Efficacy and Safety of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn’s Disease
- Conditions
- Moderately to Severely Active Crohn's DiseaseMedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2021-003314-39-DE
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 715
•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
•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 715
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•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 that has been adequately treated with no evidence of recurrence for greater than or equal to (>=)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
For an overview of all the inclusion 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><br><br><br>;Secondary Objective: 1. To evaluate the efficacy of JNJ-78934804 compared with each monotherapy across a range of outcomes<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><br><br>;Primary end point(s): Clinical remission and endoscopic response <br>;Timepoint(s) of evaluation of this end point: At Week 48
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1 Patient-Reported Outcomes (PRO)-2 remission and endoscopic remission<br>2 Clinical remission and endoscopic response of JNJ-78934804 at Week 24 compared with placebo<br>2 Frequency and type of adverse event (AEs), serious adverse events (SAEs)<br>3 Serum concentrations of guselkumab and golimumab over time <br>4 Incidence and titers of antibodies to guselkumab and golimumab<br>5 Incidence of neutralizing antibodies to guselkumab and golimumab<br><br>;Timepoint(s) of evaluation of this end point: 1 - At Week 48 <br>2 - At Week 24<br>