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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05197049
Registration number
NCT05197049
Ethics application status
Date submitted
17/01/2022
Date registered
19/01/2022
Titles & IDs
Public title
A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease
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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
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Secondary ID [1]
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2020-006165-11
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Secondary ID [2]
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CR109125
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Universal Trial Number (UTN)
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Trial acronym
GRAVITI
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn Disease
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0
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Condition category
Condition code
Oral and Gastrointestinal
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0
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0
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Inflammatory bowel disease
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Inflammatory and Immune System
0
0
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0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
0
0
0
0
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Crohn's disease
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Clinical Remission at Week 12
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Assessment method [1]
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Clinical Remission is based on Crohn's Disease Activity Index (CDAI).
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Timepoint [1]
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Week 12
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Primary outcome [2]
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Endoscopic Response at Week 12
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Assessment method [2]
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Endoscopic response is based on change from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD).
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Timepoint [2]
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Week 12
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Secondary outcome [1]
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Clinical Remission at Week 24
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Assessment method [1]
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Clinical Remission is based in CDAI.
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Timepoint [1]
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Week 24
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Secondary outcome [2]
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Patient-reported Outcome (PRO)-2 Remission at Week 12
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Assessment method [2]
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PRO-2 remission is based on abdominal pain (AP) and stool frequency (SF) score.
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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Clinical Response at Week 12
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Assessment method [3]
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Clinical response is based on change from baseline in CDAI.
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Timepoint [3]
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Week 12
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Secondary outcome [4]
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Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation of Study Intervention
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Assessment method [4]
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Percentage of participants with AEs, SAEs and AEs leading to discontinuation of study intervention will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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Timepoint [4]
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Up to 109 Weeks
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/01/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/03/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
350
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Monash Health, Monash Medical Centre - Clayton
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Recruitment hospital [2]
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Coral Sea Clinical Research Institute - North Mackay
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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4740 - North Mackay
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Recruitment outside Australia
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Hamamatsu-shi
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Country [134]
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Japan
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Hamamatsu
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Japan
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Higashi-Ibaraki
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Japan
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Hiroshima
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Japan
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Iizuka-shi
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Kagoshima
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Japan
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Kashiwa
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Japan
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Kita-kyushu
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Kobe
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Japan
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Kofu
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Japan
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Koshigaya
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Japan
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Kurume
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Japan
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Kyoto
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Japan
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Morioka
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Japan
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Nagasaki
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Japan
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Nagoya
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Japan
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Nakagami-gun
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Japan
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Niigata
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Japan
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Nishinomiya
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Japan
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Oita
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Japan
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Osaka-shi
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Japan
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Osaka
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Japan
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Otsu
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Japan
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Sapporo
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Japan
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Sendai
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Sunto-gun
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Tokyo
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Japan
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Toyota
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Japan
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Yokohama
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Jordan
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Amman
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Jordan
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Irbid
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Daejeon
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Dongdaemun-gu
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Korea, Republic of
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Goyang-si
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Gwangju
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Gyeonggi-do
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Gyeonggi
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Seoul
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Suwon
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Wonju
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Korea, Republic of
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YangCheon-Gu
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Lithuania
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Kaunas
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Lithuania
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Vilnius
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Malaysia
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Johor Bharu
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Malaysia
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Kota Bharu
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Malaysia
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Kota Kinabalu
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Malaysia
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Kuala Lumpur
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Malaysia
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Kuantan
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Amsterdam
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Christchurch
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Dunedin
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Poland
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Bialystok
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Bydgoszcz
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Chojnice
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Chrzanow
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Gdynia
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Grudziadz
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Krakow
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Lodz
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Lublin
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Nowy Targ
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Opole
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Rzeszow
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Skorzewo
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Sopot
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Sosnowiec
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Straszów
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Torun
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Tychy
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Wierzchoslawice
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Wloclawek
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Wroclaw
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Zamosc
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Banska Bystrica
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Kosice
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Presov
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Gijón
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Spain
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Huelva
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Spain
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Madrid
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Spain
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Sevilla
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Vigo
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Spain
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Villajoyosa
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Taiwan
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Kaoshiung
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Taiwan
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Taichung
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Taipei
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Taoyuan
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Turkey
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Ankara
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Mersin
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Turkey
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Samsun
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Turkey
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Zonguldak
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05197049
Query!
Trial related presentations / publications
Query!
Public notes
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Contacts
Principal investigator
Name
0
0
Janssen Research & Development, LLC Clinical Trial
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Address
0
0
Janssen Research & Development, LLC
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Country
0
0
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Phone
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0
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Fax
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Email
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Contact person for public queries
Name
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency
Query!
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/NCT05197049