A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.

Official Title
-----------------
A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Biological: Guselkumab
* Biological: Golimumab
* Biological: JNJ-78934804
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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's disease activity index (CDAI), stool frequency (SF), abdominal pain (AP) score and simple endoscopic score for Crohn's disease (SES-CD) Demonstrated inadequate response, loss of response, or intolerance to at least one biologic approved for the treatment of Crohn's disease If female and of childbearing potential, must meet the contraception and reproduction requirements Exclusion Criteria: Complications of CD that may be anticipated to require surgery Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks Has a draining (example, functioning) stoma or ostomy Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer or cervical carcinoma in situ that has been adequately treated with no evidence of recurrence for greater than or equal do (>=) 12 months before the first dose of study intervention) 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1: Placebo<br>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<br>* Placebo will be administered as subcutaneous injection.<br>|
| Experimental: Group 2: Guselkumab<br>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<br>* Guselkumab will be administered as subcutaneous injection.<br>|
| Experimental: Group 3: Golimumab<br>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<br>* Golimumab will be administered as subcutaneous injection.<br>|
| Experimental: Group 4: JNJ-78934804 (High-dose)<br>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<br>* JNJ-78934804 will be administered subcutaneously as per defined regimen.<br>|
| Experimental: Group 5: JNJ-78934804 (Mid-dose)<br>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<br>* JNJ-78934804 will be administered subcutaneously as per defined regimen.<br>|
| Experimental: Group 6: JNJ-78934804 (Low-dose)<br>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<br>* JNJ-78934804 will be administered subcutaneously as per defined regimen.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Clinical Remission at 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). | Week 48 | 
| Percentage of Participants with Endoscopic Response at 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). | Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Patient-reported Outcomes (PRO)-2 Remission at 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. | Week 48 | 
| Percentage of Participants with Endoscopic Remission at Week 48 | Percentage of participants with endoscopic remission at Week 48 will be reported. Endoscopic remission is based on the SES-CD. | Week 48 | 
| Percentage of Participants with Clinical Remission at Week 24 | Percentage of participants with clinical remission at Week 24 will be reported. Clinical remission is based on the Crohn's Disease Activity Index (CDAI). | Week 24 | 
| Percentage of Participants with Endoscopic Response at Week 24 | Percentage of participants with endoscopic response at Week 24 will be reported. Endoscopic response is based on change from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD). | Week 24 | 
| 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. | 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. | 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. | Up to Week 48 | 
| Serum Concentrations of Golimumab Over Time | 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. | Up to Week 48 | 
| Percentage of Participants with Antibodies to Guselkumab | Percentage of participants with antibodies to guselkumab will be reported. | Up to Week 48 | 
| Titers of Antibodies to Guselkumab | Titers of antibodies to guselkumab will be reported. | Up to Week 48 | 
| Percentage of Participants with Antibodies to Golimumab | Percentage of participants with antibodies to golimumab will be reported. | Up to Week 48 | 
| Titers of Antibodies to Golimumab | Titers of antibodies to golimumab will be reported. | Up to Week 48 | 
| Percentage of Participants with Neutralizing Antibodies to Guselkumab. | Percentage of participants with neutralizing antibodies to guselkumab will be reported. | Up to Week 48 | 
| Percentage of Participants with Neutralizing Antibodies to Golimumab | Percentage of participants with neutralizing antibodies to golimumab will be reported. | Up to Week 48 |