Efficacy and Safety of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis
- Conditions
- Moderately to Severely Active Ulcerative ColitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2021-005528-39-HU
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 550
•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
For an overview of all the inclusion criteria please refer to protocol section 5.1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 550
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•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
•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)
For an overview of all the exclusion criteria please refer to protocol section 5.2
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of JNJ-78934804 at Week 48 compared with each monotherapy (guselkumab alone and golimumab alone)<br>;Secondary Objective: 1 To evaluate the efficacy of JNJ-78934804 compared with each monotherapy across a range of outcome measures<br>2 To evaluate the efficacy of JNJ-78934804 at Week 24 compared with placebo<br>3 To evaluate the safety of JNJ-78934804 compared with each monotherapy and placebo<br>4 To evaluate the pharmacokinetics (PK) and immunogenicity of JNJ-78934804 compared with each monotherapy<br><br><br>;Primary end point(s): Clinical remission at Week 48;Timepoint(s) of evaluation of this end point: At Week 48
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1 Combination of histological remission and endoscopic improvement <br>2 Clinical remission of JNJ-78934804 at Week 24 compared with placebo <br>3 Frequency and type of AEs, serious adverse events (SAEs)<br>4 Serum concentrations of guselkumab and golimumab over time<br>5 Incidence and titers of antibodies to guselkumab and golimumab<br>6 Incidence of neutralizing antibodies to guselkumab and golimumab<br><br><br><br>;Timepoint(s) of evaluation of this end point: 1 - At Week 48<br>2 - At Week 24