Crohn's Disease
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.
Interventions
BIOLOGICALGuselkumab
Guselkumab will be administered as subcutaneous injection.
BIOLOGICALGolimumab
Golimumab will be administered as subcutaneous injection.
BIOLOGICALJNJ-78934804
JNJ-78934804 will be administered subcutaneously as per defined regimen.
DRUGPlacebo
Placebo will be administered as subcutaneous injection.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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'
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Titers of Antibodies to Golimumab | Up to Week 48 | Titers of antibodies to golimumab will be reported. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Jordan, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Outcome results
None listed