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NotableSponsor changed: Boehringer Ingelheim to LEO Pharmav99
MinorStudy sites: 57 to 58v98
MinorRe-verified, no change to tracked fieldsv97
MinorStudy sites revised (57)v96
Show 45 earlier versionsHide 45 earlier versions
MinorStudy sites revised (57)v95
Minor2 versionsRe-verified since Jul 7, 2025, no change to tracked fieldsv93-v94
MinorEnrollment target: 132 to 131v92
MinorRe-verified, no change to tracked fieldsv91
MinorStudy sites revised (57)v90
MinorRe-verified, no change to tracked fieldsv89
MinorStudy sites: 56 to 57
Study completion date: Jan 20, 2028 to Apr 27, 2028
v88
MinorEnrollment target: 131 to 132
Start date: May 27, 2019 to May 29, 2019
v87
MinorStudy sites revised (56)v86
Minor4 versionsRe-verified since May 27, 2023, no change to tracked fieldsv82-v85
MinorStudy sites revised (56)v81
MinorEnrollment target: 130 to 131v80
Minor4 versionsRe-verified since Jan 23, 2023, no change to tracked fieldsv76-v79
MinorTrial status: Recruiting to Active, Not Recruiting
Enrollment target: estimated 155 to confirmed 130
Site details revised at 56 of 56 sites
v75
MinorSite details revised at 11 of 56 sitesv74
MinorSite details revised at 4 of 56 sitesv73
MinorSite details revised at 6 of 56 sitesv72
MinorStudy sites: 55 to 56v71
MinorStudy sites: 54 to 55v70
MinorSite details revised at 4 of 54 sitesv69
MinorStudy sites: 51 to 54v68
MinorSite details revised at 6 of 51 sitesv67
MinorStudy sites: 50 to 51v66
MinorStudy sites: 49 to 50v65
MinorStudy sites: 47 to 49v64
MinorStudy sites: 44 to 47v63
MinorStudy sites: 38 to 44v62
MinorStudy sites: 37 to 38v61
MinorStudy sites: 33 to 37v60
MinorSite details revised at 1 of 33 sitesv59
MinorSite details revised at 1 of 33 sitesv58
MinorStudy sites: 34 to 33v57
MinorStudy sites: 32 to 34v56
MinorStudy sites: 31 to 32v55
MinorEnrollment target: 171 to 155
Study sites: 30 to 31
v54
MinorStudy sites: 29 to 30v53
MinorStudy sites: 27 to 29v52
MinorStudy sites: 28 to 27v51
Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study is open to people with generalized pustular psoriasis (GPP). People can only take part if they have completed treatment in a previous study with spesolimab (1368-0013 or 1368-0027).
The goal of this study is to find out how well people with GPP tolerate long-term treatment with spesolimab. The study also tests whether spesolimab helps improve GPP symptoms and how quickly the symptoms improve after a flare-up.
Every participant gets spesolimab for almost 5 years (252 weeks). Depending on their symptoms and whether they had a GPP flare during the previous trial, they get spesolimab every few weeks. When participants have a GPP flare during this trial, they get spesolimab as an infusion into a vein.
Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. To assess the study endpoints, doctors regularly check participants' skin.