Trial Review

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/ct2/show/NCT04033445




Registration number
NCT04033445
Ethics application status
Date submitted
24/07/2019
Date registered
26/07/2019
Date last updated
24/05/2024

Titles & IDs
Public title
A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
Scientific title
A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
Secondary ID [1] 0 0
2018-004002-25
Secondary ID [2] 0 0
CR108657
Universal Trial Number (UTN)
Trial acronym
QUASAR
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 - Placebo
Treatment: Drugs - Guselkumab

Experimental: Induction Study 1: Guselkumab Dose 1 - Participants will receive guselkumab dose 1 intravenously (IV) in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.

Experimental: Induction Study 1: Guselkumab Dose 2 - Participants will receive guselkumab dose 2 IV in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.

Placebo Comparator: Induction Study 1: Placebo IV - Participants will receive matching placebo IV in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. Clinical nonresponders will be administered guselkumab IV.

Experimental: Induction Study 2: Guselkumab IV - Participants will receive guselkumab IV in Induction Study 2. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.

Placebo Comparator: Induction Study 2: Placebo IV - Participants will receive matching placebo IV in Induction Study 2. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. Clinical nonresponders will be administered guselkumab IV.

Experimental: Maintenance Study: Maintenance Dose Regimen 1 - Participants will receive guselkumab maintenance dose regimen 1 subcutaneously (SC) every 4 weeks (q4w).

Experimental: Maintenance Study: Maintenance Dose Regimen 2 - Participants will receive guselkumab maintenance dose regimen 2 SC every 8 weeks (q8w).

Placebo Comparator: Maintenance Study: Placebo SC - Participants will receive matching placebo SC q4w.


Treatment: Drugs: Placebo
Participants will receive matching placebo IV or SC.

Treatment: Drugs: Guselkumab
Participants will receive guselkumab IV or SC.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Induction Study 1: Clinical Response at Week 12
Timepoint [1] 0 0
Week 12
Primary outcome [2] 0 0
Induction Study 2: Clinical Remission at Week 12
Timepoint [2] 0 0
Week 12
Primary outcome [3] 0 0
Maintenance Study: Clinical Remission at Week 44
Timepoint [3] 0 0
Week 44
Secondary outcome [1] 0 0
Induction Study 1: Clinical Remission at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Induction Study 1: Symptomatic Remission at Week 12
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Induction Study 1: Endoscopic Healing at Week 12
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Induction Study 1: Histo-Endoscopic Mucosal Healing at Week 12
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Induction Study 1: Endoscopic Normalization at Week 12
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Induction Study 2: Symptomatic Remission at Week 12
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Induction Study 2: Endoscopic Healing at Week 12
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Induction Study 2: Clinical Response at Week 12
Timepoint [8] 0 0
Week 12
Secondary outcome [9] 0 0
Induction Study 2: Symptomatic Remission at Week 4
Timepoint [9] 0 0
Week 4
Secondary outcome [10] 0 0
Induction Study 2: Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 12
Timepoint [10] 0 0
Week 12
Secondary outcome [11] 0 0
Induction Study 2: Histo-Endoscopic Mucosal Healing at Week 12
Timepoint [11] 0 0
Week 12
Secondary outcome [12] 0 0
Induction Study 2: Fatigue Response at Week 12
Timepoint [12] 0 0
Week 12
Secondary outcome [13] 0 0
Induction Study 2: Symptomatic Remission at Week 2
Timepoint [13] 0 0
Week 2
Secondary outcome [14] 0 0
Induction Study 2: Endoscopic Normalization at Week 12
Timepoint [14] 0 0
Week 12
Secondary outcome [15] 0 0
Maintenance Study: Symptomatic Remission at Week 44
Timepoint [15] 0 0
Week 44
Secondary outcome [16] 0 0
Maintenance Study: Endoscopic Healing at Week 44
Timepoint [16] 0 0
Week 44
Secondary outcome [17] 0 0
Maintenance Study: Corticosteroid-free Clinical Remission at Week 44
Timepoint [17] 0 0
Week 44
Secondary outcome [18] 0 0
Maintenance Study: Clinical Response at Week 44
Timepoint [18] 0 0
Week 44
Secondary outcome [19] 0 0
Maintenance Study: Histo-Endoscopic Mucosal Healing at Week 44
Timepoint [19] 0 0
Week 44
Secondary outcome [20] 0 0
Maintenance Study: IBDQ Remission at Week 44
Timepoint [20] 0 0
Week 44
Secondary outcome [21] 0 0
Maintenance Study: Fatigue Response at Week 44
Timepoint [21] 0 0
Week 44
Secondary outcome [22] 0 0
Maintenance Study: Clinical Remission at Week 44 Among the Participants Who had Achieved Clinical Remission at Maintenance Baseline
Timepoint [22] 0 0
Week 44
Secondary outcome [23] 0 0
Maintenance Study: Endoscopic Normalization at Week 44
Timepoint [23] 0 0
Week 44

Eligibility
Key inclusion criteria
- Documented diagnosis of ulcerative colitis (UC)

- Moderately to severely active UC, defined by modified Mayo score

- Demonstrated inadequate response or intolerance to medical therapies specified in the
protocol

- Screening laboratory test results within the parameters specified in the protocol
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's
disease or clinical findings suggestive of Crohn's disease

- UC limited to the rectum only or to less than (<) 20 centimeter (cm) of the colon

- Presence of a stoma

- Presence or history of a fistula

- Receiving prohibited medications and/or treatment

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 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/10/2027
Actual
Sample size
Target
Accrual to date
Final
1064
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Emeritus Research - Camberwell
Recruitment hospital [2] 0 0
Monash Health - Clayton
Recruitment hospital [3] 0 0
Western Health - Footscray
Recruitment hospital [4] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [5] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [6] 0 0
Mater Hospital - South Brisbane
Recruitment hospital [7] 0 0
St John of God Subiaco Hospital - Subiaco
Recruitment hospital [8] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
3124 - Camberwell
Recruitment postcode(s) [2] 0 0
3156 - Clayton
Recruitment postcode(s) [3] 0 0
3011 - Footscray
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment postcode(s) [5] 0 0
6000 - Perth
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment postcode(s) [7] 0 0
6008 - Subiaco
Recruitment postcode(s) [8] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Nevada
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
United States of America
State/province [22] 0 0
Wyoming
Country [23] 0 0
Argentina
State/province [23] 0 0
Buenos Aires
Country [24] 0 0
Argentina
State/province [24] 0 0
Caba
Country [25] 0 0
Argentina
State/province [25] 0 0
Ciudad De Buenos Aires
Country [26] 0 0
Argentina
State/province [26] 0 0
Cordoba
Country [27] 0 0
Argentina
State/province [27] 0 0
Florencio Varela
Country [28] 0 0
Argentina
State/province [28] 0 0
Mar Del Plata
Country [29] 0 0
Argentina
State/province [29] 0 0
Rosario
Country [30] 0 0
Austria
State/province [30] 0 0
Salzburg
Country [31] 0 0
Belgium
State/province [31] 0 0
Brugge
Country [32] 0 0
Belgium
State/province [32] 0 0
Brussels
Country [33] 0 0
Belgium
State/province [33] 0 0
Bruxelles
Country [34] 0 0
Belgium
State/province [34] 0 0
Gent
Country [35] 0 0
Belgium
State/province [35] 0 0
Merksem
Country [36] 0 0
Belgium
State/province [36] 0 0
Roeselare
Country [37] 0 0
Brazil
State/province [37] 0 0
Brasilia
Country [38] 0 0
Brazil
State/province [38] 0 0
Campinas
Country [39] 0 0
Brazil
State/province [39] 0 0
Curitiba
Country [40] 0 0
Brazil
State/province [40] 0 0
Juiz de Fora
Country [41] 0 0
Brazil
State/province [41] 0 0
Passo Fundo
Country [42] 0 0
Brazil
State/province [42] 0 0
Porto Alegre
Country [43] 0 0
Brazil
State/province [43] 0 0
Rio de Janeiro
Country [44] 0 0
Brazil
State/province [44] 0 0
Salvador
Country [45] 0 0
Brazil
State/province [45] 0 0
Sao Paulo
Country [46] 0 0
Brazil
State/province [46] 0 0
São Paulo
Country [47] 0 0
Brazil
State/province [47] 0 0
Teresina
Country [48] 0 0
Brazil
State/province [48] 0 0
Uberlandia
Country [49] 0 0
Bulgaria
State/province [49] 0 0
Dupnitsa
Country [50] 0 0
Bulgaria
State/province [50] 0 0
Sevlievo
Country [51] 0 0
Bulgaria
State/province [51] 0 0
Sofia
Country [52] 0 0
Bulgaria
State/province [52] 0 0
Varna
Country [53] 0 0
Bulgaria
State/province [53] 0 0
Veliko Tarnovo
Country [54] 0 0
Canada
State/province [54] 0 0
British Columbia
Country [55] 0 0
Canada
State/province [55] 0 0
Manitoba
Country [56] 0 0
Canada
State/province [56] 0 0
Ontario
Country [57] 0 0
Canada
State/province [57] 0 0
Quebec
Country [58] 0 0
Canada
State/province [58] 0 0
Saskatchewan
Country [59] 0 0
China
State/province [59] 0 0
Beijing
Country [60] 0 0
China
State/province [60] 0 0
Changchun
Country [61] 0 0
China
State/province [61] 0 0
Changsha
Country [62] 0 0
China
State/province [62] 0 0
Chengdu
Country [63] 0 0
China
State/province [63] 0 0
Chongqing
Country [64] 0 0
China
State/province [64] 0 0
Dalian
Country [65] 0 0
China
State/province [65] 0 0
Ganzhou
Country [66] 0 0
China
State/province [66] 0 0
Guangzhou
Country [67] 0 0
China
State/province [67] 0 0
Hangzhou
Country [68] 0 0
China
State/province [68] 0 0
Hefei
Country [69] 0 0
China
State/province [69] 0 0
Kunming City
Country [70] 0 0
China
State/province [70] 0 0
Nanchang
Country [71] 0 0
China
State/province [71] 0 0
Nanjing
Country [72] 0 0
China
State/province [72] 0 0
Shanghai
Country [73] 0 0
China
State/province [73] 0 0
Shenyang
Country [74] 0 0
China
State/province [74] 0 0
Suzhou
Country [75] 0 0
China
State/province [75] 0 0
Tianjin
Country [76] 0 0
China
State/province [76] 0 0
Wuhan
Country [77] 0 0
China
State/province [77] 0 0
Wuxi
Country [78] 0 0
Czechia
State/province [78] 0 0
Ceske Budejovice
Country [79] 0 0
Czechia
State/province [79] 0 0
Havirov
Country [80] 0 0
Czechia
State/province [80] 0 0
Hradec Kralova
Country [81] 0 0
Czechia
State/province [81] 0 0
Olomouc
Country [82] 0 0
Czechia
State/province [82] 0 0
Ostrava
Country [83] 0 0
Czechia
State/province [83] 0 0
Prague
Country [84] 0 0
Czechia
State/province [84] 0 0
Praha 2
Country [85] 0 0
Czechia
State/province [85] 0 0
Praha 4
Country [86] 0 0
Czechia
State/province [86] 0 0
Praha 5
Country [87] 0 0
Czechia
State/province [87] 0 0
Praha 9
Country [88] 0 0
Czechia
State/province [88] 0 0
Strakonice
Country [89] 0 0
France
State/province [89] 0 0
Caen
Country [90] 0 0
France
State/province [90] 0 0
Clichy
Country [91] 0 0
France
State/province [91] 0 0
Lille
Country [92] 0 0
France
State/province [92] 0 0
Montpellier
Country [93] 0 0
France
State/province [93] 0 0
Nice Cedex 3
Country [94] 0 0
France
State/province [94] 0 0
Paris
Country [95] 0 0
France
State/province [95] 0 0
Pessac
Country [96] 0 0
France
State/province [96] 0 0
Pierre-Benite
Country [97] 0 0
France
State/province [97] 0 0
Saint-Priest en Jarez
Country [98] 0 0
France
State/province [98] 0 0
Strasbourg
Country [99] 0 0
France
State/province [99] 0 0
Toulouse
Country [100] 0 0
France
State/province [100] 0 0
Vandoeuvre les Nancy
Country [101] 0 0
Germany
State/province [101] 0 0
Berlin
Country [102] 0 0
Germany
State/province [102] 0 0
Halle
Country [103] 0 0
Germany
State/province [103] 0 0
Hannover
Country [104] 0 0
Germany
State/province [104] 0 0
Jerichow
Country [105] 0 0
Germany
State/province [105] 0 0
Lueneburg
Country [106] 0 0
Germany
State/province [106] 0 0
Saarbrücken
Country [107] 0 0
Germany
State/province [107] 0 0
Ulm
Country [108] 0 0
Hungary
State/province [108] 0 0
Budapest
Country [109] 0 0
Hungary
State/province [109] 0 0
Debrecen
Country [110] 0 0
Hungary
State/province [110] 0 0
Gyongyos
Country [111] 0 0
Hungary
State/province [111] 0 0
Gyula
Country [112] 0 0
Hungary
State/province [112] 0 0
Szeged
Country [113] 0 0
Ireland
State/province [113] 0 0
Dublin 4
Country [114] 0 0
Ireland
State/province [114] 0 0
Dublin
Country [115] 0 0
Ireland
State/province [115] 0 0
Galway
Country [116] 0 0
Israel
State/province [116] 0 0
Haifa
Country [117] 0 0
Israel
State/province [117] 0 0
Holon
Country [118] 0 0
Israel
State/province [118] 0 0
Jerusalem
Country [119] 0 0
Israel
State/province [119] 0 0
Naharia
Country [120] 0 0
Israel
State/province [120] 0 0
Tel Aviv
Country [121] 0 0
Italy
State/province [121] 0 0
Bologna
Country [122] 0 0
Italy
State/province [122] 0 0
Milano
Country [123] 0 0
Italy
State/province [123] 0 0
Negrar
Country [124] 0 0
Italy
State/province [124] 0 0
Padova
Country [125] 0 0
Italy
State/province [125] 0 0
Palermo
Country [126] 0 0
Italy
State/province [126] 0 0
RHO
Country [127] 0 0
Italy
State/province [127] 0 0
Roma
Country [128] 0 0
Italy
State/province [128] 0 0
Rozzano
Country [129] 0 0
Italy
State/province [129] 0 0
San Giovanni Rotondo
Country [130] 0 0
Italy
State/province [130] 0 0
Torino
Country [131] 0 0
Japan
State/province [131] 0 0
Bunkyo Ku
Country [132] 0 0
Japan
State/province [132] 0 0
Chiba
Country [133] 0 0
Japan
State/province [133] 0 0
Chikushino
Country [134] 0 0
Japan
State/province [134] 0 0
Ehime
Country [135] 0 0
Japan
State/province [135] 0 0
Fujiidera-shi
Country [136] 0 0
Japan
State/province [136] 0 0
Fukuoka-ken
Country [137] 0 0
Japan
State/province [137] 0 0
Fukuoka
Country [138] 0 0
Japan
State/province [138] 0 0
Fukushima
Country [139] 0 0
Japan
State/province [139] 0 0
Gifu
Country [140] 0 0
Japan
State/province [140] 0 0
Hachinohe
Country [141] 0 0
Japan
State/province [141] 0 0
Hachioji
Country [142] 0 0
Japan
State/province [142] 0 0
Hakodate
Country [143] 0 0
Japan
State/province [143] 0 0
Hashima-gun
Country [144] 0 0
Japan
State/province [144] 0 0
Hirosaki
Country [145] 0 0
Japan
State/province [145] 0 0
Hiroshima
Country [146] 0 0
Japan
State/province [146] 0 0
Hokkaido
Country [147] 0 0
Japan
State/province [147] 0 0
Ibaraki
Country [148] 0 0
Japan
State/province [148] 0 0
Izumo
Country [149] 0 0
Japan
State/province [149] 0 0
Kagoshima City
Country [150] 0 0
Japan
State/province [150] 0 0
Kagoshima
Country [151] 0 0
Japan
State/province [151] 0 0
Kanagawa
Country [152] 0 0
Japan
State/province [152] 0 0
Kanazawa
Country [153] 0 0
Japan
State/province [153] 0 0
Kashihara
Country [154] 0 0
Japan
State/province [154] 0 0
Kashiwa
Country [155] 0 0
Japan
State/province [155] 0 0
Kitakyushu
Country [156] 0 0
Japan
State/province [156] 0 0
Kobe
Country [157] 0 0
Japan
State/province [157] 0 0
Kochi
Country [158] 0 0
Japan
State/province [158] 0 0
Kofu
Country [159] 0 0
Japan
State/province [159] 0 0
Kumagaya-shi
Country [160] 0 0
Japan
State/province [160] 0 0
Kure
Country [161] 0 0
Japan
State/province [161] 0 0
Kyoto
Country [162] 0 0
Japan
State/province [162] 0 0
Matsumoto
Country [163] 0 0
Japan
State/province [163] 0 0
Meguro-ku
Country [164] 0 0
Japan
State/province [164] 0 0
Minato-ku
Country [165] 0 0
Japan
State/province [165] 0 0
Mitaka
Country [166] 0 0
Japan
State/province [166] 0 0
Miyagi
Country [167] 0 0
Japan
State/province [167] 0 0
Morioka
Country [168] 0 0
Japan
State/province [168] 0 0
Nagoya
Country [169] 0 0
Japan
State/province [169] 0 0
Niigata
Country [170] 0 0
Japan
State/province [170] 0 0
Nishinomiya-shi
Country [171] 0 0
Japan
State/province [171] 0 0
Oita
Country [172] 0 0
Japan
State/province [172] 0 0
Okinawa
Country [173] 0 0
Japan
State/province [173] 0 0
Osaka Sayama shi
Country [174] 0 0
Japan
State/province [174] 0 0
Osaka
Country [175] 0 0
Japan
State/province [175] 0 0
Osaki
Country [176] 0 0
Japan
State/province [176] 0 0
Saitama
Country [177] 0 0
Japan
State/province [177] 0 0
Sakura
Country [178] 0 0
Japan
State/province [178] 0 0
Sapporo
Country [179] 0 0
Japan
State/province [179] 0 0
Shinjuku-ku
Country [180] 0 0
Japan
State/province [180] 0 0
Shizuoka
Country [181] 0 0
Japan
State/province [181] 0 0
Sumida ku
Country [182] 0 0
Japan
State/province [182] 0 0
Takamatsu
Country [183] 0 0
Japan
State/province [183] 0 0
Tokushima
Country [184] 0 0
Japan
State/province [184] 0 0
Tokyo
Country [185] 0 0
Japan
State/province [185] 0 0
Tsu
Country [186] 0 0
Japan
State/province [186] 0 0
Yokkaichi
Country [187] 0 0
Japan
State/province [187] 0 0
Yokohama
Country [188] 0 0
Japan
State/province [188] 0 0
Yoshida
Country [189] 0 0
Jordan
State/province [189] 0 0
Amman
Country [190] 0 0
Jordan
State/province [190] 0 0
Irbid
Country [191] 0 0
Korea, Republic of
State/province [191] 0 0
Busan
Country [192] 0 0
Korea, Republic of
State/province [192] 0 0
Daegu
Country [193] 0 0
Korea, Republic of
State/province [193] 0 0
Gyeonggi-do
Country [194] 0 0
Korea, Republic of
State/province [194] 0 0
Incheon
Country [195] 0 0
Korea, Republic of
State/province [195] 0 0
Seongnam-si
Country [196] 0 0
Korea, Republic of
State/province [196] 0 0
Seoul
Country [197] 0 0
Korea, Republic of
State/province [197] 0 0
Suwon
Country [198] 0 0
Latvia
State/province [198] 0 0
Riga
Country [199] 0 0
Malaysia
State/province [199] 0 0
Kajang
Country [200] 0 0
Malaysia
State/province [200] 0 0
Kelantan
Country [201] 0 0
Malaysia
State/province [201] 0 0
Kuala Lumpur
Country [202] 0 0
Netherlands
State/province [202] 0 0
Amsterdam
Country [203] 0 0
Netherlands
State/province [203] 0 0
Dordrecht
Country [204] 0 0
Netherlands
State/province [204] 0 0
Nijmegen
Country [205] 0 0
New Zealand
State/province [205] 0 0
Dunedin
Country [206] 0 0
New Zealand
State/province [206] 0 0
Grafton
Country [207] 0 0
New Zealand
State/province [207] 0 0
Hamilton
Country [208] 0 0
Poland
State/province [208] 0 0
Bialystok
Country [209] 0 0
Poland
State/province [209] 0 0
Bydgoszcz
Country [210] 0 0
Poland
State/province [210] 0 0
Krakow
Country [211] 0 0
Poland
State/province [211] 0 0
Lublin
Country [212] 0 0
Poland
State/province [212] 0 0
Oswiecim
Country [213] 0 0
Poland
State/province [213] 0 0
Rzeszow
Country [214] 0 0
Poland
State/province [214] 0 0
Sopot
Country [215] 0 0
Poland
State/province [215] 0 0
Szczecin
Country [216] 0 0
Poland
State/province [216] 0 0
Torun
Country [217] 0 0
Poland
State/province [217] 0 0
Warszawa
Country [218] 0 0
Poland
State/province [218] 0 0
Wroclaw
Country [219] 0 0
Poland
State/province [219] 0 0
Zamosc
Country [220] 0 0
Portugal
State/province [220] 0 0
Coimbra
Country [221] 0 0
Portugal
State/province [221] 0 0
Porto
Country [222] 0 0
Portugal
State/province [222] 0 0
Santa Maria da Feira
Country [223] 0 0
Portugal
State/province [223] 0 0
Viseu
Country [224] 0 0
Russian Federation
State/province [224] 0 0
Ekaterinburg
Country [225] 0 0
Russian Federation
State/province [225] 0 0
Kaliningrad
Country [226] 0 0
Russian Federation
State/province [226] 0 0
Nizhniy Novgorod
Country [227] 0 0
Russian Federation
State/province [227] 0 0
Novosibirsk
Country [228] 0 0
Russian Federation
State/province [228] 0 0
Perm
Country [229] 0 0
Russian Federation
State/province [229] 0 0
Rostov-On-Don
Country [230] 0 0
Russian Federation
State/province [230] 0 0
Saint-Petersburg
Country [231] 0 0
Russian Federation
State/province [231] 0 0
Samara
Country [232] 0 0
Russian Federation
State/province [232] 0 0
Saratov
Country [233] 0 0
Russian Federation
State/province [233] 0 0
St-Petersburg
Country [234] 0 0
Russian Federation
State/province [234] 0 0
Ufa
Country [235] 0 0
Russian Federation
State/province [235] 0 0
Yaroslavl
Country [236] 0 0
Serbia
State/province [236] 0 0
Belgrade
Country [237] 0 0
Serbia
State/province [237] 0 0
Sombor
Country [238] 0 0
Serbia
State/province [238] 0 0
Zrenjanin
Country [239] 0 0
Slovakia
State/province [239] 0 0
Banska Bystrica
Country [240] 0 0
Slovakia
State/province [240] 0 0
Bardejov
Country [241] 0 0
Slovakia
State/province [241] 0 0
Bratislava
Country [242] 0 0
Slovakia
State/province [242] 0 0
Kosice
Country [243] 0 0
Slovakia
State/province [243] 0 0
Presov
Country [244] 0 0
Slovakia
State/province [244] 0 0
Sahy
Country [245] 0 0
Spain
State/province [245] 0 0
Badalona
Country [246] 0 0
Spain
State/province [246] 0 0
Barcelona
Country [247] 0 0
Spain
State/province [247] 0 0
Girona
Country [248] 0 0
Spain
State/province [248] 0 0
Madrid
Country [249] 0 0
Spain
State/province [249] 0 0
Santander
Country [250] 0 0
Spain
State/province [250] 0 0
Sevilla
Country [251] 0 0
Sweden
State/province [251] 0 0
Stockholm
Country [252] 0 0
Sweden
State/province [252] 0 0
Uppsala
Country [253] 0 0
Taiwan
State/province [253] 0 0
Changhua
Country [254] 0 0
Taiwan
State/province [254] 0 0
Taichung
Country [255] 0 0
Taiwan
State/province [255] 0 0
Taipei
Country [256] 0 0
Taiwan
State/province [256] 0 0
Taoyuan
Country [257] 0 0
Turkey
State/province [257] 0 0
Ankara
Country [258] 0 0
Turkey
State/province [258] 0 0
Edirne
Country [259] 0 0
Turkey
State/province [259] 0 0
Istanbul
Country [260] 0 0
Turkey
State/province [260] 0 0
Izmir
Country [261] 0 0
Turkey
State/province [261] 0 0
Kocaeli
Country [262] 0 0
Turkey
State/province [262] 0 0
Mersin
Country [263] 0 0
Ukraine
State/province [263] 0 0
Ivano-Frankivsk
Country [264] 0 0
Ukraine
State/province [264] 0 0
Kharkiv
Country [265] 0 0
Ukraine
State/province [265] 0 0
Kherson
Country [266] 0 0
Ukraine
State/province [266] 0 0
Kyiv
Country [267] 0 0
Ukraine
State/province [267] 0 0
Lviv
Country [268] 0 0
Ukraine
State/province [268] 0 0
Odesa
Country [269] 0 0
Ukraine
State/province [269] 0 0
Sumy
Country [270] 0 0
Ukraine
State/province [270] 0 0
Ternopil
Country [271] 0 0
Ukraine
State/province [271] 0 0
Vinnytsya
Country [272] 0 0
United Kingdom
State/province [272] 0 0
Glasgow
Country [273] 0 0
United Kingdom
State/province [273] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of guselkumab in
participants with moderately to severely active ulcerative colitis (UC).
Trial website
https://clinicaltrials.gov/ct2/show/NCT04033445
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04033445