Mirikizumab + Surgery for Crohn's Disease
(MIRICURE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Serre-Yu Wong, MD, PhD
Principal Investigator
Icahn School of Medicine at Mount Sinai
Parakkal Deepak, MBBS, MS
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for adults with Crohn's disease who have complex, actively draining perianal fistulas. Participants should be able to undergo surgery and follow-up treatments. People with other serious health issues or conditions that could interfere with the study may not be eligible.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Fistula Tract Curettage and Closure
- Mirikizumab
Trial Overview
The study tests a combination of surgical cleaning and closure of fistula tracts along with mirikizumab, a medication given after surgery. All participants receive both treatments, and results are measured over 48 weeks.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants receive mirikizumab in combination with staged surgical management for active perianal fistulizing Crohn disease.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount Sinai
Lead Sponsor
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
Washington University School of Medicine
Collaborator
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