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New drug combo shows promise for stubborn ulcerative colitis

NCT ID NCT03123120

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 study tested whether adding spesolimab to standard TNF inhibitor therapy could help heal the gut lining in people with mild-to-moderate ulcerative colitis. Twenty-two adults who still had active disease despite TNF inhibitor treatment received spesolimab or a placebo for 12 weeks. The main goal was to see if the drug could improve endoscopic signs 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 monoclonal antibody that blocks a protein called IL-36 receptor, given as an injection)
What this could lead to
If it works, this could offer a new add-on option to help heal the gut lining in people with ulcerative colitis who still have symptoms despite TNF inhibitor therapy.
What could go wrong
This was a very small, early proof-of-concept study with only 22 participants. Results may not apply to everyone, and the drug may not prove effective or safe in larger trials.

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

22 people

The number who actually took part.

Started

Jun 2017

Finished

Sep 2020

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 and randomisation * Diagnosis of ulcerative colitis \>= 5 months prior to screening * Receiving TNFi treatment with doses (i.e. dose and dosing interval) unchanged for \>= 4 months (Infliximab) or \>= 2 Monaten (Adalimumab or Golimumab) prior to randomisation * Mild or moderate disease activity, defined as total Mayo Score (MCS) (\<= 10) * Further inclusion criteria apply Exclusion Criteria: * Prior use of more than two different TNF inhibitors or vedolizumab * Extensive colonic resection * Evidence of infection with C. difficile or other intestinal pathogen \<28 days prior to screening * Active or latent tuberculosis * Further exclusion criteria apply

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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.

Colitis ulcerative

Contacts and locations

Locations

  • Aalborg Sygehus Syd

    Aalborg, 9100, Denmark

  • Akershus Universitetssykehus HF

    Lørenskog, N-1478, Norway

  • Amsterdam UMC, Locatie AMC

    Amsterdam, 1105 AZ, Netherlands

  • Guy's Hospital

    London, SE1 9RT, United Kingdom

  • Hospital Politècnic La Fe

    Valencia, 46026, Spain

  • Hospital Puerta de Hierro

    Majadahonda, 28222, Spain

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008, Spain

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Odense University Hospital

    Odense, 5000, Denmark

  • Sanos Clinic

    Herlev, 2730, Denmark

  • St James's University Hospital

    Leeds, LS9 7TF, United Kingdom

  • Universitätsklinikum Erlangen

    Erlangen, 91054, Germany

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106, Germany

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105, Germany

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

  • Whiston Hospital

    Prescot, L35 5DR, United Kingdom

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