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MIRICURE: Mirikizumab With Curettage and Repair (Closure) for Perianal Fistulizing Crohn's Disease
Sponsor: Icahn School of Medicine at Mount Sinai
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-12
Completion Date
2029-07
Last Updated
2026-08-24
Healthy Volunteers
No
Conditions
Interventions
Mirikizumab
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.
Fistula Tract Curettage and Closure
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).
Locations (2)
Washington University in St. Louis
Louis, Missouri, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States