New drug combo shows promise for stubborn ulcerative colitis

NCT ID NCT03123120

Completed Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

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.

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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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