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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05347095




Registration number
NCT05347095
Ethics application status
Date submitted
21/04/2022
Date registered
26/04/2022

Titles & IDs
Public title
A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease
Scientific title
A Phase 3, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease
Secondary ID [1] 0 0
2021-000491-10
Secondary ID [2] 0 0
CR109189
Universal Trial Number (UTN)
Trial acronym
FUZION CD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fistulizing Crohns Disease 0 0
Perianal Crohns 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
Treatment: Drugs - Placebo

Experimental: Group 1: Guselkumab - Participants will receive guselkumab Dose 1 intravenous (IV) infusion followed by Dose 2 subcutaneously (SC). Participants will receive matching placebo to maintain the blind. Participants who are eligible and willing to continue guselkumab may enter the Long-Term Extension (LTE) period and continue to receive guselkumab.

Experimental: Group 2: Guselkumab - Participants will receive guselkumab Dose 1 IV infusion followed by Dose 3 SC. Participants will receive matching placebo to maintain the blind. At Week 24, guselkumab Dose 3 SC non-responders will switch to receive guselkumab dose 2 SC. Participants who are eligible and willing to continue guselkumab may enter the LTE period and continue to receive guselkumab.

Experimental: Group 3: Placebo - Participants will receive placebo IV infusion followed by placebo SC. At Week 24, placebo non-responders will continue to receive guselkumab Dose 4 followed by guselkumab Dose 2 SC. Participants will receive matching placebo to maintain the blind. Participants who are eligible and willing to continue guselkumab may enter the LTE period and continue to receive guselkumab.


Treatment: Drugs: Guselkumab
Guselkumab will be administered subcutaneously/IV infusion.

Treatment: Drugs: Placebo
Matching placebo will be administered subcutaneously/IV infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants who Achieve Combined Fistula Remission at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Percentage of Participants who Achieve Combined Fistula Remission at Week 48
Timepoint [1] 0 0
Week 48
Secondary outcome [2] 0 0
Percentage of Participants who Achieve Clinically Assessed Fistula Remission
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Percentage of Participants who Achieve Radiological Fistula Remission Based on Radiological Findings Assessed by MRI
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Percentage of Participants who Achieve Clinically Assessed Fistula Response at Week 24
Timepoint [4] 0 0
Week 24
Secondary outcome [5] 0 0
Percentage of Participants who Achieve Clinically Assessed Fistula Response at Week 12
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Change from Baseline in Crohn's Disease Activity Index (CDAI) by Visit Over Time Through Week 48
Timepoint [6] 0 0
Baseline up to Week 48
Secondary outcome [7] 0 0
Percentage of Participants who Achieve Clinical Remission (CDAI less than [<] 150) by Visit Over Time Through Week 48 Among Participants with CDAI Greater than (>) 150 at Baseline
Timepoint [7] 0 0
Through Week 48
Secondary outcome [8] 0 0
Percentage of Participants who Achieve a Clinical Response by Visit Over Time Through Week 48 Among Participants with CDAI >150 at Baseline
Timepoint [8] 0 0
Through Week 48
Secondary outcome [9] 0 0
Percentage of Participants who Achieve Steroid-free Clinical Remission by Visit Over Time Through Week 48 Among Participants with CDAI >150 at Baseline
Timepoint [9] 0 0
Through Week 48
Secondary outcome [10] 0 0
Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Response Among Participants With CDAI >220 at Baseline
Timepoint [10] 0 0
Week 24 and Week 48
Secondary outcome [11] 0 0
Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Remission Among Participants with CDAI >220 at Baseline
Timepoint [11] 0 0
Week 24 and Week 48
Secondary outcome [12] 0 0
Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Remission Among Participants with CDAI >220 at Baseline
Timepoint [12] 0 0
Week 24 and Week 48
Secondary outcome [13] 0 0
Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Response among Participants with CDAI >220 at Baseline
Timepoint [13] 0 0
Week 24 and Week 48
Secondary outcome [14] 0 0
Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Response at Week 24 and Week 48
Timepoint [14] 0 0
Week 24 and Week 48
Secondary outcome [15] 0 0
Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Remission at Week 24 and Week 48
Timepoint [15] 0 0
Week 24 and Week 48
Secondary outcome [16] 0 0
Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Response at Week 24 and Week 48
Timepoint [16] 0 0
Week 24 and Week 48
Secondary outcome [17] 0 0
Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Remission at Week 24 and Week 48
Timepoint [17] 0 0
Week 24 and Week 48
Secondary outcome [18] 0 0
Change from Baseline in Perianal Disease Activity Index (PDAI) Overall Score, Discharge Score, and Pain Score by Visit Over Time Through Week 48
Timepoint [18] 0 0
Baseline up to Week 48
Secondary outcome [19] 0 0
Percentage of Participants who Achieve Clinically Assessed Fistula Response by Visit Over Time Through Week 48
Timepoint [19] 0 0
Through Week 48
Secondary outcome [20] 0 0
Percentage of Participants who Achieve Clinically Assessed Fistula Remission by Visit over Time Through Week 48
Timepoint [20] 0 0
Through Week 48
Secondary outcome [21] 0 0
Percentage of Participants who Achieve Clinically Assessed Fistula Remission at Week 48 Among the Participants who Achieve Clinical Fistula Remission at Week 24
Timepoint [21] 0 0
Week 48
Secondary outcome [22] 0 0
Percentage of Participants who Achieve Clinically Assessed Fistula Remission at Week 48 Among Those who Achieve Fistula Remission or Response at Week 24
Timepoint [22] 0 0
Week 48
Secondary outcome [23] 0 0
Time to Clinical Fistula Remission
Timepoint [23] 0 0
Up to Week 96
Secondary outcome [24] 0 0
Percentage of Participants who Achieve Radiological Fistula Predominantly Fibrotic Status for all Existent Fistulas Assessed by MRI at Week 24 and Week 48
Timepoint [24] 0 0
Week 24 and Week 48
Secondary outcome [25] 0 0
Percentage of participants who Achieve Radiological Remission Based on Radiological Findings Assessed by MRI at Week 48
Timepoint [25] 0 0
Week 48
Secondary outcome [26] 0 0
Percentage of Participants who Achieve Radiological Remission Assessed by MRI at Week 48 Among the Participants who Achieve Radiological Remission at Week 24
Timepoint [26] 0 0
Week 48
Secondary outcome [27] 0 0
Percentage of Participants who Achieve Combined Clinically Assessed and Radiological Fistula Remission at Week 48 Among the Participants who Achieve Combined Clinical and Radiological Fistula Remission at Week 24
Timepoint [27] 0 0
Week 48
Secondary outcome [28] 0 0
Percentage of Participants who Achieve Combined Clinically Assessed and Radiological Fistula Remission at Week 48 Among the Participants with Clinical Fistula Response at Week 24
Timepoint [28] 0 0
Week 48
Secondary outcome [29] 0 0
Percentage of Participants with Proctitis at Week 48 Among Participants with MRI-confirmed Proctitis at Baseline
Timepoint [29] 0 0
Week 48
Secondary outcome [30] 0 0
Change from Baseline in Magnetic Resonance Novel Index for Fistula imaging in Crohn's disease (MAGNIFI-CD) by Visit Over Time Through Week 48
Timepoint [30] 0 0
Baseline up to Week 48
Secondary outcome [31] 0 0
Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) by Visit Over Time Through Week 48
Timepoint [31] 0 0
Baseline up to Week 48
Secondary outcome [32] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) Score by Visit Over Time Through Week 48
Timepoint [32] 0 0
Baseline; Up to Week 48
Secondary outcome [33] 0 0
Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Crohn's Disease (WPAI:CD) by Visit Over Time Through Week 48
Timepoint [33] 0 0
Baseline; Up to Week 48
Secondary outcome [34] 0 0
Change from Baseline in Quality-of-life as Assessed by European Quality-of-Life Five Dimension Five Level Scale (EQ5D-5L) Score by Visit Over Time Through Week 48
Timepoint [34] 0 0
Baseline up to Week 48
Secondary outcome [35] 0 0
Change from Baseline in the Jorge-Wexner Score by Visit Over Time Through Week 48
Timepoint [35] 0 0
Baseline; Through Week 48
Secondary outcome [36] 0 0
Change from Baseline in the Inflammatory Bowel Disease-Disability Index (IBD-DI) by Visit Over Time Through Week 48
Timepoint [36] 0 0
Baseline; Through Week 48
Secondary outcome [37] 0 0
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Timepoint [37] 0 0
Up to Week 48 and Week 96
Secondary outcome [38] 0 0
Number of Participants with Treatment-emergent Serious Adverse Events (TESAEs)
Timepoint [38] 0 0
Up to Week 48 and Week 96

Eligibility
Key inclusion criteria
* Must have a diagnosis of Crohn's disease with a minimum duration of at least 3 months
* Has at least one active draining perianal fistula as a complication of Crohn's disease, confirmed by screening magnetic resonance imaging (MRI) results
* Has previously demonstrated lack of initial response (that is primary non-responders), responded initially but then lost response with continued therapy (that is secondary non-responders), or were intolerant to a maximum of 2 classes of biologic agents at a dose approved for the treatment of Crohn's disease (that is infliximab, adalimumab, certolizumab pegol, vedolizumab, or approved biosimilars for these agents)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has a very severe luminal disease activity
* History of concurrent rectovaginal fistulas (other types of concurrent fistula should be confirmed with the sponsor), rectal and/or anal stenosis, stoma or functioning ostomy (include all current stoma types abscess or collections which are not properly drained
* Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery or preclude fistula evaluation
* Any medical contraindications preventing study participation
* Has a history of ongoing, chronic or recurrent enteral or systemic infectious disease

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/05/2027
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [2] 0 0
St Vincent's Hospital - Melbourne - Fitzroy
Recruitment hospital [3] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [5] 0 0
Royal Prince Alfred Hospital - Newtown
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - North Terrace
Recruitment hospital [7] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [8] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [9] 0 0
Mater Hospital - South Brisbane
Recruitment postcode(s) [1] 0 0
5042 - Adelaide
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment postcode(s) [5] 0 0
2042 - Newtown
Recruitment postcode(s) [6] 0 0
5000 - North Terrace
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment postcode(s) [8] 0 0
6000 - Perth
Recruitment postcode(s) [9] 0 0
4101 - South Brisbane
Recruitment outside Australia
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United States of America
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Alabama
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Connecticut
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Kansas
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Kentucky
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Oklahoma
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Tennessee
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Washington
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Madrid
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Sevilla
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Vigo
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Turkey
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Izmir
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Hull
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London
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Newcastle Upon Tyne
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Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen-Cilag Ltd.
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-Cilag Ltd. Clinical Trial
Address 0 0
Janssen-Cilag Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
[email protected]
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/NCT05347095