A Phase 2 interventional study of Guselkumab and Golimumab in Colitis, Ulcerative, sponsored by Janssen Research & Development, LLC. Active, not recruiting at 403 sites in 37 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Janssen Research & Development, LLC · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advanced therapy.
1,492 studies on the registry are indexed under Colitis, Ulcerative; 399 are open to participants now.
This study's enrollment of 577 is above the median of 71 across 1,042 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.
Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive placebo subcutaneously (SC). All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Drug: Placebo
Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Biological: Guselkumab
Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Biological: Golimumab
Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Biological: JNJ-78934804
Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Biological: JNJ-78934804
Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Biological: JNJ-78934804
Guselkumab will be administered as subcutaneous injection.
Golimumab will be administered as subcutaneous injection.
JNJ-78934804 will be administered subcutaneously as per defined regimen.
Placebo will be administered as subcutaneous injection.
Percentage of Participants with Clinical Remission at Week 48
Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission based on the modified Mayo subscores.
Time frame: Week 48
Percentage of Participants with Endoscopic Improvement at Week 48
Percentage of participants with endoscopic improvement at Week 48 will be reported. Endoscopic improvement at Week 48 based on the Mayo endoscopic subscore.
Time frame: Week 48
Percentage of Participants with Corticosteroid-free Clinical Remission at Week 48
Percentage of participants with corticosteroid-free (60-day) clinical remission at Week 48 will be reported.
Time frame: Week 48
Percentage of Participants with Symptomatic Remission at Week 48
Percentage of participants with symptomatic remission at Week 48 will be reported. Symptomatic remission at Week 48 based on stool and rectal bleeding symptoms.
Time frame: Week 48
Percentage of Participants with Combination of Histological Remission and Endoscopic Improvement at Week 48
Percentage of participants with combination of histological remission and endoscopic improvement at Week 48 will be reported. Histologic remission and endoscopic improvement at Week 48 based on the histologic grading and the Mayo endoscopy subscore.
Time frame: Week 48
Secondary Comparison: Percentage of Participants with Clinical Remission at Week 48
Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission based on the modified Mayo subscores will be reported.
Time frame: Week 48
Percentage of Participants with Adverse Events (AEs)
An 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.
Time frame: Up to Week 48
Percentage of Participants with Serious Adverse Events (SAEs)
A 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; is medically important.
Time frame: Up to Week 48
Laboratory Parameters Over Time
Laboratory parameters over time will be reported.
Time frame: Up to Week 48
Vital Signs Parameters Over Time
Vital signs parameters over time will be reported.
Time frame: Up to Week 48
Suicidal Ideation Assessment Using Columbia Suicide Severity Rating Scale (C-SSRS) Score
The C-SSRS scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.
Time frame: Up to Week 48
Serum Concentrations of Guselkumab Over Time
Serum concentrations of guselkumab over time will be reported. Serum samples will be analyzed to determine concentrations of guselkumab using a validated, specific, and sensitive method.
Time frame: Up to Week 48
Serum Concentrations of Golimumab Over Time
Serum concentration of golimumab over time will be reported. Serum samples will be analyzed to determine concentrations of golimumab using a validated, specific, and sensitive method.
Time frame: Up to Week 48
Percentage of Participants with Antibodies to Guselkumab
Percentage of participants with antibodies to guselkumab will be reported.
Time frame: Up to Week 48
Titers of Antibodies to Guselkumab
Titers of antibodies to guselkumab will be reported.
Time frame: Up to Week 48
Percentage of Participants with Antibodies to Golimumab
Percentage of Participants with Antibodies to golimumab will be reported.
Time frame: Up to Week 48
Titers of Antibodies to Golimumab
Titers of antibodies to golimumab will be reported.
Time frame: Up to Week 48
Percentage of Participants with Neutralizing Antibodies to Guselkumab
Percentage of participants with neutralizing antibodies to guselkumab will be reported.
Time frame: Up to Week 48
Percentage of Participants with Neutralizing Antibodies to Golimumab
Percentage of participants with neutralizing antibodies to golimumab will be reported.
Time frame: Up to Week 48
Showing the first 100 of 403 sites across 37 countries.
Plan to share: Yes — 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
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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