A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

Phase 2

Active, not recruiting

• Conditions: Colitis, Ulcerative
• Interventions: Biological: JNJ-78934804; Drug: Placebo; Biological: Guselkumab; Biological: Golimumab

• Registration Number: NCT05242484
• Lead Sponsor: Janssen Research & Development, LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-15
• Study First Submitted QC: 2022-02-15
• Study First Posted: 2022-02-16
• Study Start: 2022-09-19
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-23
• Last Update Posted: 2025-05-25
• Primary Completion: 2025-05-27
• Study Completion: 2029-03-27

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 577

Inclusion Criteria

• Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline
• Moderately to severely active UC as assessed by the modified Mayo score
• Demonstrated inadequate response, loss of response, or intolerance to at least one biologic or novel oral with biologic-like activity
• If female and of childbearing potential, must meet the contraception and reproduction requirements

Exclusion Criteria

• Has severe extensive colitis as defined in the protocol
• Extent of inflammatory disease limited to the rectum
• Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease (CD)
• Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer
• Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 4: JNJ-78934804 (High-dose)	JNJ-78934804	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.
Group 1: Placebo	Placebo	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.
Group 5: JNJ-78934804 (Mid-dose)	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.
Group 6: JNJ-78934804 (Low-dose)	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.
Group 2: Guselkumab	Guselkumab	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.
Group 3: Golimumab	Golimumab	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Clinical Remission at Week 48	Week 48	Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission based on the modified Mayo subscores.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants with Endoscopic Improvement at Week 48	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.
Percentage of Participants with Corticosteroid-free Clinical Remission at Week 48	Week 48	Percentage of participants with corticosteroid-free (60-day) clinical remission at Week 48 will be reported.
Percentage of Participants with Symptomatic Remission at Week 48	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.
Percentage of Participants with Combination of Histological Remission and Endoscopic Improvement at Week 48	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.
Secondary Comparison: Percentage of Participants with Clinical Remission at Week 48	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.
Percentage of Participants with Adverse Events (AEs)	Up to Week 48	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.
Percentage of Participants with Serious Adverse Events (SAEs)	Up to Week 48	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.
Vital Signs Parameters Over Time	Up to Week 48	Vital signs parameters over time will be reported.
Suicidal Ideation Assessment Using Columbia Suicide Severity Rating Scale (C-SSRS) Score	Up to Week 48	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.
Serum Concentrations of Guselkumab Over Time	Up to Week 48	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.
Serum Concentrations of Golimumab Over Time	Up to Week 48	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.
Percentage of Participants with Antibodies to Guselkumab	Up to Week 48	Percentage of participants with antibodies to guselkumab will be reported.
Titers of Antibodies to Guselkumab	Up to Week 48	Titers of antibodies to guselkumab will be reported.
Percentage of Participants with Antibodies to Golimumab	Up to Week 48	Percentage of Participants with Antibodies to golimumab will be reported.
Titers of Antibodies to Golimumab	Up to Week 48	Titers of antibodies to golimumab will be reported.
Percentage of Participants with Neutralizing Antibodies to Guselkumab	Up to Week 48	Percentage of participants with neutralizing antibodies to guselkumab will be reported.
Percentage of Participants with Neutralizing Antibodies to Golimumab	Up to Week 48	Percentage of participants with neutralizing antibodies to golimumab will be reported.
Laboratory Parameters Over Time	Up to Week 48	Laboratory parameters over time will be reported.

Trial Locations

Locations (399)

Valley Gastroenterology Medical Group; 🇺🇸 Arcadia, California, United States

Southern California Research Center; 🇺🇸 Coronado, California, United States

Om Research LLC; 🇺🇸 Lancaster, California, United States

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Peak Gastroenterology Associates; 🇺🇸 Colorado Springs, Colorado, United States

Medical Research Center of Connecticut; 🇺🇸 Hamden, Connecticut, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

MedStar Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States

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