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

To be able to join this study, you need to be an adult, aged 18 or over. You must also have a clear diagnosis of ulcerative pyoderma gangrenosum (PG), which means you have ulcers on your skin related to this condition. These ulcers need to be a certain size, not too small and not too large (between 5 and 80 square centimetres).

Your PG ulcer should also have been diagnosed within the last six months, though some older, active ulcers might be considered. It's important that your ulcers are not infected when you start the study. Also, if you are a woman who could become pregnant, you'll need to agree to use effective birth control throughout the study.

You cannot join if you have other types of skin sores that are not PG, or if your PG ulcers are very large. Also, if your ulcers are chronic and don't respond to usual treatments that calm the immune system, you might not be suitable for this particular study.

If you decide to join this study, it will last for about 1.5 years. During this time, you'll visit the study clinic 20 times. At these visits, doctors will carefully check your skin – especially your PG ulcers – to see how they are healing. They will also keep a close eye on your general health and write down any side effects you might experience.

In the study, you'll receive either the medicine spesolimab or a placebo (a dummy medicine) through a drip into your arm. This drip will be given every four weeks. For the first eight weeks, all participants will also take steroid tablets by mouth. The study involves two parts, and the treatment you receive will be decided by chance, meaning it's random.

If you have open ulcers, during the second part of the study, you will receive spesolimab. If your ulcers have healed, you might get either spesolimab or the placebo. You can also withdraw from the study at any time.