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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
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 260 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
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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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


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