Icahn School of Medicine at Mount Sinai
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.
Perianal fistulizing Crohn disease is a severe manifestation of Crohn disease associated with persistent fistula drainage, impaired quality of life, and substantial morbidity. Although biologic therapies have improved outcomes, durable fistula healing remains uncommon, and optimal treatment strategies continue to be defined. Mirikizumab is an interleukin-23 p19 antagonist approved for the treatment of moderately to severely active Crohn disease. Surgical management, including fistula tract curettage and closure of the internal opening, has demonstrated favorable outcomes when incorporated int…
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
Mirikizumab is administered as a 900 mg intravenous infusion at Weeks 0, 4, and 8, followed by a 300 mg subcutaneous maintenance injection beginning at Week 12 and every 4 weeks thereafter through the end of the study.
Participants undergo an initial examination under anesthesia with fistula tract curettage and seton placement before initiation of mirikizumab therapy. After 8 to 10 weeks of induction therapy, participants undergo a second examination under anesthesia with seton removal, repeat fistula tract curettage, and closure of the internal fistula opening(s).
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