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New drug vixarelimab tested for Tough-to-Treat ulcerative colitis

NCT ID NCT06693908

Disease control Sponsor: Genentech, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Updated 5 times

Summary

This early-stage trial is testing a drug called vixarelimab in 24 people with moderate to severe ulcerative colitis who have not improved with standard treatments. The study looks at how the drug affects the gut, how it moves through the body, and whether it is safe. It is too early to know if it will help symptoms.

What this could mean

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

Active substance
vixarelimab
What this could lead to
If successful, this could point toward a new treatment option for people with moderate to severe ulcerative colitis who have not responded to other therapies.
What could go wrong
This is a very early, small study (24 people) focused on safety and biological effects, not yet on symptom improvement. The drug may not work or could cause 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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

24 people

The number who actually took part.

Started

Mar 2025

Finished

Aug 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Diagnosis of UC established at least 3 months * Moderately to severely active UC * Participants must meet criteria for either advanced therapy failure or conventional therapy failure Exclusion Criteria: * Diagnosis of Crohn's disease or indeterminate colitis * Suspicion of ischemic colitis, radiation colitis, microscopic colitis or infectious colitis * Prior colectomy * Prior treatment with systemic janus kinase (JAK) inhibitors

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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.

Moderate to severe ulcerative colitis

Contacts and locations

Locations

  • Charité Research Organisation GmbH

    Berlin, 10117, Germany

More trials for these conditions

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