Spesolimab for Pyoderma Gangrenosum

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Boehringer Ingelheim

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 jurisdictions

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.

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.

Treatment Details

The study tests if spesolimab helps heal ulcers caused by PG compared to placebo. Participants are randomly assigned to receive either spesolimab or placebo, alongside corticosteroids initially, over approximately 1.5 years with regular health checks.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SpesolimabExperimental Treatment3 Interventions

Group II: PlaceboPlacebo Group3 Interventions

Spesolimab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Spevigo for: