ClinicalTrials.gov
Cure8 trial brief
Why This Matters
Patients and clinicians are interested in whether combining two targeted biologic therapies can induce stronger endoscopic healing for people with difficult-to-treat Crohn's disease, and whether benefit can be maintained with vedolizumab alone.
Who Should Pay Attention
Adults with moderate-to-severe Crohn's disease, patients with prior biologic or JAK inhibitor treatment failure or intolerance, clinicians treating refractory IBD, and researchers studying dual-targeted biologic strategies.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 4
Enrollment100 participants
Study statusRecruiting
Source depthTrial registry record
What To Know
This is a Phase 4 interventional trial run by Takeda enrolling about 100 adults with moderate-to-severe Crohn's disease who have had an inadequate response, loss of response, or intolerance to prior biologic or small-molecule therapies.
Part A gives dual targeted treatment (vedolizumab + either adalimumab or ustekinumab) for about 6 months; participants who benefit move to Part B and receive vedolizumab monotherapy through Week 46, with safety follow-up to Week 72. The primary outcome is endoscopic response measured by SES-CD (>=50% reduction) at Week 26 for Part A and Week 52 for Part B.
The trial includes detailed dosing schedules for each drug and excludes or stratifies participants based on prior biologic/small-molecule treatment history. This summary is based on the ClinicalTrials.gov record (trial registry entry) and describes the registered study design and planned outcomes, not results.
Keep In Mind
This is a trial registry entry (Phase 4, recruiting) describing the planned study design and endpoints; it does not report results. As a registered interventional study, inclusion/exclusion criteria and dosing schedules are specified and determine eligibility and applicability.
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
SponsorTakeda
Trial IDNCT06045754
Study typeInterventional
Trial phasePhase 4
Enrollment100 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedAug 12, 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.
Comparison of the Efficacy of Different Biologic Agents in Preventing Postoperative Endoscopic Recurrence of Crohn's Disease
The study is comparing common biologics given after Crohn's surgery to prevent endoscopic recurrence—a key issue for people who have had bowel resection. Knowing which drugs perform better in real‑world practice could...
Immunomodulators and advanced therapies for maintenance of remission in Crohn's disease: systematic review and network meta-analysis.
A broad comparison of many maintenance therapies helps patients and clinicians understand which drugs have trial evidence for preventing relapse or loss of response in Crohn's disease. The review highlights adalimumab,...
VIDEO: Longstanding therapies, recent approvals provide options in Crohn’s disease
This video quickly outlines the range of medical treatments now available for Crohn’s disease, including newer approvals. Knowing drug classes and recent options can help patients and clinicians discuss treatment plans...