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

Part of paid clinical trials in Louis, Missouri.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT07782021
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mirikizumab — DRUG
    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 — PROCEDURE
    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).

Study Details

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 Dates

First listed
Aug 24, 2026
Start date
Dec 31, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2028
Completion
Jul 31, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants with active perianal fistulizing Crohn disease
    Participants receive mirikizumab in combination with staged surgical management for active perianal fistulizing Crohn disease.

Primary Outcome Measure

Proportion of participants achieving combined clinical remission and radiologic response [ Time Frame: Week 24 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Washington University in St. LouisLouisMissouri63130
Parakkal Deepak, MBBS, MS
[email protected]
314-273-1947
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Serre-Yu Wong, MD, PhD
[email protected]
212-241-3179
Serre-Yu Wong, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Washington University in St. Louis· Louis, MOIcahn School of Medicine at Mount Sinai· New York, NY

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