Janssen posts Phase 3 ExPEC9V vaccine results; registers new guselkumab IBD study

Janssen's registry activity this period spanned a completed Phase 3 vaccine trial with new results and a newly listed observational study in inflammatory bowel disease.

• ExPEC9V (JNJ-78901563), Phase 3, for prevention of invasive extraintestinal pathogenic E. coli disease in adults 60 and older with prior urinary tract infection: results were first posted on 2026-09-28. The trial is a randomized, double-blind, placebo-controlled study to assess the efficacy, safety and immunogenicity of vaccination with ExPEC9V in the prevention of invasive extraintestinal pathogenic Escherichia coli disease in adults aged 60 years and older with a history of urinary tract infection in the past 2 years¹, with 17797 participants enrolled¹ and a primary outcome measuring the number of participants with first occurrence of invasive E. coli disease event per adjudication in blood or other sterile sites caused by ExPEC9V O-serotypes¹.
• Guselkumab (Tremfya), observational study, for moderate-to-severe Crohn's disease and ulcerative colitis: the GALILEO study (NCT07848737) was first posted on 2026-09-30 and is not yet recruiting. Sponsored by Janssen-Cilag, S.A., the study aims to evaluate how long participants with moderate-to-severe Crohn's Disease and Ulcerative Colitis continue treatment with guselkumab in a real-world setting², with an estimated enrollment of 200 participants² and an estimated start date of 2026-10-30.