ClinicalTrials.gov
Cure8 trial brief
Why This Matters
New oral therapies in Phase 2/3 could expand treatment options for adults with moderate–severe Crohn's disease, including those who are naïve to advanced therapies or who failed prior biologics.
Who Should Pay Attention
Adults with moderately to severely active Crohn's disease, clinicians treating IBD, and researchers following drug development for Crohn's disease.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 2, Phase 3
Enrollment1,092 participants
Study statusRecruiting
Source depthTrial registry record
What To Know
This is a randomized interventional Phase 2/3 study recruiting roughly 1,092 participants. The trial has separate induction studies assessing clinical response or remission at Week 12 (CDAI and SES-CD based endpoints) and a maintenance phase assessing remission at Week 40.
Participants may be either advanced-therapy–naïve or have had inadequate response to biologics/advanced oral agents, per protocol definitions.
The protocol requires endoscopic confirmation of active disease (SES-CD thresholds) and excludes people with stomas/ostomies or recent major surgery; participants with active fistulas may be eligible if no surgery is needed. Practical note: This registry entry describes the study design and eligibility; it does not report results or safety findings.
Keep In Mind
This is a clinicaltrials.gov record for a recruiting Phase 2/3 study—no efficacy or safety results are reported here. The endpoints use CDAI and SES-CD scores assessed at specified time points.
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 IDNCT07196722
Study typeInterventional
Trial phasePhase 2, Phase 3
Enrollment1,092 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedJul 31, 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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