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Can a drug plus surgery heal Crohn's fistulas for good?

NCT ID NCT07782021

Disease control Sponsor: Icahn School of Medicine at Mount Sinai Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This trial is testing whether combining the drug mirikizumab with a surgical procedure can help heal perianal fistulas in people with Crohn's disease. Participants will receive the drug through infusions and injections, along with two surgical steps to clean and close the fistula tract. The goal is to see if this approach leads to complete closure of the fistulas and improvement on MRI scans, with participants followed for about a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mirikizumab (Omvoh) combined with surgical curettage and closure of the fistula tract
What this could lead to
If successful, this combination could offer a more effective way to heal perianal fistulas in Crohn's disease, potentially reducing the need for repeated surgeries or long-term symptoms.
What could go wrong
This is a single-arm, open-label study with a modest number of participants, so results may not be definitive. The surgery carries risks like infection or poor healing, and mirikizumab may have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

anal fistula Crohn disease perianal Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn's disease Perianal fistula

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Washington University in St. Louis

    Louis, Missouri, 63130, United States

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