Phase 3 Randomized Double‑Blind Study Evaluating Efficacy and Safety of JNJ‑78934804 Combination Therapy versus Guselkumab in Moderately to Severely Active Crohn’s Disease

The primary objective is to assess the efficacy of JNJ‑78934804 at Week 48 in participants with moderately to severely active Crohn’s disease compared with the active comparator guselkumab, thereby determining the relative clinical benefit of the investigational therapy.

The trial enrolled 267 participants diagnosed with Crohn’s disease, specifically those with moderately to severely active disease. Eligible individuals were adults aged 18 years or older, encompassing both male and female subjects. Enrollment required a confirmed diagnosis of Crohn’s disease for at least 12 weeks based on endoscopic evidence and histopathology, a baseline Crohn’s Disease Activity Index (CDAI) score between 220 and 450, and either a mean daily stool frequency of ≥4.0 or a mean daily abdominal pain score of ≥2.0. Additional criteria included a screening Simple Endoscopic Score for Crohn’s Disease (SES‑CD) of ≥6 (or ≥4 for isolated ileal disease) and a history of inadequate response, loss of response, or intolerance to previously approved systemic therapies. The population comprised patients meeting these clinical and endoscopic parameters, representing a group with active disease despite prior treatment.

The study is a Phase 3, randomized, double‑blind, active‑controlled, multicenter trial evaluating the efficacy and safety of JNJ‑78934804 compared with guselkumab in adults with moderately to severely active Crohn’s disease. Participants undergo a screening visit to confirm eligibility, followed by a baseline visit (Week 0) where they are randomized to receive subcutaneous injections of the investigational product or the comparator. Subsequent study visits are scheduled at Weeks 4, 8, 12, 24, 36, and 48, with each visit including clinical assessment, laboratory testing, and endoscopic evaluation as required; the final visit at Week 48 serves as the end‑of‑study assessment. The primary efficacy endpoints are clinical remission and endoscopic remission at Week 48. Participant involvement therefore spans approximately 48 weeks. Early termination of individual participation may occur due to serious adverse events, lack of protocol compliance, withdrawal of consent, or failure to meet predefined safety or efficacy criteria. The overall trial recruitment period is projected from August 2026 to July 2030.

The investigational product identified as JNJ-78934804 is a combination formulation containing the monoclonal antibodies guselkumab and golimumab. It is supplied as a solution for injection intended for subcutaneous administration. The protocol specifies a dose of 0 U per administration, delivered according to a predefined dosing schedule that may include multiple visits over the 48‑week treatment period. Each injection is performed by qualified personnel, and the volume and timing are recorded in the study drug accountability log.

The active comparator is the single‑agent product guselkumab, provided in a pre‑filled syringe containing a solution for injection for subcutaneous use. The assigned dose is 0 U per administration, with dosing intervals aligned with the investigational arm to maintain blinding. Administration follows the same procedural standards as the test product, and all dosing details are captured in the trial’s electronic case report form.

Compliance with the dosing regimen is monitored through regular site visits, review of injection site records, and verification of returned unused product. Participants receive standardized instructions on injection technique, and adherence is assessed by counting remaining units and cross‑checking with the dosing log at each scheduled visit.

Efficacy will be evaluated by determining the proportion of participants achieving clinical remission and endoscopic remission at Week 48. These primary endpoints will be assessed at the end of the 48‑week treatment period according to the predefined criteria for remission in Crohn’s disease.