New drug combo shows promise for stubborn ulcerative colitis

NCT ID NCT03123120

First seen Jun 24, 2026 · Last updated Jun 24, 2026

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.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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

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.

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.