NCT07782021Not yet recruitingPhase 4
MIRICURE: Mirikizumab With Curettage and Repair (Closure) for Perianal Fistulizing Crohn's Disease
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 19 Aug 2026
- Start date
- Dec 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Diseases
- Crohn's disease
- NCT number
- NCT07782021
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 50
- From Dec 2026 to the primary completion date, Dec 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe proctitis preventing surgical closure
- Concurrent investigational drug trial
Other illness
- Rectovaginal fistula
- Active tuberculosis
- Active hepatitis B
- Active serious infection
Lab values
- Additional laboratory exclusions as specified in the protocol
Other
- Only low intersphincteric or submucosal fistulas
- Stoma
- Pregnancy
- MRI contraindication
Who the study is looking for
- Adults ≥18 years
- Diagnosis of Crohn disease for at least 3 months
- Active draining complex perianal fistula
- Able to provide informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Washington University in St. Louis Coordinator of this site? Confirm its status | Louis | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.