Comparing JNJ-78934804 with Guselkumab for ulcerative colitis
Official title: A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 3 Randomized, Double-blind, and Active Controlled, Multi-center Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis
- Phase 3
- 2 groups
- Sites in Edmonton, Vancouver and 6 more cities
- Recruiting
Interventions
- Medication
JNJ-78934804
JNJ-78934804 will be administered subcutaneously.
- Medication
Guselkumab
Guselkumab will be administered subcutaneously.
Canadian Sites (10)
10 of 10 recruiting
- Recruiting
South Edmonton Gastroenterology Research Clinic
Edmonton, Alberta
- Recruiting
Gastroenterology and Internal Medicine Research Institute (GIRI)
Edmonton, Alberta
- Recruiting
GI Research Institute (G.I.R.I.)
Vancouver, British Columbia
- Recruiting
Viable Clinical Research
Kentville, Nova Scotia
- Recruiting
Barrie GI Associates
Barrie, Ontario
- Recruiting
Charlton Digestive Disease Centre
Hamilton, Ontario
- Recruiting
London Digestive Disease Institute
London, Ontario
- Recruiting
Toronto Immune and Digestive Health Institute Inc
Toronto, Ontario
- Recruiting
CHUM - Centre hospitalier universitaire de Montreal
Montreal, Quebec
- Recruiting
Clinique IMD
Montreal, Quebec
Eligibility Criteria
See who this study is looking for9 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Moderately to severely active UC defined as baselineBaselineYour starting measurements, taken before treatment begins.Read more → (Week 0) modified Mayo score of 5 to 9, inclusive, using the Mayo endoscopy subscore obtained during central review of the screeningScreeningThe checks done before joining, to see whether a study fits.Read more → video endoscopy
- +Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC.
- +An endoscopy subscore \>=2 as obtained during central review of the screening video endoscopy
- +Have had an inadequate initial response, loss of response, or intolerance to previous approved systemic therapies
Exclusion
- −Has previously demonstrated inadequate initial response, loss of response, allergy, hypersensitivity or intolerance to guselkumab or to golimumab
- −Isolated proctitis (UC limited to the rectum only or to less than \[\<\] 20 centimeter \[cm\] from the anal verge) as determined during central review of the screeningScreeningThe checks done before joining, to see whether a study fits.Read more → video endoscopy OR Has a diagnosis of isolated proctitis
- −Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or any findings suggestive of CD
- −Has a history of or ongoing chronic or recurrent infectious disease
- −Is a participant who is pregnant, breastfeeding, or planning to become pregnant, or plans to father a child, while enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in this study or within 6 months after the last dose of study intervention
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives JNJ-78934804.
Registry label: A: JNJ-78934804
Group B, the comparison group, receives Guselkumab, together with one or more of: JNJ-78934804.
Registry label: B: Guselkumab
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 644 people.
The study is currently expected to finish around October 2030.
The main measurement is taken over: At Week 48.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Percentage of Participants in Clinical Remission at Week 48 — measured over At Week 48.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07577856 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About JNJ-78934804Drug
JNJ-78934804 will be administered subcutaneously.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About GuselkumabDrug
Guselkumab will be administered subcutaneously.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: At Week 48.
The study as a whole is currently expected to finish around 2030-10-16.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 644 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 11 locations, including: Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Kentville, Nova Scotia, Canada; Barrie, Ontario, Canada; Hamilton, Ontario, Canada; London, Ontario, Canada, and 5 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops ulcers).
Other Sites (3)
Michigan Center of Medical Research
Farmington Hills, Michigan, United States
New York Gastroenterology Associates
New York, New York, United States
GI Alliance Tacoma
Tacoma, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.