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New biologic shows promise for Tough-to-Treat ulcerative colitis

NCT ID NCT06626165

Disease control Sponsor: Showa Inan General Hospital 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether mirikizumab, a biologic drug, can improve symptoms and gut healing in 100 people with moderate-to-severe ulcerative colitis who had a specific type of inflammation seen on biopsy. Participants received either mirikizumab or vedolizumab, and doctors tracked changes in clinical activity and endoscopic scores. The goal is to see if mirikizumab offers a better option for patients not responding to standard maintenance therapy.

What this could mean

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

Active substance
Mirikizumab (a biologic drug given by infusion or injection)
What this could lead to
If successful, this could confirm that mirikizumab helps control moderate-to-severe ulcerative colitis in patients with a specific type of gut inflammation.
What could go wrong
This is a small, completed Phase 4 study (100 people) without published results yet. It compares two existing drugs, so no breakthrough is expected, and individual responses may 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

100 people

The number who actually took part.

Started

Jul 2024

Finished

Sep 2025

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

19 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: * They were endoscopically active ulcerative colitis patients. Exclusion Criteria: * the presence of a long-term illness, colorectal cancer, or infectious colitis

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

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

Ulcerative colitis

Contacts and locations

Locations

  • Showa Inan General Hospital

    Komagane, Nagano, 399-4117, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.