A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease
- Conditions
- Crohn's Disease
- Interventions
- Registration Number
- NCT05242471
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 703
- Diagnosis of Crohn's disease (CD) for at least 3 months prior to baseline
- Confirmed diagnosis of moderate to severe CD as assessed by Crohn'
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 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 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 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 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 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 is based on the Crohn's Disease Activity Index (CDAI).
Percentage of Participants with Endoscopic Response at Week 48 Week 48 Percentage of participants with endoscopic response at Week 48 will be reported. Endoscopic response is based on change from baseline in the simple endoscopic score for Crohn's disease (SES-CD), as assessed by central endoscopy reading.
- Secondary Outcome Measures
Name Time Method Percentage of Participants with Patient-reported Outcomes (PRO)-2 Remission at Week 48 Week 48 Percentage of participants with PRO-2 remission at Week 48 will be reported. PRO-2 remission is based on the average daily abdominal pain (AP) and stool frequency (SF) scores.
Percentage of Participants with Endoscopic Remission at Week 48 Week 48 Percentage of participants with endoscopic remission at Week 48 will be reported. Endoscopic remission is based on the SES-CD, as assessed by central endoscopy reading.
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.
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 is based on the Crohn's Disease Activity Index (CDAI).
Secondary Comparison: Percentage of Participants with Endoscopic Response at Week 48 Week 48 Percentage of participants with endoscopic response at Week 48 will be reported. Endoscopic response is based on change from baseline in the SES-CD, as assessed by central endoscopy reading.
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.
Clinical Laboratory Parameters Over Time Up to Week 48 Clinical laboratory parameters over time will be reported.
Vital Sign Parameters Over Time Up to Week 48 Vital sign 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 is defined as 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 concentrations 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.
Trial Locations
- Locations (451)
University of Alabama Liver Center
🇺🇸Birmingham, Alabama, United States
Del Sol Research Management, LLC
🇺🇸Tucson, Arizona, United States
Moore Clinical Trials, LLC
🇺🇸Little Rock, Arkansas, United States
Om Research LLC
🇺🇸Apple Valley, California, United States
Valley Gastroenterology Medical Group
🇺🇸Arcadia, California, United States
Southern California Research Center
🇺🇸Coronado, California, United States
Desert Gastroenterology Associates
🇺🇸Lancaster, California, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
UCLA
🇺🇸Los Angeles, California, United States
Hoag Memorial Hospital
🇺🇸Newport Beach, California, United States
Scroll for more (441 remaining)University of Alabama Liver Center🇺🇸Birmingham, Alabama, United States