Colitis, Ulcerative
Conditions
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.
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
* 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)
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 based on the modified Mayo subscores. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Laboratory Parameters Over Time | Up to Week 48 | Laboratory parameters over time will be reported. |
| 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 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. |
| 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. |
| Percentage of Participants with Neutralizing Antibodies to Golimumab | Up to Week 48 | Percentage of participants with neutralizing antibodies to golimumab will be reported. |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Jordan, Netherlands, New Zealand, Norway, Poland, Portugal, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Contacts
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed