Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug shows promise for ulcerative colitis in early trial

NCT ID NCT03100864

Disease control Sponsor: Boehringer Ingelheim 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested a drug called spesolimab in 8 adults with moderate to severe ulcerative colitis. The main goal was to understand how the drug works in the body, while also checking for safety and any signs of improvement. Participants received the drug for 12 weeks, and researchers looked at changes in genes from gut biopsies and markers of inflammation.

What this could mean

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

Active substance
Spesolimab (a drug given as an infusion)
What this could lead to
If successful, this could point toward a new treatment option for people with moderate to severe ulcerative colitis.
What could go wrong
This was a very small, early-phase trial with only 8 participants, so results may not apply to everyone. The main goal was to study how the drug works, not to prove it is effective.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

8 people

The number who actually took part.

Started

May 2017

Finished

Oct 2019

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 to 75 years

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: * 18 - 75 years at screening * Diagnosis of UC \>= 3 months prior to screening. * Moderately to severely active UC as confirmed by Mayo Score ≥6 * Receiving conventional, non-biologic therapy for UC. * Negative colon cancer screening * Further inclusion criteria apply Exclusion Criteria: * Prior use of any biological treatment in the past (e.g.integrin inhibitors, IL12/23 or IL23 inhibitors, any investigational biological drugs) * Extensive colonic resection * Evidence of infection with C. difficile or other intestinal pathogen \< 30 days prior to screening * Active or latent tuberculosis * Further exclusion criteria apply

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Colitis ulcerative are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

Colitis ulcerative

Contacts and locations

Locations

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • Asklepios Kliniken Westklinikum Hamburg

    Hamburg, 22559, Germany

  • UZ Leuven

    Leuven, 3000, Belgium

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105, Germany

More trials for these conditions

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