Spesolimab for Pyoderma Gangrenosum

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

Recruiting Phase 3 Interventional Study
Pyoderma Gangrenosum
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
90 (estimated)
Sponsor
LEO Pharma · Industry
Who this trial is looking for

This trial is looking for adults with a skin condition called pyoderma gangrenosum who have at least one ulcer. Participants will receive either the study medicine, spesolimab, or a placebo every four weeks for about 1.5 years, along with regular check-ups.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I have been diagnosed with ulcerative pyoderma gangrenosum.
  • I have at least one ulcer that is at least 5 cm² in size.
  • I currently have an ulcer that was diagnosed no more than 6 months ago.
  • I agree to use effective birth control if I can become pregnant.

You may not be able to join if

  • I do not have pyoderma gangrenosum.
  • My target ulcer is larger than 80 cm².
  • I have chronic non-inflamed ulcers that don't respond to treatment.
  • I have an active infection in my ulcer right now.
  • I have a bacterial infection requiring antibiotics within 2 weeks before the study.
  • I have active tuberculosis.
  • I have uncontrolled liver disease.
  • I have HIV or viral hepatitis.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
The purpose of this study is to find out whether a medicine called spesolimab helps people with pyoderma gangrenosum (PG). The main aim is to see whether spesolimab leads to closure of PG ulcers. This study is open to adults with ulcerative PG with at least 1 ulcer that measures between 5 cm\^2 to 80 cm\^2 in size. This study has 2 parts. In Part 1, participants are put into groups randomly, whic…
Trial Locations
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Eligibility Criteria
Inclusion criteria: 1. Adult trial participants, aged ≥18 years (if local legislation for age of consent differs, then local legislation will be followed) at screening. 2. Signed and dated written informed consent in accordance with International Council on Harmonisation-Good Clinical Practice (ICH…
Contacts

Clinical Disclosure

+45 4494 5888

clinicaldisclosure@leo-pharma.com

CONTACT