ClinicalTrials.gov
Cure8 trial brief
Why This Matters
This trial could directly influence which biologic class doctors choose first for people with ileal‑dominant Crohn’s disease by comparing approved treatments head‑to‑head using an important outcome — steroid‑free endoscopic healing at 1 year.
Who Should Pay Attention
Adult patients with moderate‑to‑severe, ileal‑dominant Crohn’s disease (especially biologic‑naïve), gastroenterologists and IBD clinicians, and researchers interested in comparative effectiveness of biologics.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 4
Enrollment210 participants
Study statusRecruiting
Source depthTrial registry record
What To Know
PATHFINDER is a Phase 4, randomized (1:1:1) pragmatic trial enrolling biologic‑naïve adults with documented large ileal ulcers. Participants receive one of the following per standard of care: infliximab or adalimumab (anti‑TNF), vedolizumab (anti‑integrin), or ustekinumab or risankizumab (anti‑IL‑12/23 or anti‑IL‑23).
No experimental drugs are included; dosing follows approved regimens and care is delivered in routine practice settings. The primary outcome is corticosteroid‑free endoscopic remission at 1 year, assessed by video ileocolonoscopy and SES‑CD criteria.
Patients will also have symptom scores (HBI), quality‑of‑life (EQ‑5D), CRP, and fecal calprotectin measured during follow‑up. The trial is pragmatic and aims to inform real‑world choice of first‑line biologic class for ileal‑dominant Crohn’s disease.
It includes monitoring per standard of care and requires biologic‑naïve status and documented ileal ulcers for eligibility.
Keep In Mind
This is a Phase 4, pragmatic trial using approved drugs and routine dosing; it compares classes rather than testing new agents. Results will reflect real‑world practice but applicability may be limited to patients meeting the trial’s strict ileal‑ulcer eligibility criteria. The record describes study design and planned outcomes but does not report results.
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
SponsorUniversity of Calgary
Trial IDNCT05928039
Study typeInterventional
Trial phasePhase 4
Enrollment210 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedOct 26, 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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