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.
Disclaimer
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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.
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
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Locations
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Aalborg Sygehus Syd
Aalborg, 9100, Denmark
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Akershus Universitetssykehus HF
Lørenskog, N-1478, Norway
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Amsterdam UMC, Locatie AMC
Amsterdam, 1105 AZ, Netherlands
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Guy's Hospital
London, SE1 9RT, United Kingdom
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Hospital Politècnic La Fe
Valencia, 46026, Spain
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Hospital Puerta de Hierro
Majadahonda, 28222, Spain
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Hospital Universitario Marqués de Valdecilla
Santander, 39008, Spain
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Medizinische Hochschule Hannover
Hanover, 30625, Germany
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Odense University Hospital
Odense, 5000, Denmark
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Sanos Clinic
Herlev, 2730, Denmark
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St James's University Hospital
Leeds, LS9 7TF, United Kingdom
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Universitätsklinikum Erlangen
Erlangen, 91054, Germany
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Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
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Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105, Germany
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Universitätsklinikum Ulm
Ulm, 89081, Germany
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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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.