Spesolimab for Pyoderma Gangrenosum
Trial Summary
What is the purpose of 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, which means by chance. 1 group gets spesolimab and the other group gets placebo. Placebo injections look like spesolimab injections, but do not contain any medicine. Every participant has a 2 in 3 chance of getting spesolimab. For the first 8 weeks, participants also take corticosteroid medicine by mouth. In Part 2, participants are put into groups again. Participants without open ulcers have an equal chance of getting spesolimab or placebo. Participants with open skin ulcers will get spesolimab. In both parts, participants receive spesolimab or placebo as an infusion into a vein every 4 weeks. Participants are in the study for about 1.5 years. During this time, they visit the study site 20 times. At study visits, doctors check the participant's skin for signs of PG. The doctors also regularly check participants' health and take note of any unwanted effects. The results of the groups are compared to see whether the treatment works.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, since participants will be taking corticosteroids and possibly other treatments, it's best to discuss your current medications with the trial doctors to ensure there are no interactions.
Is spesolimab safe for human use?
How is the drug Spesolimab different from other treatments for pyoderma gangrenosum?
Eligibility Criteria
Adults diagnosed with ulcerative pyoderma gangrenosum (PG) who need systemic therapy can join this trial. They must have a PG ulcer between 5 cm² and 80 cm² that's been active for less than 6 months or still progressing if older. Women must use effective birth control.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Participants receive spesolimab or placebo infusions every 4 weeks, with additional corticosteroid treatment for the first 8 weeks
Treatment Part 2
Participants continue to receive spesolimab or placebo infusions every 4 weeks, with allocation based on ulcer status
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Spesolimab
Spesolimab is already approved in United States, European Union for the following indications:
- Generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg
- Generalized pustular psoriasis (GPP) flares in adults
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Who Is Running the Clinical Trial?
Boehringer Ingelheim
Lead Sponsor