Evaluating Spesolimab Infusions for Healing Skin Ulcers in Adults with Ulcerative Pyoderma Gangrenosum

What this Trial Is About

Researchers are evaluating whether the medicine spesolimab can help adults with ulcerative pyoderma gangrenosum PG, a skin condition characterized by painful ulcers. The main goal is to see if spesolimab can lead to healing and closure of these ulcers. This Phase 3 study includes adults with at least one ulcer measuring between 5 cm and 80 cm and is sponsored by LEO Pharma. The study has two parts. In Part 1, participants are randomly assigned to receive either spesolimab or a placebo infusion every 4 weeks, with a 2 in 3 chance of receiving spesolimab. Alongside this, all participants take corticosteroid medicine by mouth for the first 8 weeks. In Part 2, participants are grouped again, where those without open ulcers have an equal chance of receiving spesolimab or placebo, while those with open ulcers receive spesolimab. Treatment infusions continue every 4 weeks throughout the study. Participants will be involved in the study for about 1.5 years, attending around 20 visits to the study site. During visits, doctors will examine their skin for signs of PG, monitor their overall health, and check for any side effects. The study team will compare results between groups, focusing especially on the complete closure of ulcers up to 28 weeks, among other measures of skin healing and pain reduction.

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