Cure8 trial brief
A new IL-23–targeting therapy (JNJ-78934804) is being tested against an approved IL-23 inhibitor (guselkumab) in a large Phase 3 trial for moderate–severe ulcerative colitis, which could affect future treatment options if successful. The primary outcome is clinical remission at Week 48, a patient-relevant endpoint.
Adults with moderately to severely active ulcerative colitis; clinicians and researchers interested in biologic and IL-23 therapies; patients on or considering guselkumab or other IL-23 inhibitors.
This is a Phase 3 randomized trial comparing a new investigational subcutaneous drug, JNJ-78934804, against guselkumab in adults with moderately to severely active ulcerative colitis. The study will assess clinical remission at Week 48 using stool frequency, rectal bleeding, and endoscopy subscores.
Dosing schedules for both JNJ-78934804 and guselkumab include induction at Weeks 0, 4, and 8 and maintenance every 4 weeks starting at Week 12; participants meeting rescue criteria may receive additional induction and switch to JNJ-78934804 per the protocol.
Participants who complete the 48-week double-blind phase and are judged by investigators to benefit may enter a long-term extension.
The trial is actively recruiting, plans to enroll about 644 participants, and excludes people with prior inadequate response or intolerance to guselkumab or golimumab and several other conditions noted in the eligibility criteria.
This is a clinicaltrials.gov registration (trial record) describing study design and planned outcomes. It does not present efficacy or safety results; interpret any future claims only after peer-reviewed publication or regulatory review.
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.
If approved, Tremfya SC induction could provide a fully subcutaneous induction and maintenance option for people with moderately to severely active ulcerative colitis, which may be more convenient than IV induction.
This reports phase 2b trial results showing a fixed-dose combination of two biologics (anti‑TNF + anti‑IL‑23) improved outcomes in people with refractory IBD compared with one biologic alone.
TREMFYA (guselkumab) is an IL-23 inhibitor being studied for ulcerative colitis and Crohn's disease; new trial data could affect future treatment options. For people with IBD, drug-development news may indicate upcoming...
