A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease (FUZION CD)

• ClinicalTrials.gov Identifier: NCT05347095
• Recruitment Status: Recruiting
• First Posted: April 26, 2022
• Last Update Posted: April 24, 2024
• Sponsor: Janssen-Cilag Ltd.
• Information provided by (Responsible Party): Janssen-Cilag Ltd.

Study Description

Brief Summary:

The purpose of this study to evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn's disease and to assess the overall safety of guselkumab.

Condition or disease	Intervention/treatment	Phase
Fistulizing Crohns Disease; Perianal Crohns Disease	Drug: Guselkumab; Drug: Placebo	Phase 3

Detailed Description:

Crohn's disease is a chronic, progressive, and potentially life-threatening disorder which may affect any part of the gastrointestinal tract. Guselkumab is a fully human immunoglobulin G1 (IgG1) lambda monoclonal antibody (mAb) that binds to the p19 subunit of human interleukin (IL)-23 with high specificity and affinity, without blocking IL-12. The aim is to evaluate the efficacy and safety of guselkumab in the treatment of adult participants with active fistulizing, perianal Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or biologic therapy or have medical contraindications to such therapies. This study consists of 3 phases: 6 weeks screening phase, 48 weeks treatment phase, and a 16 weeks follow-up phase. The study will have long term extension (LTE) period for participants who complete the 48-week treatment period and in the opinion of the investigator, will continue to benefit from the study intervention. Comprehensive safety data will be collected and the total duration of the study for participants will be up to 118 weeks (including the LTE period).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 280 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official 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
• Actual Study Start Date: September 27, 2022
• Estimated Primary Completion Date: March 15, 2025
• Estimated Study Completion Date: May 17, 2027

Arms and Interventions

Arm	Intervention/treatment
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.	Drug: Guselkumab; Guselkumab will be administered subcutaneously/IV infusion.; Other Name: CNTO1959; Drug: Placebo; Matching placebo will be administered subcutaneously/IV infusion.
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. Participants who are eligible and willing to continue guselkumab may enter the LTE period and continue to receive guselkumab.	Drug: Guselkumab; Guselkumab will be administered subcutaneously/IV infusion.; Other Name: CNTO1959; Drug: Placebo; Matching placebo will be administered subcutaneously/IV infusion.
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.	Drug: Guselkumab; Guselkumab will be administered subcutaneously/IV infusion.; Other Name: CNTO1959; Drug: Placebo; Matching placebo will be administered subcutaneously/IV infusion.

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants who Achieve Combined Fistula Remission at Week 24 [ Time Frame: Week 24 ]
   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.

Secondary Outcome Measures :

1. Percentage of Participants who Achieve Combined Fistula Remission at Week 48 [ Time Frame: Week 48 ]
   Percentage of participants who achieve combined fistula remission at Week 48 will be reported.
2. Percentage of Participants who Achieve Clinically Assessed Fistula Remission [ Time Frame: Week 24 ]
   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.
3. Percentage of Participants who Achieve Radiological Fistula Remission Based on Radiological Findings Assessed by MRI [ Time Frame: Week 24 ]
   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.
4. Percentage of Participants who Achieve Clinically Assessed Fistula Response at Week 24 [ Time Frame: Week 24 ]
   Percentage of participants who achieve clinically assessed fistula response at Week 24 will be reported. Clinically assessed fistula response is defined as closure of at least 50 percent (%) of all external openings that were draining at baseline.
5. Percentage of Participants who Achieve Clinically Assessed Fistula Response at Week 12 [ Time Frame: Week 12 ]
   Percentage of participants who achieve clinically assessed fistula response at Week 12 will be reported. Clinically assessed fistula response is defined as closure of at least 50% of all external openings that were draining at baseline.
6. Change from Baseline in Crohn's Disease Activity Index (CDAI) by Visit Over Time Through Week 48 [ Time Frame: Baseline up to Week 48 ]
   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.
7. 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 [ Time Frame: Through Week 48 ]
   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.
8. Percentage of Participants who Achieve a Clinical Response by Visit Over Time Through Week 48 Among Participants with CDAI >150 at Baseline [ Time Frame: Through Week 48 ]
   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.
9. Percentage of Participants who Achieve Steroid-free Clinical Remission by Visit Over Time Through Week 48 Among Participants with CDAI >150 at Baseline [ Time Frame: Through Week 48 ]
   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.
10. Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Response Among Participants With CDAI >220 at Baseline [ Time Frame: Week 24 and Week 48 ]
    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 closure of at least 50% of all external openings that were draining at baseline.
11. Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Remission Among Participants with CDAI >220 at Baseline [ Time Frame: Week 24 and Week 48 ]
    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.
12. Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Remission Among Participants with CDAI >220 at Baseline [ Time Frame: Week 24 and Week 48 ]
    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.
13. Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Response among Participants with CDAI >220 at Baseline [ Time Frame: Week 24 and Week 48 ]
    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 closure of at least 50% of all external openings that were draining at baseline.
14. Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Response at Week 24 and Week 48 [ Time Frame: Week 24 and Week 48 ]
    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 closure of at least 50% of all external openings that were draining at baseline.
15. Percentage of Participants who Achieve Combined Clinical Response and Clinically Assessed Fistula Remission at Week 24 and Week 48 [ Time Frame: Week 24 and Week 48 ]
    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.
16. Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Response at Week 24 and Week 48 [ Time Frame: Week 24 and Week 48 ]
    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 closure of at least 50% of all external openings that were draining at baseline.
17. Percentage of Participants who Achieve Combined Clinical Remission and Clinically Assessed Fistula Remission at Week 24 and Week 48 [ Time Frame: Week 24 and Week 48 ]
    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.
18. Change from Baseline in Perianal Disease Activity Index (PDAI) Overall Score, Discharge Score, and Pain Score by Visit Over Time Through Week 48 [ Time Frame: Baseline up to Week 48 ]
    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.
19. Percentage of Participants who Achieve Clinically Assessed Fistula Response by Visit Over Time Through Week 48 [ Time Frame: Through Week 48 ]
    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 closure of at least 50% of all external openings that were draining at baseline.
20. Percentage of Participants who Achieve Clinically Assessed Fistula Remission by Visit over Time Through Week 48 [ Time Frame: Through Week 48 ]
    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.
21. Percentage of Participants who Achieve Clinically Assessed Fistula Remission at Week 48 Among the Participants who Achieve Clinical Fistula Remission at Week 24 [ Time Frame: Week 48 ]
    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.
22. Percentage of Participants who Achieve Clinically Assessed Fistula Remission at Week 48 Among Those who Achieve Fistula Remission or Response at Week 24 [ Time Frame: Week 48 ]
    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.
23. Time to Clinical Fistula Remission [ Time Frame: Up to Week 96 ]
    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).
24. Percentage of Participants who Achieve Radiological Fistula Predominantly Fibrotic Status for all Existent Fistulas Assessed by MRI at Week 24 and Week 48 [ Time Frame: Week 24 and Week 48 ]
    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.
25. Percentage of participants who Achieve Radiological Remission Based on Radiological Findings Assessed by MRI at Week 48 [ Time Frame: Week 48 ]
    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.
26. Percentage of Participants who Achieve Radiological Remission Assessed by MRI at Week 48 Among the Participants who Achieve Radiological Remission at Week 24 [ Time Frame: Week 48 ]
    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.
27. 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 [ Time Frame: Week 48 ]
    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.
28. Percentage of Participants who Achieve Combined Clinically Assessed and Radiological Fistula Remission as Week 48 Among the Participants with Clinical Fistula Response at Week 24 [ Time Frame: Week 48 ]
    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.
29. Percentage of Participants with Proctitis at Week 48 Among Participants with MRI-confirmed Proctitis at Baseline [ Time Frame: Week 48 ]
    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.
30. Change from Baseline in Magnetic Resonance Novel Index for Fistula imaging in Crohn's disease (MAGNIFI-CD) by Visit Over Time Through Week 48 [ Time Frame: Baseline up to Week 48 ]
    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).
31. Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) by Visit Over Time Through Week 48 [ Time Frame: Baseline up to Week 48 ]
    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.
32. Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) Score by Visit Over Time Through Week 48 [ Time Frame: Baseline; Up to Week 48 ]
    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.
33. Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Crohn's Disease (WPAI:CD) by Visit Over Time Through Week 48 [ Time Frame: Baseline; Up to Week 48 ]
    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.
34. 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 [ Time Frame: Baseline up to Week 48 ]
    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).
35. Change from Baseline in the Jorge-Wexner Score by Visit Over Time Through Week 48 [ Time Frame: Baseline; Through Week 48 ]
    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.
36. Change from Baseline in the Inflammatory Bowel Disease-Disability Index (IBD-DI) by Visit Over Time Through Week 48 [ Time Frame: Baseline; Through Week 48 ]
    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).
37. Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to Week 48 ]
    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.
38. Number of Participants with Treatment-emergent Serious Adverse Events (TESAEs) [ Time Frame: Up to Week 48 ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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
• Is naïve to biologics, or demonstrated inadequate response or intolerance to conventional therapies or approved biologic therapies for Crohn's Disease (CD)

Exclusion Criteria:

• Has a very severe luminal disease activity
• History of or concurrent rectovaginal fistulas, rectal and/or anal stenosis or other active complications of perianal disease
• 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

Contacts and Locations

Contacts

Contact: Study Contact; 844-434-4210; Participate-In-This-Study@its.jnj.com

Locations

United States, Alabama

University of Alabama at Birmingham; Recruiting

Birmingham, Alabama, United States, 35294

United States, Connecticut

Yale University; Recruiting

New Haven, Connecticut, United States, 06510

United States, Florida

University of Miami; Recruiting

Miami, Florida, United States, 33136

Gastroenterology Group Of Naples; Recruiting

Naples, Florida, United States, 34102

AdventHealth Medical Group Blood & Marrow Transplant at Orlando; Recruiting

Orlando, Florida, United States, 32804

United States, Kansas

Kansas University Medical Center; Recruiting

Kansas City, Kansas, United States, 66160

United States, Kentucky

University of Kentucky Chandler Medical Center; Recruiting

Lexington, Kentucky, United States, 40536

University of Louisville; Recruiting

Louisville, Kentucky, United States, 40202

United States, Missouri

Washington University School of Medicine; Recruiting

Saint Louis, Missouri, United States, 63110

United States, New York

Mount Sinai School of Medicine; Recruiting

New York, New York, United States, 10029

United States, Oklahoma

Digestive Disease Specialists Inc; Recruiting

Oklahoma City, Oklahoma, United States, 73112

United States, Tennessee

Gastro One; Recruiting

Germantown, Tennessee, United States, 38138

Vanderbilt University Medical Center; Recruiting

Nashville, Tennessee, United States, 37212

United States, Texas

Tyler Research Institute, LLC; Recruiting

Tyler, Texas, United States, 75701

United States, Washington

Swedish Medical Center; Recruiting

Seattle, Washington, United States, 98122

Australia

Flinders Medical Centre; Recruiting

Adelaide, Australia, 5042

St Vincent's Hospital - Melbourne; Recruiting

Fitzroy, Australia, 3065

Liverpool Hospital; Recruiting

Liverpool, Australia, 2170

Fiona Stanley Hospital; Recruiting

Murdoch, Australia, 6150

Royal Prince Alfred Hospital; Recruiting

Newtown, Australia, 2042

Royal Adelaide Hospital; Recruiting

North Terrace, Australia, 5000

Royal Melbourne Hospital; Recruiting

Parkville, Australia, 3050

Royal Perth Hospital; Recruiting

Perth, Australia, 6000

Mater Hospital; Recruiting

South Brisbane, Australia, 4101

Belgium

Hopital Erasme; Recruiting

Bruxelles, Belgium, 1070

UZ Leuven; Recruiting

Leuven, Belgium, 3000

CHU Sart Tilman; Recruiting

Liege, Belgium, B-4000

Canada, Ontario

London Health Sciences Centre; Recruiting

London, Ontario, Canada, N6A 5A5

Mount Sinai Hospital; Recruiting

Toronto, Ontario, Canada, M5G 1X5

Canada, Quebec

McGill University Health Centre; Recruiting

Montreal, Quebec, Canada, H3G 1A4

Czechia

Nemocnice Ceske Budejovice, a.s.; Recruiting

Ceske Budejovice, Czechia, 37001

ISCARE a.s.; Recruiting

Praha 9, Czechia, 190 00

France

Clinique Ambroise Pare; Recruiting

Neuilly-sur-Seine, France, 92200

CHU de Nice Hopital de l Archet; Recruiting

Nice, France, 06202

Centre Hospitalier Lyon Sud; Recruiting

Pierre-Benite, France, 69495

CHRU Hopital de Pontchaillou; Recruiting

Rennes, France, 35033

CHRU Nancy-Brabois; Recruiting

Vandoeuvre-les-Nancy, France, 54511

Germany

Charite - Campus Mitte; Recruiting

Berlin, Germany, 10117

JWG-University Hospital; Recruiting

Frankfurt, Germany, 60590

Universitatsklinikum Schleswig Holstein Kiel; Recruiting

Kiel, Germany, 24105

Universitaetsklinikum Mannheim; Recruiting

Mannheim, Germany, 68167

Greece

Evangelismos General Hospital of Athens; Recruiting

Athens, Greece, 10676

Hippokration Hospital; Recruiting

Athens, Greece, 11528

University Hospital of Heraklion; Recruiting

Heraklion, Greece, 71110

Patras University Hospital; Recruiting

Patras, Greece, 26504

Hungary

Magyar Honvedseg Egeszsegugyi Kozpont; Recruiting

Budapest, Hungary, 1062

Semmelweis Egyetem; Recruiting

Budapest, Hungary, 1082

Semmelweis Egyetem; Recruiting

Budapest, Hungary, H-1088

Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika; Recruiting

Pecs, Hungary, 7624

Israel

Rambam Medical Center; Recruiting

Haifa, Israel, 31096

Shaare Zedek Medical Center; Recruiting

Jerusalem, Israel, 9103102

Rabin Medical Center Beilinson Campus; Recruiting

Petah Tikva, Israel, 4941492

Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico; Recruiting

Milano, Italy, 20122

Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar; Recruiting

Negrar ( Ve), Italy, 37024

Azienda Ospedaliera Universitaria Pisana; Recruiting

Pisa, Italy, 56124

Azienda Ospedaliera G.Salvini Ospedale di Rho; Recruiting

RHO, Italy

Casa Sollievo della Sofferenza; Recruiting

San Giovanni Rotondo, Italy, 71013

Japan

KOKIKAI Tokatsu Tsujinaka Hospital; Recruiting

Abiko, Japan, 270-1168

Fukuoka University Chikushi Hospital; Recruiting

Chikushino-shi, Japan, 818-8502

Kitakyushu Municipal Medical Center; Recruiting

Fukuoka-ken, Japan, 802-0077

Fukuoka University Hospital; Recruiting

Fukuoka, Japan, 814 0180

Hiroshima University Hospital; Recruiting

Hiroshima shi, Japan, 734 8551

Hospital of the University of Occupational and Environmental Health; Recruiting

Hukuoka, Japan, 807-8555

Sameshima Hospital; Recruiting

Kagoshima, Japan, 892-0846

Nara Medical University Hospital; Recruiting

Kashihara, Japan, 634-8521

Tsujinaka Hospital Kashiwanoha; Recruiting

Kashiwa, Japan, 277-0871

Nagasaki University Hospital; Recruiting

Nagasaki, Japan, 852-8501

Kojunkai Daido Clinic; Recruiting

Nagoya, Japan, 457-8511

Nagoya University Hospital; Recruiting

Nagoya, Japan, 466-8560

The Hospital of Hyogo College of Medicine; Recruiting

Nishinomiya, Japan, 663-8501

Okayama University Hospital; Recruiting

Okayama, Japan, 700-8558

Kinshukai Infusion Clinic; Recruiting

Osaka, Japan, 530-0011

JOHAS Osaka Rosai Hospital; Recruiting

Sakai, Japan, 591-8025

Sapporo Higashi Tokushukai Hospital; Recruiting

Sapporo, Japan, 065-0033

Tokyo Yamate Medical Center; Recruiting

Shinjuku-ku, Japan, 169-0073

Matsuda Hospital; Recruiting

Shizuoka, Japan, 432-8061

Osaka University Hospital; Recruiting

Suita, Japan, 565-0871

Kyorin University Hospital; Recruiting

Tokyo, Japan, 181 8611

Ieda Hospital; Recruiting

Toyota, Japan, 470-1219

Mie University Hospital; Recruiting

Tsu, Japan, 514 8507

Yokkaichi Hazu Medical Center; Recruiting

Yokkaichi, Japan, 510-0016

Yokohama Municipal Citizens Hospital; Recruiting

Yokohama, Japan, 221 0855

Jordan

The Speciality Hospital (TSH) / Advanced Clinical Center; Recruiting

Amman, Jordan, 11194

Jordan University Hospital; Recruiting

Amman, Jordan, 11942

Abdali Hospital; Recruiting

Amman, Jordan

Irbid Specialty Hospital; Recruiting

Irbid, Jordan, 21110

King Abdullah University Hospital; Recruiting

Irbid, Jordan, 22110

Korea, Republic of

Inje University Haeundae Paik Hospital; Recruiting

Busan, Korea, Republic of, 48108

Yeungnam University Hospital; Recruiting

Daegu, Korea, Republic of, 42415

Seoul National University Bundang Hospital; Recruiting

Gyeonggi-do, Korea, Republic of, 13620

Seoul National University Hospital; Recruiting

Seoul, Korea, Republic of, 03080

Gangnam Severance Hospital, Yonsei University Health System; Recruiting

Seoul, Korea, Republic of, 06273

Netherlands

Academisch Medisch Centrum Universiteit van Amsterdam; Recruiting

Amsterdam, Netherlands, 1105 AZ

Radboudumc; Recruiting

Nijmegen, Netherlands, 6525 GA

UMC Utrecht; Recruiting

Utrecht, Netherlands, 3584 CX

Poland

Gastromed Kralisz Romatowski Stachurska Sp. j.; Recruiting

Bialystok, Poland, 15-322

Centrum Medyczne Promed; Recruiting

Krakow, Poland, 31-513

Centrum Medyczne Med-Gastr; Recruiting

Lodz, Poland, 91-034

Centrum Medyczne Medyk; Recruiting

Rzeszow, Poland, 35-326

Twoja Przychodnia - Szczecinskie Centrum Medyczne; Recruiting

Szczecin, Poland, 71-434

GASTROMED Kopon, Zmudzinski i wspolnicy SP.j., Specjalistyczne Centrum Gastrologii i Endoskopii; Recruiting

Torun, Poland, 87-100

WIP Warsaw IBD Point Profesor Kierkus; Recruiting

Warszawa, Poland, 00-728

Melita Medical Sp. z o.o.; Recruiting

Wroclaw, Poland, 50-449

Centrum Medyczne Oporow; Recruiting

Wrocław, Poland, 52 416

Portugal

Ccab - Hosp. de Braga; Recruiting

Braga, Portugal, 4710-243

Chlc - Hosp. Sto Antonio Dos Capuchos; Recruiting

Lisboa, Portugal, G1R 2J6

H. Santo António - Centro Hospitalar do Porto; Recruiting

Porto, Portugal, 4099-001

Saudi Arabia

King Fahad Specialist hospital; Recruiting

Dammam, Saudi Arabia, 31444

King Abdulaziz Medical City; Recruiting

Jeddah, Saudi Arabia, 21423

King Saud University Medical City; Recruiting

Riyadh, Saudi Arabia, 11472

King Faisal Specialist Hospital & Research Center; Recruiting

Riyadh, Saudi Arabia, 12713

Spain

Hosp. Clinic de Barcelona; Recruiting

Barcelona, Spain, 08036

Hosp. Arquitecto Marcide; Recruiting

Ferrol, Spain, 15405

Hosp. Univ. de La Princesa; Recruiting

Madrid, Spain, 28006

Hosp. Univ. Pta. de Hierro Majadahonda; Recruiting

Majadahonda, Spain, 28222

Hosp. Virgen Macarena; Recruiting

Sevilla, Spain, 41009

Hosp. Alvaro Cunqueiro; Recruiting

Vigo, Spain, 36312

Hosp. Univ. Miguel Servet; Recruiting

Zaragoza, Spain, 50009

Taiwan

Changhua Christian Hospital; Recruiting

Changhua, Taiwan, 500

Taichung Veterans General Hospital; Recruiting

Taichung, Taiwan, 40705

National Taiwan University Hospital; Recruiting

Taipei City, Taiwan, 10002

Chang Gung Memorial Hospital Linkou Branch; Recruiting

Taoyuan City, Taiwan, 333

Turkey

Gazi University Medical Faculty; Recruiting

Ankara, Turkey, 06560

Istanbul University Cerrahpasa Medical Faculty; Recruiting

Istanbul, Turkey, 34098

Acibadem Kozyatagi Hospital; Recruiting

Istanbul, Turkey, 34734

Ege University Medical Faculty; Recruiting

İzmir, Turkey, 35100

Mersin University Medical Faculty Hospital; Recruiting

Mersin, Turkey, 33110

United Kingdom

Hull University Teaching Hospitals NHS Trust; Recruiting

Hull, United Kingdom, HU3 2JZ

London North West University Healthcare NHS Trust; Recruiting

London, United Kingdom, HA1 3UJ

Guy's and St Thomas' NHS Foundation Trust; Recruiting

London, United Kingdom, SE1 9RT

St George's University Hospital NHS Foundation Trust; Recruiting

London, United Kingdom, SW17 0QT

Newcastle upon Tyne Hospitals NHS Foundation Trust; Recruiting

Newcastle Upon Tyne, United Kingdom, NE3 3HD

Pennine Acute Hospitals NHS Trust; Recruiting

Salford, United Kingdom, M6 8HD

Sponsors and Collaborators

Janssen-Cilag Ltd.

Investigators

• Study Director: Janssen-Cilag Ltd. Clinical Trial; Janssen-Cilag Ltd.

More Information

• Responsible Party: Janssen-Cilag Ltd.
• ClinicalTrials.gov Identifier: NCT05347095
• Other Study ID Numbers: CR109189; 2021-000491-10 ( EudraCT Number ); CNTO1959CRD3005 ( Other Identifier: Janssen-Cilag Ltd. )
• First Posted: April 26, 2022
• Last Update Posted: April 24, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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
• URL: https://www.janssen.com/clinical-trials/transparency

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Crohn Disease; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases