every 4 Weeks (Q4W) - Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.

Experimental: 300 Milligram (mg) Mirikizumab IV Q4W - 300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.

Placebo comparator: Placebo IV Q4W Maximum Extended Enrollment (ME2) - Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.

Experimental: 300 mg Mirikizumab IV Q4W ME2 - 300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.


Treatment: Drugs: Mirikizumab
Administered IV

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

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Clinical Remission at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Percentage of Participants With Clinical Response at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Percentage of Participants With Endoscopic Remission at Week 12
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Percentage of Participants With Symptomatic Remission at Week 12
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Percentage of Participants With Symptomatic Response at Week 12
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Percentage of Participants With Histologic Remission at Week 12
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Percentage of Participants With Endoscopic Response at Week 12
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Change From Baseline to Week 12 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS)
Timepoint [7] 0 0
Baseline, Week 12
Secondary outcome [8] 0 0
Change From Baseline to Week 12 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
Timepoint [8] 0 0
Baseline, Week 12
Secondary outcome [9] 0 0
Change From Baseline to Week 12 in Fecal Calprotectin
Timepoint [9] 0 0
Baseline, Week 12
Secondary outcome [10] 0 0
Pharmacokinetics (PK): Clearance of Mirikizumab
Timepoint [10] 0 0
Predose on week 0, week 4, week 8 and post dose on week 0, 4 and 12

Eligibility
Key inclusion criteria
* Diagnosis of UC for at least 3 months prior to baseline.
* Confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS).
* Demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC.
* If female, must meet the contraception requirements.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants with a current diagnosis of Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis).
* Participants with a previous colectomy.
* Participants with current evidence of toxic megacolon.
* Prior exposure to anti-IL12p40 antibodies (e.g. ustekinumab) or anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab).

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 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
18/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/05/2024
Sample size
Target
Accrual to date
Final
1281
Recruitment in Australia
Recruitment state(s)
EssexNSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Harlow
Recruitment hospital [2] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [3] 0 0
Coastal Digestive Health - Maroochydore
Recruitment hospital [4] 0 0
Mater University Hospital - South Brisbane
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
Box Hill Hospital Outpatients - Box Hill
Recruitment hospital [7] 0 0
Melbourne Gastrointestinal Investigation Unit (MGIU) - Malvern
Recruitment hospital [8] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [9] 0 0
Northern Hospital - Melbourne
Recruitment hospital [10] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
CM20 1QX - Harlow
Recruitment postcode(s) [2] 0 0
2305 - Newcastle
Recruitment postcode(s) [3] 0 0
4558 - Maroochydore
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3144 - Malvern
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment postcode(s) [9] 0 0
3076 - Melbourne
Recruitment postcode(s) [10] 0 0
3050 - Parkville
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
Colorado
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
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
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
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Mississippi
Country [16] 0 0
United States of America
State/province [16] 0 0
Missouri
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
North Dakota
Country [21] 0 0
United States of America
State/province [21] 0 0
Ohio
Country [22] 0 0
United States of America
State/province [22] 0 0
Oklahoma
Country [23] 0 0
United States of America
State/province [23] 0 0
Pennsylvania
Country [24] 0 0
United States of America
State/province [24] 0 0
Rhode Island
Country [25] 0 0
United States of America
State/province [25] 0 0
South Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
South Dakota
Country [27] 0 0
United States of America
State/province [27] 0 0
Tennessee
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Utah
Country [30] 0 0
United States of America
State/province [30] 0 0
Virginia
Country [31] 0 0
United States of America
State/province [31] 0 0
Washington
Country [32] 0 0
United States of America
State/province [32] 0 0
Wisconsin
Country [33] 0 0
Argentina
State/province [33] 0 0
Buenos Aires
Country [34] 0 0
Argentina
State/province [34] 0 0
Santa Fe
Country [35] 0 0
Argentina
State/province [35] 0 0
Tucuman
Country [36] 0 0
Argentina
State/province [36] 0 0
Tucumán
Country [37] 0 0
Argentina
State/province [37] 0 0
Cordoba
Country [38] 0 0
Austria
State/province [38] 0 0
Wien
Country [39] 0 0
Austria
State/province [39] 0 0
Innsbruck
Country [40] 0 0
Austria
State/province [40] 0 0
Salzburg
Country [41] 0 0
Austria
State/province [41] 0 0
Vienna
Country [42] 0 0
Belgium
State/province [42] 0 0
Oost-Vlaanderen
Country [43] 0 0
Belgium
State/province [43] 0 0
Wallonne, Région
Country [44] 0 0
Belgium
State/province [44] 0 0
Brasschaat
Country [45] 0 0
Belgium
State/province [45] 0 0
Kortrijk
Country [46] 0 0
Belgium
State/province [46] 0 0
Leuven
Country [47] 0 0
Canada
State/province [47] 0 0
Alberta
Country [48] 0 0
Canada
State/province [48] 0 0
British Columbia
Country [49] 0 0
Canada
State/province [49] 0 0
Ontario
Country [50] 0 0
Canada
State/province [50] 0 0
Quebec
Country [51] 0 0
China
State/province [51] 0 0
Anhui
Country [52] 0 0
China
State/province [52] 0 0
Beijing
Country [53] 0 0
China
State/province [53] 0 0
Changsha City
Country [54] 0 0
China
State/province [54] 0 0
Chongqing
Country [55] 0 0
China
State/province [55] 0 0
Fujian
Country [56] 0 0
China
State/province [56] 0 0
Fuzhou
Country [57] 0 0
China
State/province [57] 0 0
Guangdong
Country [58] 0 0
China
State/province [58] 0 0
Hainan
Country [59] 0 0
China
State/province [59] 0 0
Henan
Country [60] 0 0
China
State/province [60] 0 0
Hubei
Country [61] 0 0
China
State/province [61] 0 0
Hunan
Country [62] 0 0
China
State/province [62] 0 0
Jiangsu
Country [63] 0 0
China
State/province [63] 0 0
Jiangxi
Country [64] 0 0
China
State/province [64] 0 0
Jilin
Country [65] 0 0
China
State/province [65] 0 0
Lianing
Country [66] 0 0
China
State/province [66] 0 0
Liaoning
Country [67] 0 0
China
State/province [67] 0 0
Shandong
Country [68] 0 0
China
State/province [68] 0 0
Shanghai
Country [69] 0 0
China
State/province [69] 0 0
Sichuan
Country [70] 0 0
China
State/province [70] 0 0
Urumchi
Country [71] 0 0
China
State/province [71] 0 0
Yunnan
Country [72] 0 0
China
State/province [72] 0 0
Zhejiang
Country [73] 0 0
China
State/province [73] 0 0
Wuhan
Country [74] 0 0
Croatia
State/province [74] 0 0
Osijek
Country [75] 0 0
Croatia
State/province [75] 0 0
Zagreb
Country [76] 0 0
Czechia
State/province [76] 0 0
Brno-mesto
Country [77] 0 0
Czechia
State/province [77] 0 0
Hl. M. Praha
Country [78] 0 0
Czechia
State/province [78] 0 0
Hradec Králové
Country [79] 0 0
Czechia
State/province [79] 0 0
Modrany
Country [80] 0 0
Czechia
State/province [80] 0 0
Olomoucký Kraj
Country [81] 0 0
Czechia
State/province [81] 0 0
Plzen-mesto
Country [82] 0 0
Czechia
State/province [82] 0 0
Praha 8
Country [83] 0 0
Czechia
State/province [83] 0 0
Brno
Country [84] 0 0
Czechia
State/province [84] 0 0
Olomouc
Country [85] 0 0
Czechia
State/province [85] 0 0
Praha 9
Country [86] 0 0
Denmark
State/province [86] 0 0
Esbjerg
Country [87] 0 0
Denmark
State/province [87] 0 0
Herlev
Country [88] 0 0
Denmark
State/province [88] 0 0
Køge
Country [89] 0 0
France
State/province [89] 0 0
Bas Rhin
Country [90] 0 0
France
State/province [90] 0 0
Cedex 10
Country [91] 0 0
France
State/province [91] 0 0
Nord
Country [92] 0 0
France
State/province [92] 0 0
Paris
Country [93] 0 0
France
State/province [93] 0 0
Pyrénées-Atlantiques
Country [94] 0 0
France
State/province [94] 0 0
Rhone
Country [95] 0 0
France
State/province [95] 0 0
Somme
Country [96] 0 0
France
State/province [96] 0 0
Chambray les Tours
Country [97] 0 0
France
State/province [97] 0 0
Marseille Cedex 20
Country [98] 0 0
France
State/province [98] 0 0
Montpellier
Country [99] 0 0
France
State/province [99] 0 0
Nice Cedex
Country [100] 0 0
France
State/province [100] 0 0
Pessac Cedex
Country [101] 0 0
France
State/province [101] 0 0
Poitiers Cedex
Country [102] 0 0
France
State/province [102] 0 0
Reims
Country [103] 0 0
France
State/province [103] 0 0
Saint Priest en Jarez
Country [104] 0 0
France
State/province [104] 0 0
Vandoeuvre les Nancy
Country [105] 0 0
Germany
State/province [105] 0 0
Niedersachsen
Country [106] 0 0
Germany
State/province [106] 0 0
Nordrhein Westfalen
Country [107] 0 0
Germany
State/province [107] 0 0
Rheinland-Pfalz
Country [108] 0 0
Germany
State/province [108] 0 0
Sachsen Anhalt
Country [109] 0 0
Germany
State/province [109] 0 0
Sachsen-Anhalt
Country [110] 0 0
Germany
State/province [110] 0 0
Berlin
Country [111] 0 0
Germany
State/province [111] 0 0
Brandenburg
Country [112] 0 0
Germany
State/province [112] 0 0
Hamburg
Country [113] 0 0
Germany
State/province [113] 0 0
Regensburg
Country [114] 0 0
Germany
State/province [114] 0 0
Weyhe
Country [115] 0 0
Hungary
State/province [115] 0 0
EU
Country [116] 0 0
Hungary
State/province [116] 0 0
Pest
Country [117] 0 0
Hungary
State/province [117] 0 0
Budapest
Country [118] 0 0
Hungary
State/province [118] 0 0
Debrecen
Country [119] 0 0
Hungary
State/province [119] 0 0
Miskolc
Country [120] 0 0
Hungary
State/province [120] 0 0
Mosonmagyarovar
Country [121] 0 0
Hungary
State/province [121] 0 0
Szeged
Country [122] 0 0
Hungary
State/province [122] 0 0
Szekszard
Country [123] 0 0
India
State/province [123] 0 0
Andhra Pradesh
Country [124] 0 0
India
State/province [124] 0 0
Assam
Country [125] 0 0
India
State/province [125] 0 0
Delhi
Country [126] 0 0
India
State/province [126] 0 0
Gujarat
Country [127] 0 0
India
State/province [127] 0 0
Karnataka
Country [128] 0 0
India
State/province [128] 0 0
Maharashtra
Country [129] 0 0
India
State/province [129] 0 0
Punjab
Country [130] 0 0
India
State/province [130] 0 0
Rajasthan
Country [131] 0 0
India
State/province [131] 0 0
Telangana
Country [132] 0 0
India
State/province [132] 0 0
Uttar Pradesh
Country [133] 0 0
India
State/province [133] 0 0
West Bengal
Country [134] 0 0
Ireland
State/province [134] 0 0
Dublin
Country [135] 0 0
Israel
State/province [135] 0 0
HaMerkaz
Country [136] 0 0
Israel
State/province [136] 0 0
Jerusalem
Country [137] 0 0
Israel
State/province [137] 0 0
Beer-Sheva
Country [138] 0 0
Israel
State/province [138] 0 0
Nahariya
Country [139] 0 0
Israel
State/province [139] 0 0
Ramat Gan
Country [140] 0 0
Israel
State/province [140] 0 0
Rehovot
Country [141] 0 0
Israel
State/province [141] 0 0
Tel Aviv
Country [142] 0 0
Israel
State/province [142] 0 0
Zerifin
Country [143] 0 0
Italy
State/province [143] 0 0
Milano
Country [144] 0 0
Italy
State/province [144] 0 0
Roma
Country [145] 0 0
Italy
State/province [145] 0 0
Brescia
Country [146] 0 0
Italy
State/province [146] 0 0
Catanzaro
Country [147] 0 0
Italy
State/province [147] 0 0
Firenze
Country [148] 0 0
Italy
State/province [148] 0 0
Genova
Country [149] 0 0
Italy
State/province [149] 0 0
Modena
Country [150] 0 0
Italy
State/province [150] 0 0
Pisa
Country [151] 0 0
Italy
State/province [151] 0 0
Salerno
Country [152] 0 0
Italy
State/province [152] 0 0
San Donato Milanese (MI)
Country [153] 0 0
Italy
State/province [153] 0 0
Torino
Country [154] 0 0
Italy
State/province [154] 0 0
Udine
Country [155] 0 0
Japan
State/province [155] 0 0
Aichi-ken
Country [156] 0 0
Japan
State/province [156] 0 0
Aichi
Country [157] 0 0
Japan
State/province [157] 0 0
Aomori
Country [158] 0 0
Japan
State/province [158] 0 0
Chiba
Country [159] 0 0
Japan
State/province [159] 0 0
Fukoka
Country [160] 0 0
Japan
State/province [160] 0 0
Fukuoka-Ken
Country [161] 0 0
Japan
State/province [161] 0 0
Fukuoka
Country [162] 0 0
Japan
State/province [162] 0 0
Gunma
Country [163] 0 0
Japan
State/province [163] 0 0
HigaShiibaraki-Gun
Country [164] 0 0
Japan
State/province [164] 0 0
Hiroshima-ken
Country [165] 0 0
Japan
State/province [165] 0 0
Hokkaido
Country [166] 0 0
Japan
State/province [166] 0 0
Hyogo-Ken
Country [167] 0 0
Japan
State/province [167] 0 0
Kagawa
Country [168] 0 0
Japan
State/province [168] 0 0
Kanagawa-Ken
Country [169] 0 0
Japan
State/province [169] 0 0
Kanagawa
Country [170] 0 0
Japan
State/province [170] 0 0
Kumamoto
Country [171] 0 0
Japan
State/province [171] 0 0
Mie
Country [172] 0 0
Japan
State/province [172] 0 0
Miyagi-Ken
Country [173] 0 0
Japan
State/province [173] 0 0
Niigata
Country [174] 0 0
Japan
State/province [174] 0 0
Oita-Ken
Country [175] 0 0
Japan
State/province [175] 0 0
Osaka
Country [176] 0 0
Japan
State/province [176] 0 0
Saga-Ken
Country [177] 0 0
Japan
State/province [177] 0 0
Saitama-Ken
Country [178] 0 0
Japan
State/province [178] 0 0
Shizuoka-Ken
Country [179] 0 0
Japan
State/province [179] 0 0
Tochigi-Ken
Country [180] 0 0
Japan
State/province [180] 0 0
Tokyo-To
Country [181] 0 0
Japan
State/province [181] 0 0
Tokyo
Country [182] 0 0
Japan
State/province [182] 0 0
Kagoshima
Country [183] 0 0
Japan
State/province [183] 0 0
Kyoto
Country [184] 0 0
Japan
State/province [184] 0 0
Okayama
Country [185] 0 0
Japan
State/province [185] 0 0
Saitama
Country [186] 0 0
Japan
State/province [186] 0 0
Toyama
Country [187] 0 0
Korea, Republic of
State/province [187] 0 0
Gangwon-do
Country [188] 0 0
Korea, Republic of
State/province [188] 0 0
Gyeonggi-do
Country [189] 0 0
Korea, Republic of
State/province [189] 0 0
Korea
Country [190] 0 0
Korea, Republic of
State/province [190] 0 0
Pusan-Kwangyokshi
Country [191] 0 0
Korea, Republic of
State/province [191] 0 0
Seoul-teukbyeolsi [Seoul]
Country [192] 0 0
Korea, Republic of
State/province [192] 0 0
Taejon-Kwangyokshi
Country [193] 0 0
Korea, Republic of
State/province [193] 0 0
Busan
Country [194] 0 0
Korea, Republic of
State/province [194] 0 0
Daegu
Country [195] 0 0
Latvia
State/province [195] 0 0
Riga
Country [196] 0 0
Lithuania
State/province [196] 0 0
Panevežio Apskritis
Country [197] 0 0
Lithuania
State/province [197] 0 0
Kaunas
Country [198] 0 0
Lithuania
State/province [198] 0 0
Klaipeda
Country [199] 0 0
Lithuania
State/province [199] 0 0
Vilnius
Country [200] 0 0
Malaysia
State/province [200] 0 0
Kedah
Country [201] 0 0
Malaysia
State/province [201] 0 0
Kelantan
Country [202] 0 0
Malaysia
State/province [202] 0 0
Kuala Lumpur
Country [203] 0 0
Malaysia
State/province [203] 0 0
Penang
Country [204] 0 0
Malaysia
State/province [204] 0 0
Selangor
Country [205] 0 0
Mexico
State/province [205] 0 0
DF
Country [206] 0 0
Mexico
State/province [206] 0 0
Distrito Federal
Country [207] 0 0
Mexico
State/province [207] 0 0
Edo De Mex
Country [208] 0 0
Mexico
State/province [208] 0 0
Jalisco
Country [209] 0 0
Mexico
State/province [209] 0 0
Sinaloa
Country [210] 0 0
Mexico
State/province [210] 0 0
Chihuahua
Country [211] 0 0
Mexico
State/province [211] 0 0
Veracruz
Country [212] 0 0
Netherlands
State/province [212] 0 0
Noord Brabant
Country [213] 0 0
Netherlands
State/province [213] 0 0
Noord-Holland
Country [214] 0 0
Netherlands
State/province [214] 0 0
Uden
Country [215] 0 0
Netherlands
State/province [215] 0 0
Utrecht
Country [216] 0 0
Poland
State/province [216] 0 0
Dolnoslaskie
Country [217] 0 0
Poland
State/province [217] 0 0
Kujawsko-pomorskie
Country [218] 0 0
Poland
State/province [218] 0 0
Lubelskie
Country [219] 0 0
Poland
State/province [219] 0 0
Mazowieckie
Country [220] 0 0
Poland
State/province [220] 0 0
Malopolskie
Country [221] 0 0
Poland
State/province [221] 0 0
Pomorskie
Country [222] 0 0
Poland
State/province [222] 0 0
Zachodniopomorskie
Country [223] 0 0
Poland
State/province [223] 0 0
Bedzin
Country [224] 0 0
Poland
State/province [224] 0 0
Katowice
Country [225] 0 0
Poland
State/province [225] 0 0
Knurow
Country [226] 0 0
Poland
State/province [226] 0 0
Olsztyn
Country [227] 0 0
Poland
State/province [227] 0 0
Szczecin
Country [228] 0 0
Poland
State/province [228] 0 0
Torun
Country [229] 0 0
Poland
State/province [229] 0 0
Warszawa
Country [230] 0 0
Poland
State/province [230] 0 0
Wroclaw
Country [231] 0 0
Poland
State/province [231] 0 0
Zamosc
Country [232] 0 0
Poland
State/province [232] 0 0
Swietokrzyskie
Country [233] 0 0
Romania
State/province [233] 0 0
Bucure?ti
Country [234] 0 0
Romania
State/province [234] 0 0
Bucuresti
Country [235] 0 0
Romania
State/province [235] 0 0
Oradea
Country [236] 0 0
Russian Federation
State/province [236] 0 0
Irkutskaya Oblast'
Country [237] 0 0
Russian Federation
State/province [237] 0 0
Kareliya, Respublika
Country [238] 0 0
Russian Federation
State/province [238] 0 0
Nizhegorodskaya Oblast'
Country [239] 0 0
Russian Federation
State/province [239] 0 0
Novosibirskaya Oblast'
Country [240] 0 0
Russian Federation
State/province [240] 0 0
Rostovskaya Oblast'
Country [241] 0 0
Russian Federation
State/province [241] 0 0
Sankt-Peterburg
Country [242] 0 0
Russian Federation
State/province [242] 0 0
Barnaul
Country [243] 0 0
Russian Federation
State/province [243] 0 0
Cherepovets
Country [244] 0 0
Russian Federation
State/province [244] 0 0
Ekaterinburg
Country [245] 0 0
Russian Federation
State/province [245] 0 0
Izhevsk
Country [246] 0 0
Russian Federation
State/province [246] 0 0
Kaliningrad
Country [247] 0 0
Russian Federation
State/province [247] 0 0
Kazan
Country [248] 0 0
Russian Federation
State/province [248] 0 0
Kemerovo
Country [249] 0 0
Russian Federation
State/province [249] 0 0
Krasnodar
Country [250] 0 0
Russian Federation
State/province [250] 0 0
Moscow
Country [251] 0 0
Russian Federation
State/province [251] 0 0
Novosibirsk
Country [252] 0 0
Russian Federation
State/province [252] 0 0
Omsk
Country [253] 0 0
Russian Federation
State/province [253] 0 0
Saint Petersburg
Country [254] 0 0
Russian Federation
State/province [254] 0 0
Saint-Petersburg
Country [255] 0 0
Russian Federation
State/province [255] 0 0
Samara
Country [256] 0 0
Russian Federation
State/province [256] 0 0
St. Petersburg
Country [257] 0 0
Russian Federation
State/province [257] 0 0
Stavropol
Country [258] 0 0
Russian Federation
State/province [258] 0 0
Tosno
Country [259] 0 0
Russian Federation
State/province [259] 0 0
Yaroslavl
Country [260] 0 0
Serbia
State/province [260] 0 0
Beograd
Country [261] 0 0
Serbia
State/province [261] 0 0
NAP
Country [262] 0 0
Serbia
State/province [262] 0 0
Vojvodina
Country [263] 0 0
Serbia
State/province [263] 0 0
Belgrade
Country [264] 0 0
Serbia
State/province [264] 0 0
Kragujevac
Country [265] 0 0
Serbia
State/province [265] 0 0
Uzice
Country [266] 0 0
Slovakia
State/province [266] 0 0
Nitriansky Kraj
Country [267] 0 0
Slovakia
State/province [267] 0 0
Prešovský Kraj
Country [268] 0 0
Slovakia
State/province [268] 0 0
Slovak Republic
Country [269] 0 0
Slovakia
State/province [269] 0 0
Banska Bystrica
Country [270] 0 0
Slovakia
State/province [270] 0 0
Bratislava
Country [271] 0 0
Spain
State/province [271] 0 0
Andalucía
Country [272] 0 0
Spain
State/province [272] 0 0
Asturias
Country [273] 0 0
Spain
State/province [273] 0 0
Baleares Islands
Country [274] 0 0
Spain
State/province [274] 0 0
Cantabria
Country [275] 0 0
Spain
State/province [275] 0 0
Madrid
Country [276] 0 0
Spain
State/province [276] 0 0
Navarra
Country [277] 0 0
Spain
State/province [277] 0 0
Valencia
Country [278] 0 0
Spain
State/province [278] 0 0
Alicante
Country [279] 0 0
Spain
State/province [279] 0 0
Cordoba
Country [280] 0 0
Spain
State/province [280] 0 0
Girona
Country [281] 0 0
Spain
State/province [281] 0 0
Huelva
Country [282] 0 0
Spain
State/province [282] 0 0
La Coruña
Country [283] 0 0
Spain
State/province [283] 0 0
Las Palmas de Gran Canaria
Country [284] 0 0
Switzerland
State/province [284] 0 0
Bern
Country [285] 0 0
Switzerland
State/province [285] 0 0
St.Gallen
Country [286] 0 0
Switzerland
State/province [286] 0 0
Zürich
Country [287] 0 0
Taiwan
State/province [287] 0 0
Changhua
Country [288] 0 0
Taiwan
State/province [288] 0 0
Taichung
Country [289] 0 0
Taiwan
State/province [289] 0 0
Taipei
Country [290] 0 0
Turkey
State/province [290] 0 0
Ankara
Country [291] 0 0
Turkey
State/province [291] 0 0
Antayla
Country [292] 0 0
Turkey
State/province [292] 0 0
Istanbul
Country [293] 0 0
Turkey
State/province [293] 0 0
Kocaeli
Country [294] 0 0
Turkey
State/province [294] 0 0
Mersin
Country [295] 0 0
Turkey
State/province [295] 0 0
Izmir
Country [296] 0 0
Ukraine
State/province [296] 0 0
Ivano-Frankivsk Region
Country [297] 0 0
Ukraine
State/province [297] 0 0
Kharkivska Oblast
Country [298] 0 0
Ukraine
State/province [298] 0 0
Khersonska Oblast
Country [299] 0 0
Ukraine
State/province [299] 0 0
Kyiv
Country [300] 0 0
Ukraine
State/province [300] 0 0
Lvivska Oblast
Country [301] 0 0
Ukraine
State/province [301] 0 0
Poltavska Oblast
Country [302] 0 0
Ukraine
State/province [302] 0 0
Zaporizka Oblast
Country [303] 0 0
Ukraine
State/province [303] 0 0
Dnipro
Country [304] 0 0
Ukraine
State/province [304] 0 0
Kharkiv
Country [305] 0 0
Ukraine
State/province [305] 0 0
Kropyvnytskyi
Country [306] 0 0
Ukraine
State/province [306] 0 0
Odesa
Country [307] 0 0
Ukraine
State/province [307] 0 0
Uzhgorod
Country [308] 0 0
Ukraine
State/province [308] 0 0
Vinnytsia
Country [309] 0 0
Ukraine
State/province [309] 0 0
Vinnytsya
Country [310] 0 0
Ukraine
State/province [310] 0 0
Zaporizhzhia
Country [311] 0 0
United Kingdom
State/province [311] 0 0
Essex
Country [312] 0 0
United Kingdom
State/province [312] 0 0
Great Britain
Country [313] 0 0
United Kingdom
State/province [313] 0 0
Hants
Country [314] 0 0
United Kingdom
State/province [314] 0 0
London
Country [315] 0 0
United Kingdom
State/province [315] 0 0
Scotland
Country [316] 0 0
United Kingdom
State/province [316] 0 0
Surrey
Country [317] 0 0
United Kingdom
State/province [317] 0 0
Swansea [Abertawe Gb-ata]
Country [318] 0 0
United Kingdom
State/province [318] 0 0
Vinnytsia
Country [319] 0 0
United Kingdom
State/province [319] 0 0
Glasgow

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 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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03518086