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A Study of Spesolimab for Pyoderma Gangrenosum

This study is looking into whether a medicine called spesolimab can help people with pyoderma gangrenosum (PG), a skin condition that causes painful ulcers. The main goal is to see if spesolimab can help these ulcers completely close. You might be able to join if you are an adult with PG and have at least one ulcer between 5 and 80 square centimeters in size. The study will involve 90 participants and is divided into two parts. In the first part, you will be randomly assigned to receive either spesolimab or a placebo (an inactive substance that looks like the medicine), along with corticosteroid medicine by mouth for the first 8 weeks. You have a 2 in 3 chance of receiving spesolimab.

Study design
This is an interventional study with 90 planned participants. In Part 1, participants are randomly assigned to receive either spesolimab or a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured up to Week 28, looking for ulcer closure confirmed at least 2 weeks later.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06624670

A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum

Recruiting
PHASE3Ages 18+InterventionalTreatment
LEO Pharma
~90 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:SpesolimabPlacebo matching to spesolimabPrednisonePrednisolone

At a glance

Recruiting sites
87 of 100 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Achievement of complete closure (PGAR-100 (100% pyoderma gangrenosum area reduction)) of the target PG ulcer at any time up to Week 26 and confirmed at the next consecutive visit (at least 2 weeks later)
Measured over Up to Week 28.

Conditions

Pyoderma Gangrenosum

Explore related trials

Pyoderma gangrenosum

Where it's being run

100 sites across 43 states
China13
Germany8
Japan8
Italy6
France4
Portugal4
Spain4
Argentina3

Study leadership

  • Medical Expert · STUDY_DIRECTOR · LEO Pharma

Who to contact

Clinical Disclosure
[email protected]
+45 4494 5888
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Participants with active TB are excluded
Participants with latent TB may be included if treatment of latent TB, as per local guidelines, is initiated prior to randomization and completed during the course of the trial." 7. Chronic or acute infections including Human immunodeficiency virus (HIV) infections and viral hepatitis (including occult hepatitis); the corresponding laboratory tests will be performed during screening. A trial participant can be re-screened if the trial participant was treated and is cured from the acute infection. 8. Severe, progressive, or uncontrolled hepatic disease, defined as \>3x Upper Limit of Normal (ULN) elevation in Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) or alkaline phosphatase, or \>2x ULN elevation in total bilirubin.

What this trial measures

  • Achievement of complete closure (PGAR-100 (100% pyoderma gangrenosum area reduction)) of the target PG ulcer at any time up to Week 26 and confirmed at the next consecutive visit (at least 2 weeks later)Up to Week 28.

    PGAR-100 is defined as complete closure and re-epithelisation of a PG ulcer without drainage and requirements for dressing.