ClinicalTrials.gov
Cure8 trial brief
Why This Matters
This registered Phase 2/3 program is evaluating guselkumab (an IL‑23 inhibitor) for moderate–severe Crohn's disease and could expand treatment options if trials show benefit and safety. The studies include clinical and endoscopic outcomes and a long‑term extension.
Who Should Pay Attention
Adults with moderate–severe Crohn's disease, clinicians treating IBD, researchers focused on biologic therapies/IL‑23, and patients considering trial participation or new biologic options.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 2, Phase 3
Enrollment1,409 participants
Study statusActive_not_recruiting
Source depthTrial registry record
What To Know
This ClinicalTrials.gov record describes three linked studies: a 48‑week Phase 2 dose‑ranging trial (GALAXI 1) to choose induction and maintenance dosing, and two 48‑week Phase 3 confirmatory trials (GALAXI 2 and GALAXI 3). Participants who complete the parent studies may be eligible for a long‑term extension (LTE).
Efficacy, pharmacokinetics, biomarkers, and safety are being assessed, with both clinical and endoscopic outcomes (including CDAI and SES‑CD) specified. The Phase 2 arms include multiple IV and SC guselkumab dosing regimens and an active ustekinumab comparator arm; there is also a placebo arm with provision for switching nonresponders to ustekinumab.
Primary outcomes include change in CDAI at Week 12 (Phase 2) and combined clinical response/remission endpoints in Phase 3.
Keep In Mind
This entry is a ClinicalTrials.gov record describing study design, eligibility, interventions, and planned outcomes (trial‑record depth). It does not report trial results; interpretive conclusions require publication of the trial findings.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorJanssen Research & Development, LLC
Trial IDNCT03466411
Study typeInterventional
Trial phasePhase 2, Phase 3
Enrollment1,409 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedAug 3, 2026, 12:00 AM
Content availableTrial registry record
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.
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