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NCT07782021
MIRICURE: Mirikizumab With Curettage and Repair (Closure) for Perianal Fistulizing Crohn's Disease
Conditions: Crohn's Disease, Perianal Fistula
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 50
Sponsor: Icahn School of Medicine at Mount Sinai
Location: Washington University in St. Louis Louis Missouri
Summary
This Phase 4, single-arm, open-label study will evaluate the effectiveness and safety of mirikizumab combined with surgical curettage and closure in adults with active perianal fistulizing Crohn's disease. Fifty participants with complex draining fistulas will undergo staged surgical management followed by mirikizumab induction and maintenance therapy. The primary endpoint is combined clinical remission and radiologic response at Week 24. Participants will be followed through Week 48.
Eligibility Criteria
Inclusion Criteria:
* Adults ≥18 years
* Diagnosis of Crohn disease for at least 3 months
* Active draining complex perianal fistula
* Able to provide informed consent
Exclusion Criteria:
* Rectovaginal fistula
* Only low intersphincteric or submucosal fistulas
* Severe proctitis preventing surgical closure
* Stoma
* Active tuberculosis
* Active hepatitis B
* Active serious infection
* Pregnancy
* Concurrent investigational drug trial
* MRI contraindication
* Additional laboratory exclusions as specified in the protocol
Source: ClinicalTrials.gov (NCT07782021). StuddyBuddy aggregates publicly available trial information.
