Experimental drug aims to heal painful fistulas in Crohn's patients
NCT ID NCT03752970
First seen Oct 31, 2025
Summary
This study tested a drug called spesolimab in 27 adults with Crohn's disease who also have fistulas near the anus. The drug is given by IV every 4 weeks for 24 weeks. The study had two parts: first, researchers took tissue samples to learn what causes the fistulas; second, they compared spesolimab to a placebo to see if the drug helps close the fistulas. The main goal was to see how the drug changes gene activity in the fistula tissue.
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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AKH - Medical University of Vienna
Vienna, 1090, Austria
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Amsterdam UMC, Locatie AMC
Amsterdam, 1105 AZ, Netherlands
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Centre Hospitalier Universitaire de Liège
Liège, 4000, Belgium
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Herlev and Gentofte Hospital
Herlev, 2730, Denmark
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Hospital Universitari de Girona Doctor Josep Trueta
Girona, 17007, Spain
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Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
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Semmelweis University
Budapest, 1088, Hungary
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UZ Leuven
Leuven, 3000, Belgium
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Universitätsklinikum Erlangen
Erlangen, 91054, Germany
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Universitätsklinikum Ulm
Ulm, 89081, Germany
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 by IV infusion)
What this could lead to
If it works, this could point toward a new treatment option for people with Crohn's disease who have hard-to-treat fistulas near the anus.
What could go wrong
This is a small, early-phase study (27 people) that mainly looks at how the drug works in the body, not whether it definitely helps. The results may not apply to everyone with Crohn's disease.
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.