Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

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/NCT05197049




Registration number
NCT05197049
Ethics application status
Date submitted
17/01/2022
Date registered
19/01/2022
Date last updated
28/05/2024

Titles & IDs
Public title
A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease
Scientific title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Crohn's Disease
Secondary ID [1] 0 0
2020-006165-11
Secondary ID [2] 0 0
CR109125
Universal Trial Number (UTN)
Trial acronym
GRAVITI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn 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 - Guselkumab Dose 1
Treatment: Drugs - Guselkumab Dose 2
Treatment: Drugs - Guselkumab Dose 3
Treatment: Drugs - Placebo

Experimental: Group 1: Guselkumab - Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 2) injection subcutaneously.

Experimental: Group 2: Guselkumab - Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 3) injection subcutaneously.

Placebo Comparator: Group 3: Placebo - Participants will receive placebo injection subcutaneously.


Treatment: Drugs: Guselkumab Dose 1
Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection.

Treatment: Drugs: Guselkumab Dose 2
Guselkumab (Dose 2) will be administered by SC injection.

Treatment: Drugs: Guselkumab Dose 3
Guselkumab (Dose 3) will be administered by SC injection.

Treatment: Drugs: Placebo
Placebo will be administered by SC injection.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical Remission at Week 12
Timepoint [1] 0 0
Week 12
Primary outcome [2] 0 0
Endoscopic Response at Week 12
Timepoint [2] 0 0
Week 12
Secondary outcome [1] 0 0
Clinical Remission at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Patient-reported Outcome (PRO)-2 Remission at Week 12
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Clinical Response at Week 12
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation of Study Intervention
Timepoint [4] 0 0
Up to 109 Weeks

Eligibility
Key inclusion criteria
- Diagnosis of Crohn's disease (CD) of at least 3 months in duration

- Have moderate to severe CD as assessed by CDAI, stool frequency, and abdominal pain
score, and Simple Endoscopic Score for Crohn's disease (SES-CD).

- Demonstrated intolerance or inadequate response to conventional or to biologic therapy
for CD
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Current diagnosis of ulcerative colitis or indeterminate colitis

- Complications of Crohn's disease that require surgical intervention or confound
efficacy assessments

- Unstable doses of concomitant Crohn's disease therapy

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
Accrual to date
Final
350
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash Health, Monash Medical Centre - Clayton
Recruitment hospital [2] 0 0
Coral Sea Clinical Research Institute - North Mackay
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
4740 - North Mackay
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
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Idaho
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
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
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
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
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
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Oklahoma
Country [22] 0 0
United States of America
State/province [22] 0 0
Oregon
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
South Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
Texas
Country [26] 0 0
United States of America
State/province [26] 0 0
Utah
Country [27] 0 0
United States of America
State/province [27] 0 0
Virginia
Country [28] 0 0
Belgium
State/province [28] 0 0
Aalst
Country [29] 0 0
Belgium
State/province [29] 0 0
Bruxelles
Country [30] 0 0
Belgium
State/province [30] 0 0
Gent
Country [31] 0 0
Belgium
State/province [31] 0 0
Roeselare
Country [32] 0 0
Bosnia and Herzegovina
State/province [32] 0 0
Banja Luka
Country [33] 0 0
Bosnia and Herzegovina
State/province [33] 0 0
Sarajevo
Country [34] 0 0
Bosnia and Herzegovina
State/province [34] 0 0
Tesanj
Country [35] 0 0
Bosnia and Herzegovina
State/province [35] 0 0
Tuzla
Country [36] 0 0
Bosnia and Herzegovina
State/province [36] 0 0
Zenica
Country [37] 0 0
Brazil
State/province [37] 0 0
Botucatu
Country [38] 0 0
Brazil
State/province [38] 0 0
Brasilia
Country [39] 0 0
Brazil
State/province [39] 0 0
Campinas
Country [40] 0 0
Brazil
State/province [40] 0 0
Curitiba
Country [41] 0 0
Brazil
State/province [41] 0 0
Fortaleza
Country [42] 0 0
Brazil
State/province [42] 0 0
Jau
Country [43] 0 0
Brazil
State/province [43] 0 0
Macae
Country [44] 0 0
Brazil
State/province [44] 0 0
Natal
Country [45] 0 0
Brazil
State/province [45] 0 0
Passo Fundo
Country [46] 0 0
Brazil
State/province [46] 0 0
Porto Alegre
Country [47] 0 0
Brazil
State/province [47] 0 0
Recife
Country [48] 0 0
Brazil
State/province [48] 0 0
Salvador
Country [49] 0 0
Brazil
State/province [49] 0 0
Santo Andre
Country [50] 0 0
Brazil
State/province [50] 0 0
Santos
Country [51] 0 0
Brazil
State/province [51] 0 0
Sao Jose do Rio Preto
Country [52] 0 0
Brazil
State/province [52] 0 0
Sao Paulo
Country [53] 0 0
Brazil
State/province [53] 0 0
São Bernardo do Campo
Country [54] 0 0
Brazil
State/province [54] 0 0
São José Do Rio Preto
Country [55] 0 0
Brazil
State/province [55] 0 0
São Paulo
Country [56] 0 0
Brazil
State/province [56] 0 0
Teresina
Country [57] 0 0
Brazil
State/province [57] 0 0
Votuporanga
Country [58] 0 0
Canada
State/province [58] 0 0
Ontario
Country [59] 0 0
China
State/province [59] 0 0
Bengbu
Country [60] 0 0
China
State/province [60] 0 0
Changsha
Country [61] 0 0
China
State/province [61] 0 0
Changzhou City
Country [62] 0 0
China
State/province [62] 0 0
Chengdu
Country [63] 0 0
China
State/province [63] 0 0
China
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
Ganzhou
Country [67] 0 0
China
State/province [67] 0 0
Guangzhou
Country [68] 0 0
China
State/province [68] 0 0
GuangZhou
Country [69] 0 0
China
State/province [69] 0 0
Hangzhou
Country [70] 0 0
China
State/province [70] 0 0
Hefei
Country [71] 0 0
China
State/province [71] 0 0
Nanchang
Country [72] 0 0
China
State/province [72] 0 0
Nanjing
Country [73] 0 0
China
State/province [73] 0 0
Quanzhou
Country [74] 0 0
China
State/province [74] 0 0
Shanghai
Country [75] 0 0
China
State/province [75] 0 0
Shenyang
Country [76] 0 0
China
State/province [76] 0 0
Suzhou
Country [77] 0 0
China
State/province [77] 0 0
Wuxi
Country [78] 0 0
China
State/province [78] 0 0
Yangzhou
Country [79] 0 0
China
State/province [79] 0 0
ZhuZhou
Country [80] 0 0
Croatia
State/province [80] 0 0
Bjelovar
Country [81] 0 0
Croatia
State/province [81] 0 0
Split
Country [82] 0 0
Croatia
State/province [82] 0 0
Zadar
Country [83] 0 0
Croatia
State/province [83] 0 0
Zagreb
Country [84] 0 0
Czechia
State/province [84] 0 0
Brno
Country [85] 0 0
Czechia
State/province [85] 0 0
Hradec Kralove
Country [86] 0 0
Czechia
State/province [86] 0 0
Kladno
Country [87] 0 0
Czechia
State/province [87] 0 0
Praha 10
Country [88] 0 0
Czechia
State/province [88] 0 0
Slany
Country [89] 0 0
Denmark
State/province [89] 0 0
Esbjerg
Country [90] 0 0
Denmark
State/province [90] 0 0
Hilleroed
Country [91] 0 0
France
State/province [91] 0 0
Bayonne
Country [92] 0 0
France
State/province [92] 0 0
Besancon Cedex
Country [93] 0 0
France
State/province [93] 0 0
Colombes Cedex
Country [94] 0 0
France
State/province [94] 0 0
Nantes
Country [95] 0 0
France
State/province [95] 0 0
Nice
Country [96] 0 0
France
State/province [96] 0 0
Paris
Country [97] 0 0
France
State/province [97] 0 0
Pierre Bénite
Country [98] 0 0
France
State/province [98] 0 0
Reims
Country [99] 0 0
France
State/province [99] 0 0
Saint-Priest en Jarez
Country [100] 0 0
France
State/province [100] 0 0
Strasbourg
Country [101] 0 0
France
State/province [101] 0 0
Toulouse
Country [102] 0 0
Germany
State/province [102] 0 0
Berlin-Karlshorst
Country [103] 0 0
Germany
State/province [103] 0 0
Berlin
Country [104] 0 0
Germany
State/province [104] 0 0
Braunschweig
Country [105] 0 0
Germany
State/province [105] 0 0
Dachau
Country [106] 0 0
Germany
State/province [106] 0 0
Duisburg
Country [107] 0 0
Germany
State/province [107] 0 0
Halle
Country [108] 0 0
Germany
State/province [108] 0 0
Hannover
Country [109] 0 0
Germany
State/province [109] 0 0
Jerichow
Country [110] 0 0
Germany
State/province [110] 0 0
Köln
Country [111] 0 0
Germany
State/province [111] 0 0
Mannheim
Country [112] 0 0
Germany
State/province [112] 0 0
Nordhausen
Country [113] 0 0
Hungary
State/province [113] 0 0
Budapest
Country [114] 0 0
Hungary
State/province [114] 0 0
Kistarcsa
Country [115] 0 0
Hungary
State/province [115] 0 0
Mohacs
Country [116] 0 0
Hungary
State/province [116] 0 0
Pecs
Country [117] 0 0
Israel
State/province [117] 0 0
Afula
Country [118] 0 0
Israel
State/province [118] 0 0
Beer-Sheva
Country [119] 0 0
Israel
State/province [119] 0 0
Ramat Gan
Country [120] 0 0
Israel
State/province [120] 0 0
Rehovot
Country [121] 0 0
Israel
State/province [121] 0 0
Tzrifin
Country [122] 0 0
Italy
State/province [122] 0 0
Bologna
Country [123] 0 0
Italy
State/province [123] 0 0
Milano
Country [124] 0 0
Italy
State/province [124] 0 0
Roma
Country [125] 0 0
Japan
State/province [125] 0 0
Bunkyo-ku
Country [126] 0 0
Japan
State/province [126] 0 0
Chuo-ku
Country [127] 0 0
Japan
State/province [127] 0 0
Fukui-ken
Country [128] 0 0
Japan
State/province [128] 0 0
Fukuoka
Country [129] 0 0
Japan
State/province [129] 0 0
Fukuyama
Country [130] 0 0
Japan
State/province [130] 0 0
Gamagori
Country [131] 0 0
Japan
State/province [131] 0 0
Gunma
Country [132] 0 0
Japan
State/province [132] 0 0
Hachinohe
Country [133] 0 0
Japan
State/province [133] 0 0
Hamamatsu-shi
Country [134] 0 0
Japan
State/province [134] 0 0
Hamamatsu
Country [135] 0 0
Japan
State/province [135] 0 0
Higashi-Ibaraki
Country [136] 0 0
Japan
State/province [136] 0 0
Hiroshima
Country [137] 0 0
Japan
State/province [137] 0 0
Iizuka-shi
Country [138] 0 0
Japan
State/province [138] 0 0
Kagoshima
Country [139] 0 0
Japan
State/province [139] 0 0
Kashiwa
Country [140] 0 0
Japan
State/province [140] 0 0
Kita-kyushu
Country [141] 0 0
Japan
State/province [141] 0 0
Kobe
Country [142] 0 0
Japan
State/province [142] 0 0
Kofu
Country [143] 0 0
Japan
State/province [143] 0 0
Koshigaya
Country [144] 0 0
Japan
State/province [144] 0 0
Kurume
Country [145] 0 0
Japan
State/province [145] 0 0
Kyoto
Country [146] 0 0
Japan
State/province [146] 0 0
Morioka
Country [147] 0 0
Japan
State/province [147] 0 0
Nagasaki
Country [148] 0 0
Japan
State/province [148] 0 0
Nagoya
Country [149] 0 0
Japan
State/province [149] 0 0
Nakagami-gun
Country [150] 0 0
Japan
State/province [150] 0 0
Niigata
Country [151] 0 0
Japan
State/province [151] 0 0
Nishinomiya
Country [152] 0 0
Japan
State/province [152] 0 0
Oita
Country [153] 0 0
Japan
State/province [153] 0 0
Osaka-shi
Country [154] 0 0
Japan
State/province [154] 0 0
Osaka
Country [155] 0 0
Japan
State/province [155] 0 0
Otsu
Country [156] 0 0
Japan
State/province [156] 0 0
Sapporo
Country [157] 0 0
Japan
State/province [157] 0 0
Sendai
Country [158] 0 0
Japan
State/province [158] 0 0
Sunto-gun
Country [159] 0 0
Japan
State/province [159] 0 0
Tokyo
Country [160] 0 0
Japan
State/province [160] 0 0
Toyota
Country [161] 0 0
Japan
State/province [161] 0 0
Yokohama
Country [162] 0 0
Jordan
State/province [162] 0 0
Amman
Country [163] 0 0
Jordan
State/province [163] 0 0
Irbid
Country [164] 0 0
Korea, Republic of
State/province [164] 0 0
Busan
Country [165] 0 0
Korea, Republic of
State/province [165] 0 0
Daegu
Country [166] 0 0
Korea, Republic of
State/province [166] 0 0
Daejeon
Country [167] 0 0
Korea, Republic of
State/province [167] 0 0
Dongdaemun-gu
Country [168] 0 0
Korea, Republic of
State/province [168] 0 0
Goyang-si
Country [169] 0 0
Korea, Republic of
State/province [169] 0 0
Gwangju
Country [170] 0 0
Korea, Republic of
State/province [170] 0 0
Gyeonggi-do
Country [171] 0 0
Korea, Republic of
State/province [171] 0 0
Gyeonggi
Country [172] 0 0
Korea, Republic of
State/province [172] 0 0
Seoul
Country [173] 0 0
Korea, Republic of
State/province [173] 0 0
Suwon
Country [174] 0 0
Korea, Republic of
State/province [174] 0 0
Wonju
Country [175] 0 0
Korea, Republic of
State/province [175] 0 0
YangCheon-Gu
Country [176] 0 0
Lithuania
State/province [176] 0 0
Kaunas
Country [177] 0 0
Lithuania
State/province [177] 0 0
Vilnius
Country [178] 0 0
Malaysia
State/province [178] 0 0
Johor Bharu
Country [179] 0 0
Malaysia
State/province [179] 0 0
Kota Bharu
Country [180] 0 0
Malaysia
State/province [180] 0 0
Kota Kinabalu
Country [181] 0 0
Malaysia
State/province [181] 0 0
Kuala Lumpur
Country [182] 0 0
Malaysia
State/province [182] 0 0
Kuantan
Country [183] 0 0
Netherlands
State/province [183] 0 0
Amsterdam
Country [184] 0 0
Netherlands
State/province [184] 0 0
Rotterdam
Country [185] 0 0
Netherlands
State/province [185] 0 0
Tilburg
Country [186] 0 0
New Zealand
State/province [186] 0 0
Christchurch
Country [187] 0 0
New Zealand
State/province [187] 0 0
Dunedin
Country [188] 0 0
Poland
State/province [188] 0 0
Bialystok
Country [189] 0 0
Poland
State/province [189] 0 0
Bydgoszcz
Country [190] 0 0
Poland
State/province [190] 0 0
Chojnice
Country [191] 0 0
Poland
State/province [191] 0 0
Chrzanow
Country [192] 0 0
Poland
State/province [192] 0 0
Gdynia
Country [193] 0 0
Poland
State/province [193] 0 0
Grudziadz
Country [194] 0 0
Poland
State/province [194] 0 0
Krakow
Country [195] 0 0
Poland
State/province [195] 0 0
Lodz
Country [196] 0 0
Poland
State/province [196] 0 0
Lublin
Country [197] 0 0
Poland
State/province [197] 0 0
Nowy Targ
Country [198] 0 0
Poland
State/province [198] 0 0
Olsztyn
Country [199] 0 0
Poland
State/province [199] 0 0
Opole
Country [200] 0 0
Poland
State/province [200] 0 0
Piotrkow Trybunalski
Country [201] 0 0
Poland
State/province [201] 0 0
Poznan
Country [202] 0 0
Poland
State/province [202] 0 0
Rzeszow
Country [203] 0 0
Poland
State/province [203] 0 0
Skorzewo
Country [204] 0 0
Poland
State/province [204] 0 0
Sopot
Country [205] 0 0
Poland
State/province [205] 0 0
Sosnowiec
Country [206] 0 0
Poland
State/province [206] 0 0
Straszów
Country [207] 0 0
Poland
State/province [207] 0 0
Szczecin
Country [208] 0 0
Poland
State/province [208] 0 0
Torun
Country [209] 0 0
Poland
State/province [209] 0 0
Tychy
Country [210] 0 0
Poland
State/province [210] 0 0
Warsaw
Country [211] 0 0
Poland
State/province [211] 0 0
Warszawa
Country [212] 0 0
Poland
State/province [212] 0 0
Wierzchoslawice
Country [213] 0 0
Poland
State/province [213] 0 0
Wloclawek
Country [214] 0 0
Poland
State/province [214] 0 0
Wroclaw
Country [215] 0 0
Poland
State/province [215] 0 0
Zamosc
Country [216] 0 0
Slovakia
State/province [216] 0 0
Banska Bystrica
Country [217] 0 0
Slovakia
State/province [217] 0 0
Kosice
Country [218] 0 0
Slovakia
State/province [218] 0 0
Presov
Country [219] 0 0
Spain
State/province [219] 0 0
Gijón
Country [220] 0 0
Spain
State/province [220] 0 0
Huelva
Country [221] 0 0
Spain
State/province [221] 0 0
Madrid
Country [222] 0 0
Spain
State/province [222] 0 0
Sevilla
Country [223] 0 0
Spain
State/province [223] 0 0
Vigo
Country [224] 0 0
Spain
State/province [224] 0 0
Villajoyosa
Country [225] 0 0
Taiwan
State/province [225] 0 0
Kaoshiung
Country [226] 0 0
Taiwan
State/province [226] 0 0
Taichung
Country [227] 0 0
Taiwan
State/province [227] 0 0
Taipei
Country [228] 0 0
Taiwan
State/province [228] 0 0
Taoyuan
Country [229] 0 0
Turkey
State/province [229] 0 0
Ankara
Country [230] 0 0
Turkey
State/province [230] 0 0
Istanbul
Country [231] 0 0
Turkey
State/province [231] 0 0
Izmir
Country [232] 0 0
Turkey
State/province [232] 0 0
Mersin
Country [233] 0 0
Turkey
State/province [233] 0 0
Samsun
Country [234] 0 0
Turkey
State/province [234] 0 0
Zonguldak

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 Crohn's disease.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05197049
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