ClinicalTrials.gov
Cure8 trial brief
Why This Matters
This study asks whether using PK‑PD models to personalize dosing of ustekinumab or vedolizumab can keep people with IBD in remission while potentially optimizing treatment intervals and drug exposure.
Who Should Pay Attention
Adults with Crohn's disease or ulcerative colitis receiving ustekinumab or vedolizumab, clinicians who manage biologic dosing, and researchers interested in therapeutic drug monitoring, PK‑PD modeling, and biomarker‑guided care.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 4
Enrollment166 participants
Study statusEnrolling_by_invitation
Source depthTrial registry record
What To Know
The study randomizes adults with stable Crohn’s disease or ulcerative colitis on ustekinumab or vedolizumab to either MIPD (regular blood/stool sampling with drug concentrations used to adjust timing/dose) or usual care (samples collected but blinded to treating clinicians).
Primary outcome is the proportion in steroid‑free remission at 48 weeks (clinical PRO2 plus fecal calprotectin ≤200). Participants will have regular blood and stool tests, patient‑reported outcomes, and an endoscopy (or MRI/capsule endoscopy if small bowel disease).
The protocol includes biobanking of serum, stool, buffy coat, and optional paired biopsies and intestinal ultrasound substudies for future research. Enrollment and scope: Phase 4 interventional trial with planned enrollment ~166 across multiple Danish centers; adults on stable ustekinumab or vedolizumab therapy are eligible.
The PK model incorporates drug concentrations, inflammatory markers, weight, sex, and prior treatments to recommend dosing intervals.
Keep In Mind
This is a registered Phase 4 interventional trial (enrolling by invitation) and not a report of results. The trial uses standardized clinical and biomarker endpoints; samples will be biobanked for future studies. Interpret any implications for care only after peer‑reviewed results are available.
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
SponsorOdense University Hospital
Trial IDNCT06788340
Study typeInterventional
Trial phasePhase 4
Enrollment166 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedNov 6, 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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