Register a trial

Please note that the ANZCTR website will be unavailable from 1pm until 2pm (AEST) on Thursday 15th May for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

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/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
Assessment method [1] 0 0
Percentage of participants who achieve combined fistula remission at Week 24 will be reported. Combined fistula remission is defined as 100 percentage (%) closure of all treated external openings without development of new fistulas or abscesses and without any drainage by the external openings \[occurring spontaneously or after gentle finger compression\] and absence of collections greater than (\>) 2 centimeters (cm) of the perianal fistulas in at least two of three dimensions, confirmed by a blinded central review of the magnetic resonance imaging \[MRI\] results.
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Percentage of Participants who Achieve Combined Fistula Remission at Week 48
Assessment method [1] 0 0
Percentage of participants who achieve combined fistula remission at Week 48 will be reported.
Timepoint [1] 0 0
Week 48
Secondary outcome [2] 0 0
Percentage of Participants who Achieve Clinically Assessed Fistula Remission
Assessment method [2] 0 0
Percentage of participants who achieve clinically assessed fistula remission will be reported. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression.
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
Assessment method [3] 0 0
Percentage of participants who achieve radiological fistula remission based on radiological findings assessed by MRI will be reported. Radiological remission is defined as absence of collections \>2 cm of the perianal fistulas in at least two of three dimensions, confirmed by a blinded central review of the MRI results.
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Percentage of Participants who Achieve Clinically Assessed Fistula Response at Week 24
Assessment method [4] 0 0
Percentage of participants who achieve clinically assessed fistula response at Week 24 will be reported. Clinically assessed fistula response is defined as a greater than or equal to (\>=) 50% reduction from baseline in number of open or draining perianal fistulas.
Timepoint [4] 0 0
Week 24
Secondary outcome [5] 0 0
Percentage of Participants who Achieve Clinically Assessed Fistula Response at Week 12
Assessment method [5] 0 0
Percentage of participants who achieve clinically assessed fistula response at Week 12 will be reported. Clinically assessed fistula response is defined as \>=50% reduction from baseline in number of open or draining perianal fistulas.
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
Assessment method [6] 0 0
Change from baseline in CDAI by visit over time will be reported. CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid or very soft stools, abdominal pain (AP)/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being with scores ranging from 0 to approximately 600. The last 4 variables are scored over 7 days by the participant on a diary card that participants are to complete on a daily basis.
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
Assessment method [7] 0 0
Percentage of participants who achieve clinical remission (CDAI \<150) by visit over time through Week 48 among participants with CDAI \>150 at baseline will be reported. CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid or very soft stools, abdominal pain \[AP\]/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being with scores ranging from 0 to approximately 600. The last 4 variables are scored over 7 days by the participant on a diary card that participants are to complete on a daily basis.
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
Assessment method [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 will be reported. Clinical response is defined greater than or equal to (\>=) 100-point reduction from baseline in CDAI, or CDAI \<150.
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
Assessment method [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 will be reported. Steroid-free clinical remission is defined as CDAI \<150 and not receiving corticosteroids 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
Assessment method [10] 0 0
Percentage of participants who achieve combined clinical response and clinically assessed fistula response among participants with CDAI \>220 at baseline at baseline will be reported. Clinical response is defined \>=100-point reduction from baseline in CDAI, or CDAI \<150. Clinically assessed fistula response is defined as \>=50% reduction from baseline in number of open or draining perianal fistulas.
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
Assessment method [11] 0 0
Percentage of participants who achieve combined clinical remission and clinically assessed fistula remission among participants with CDAI \>220 at baseline at will be reported. Clinical remission is defined as CDAI \<150. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression.
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
Assessment method [12] 0 0
Percentage of participants who achieve combined clinical response and clinically assessed fistula remission among participants with CDAI \>220 at baseline will be reported. Clinical response is defined \>=100-point reduction from baseline in CDAI, or CDAI \<150. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression.
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
Assessment method [13] 0 0
Percentage of participants who achieve combined clinical remission and clinically assessed fistula response among participants with CDAI \>220 at baseline will be reported. Clinically assessed fistula response is defined as \>=50% reduction from baseline in number of open or draining perianal fistulas.
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
Assessment method [14] 0 0
Percentage of participants who achieve combined clinical response and clinically assessed fistula response at Week 24 and Week 48 will be reported. Clinical response is defined \>=100-point reduction from baseline in CDAI, or CDAI \<150. Clinically assessed fistula response is defined as \>=50% reduction from baseline in number of open or draining perianal fistulas.
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
Assessment method [15] 0 0
Percentage of participants who achieve combined clinical response and clinically assessed fistula remission at Week 24 and Week 48 will be reported. Clinical response is defined \>=100-point reduction from baseline in CDAI, or CDAI \<150. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression.
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
Assessment method [16] 0 0
Percentage of participants who achieve combined clinical remission and clinically assessed fistula response at Week 24 and Week 48 will be reported. Clinically assessed fistula response is defined as \>=50% reduction from baseline in number of open or draining perianal fistulas.
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
Assessment method [17] 0 0
Percentage of participants who achieve combined clinical remission and clinically assessed fistula remission will be reported. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression.
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
Assessment method [18] 0 0
Change from baseline in PDAI overall score, discharge score, and pain score by visit over time through Week 48 will be reported. The PDAI is a scoring system to evaluate the severity of perianal lesion associated with Crohn's disease. It includes the following 5 items: (a) Discharge; (0=no discharge to 4= Gross fecal soiling) (b) Pain; (0=no activity to 4= severe pain, severe limitation) (c) Restriction of sexual activity;(0=no perianal disease/skin tags to 4= unable to engage in sexual activity) (d) Type of perianal disease; (0=no perianal disease/skin tags to 4=Anal sphincter ulceration or fistulae with significant undermining ok skin) and (e) Degree of induration; (0=no induration to 4=gross fluctuance/abscess. Higher scores indicate more severe or active disease.
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
Assessment method [19] 0 0
Percentage of participants with clinically assessed fistula response by visit over time through Week 48 will be reported. Clinically assessed fistula response is defined as \>=50% reduction from baseline in number of open or draining perianal fistulas.
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
Assessment method [20] 0 0
Percentage of participants with clinically assessed fistula remission by visit over through Week 48 time will be reported. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression.
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
Assessment method [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 will be reported. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression.
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
Assessment method [22] 0 0
Percentage of participants achieving clinically assessed fistula remission at Week 48 among those who achieve fistula remission or response (defined either by clinical or radiological assessment) at Week 24 will be reported. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression.
Timepoint [22] 0 0
Week 48
Secondary outcome [23] 0 0
Time to Clinical Fistula Remission
Assessment method [23] 0 0
Time to clinical fistula remission will be reported. Clinical fistula remission is defined as 100% closure of all treated external openings without development of new fistulas or abscesses and without any drainage by the external openings (occurring spontaneously or after gentle finger compression).
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
Assessment method [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 will be reported.
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
Assessment method [25] 0 0
Percentage of participants with radiological remission based on radiological findings assessed by MRI at Week 48 will be reported. Radiological remission is defined as absence of collections \>2 cm of the perianal fistulas, confirmed by a blinded central review of the MRI results.
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
Assessment method [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 will be reported. Radiological remission is defined as absence of collections \>2 cm of the perianal fistulas, confirmed by a blinded central review of the MRI results.
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
Assessment method [27] 0 0
Percentage of participants who achieve combined clinically assessed and radiological (assessed by MRI) 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
Assessment method [28] 0 0
Percentage of participants who achieve combined clinically assessed and radiological (assessed by MRI) fistula remission at Week 48 among the participants who achieve clinical fistula response at Week 24 will be reported.
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
Assessment method [29] 0 0
Percentage of participants with proctitis at Week 48 among participants with MRI-confirmed proctitis at baseline will be reported. Proctitis is defined as the inflammation of the lining of the rectum.
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
Assessment method [30] 0 0
Change from baseline in MAGNIFI-CD by visit over time through Week 48 will be reported. The MAGNIFI-CD is based on MRI assessment of 6 items including number of fistula tracts, fistula length, hyperintensity of primary tract on post-contrast T1-weighted images, dominant feature, extension, and inflammatory mass. The total MAGNIFI-CD score ranges from 0 (no disease activity) to 25 (severe disease activity). It assesses the MRI data and determines perianal fistulizing CD activity with improved operating characteristics compared to the Van Assche Index (VAI) and the modified VAI (mVAI).
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
Assessment method [31] 0 0
Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) by visit over time through Week 48 will be reported. The IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD to evaluate patient reported outcomes (PROs) across 4 dimensions: bowel symptoms (loose stools, AP), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.
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
Assessment method [32] 0 0
Change From baseline in FACIT-F Score at Week 48 will be reported. The FACIT-F is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists of 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score is calculated as the sum of the 13 item scores (reserved scores \[4 - score\]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items are reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.
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
Assessment method [33] 0 0
Change from baseline in WPAI:CD by visit over time through Week 48 will be reported. The WPAI:CD assesses the impact of CD on work and activity during the past 7 days. The specificity of WPAI:CD is achieved by replacing "health problems" in the general health version of the WPAI with "CD." It consists of 6 questions, which elicit the following information: employment status; hours missed due to CD; hours missed due to other reasons; hours actually worked; the degree to which CD affected productivity while working from 0 (no effect) to 10 (maximum impairment); and the degree to which CD affected regular activities (from 0-10). The sum of worktime missed and impairment at work yields the overall work impairment (productivity loss) score; scores are expressed as percent of impairment/productivity loss, with higher scores indicating greater impairment.
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
Assessment method [34] 0 0
Change from baseline in quality-of-life (EQ5D-5L) score by visit over time through Week 48 will be reported. The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
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
Assessment method [35] 0 0
Change from baseline in the Jorge-Wexner score by visit over time through Week 48 will be reported. The Jorge-Wexner scoring system cross-tabulates frequencies and different anal incontinence presentations.
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
Assessment method [36] 0 0
Change from baseline in the Inflammatory Bowel Disease-Disability Index (IBD-DI) by visit over time through Week 48 will be reported. The IBD-DI consists of 28 items that evaluate the 5 domains of overall health, body function, body structures, activity participation and environmental factors. Each item response is graded from 0 to 4 for each area evaluated (0 = very good; 1 = Good; 2 = medium; 3 = Bad; 4 = Very bad). The final composite score representative of the overall degree of disability ranging from -80 (maximum degree of disability) to 22 (no disability).
Timepoint [36] 0 0
Baseline; Through Week 48
Secondary outcome [37] 0 0
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Assessment method [37] 0 0
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
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)
Assessment method [38] 0 0
An serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. TESAEs are defined as serious events between administration of study drug and after the last dose that were absent before treatment or that worsen relative to pretreatment state.
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 advanced drug therapies at a dose approved for the treatment of Crohn's disease (that is infliximab, adalimumab, certolizumab pegol, vedolizumab, or approved biosimilars for these agents) or JAK inhibitors licensed for Crohn's disease treatment (that is, upadacitinib)
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) colonic mucosal dysplasia or pre-cancerous lesions that have not been removed, demyelinating disease, or systemic lupus erythematosus
* 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
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
Connecticut
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
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Oklahoma
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Belgium
State/province [12] 0 0
Bruxelles
Country [13] 0 0
Belgium
State/province [13] 0 0
Genk
Country [14] 0 0
Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
Belgium
State/province [15] 0 0
Liege
Country [16] 0 0
Canada
State/province [16] 0 0
Alberta
Country [17] 0 0
Canada
State/province [17] 0 0
Nova Scotia
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
Czechia
State/province [20] 0 0
Ceske Budejovice
Country [21] 0 0
Czechia
State/province [21] 0 0
Praha 9
Country [22] 0 0
Egypt
State/province [22] 0 0
Alexandria
Country [23] 0 0
Egypt
State/province [23] 0 0
Cairo
Country [24] 0 0
Egypt
State/province [24] 0 0
Giza
Country [25] 0 0
France
State/province [25] 0 0
Neuilly-sur-Seine
Country [26] 0 0
France
State/province [26] 0 0
Nice
Country [27] 0 0
France
State/province [27] 0 0
Paris
Country [28] 0 0
France
State/province [28] 0 0
Pierre-Benite
Country [29] 0 0
France
State/province [29] 0 0
Rennes
Country [30] 0 0
France
State/province [30] 0 0
Vandoeuvre les Nancy
Country [31] 0 0
Germany
State/province [31] 0 0
Berlin
Country [32] 0 0
Germany
State/province [32] 0 0
Frankfurt
Country [33] 0 0
Germany
State/province [33] 0 0
Kiel
Country [34] 0 0
Germany
State/province [34] 0 0
Mannheim
Country [35] 0 0
Germany
State/province [35] 0 0
Ulm
Country [36] 0 0
Greece
State/province [36] 0 0
Athens Attica
Country [37] 0 0
Greece
State/province [37] 0 0
Athens
Country [38] 0 0
Greece
State/province [38] 0 0
Heraklion
Country [39] 0 0
Greece
State/province [39] 0 0
Larissa
Country [40] 0 0
Greece
State/province [40] 0 0
Patras
Country [41] 0 0
Greece
State/province [41] 0 0
Thessaloniki
Country [42] 0 0
Hungary
State/province [42] 0 0
Budapest
Country [43] 0 0
Hungary
State/province [43] 0 0
Pecs
Country [44] 0 0
Hungary
State/province [44] 0 0
Szeged
Country [45] 0 0
Israel
State/province [45] 0 0
Afula
Country [46] 0 0
Israel
State/province [46] 0 0
Haifa
Country [47] 0 0
Israel
State/province [47] 0 0
Jerusalem
Country [48] 0 0
Israel
State/province [48] 0 0
Petah Tikva
Country [49] 0 0
Italy
State/province [49] 0 0
Milano
Country [50] 0 0
Italy
State/province [50] 0 0
Negrar ( Ve)
Country [51] 0 0
Italy
State/province [51] 0 0
Pisa
Country [52] 0 0
Italy
State/province [52] 0 0
RHO
Country [53] 0 0
Italy
State/province [53] 0 0
Roma
Country [54] 0 0
Italy
State/province [54] 0 0
Rozzano
Country [55] 0 0
Italy
State/province [55] 0 0
San Giovanni Rotondo
Country [56] 0 0
Japan
State/province [56] 0 0
Abiko
Country [57] 0 0
Japan
State/province [57] 0 0
Chikushino-shi
Country [58] 0 0
Japan
State/province [58] 0 0
Fukuoka-ken
Country [59] 0 0
Japan
State/province [59] 0 0
Fukuoka
Country [60] 0 0
Japan
State/province [60] 0 0
Hiroshima shi
Country [61] 0 0
Japan
State/province [61] 0 0
Hukuoka
Country [62] 0 0
Japan
State/province [62] 0 0
Kagoshima
Country [63] 0 0
Japan
State/province [63] 0 0
Kashihara
Country [64] 0 0
Japan
State/province [64] 0 0
Kashiwa
Country [65] 0 0
Japan
State/province [65] 0 0
Nagasaki
Country [66] 0 0
Japan
State/province [66] 0 0
Nagoya
Country [67] 0 0
Japan
State/province [67] 0 0
Nishinomiya
Country [68] 0 0
Japan
State/province [68] 0 0
Okayama
Country [69] 0 0
Japan
State/province [69] 0 0
Osaka
Country [70] 0 0
Japan
State/province [70] 0 0
Sakai
Country [71] 0 0
Japan
State/province [71] 0 0
Sapporo
Country [72] 0 0
Japan
State/province [72] 0 0
Shinjuku-ku
Country [73] 0 0
Japan
State/province [73] 0 0
Shizuoka
Country [74] 0 0
Japan
State/province [74] 0 0
Suita
Country [75] 0 0
Japan
State/province [75] 0 0
Tokyo
Country [76] 0 0
Japan
State/province [76] 0 0
Toyota
Country [77] 0 0
Japan
State/province [77] 0 0
Tsu
Country [78] 0 0
Japan
State/province [78] 0 0
Yokkaichi
Country [79] 0 0
Japan
State/province [79] 0 0
Yokohama
Country [80] 0 0
Jordan
State/province [80] 0 0
Amman
Country [81] 0 0
Jordan
State/province [81] 0 0
Irbid
Country [82] 0 0
Korea, Republic of
State/province [82] 0 0
Busan
Country [83] 0 0
Korea, Republic of
State/province [83] 0 0
Daegu
Country [84] 0 0
Korea, Republic of
State/province [84] 0 0
Gyeonggi-do
Country [85] 0 0
Korea, Republic of
State/province [85] 0 0
Seoul
Country [86] 0 0
Netherlands
State/province [86] 0 0
Amsterdam
Country [87] 0 0
Netherlands
State/province [87] 0 0
Nijmegen
Country [88] 0 0
Netherlands
State/province [88] 0 0
Rotterdam
Country [89] 0 0
Netherlands
State/province [89] 0 0
Utrecht
Country [90] 0 0
Poland
State/province [90] 0 0
Bialystok
Country [91] 0 0
Poland
State/province [91] 0 0
Krakow
Country [92] 0 0
Poland
State/province [92] 0 0
Lodz
Country [93] 0 0
Poland
State/province [93] 0 0
Rzeszow
Country [94] 0 0
Poland
State/province [94] 0 0
Szczecin
Country [95] 0 0
Poland
State/province [95] 0 0
Torun
Country [96] 0 0
Poland
State/province [96] 0 0
Warszawa
Country [97] 0 0
Poland
State/province [97] 0 0
Wroclaw
Country [98] 0 0
Portugal
State/province [98] 0 0
Braga
Country [99] 0 0
Portugal
State/province [99] 0 0
Lisboa
Country [100] 0 0
Portugal
State/province [100] 0 0
Porto
Country [101] 0 0
Saudi Arabia
State/province [101] 0 0
Dammam
Country [102] 0 0
Saudi Arabia
State/province [102] 0 0
Jeddah
Country [103] 0 0
Saudi Arabia
State/province [103] 0 0
Riyadh
Country [104] 0 0
Spain
State/province [104] 0 0
Barcelona
Country [105] 0 0
Spain
State/province [105] 0 0
Ferrol
Country [106] 0 0
Spain
State/province [106] 0 0
Girona
Country [107] 0 0
Spain
State/province [107] 0 0
Madrid
Country [108] 0 0
Spain
State/province [108] 0 0
Majadahonda
Country [109] 0 0
Spain
State/province [109] 0 0
Sevilla
Country [110] 0 0
Spain
State/province [110] 0 0
Vigo
Country [111] 0 0
Spain
State/province [111] 0 0
Zaragoza
Country [112] 0 0
Taiwan
State/province [112] 0 0
Changhua
Country [113] 0 0
Taiwan
State/province [113] 0 0
Taichung
Country [114] 0 0
Taiwan
State/province [114] 0 0
Taipei City
Country [115] 0 0
Taiwan
State/province [115] 0 0
Taoyuan City
Country [116] 0 0
Turkey
State/province [116] 0 0
Ankara
Country [117] 0 0
Turkey
State/province [117] 0 0
Istanbul
Country [118] 0 0
Turkey
State/province [118] 0 0
Izmir
Country [119] 0 0
Turkey
State/province [119] 0 0
Mersin
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Hull
Country [121] 0 0
United Kingdom
State/province [121] 0 0
London
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Newcastle Upon Tyne
Country [123] 0 0
United Kingdom
State/province [123] 0 0
Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen-Cilag Ltd.
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
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
Email 0 0
Participate-In-This-Study@its.jnj.com
Contact person for scientific queries

Data sharing statement


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