MIRICURE: Mirikizumab With Curettage and Repair (Closure) for Perianal Fistulizing Crohn's Disease
Phase 4 · Testing Mirikizumab and Fistula Tract Curettage and Closure · 2 sites · Icahn School of Medicine at Mount Sinai
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Mirikizumab (a drug) and Fistula Tract Curettage and Closure (a procedure) as a possible treatment. Condition(s) listed: Crohn's Disease and Perianal Fistula.
It is open-label: participants know what they are receiving.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Adults ≥18 years
- Diagnosis of Crohn disease for at least 3 months
- Active draining complex perianal fistula
Plus 1 more requirement(s). There are also 11 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 50 participants are expected to take part.
- Start date: 2026-12 (planned).
- Main results expected around 2028-12 (estimate from the record).
- 2 study sites listed in United States.
Main thing being measured
- Proportion of participants achieving combined clinical remission and radiologic response (Week 24)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Crohn's Disease; Perianal Fistula |
| Lead sponsor | Icahn School of Medicine at Mount Sinai |
| Collaborators | Eli Lilly and Company; Washington University School of Medicine |
| Enrollment | 50 (estimated) |
| Start date | 2026-12 |
| Primary completion (est.) | 2028-12 |
| First posted | 2026-08-24 |
| Last updated | 2026-08-24 |
| Official title | MIRICURE: Mirikizumab With Curettage and Repair (Closure) for Perianal Fistulizing Crohn's Disease |
| ClinicalTrials.gov ID | NCT07782021 |
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).
Full eligibility criteria (from the record)
Inclusion Criteria: * Adults ≥18 years * Diagnosis of Crohn disease for at least 3 months * Active draining complex perianal fistula * Able to provide informed consent Exclusion Criteria: * 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 * Additional laboratory exclusions as specified in the protocol
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| Washington University in St. Louis | Louis, Missouri | United States | |
| Icahn School of Medicine at Mount Sinai | New York, New York | United States |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.