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New biologic mirikizumab put to the test against standard therapies for IBD

NCT ID NCT07686757

Disease control Sponsor: Specialty Networks Research. 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
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Sep 01, 2026 · Updated 7 times

Summary

This study compares the real-world effectiveness of mirikizumab against standard biologic therapies for adults with ulcerative colitis or Crohn's disease. Researchers will track whether mirikizumab reduces the need for extra medical care, like emergency visits or treatment changes, over 18 months. Participants receive either mirikizumab or another biologic as part of their routine care, and their health data and symptom reports are collected to see which approach leads to better disease control.

What this could mean

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

Active substance
Mirikizumab
What this could lead to
If mirikizumab works better than current biologics, it could offer a new, more effective option for controlling inflammatory bowel disease and reducing hospital visits.
What could go wrong
This is a real-world study, not a tightly controlled trial, so results may be less clear. Mirikizumab may not prove superior to existing treatments, and individual responses vary.

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 400 people

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

Started

Aug 2026

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Ages

21 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: * Age ≥21 years at the time of enrollment * Confirmed diagnosis of ulcerative colitis (UC) or Crohn's disease (CD) * Eligible for treatment with biologic therapy for IBD, defined as failure of prior conventional therapy and/or prior biologic therapy (excluding IL-23p19 antagonists) * No prior exposure to mirikizumab and no contraindications to mirikizumab * Ability to provide informed consent * Willingness to comply with study procedures and follow-up requirements Exclusion Criteria: * Prior exposure to IL-23p19 antagonists (e.g., mirikizumab, risankizumab, guselkumab) * Prior exposure to small molecule targeted therapies for IBD (e.g., JAK inhibitors or S1P receptor modulators) * Participation in an interventional clinical trial within 90 days prior to enrollment * History of extensive colorectal resection, including: * Total proctocolectomy (for UC), or * Surgical removal of two or more intestinal segments (for CD) * Any condition that, in the investigator's judgment, may compromise patient safety, data integrity, or ability to participate in the study

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Conditions

The condition(s) this trial relates to.

Crohn disease ulcerative colitis

As listed by the trial registrant

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

Crohn disease (CD) Ulcerative colitis (UC)

How to take part

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

  1. The places running it

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

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Arizona Digestive Health

    Sun City, Arizona, 85351, United States

  • Digestive Health Associates

    Houston, Texas, 77024, United States

  • GI Alliance Richmond

    Richmond, Virginia, 23229, United States

  • GI Alliance of Illinois

    Glenview, Illinois, 60005, United States

  • Gastroenterology Group of Rochester

    Rochester, New York, 14618, United States

  • Lake Shore Gastro-Gurnee Research

    Gurnee, Illinois, 60031, United States

  • Texas Digestive Disease Consultants

    Cedar Park, Texas, 78613, United States

  • Texas Digestive Disease Consultants

    Fort Worth, Texas, 76104, United States

  • Texas Digestive Disease Consultants: Plano

    Plano, Texas, 75093, United States

  • Texas Digestive Disease Consultants: San Antonio

    San Antonio, Texas, 78215, United States

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