Experimental drug aims to heal painful fistulas in Crohn's patients

NCT ID NCT03752970

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

First seen Jun 27, 2026 · Last updated Jun 27, 2026

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.

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.

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CROHN DISEASE

Contacts and locations

Locations

AKH - Medical University of Vienna

Vienna, 1090, Austria
Amsterdam UMC, Locatie AMC

Amsterdam, 1105 AZ, Netherlands
Centre Hospitalier Universitaire de Liège

Liège, 4000, Belgium
Herlev and Gentofte Hospital

Herlev, 2730, Denmark
Hospital Universitari de Girona Doctor Josep Trueta

Girona, 17007, Spain
Inje University Haeundae Paik Hospital

Busan, 48108, South Korea
Semmelweis University

Budapest, 1088, Hungary
UZ Leuven

Leuven, 3000, Belgium
Universitätsklinikum Erlangen

Erlangen, 91054, Germany
Universitätsklinikum Ulm

Ulm, 89081, Germany

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