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

NCT07782021 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: SW-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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

Crohn's Disease; Perianal Fistula

Keywords

Perianal Fistula; Perianal Fistulizing Crohn's Disease; Mirikizumab; Interleukin-23 inhibitor; Magnetic resonance imaging; Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Proportion of participants achieving combined clinical remission and radiologic response

  Proportion of participants achieving combined clinical remission and radiologic response. Clinical remission is defined as complete closure of all treated external fistula openings without spontaneous drainage or drainage upon gentle finger compression and without development of new fistulas or abscesses greater than 1 cm. Radiologic response is defined using MAGNIFI-CD criteria as greater than 50% reduction in MAGNIFI-CD score together with improvement in fibrosis-to-fluid ratio compared with baseline MRI. The MAGNIFI-CD is an MRI-based composite index that assesses perianal fistulizing Crohn disease activity using six weighted domains, including fistula complexity, tract length, fistula composition, tract enhancement, extension, and inflammatory mass/abscess. Total scores range from 0 to 25, with higher scores indicating greater disease activity and lower scores indicating improvement.

  Week 24

Secondary Outcomes (1)

• Proportion of participants achieving combined clinical remission and radiologic response

  48 week

Study Arms (1)

Participants with active perianal fistulizing Crohn disease

EXPERIMENTAL

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

Drug: Mirikizumab; Procedure: Fistula Tract Curettage and Closure

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.

Also known as: Omvoh

Participants with active perianal fistulizing Crohn disease

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).

Participants with active perianal fistulizing Crohn disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥18 years
• Diagnosis of Crohn disease for at least 3 months
• Active draining complex perianal fistula
• Able to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Eli Lilly and Company: collaborator
• Washington University School of Medicine: collaborator

Study Sites (2)

Washington University in St. Louis

Louis, Missouri, 63130, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

mirikizumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Serre-Yu Wong, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Parakkal Deepak, MBBS, MS

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Serre-Yu Wong, MD, PhD

CONTACT

212-241-3179; serre-yu.wong@mountsinai.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label, single-arm study. All participants and study personnel are aware that participants receive mirikizumab in combination with staged surgical curettage and closure. No masking or blinding is performed.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All participants are assigned to a single treatment group receiving mirikizumab in combination with staged surgical curettage and closure for active perianal fistulizing Crohn's disease.

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. To achieve aims in the approved proposal. Proposals should be directed to serre-yu.wong@mountsinai.org and deepak.parakkal@wustl.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (TBD).

Locations

US (2)