ClinicalTrials.gov
Cure8 trial brief
Why This Matters
Perianal fistulas are a serious, common complication of Crohn's disease that are often difficult to heal. This study tests a real-world combination of surgery plus an approved IL-23 inhibitor (mirikizumab) to see if coordinated treatment improves healing and MRI-defined outcomes.
Who Should Pay Attention
Adults with Crohn's disease and active complex perianal fistulas, colorectal surgeons and gastroenterologists who manage perianal disease, and researchers studying fistula healing or biologic-surgery combination strategies.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 4
Enrollment50 participants
Study statusNot_yet_recruiting
Source depthTrial registry record
What To Know
This single-arm, open-label study plans to enroll about 50 adults with active complex draining perianal fistulas.
Participants will receive surgical management (examination under anesthesia with fistula tract curettage and initial seton placement), start mirikizumab induction (IV at Weeks 0, 4, 8), then return for seton removal, repeat curettage, and closure of the internal opening after 8–10 weeks, followed by subcutaneous mirikizumab maintenance every 4 weeks through Week 48.
The trial’s primary endpoint is combined clinical remission and radiologic response at Week 24 (using MAGNIFI-CD MRI criteria); secondary assessments include radiologic remission, fistula healing, quality of life, disease activity, and safety through Week 48.
This is a mechanistic and pragmatic Phase 4 study aiming to evaluate whether adding standardized surgical repair to IL-23 p19 antagonist therapy can improve fistula outcomes when managed in a multidisciplinary protocol.
Keep In Mind
This is a Phase 4, single-arm, open-label trial with about 50 participants and no control arm; outcomes include combined clinical and MRI-based endpoints (MAGNIFI-CD). As a trial record, it describes planned interventions and endpoints 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
SponsorIcahn School of Medicine at Mount Sinai
Trial IDNCT07782021
Study typeInterventional
Trial phasePhase 4
Enrollment50 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedAug 24, 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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