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MIRICURE: Mirikizumab With Curettage and Repair (Closure) for Perianal Fistulizing Crohn's Disease

NCT07782021 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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.

PROCEDURE

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).

Sponsors & Collaborators

Principal Investigators

  • Serre-Yu Wong, MD, PhD · Icahn School of Medicine at Mount Sinai

  • Parakkal Deepak, MBBS, MS · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2028-12-31
Completion
2029-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07782021 on ClinicalTrials.gov