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Real-World study tests Mirikizumab's power against ulcerative colitis

NCT ID NCT07695636

Disease control Sponsor: IRCCS San Raffaele 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This study tracks 282 adults with moderate-to-severe ulcerative colitis who are taking mirikizumab as part of their routine care. Researchers will measure how many achieve clinical remission at 12 weeks and endoscopic remission at 24 and 52 weeks, along with changes in symptoms and inflammation markers. The goal is to see if the drug works as well in real life as it does in clinical trials.

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 successful, this study could confirm that mirikizumab is effective and safe for treating ulcerative colitis in real-world settings, not just in controlled trials.
What could go wrong
This is an observational study, not a controlled experiment, so results may be influenced by other factors. It is also relatively small and short-term, so long-term benefits or rare risks may not be captured.

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.

Participants

282 people

The number who actually took part.

Started

Jan 2024

Finished

Jan 2026

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.

Who is studied

Patients \> 18 years, with no distinction based on age, demographic group, special population, or general health status will be included. Eligible patients will be identified at each participating center among those receiving mirikizumab as part of routine clinical practice.

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: 1. Established diagnosis of UC according to the current ECCO Guidelines; 2. Age ≥18 years old; 3. Patients must have received mirikizumab as UC treatment, as per clinical practice; 4. At least 12 weeks follow-up visits after baseline; Exclusion Criteria: 1. Diagnosis of undetermined IBD, CD or other gastrointestinal inflammatory conditions; 2. Age \< 18 years-old; 3. Acute severe IBD complications necessitating hospitalization at baseline;

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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 (UC)

Contacts and locations

Locations

  • IRCCS San Raffaele

    Milan, Mi, 20132, Italy

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