Cure8 trial brief
A successful Phase 3 trial could add guselkumab — an IL-23–targeting biologic — as a treatment option for people with moderate to severe Crohn's disease, especially those who haven’t responded to prior therapies.
Adults with moderately to severely active Crohn's disease (including those who failed prior biologics or conventional therapy), clinicians who treat IBD, and researchers following new biologic therapies.
This registered study (NCT05197049) is an interventional Phase 3 trial run by Janssen with planned enrollment of about 350 adults. Participants are randomized to receive one of two guselkumab dosing regimens or placebo, given by subcutaneous injection.
The study’s primary outcome is the percentage of participants achieving clinical remission at Week 12, with endoscopic response assessed using the SES-CD. The trial excludes people with current ulcerative or indeterminate colitis and those with Crohn’s complications requiring surgery. Sites are located in multiple U.S. centers.
This is a clinicaltrials.gov registry record (Phase 3, active-not-recruiting). The record describes planned outcomes and design but does not provide efficacy or safety results. Guselkumab is an IL-23 inhibitor; the registry entry does not replace peer-reviewed trial publications or regulatory decisions.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
Perianal fistulas are a significant complication of Crohn’s disease that can be hard to treat. A phase 3 trial reported that guselkumab improved combined fistula remission versus placebo, which could represent a new...
Cure8 could only read part of this source from rttnews.com, so this card uses cautious topic tags instead of a full summary. It is tagged for Crohn's disease, Guselkumab, and IL-23 inhibitor.
Long-term data help patients and clinicians understand whether a biologic maintains benefit and safety over years. Sustained clinical remission and endoscopic healing are important outcomes linked to better long-term...
