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NotableSponsor changed: Boehringer Ingelheim to LEO Pharma
Collaborators expanded, about 2 words
v41
MinorStudy sites: 98 to 100v40
MinorStudy sites: 97 to 98
Start date: Feb 4, 2025 to Feb 5, 2025
v39
MinorStudy sites: 96 to 97v38
Show 3 earlier versionsHide 3 earlier versions
MinorSite details revised at 1 of 96 sitesv37
MinorStudy sites: 97 to 96v36
MinorStudy sites: 96 to 97v35
NotablePrimary completion pushed from Apr 12, 2027 to Nov 12, 2027
Study completion pushed from Feb 1, 2028 to Aug 19, 2028
Study sites revised (96)
v34
MinorStudy sites: 95 to 96v33
MinorTrial sites expanded: 90 → 95 locationsv32
MinorStudy sites revised (90)v31
MinorStudy sites revised (90)v30
MinorStudy sites revised (90)v29
MinorStudy sites: 89 to 90v28
MinorSecondary endpoints: 7 to 8
Study sites revised (89)
v27
MinorStudy sites revised (89)v26
MinorStudy sites: 90 to 89v25
MinorSite details revised at 4 of 90 sitesv24
MinorStudy sites: 91 to 90v23
MinorRe-verified, no change to tracked fieldsv22
MinorStudy sites revised (91)v21
MinorPrimary completion date: Dec 28, 2026 to Apr 12, 2027
Study completion date: Oct 5, 2027 to Feb 1, 2028
Site details revised at 9 of 91 sites
v20
MinorStudy sites revised (91)v19
MinorStudy sites: 86 to 91v18
MinorSite details revised at 10 of 86 sitesv17
MinorStudy sites: 87 to 86v16
MinorSite details revised at 5 of 87 sitesv15
MinorSite details revised at 9 of 87 sitesv14
MinorSite details revised at 3 of 87 sitesv13
MinorSecondary endpoints: 5 to 7
Study sites revised (87)
v12
MinorStudy sites: 109 to 87v11
MinorStudy sites: 43 to 109v10
MinorStudy sites: 45 to 43v9
MinorStudy sites: 49 to 45v8
MinorStudy sites: 51 to 49v7
MinorStudy sites: 61 to 51v6
NotableTrial status: Not Yet Recruiting to Recruiting
Study sites: 83 to 61
Start date changed from estimate of Jan 31, 2025 to Feb 4, 2025
v5
MinorStudy sites: 85 to 83
Start date: Jan 17, 2025 to Jan 31, 2025
v4
MinorStudy sites: 94 to 85v3
MinorStudy sites: 0 to 94
Start date: Jan 15, 2025 to Jan 17, 2025
v2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 infusions look like spesolimab infusions, 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.