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Not yet recruitingPhase 4

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 48 weeks
  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will receive mirikizumab induction followed by maintenance therapy and will be followed for 48 weeks."
  • "Pelvic MRI will be performed at Weeks 12, 24, and 48 and evaluated using standardized MAGNIFI-CD and TOpCLASS criteria."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well mirikizumab works and how safe it is when used with surgery to clean out and close fistulas. It is for adults with Crohn’s disease and complex fistulas near the anus—abnormal tunnels that drain fluid. The study will follow participants for 48 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Have had a Crohn’s disease diagnosis for at least 3 months.
  • Have a complex fistula near the anus that is actively draining fluid.
  • Able to understand the study and agree to join.

Who can't join

  • Have a fistula connecting the rectum to the vagina.
  • Have only low fistulas between the anal muscles or fistulas just under the lining.
  • Have severe swelling in the rectum that prevents surgery to close the fistula.
  • Have a stoma—an opening made by surgery for waste to leave the body.
  • Have active tuberculosis, active hepatitis B, or another active serious infection.
  • Are pregnant or taking part in another trial of an experimental drug.
  • Cannot safely have an MRI scan.
  • Have lab results that rule out joining under the study’s rules.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (2)

MO

NY