Clinical Trial

Effisayil™ ON: A Study to Test Long-term Treatment With Spesolimab in People With Generalized Pustular Psoriasis Who Took Part in a Previous Study

Active, Not Recruiting Phase 2
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Summary
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.
Protocol Amendment History 1 change
notable Sponsor changed: Boehringer Ingelheim -> LEO Pharma 2026-08-04
Trial Details
NCT Number NCT03886246
Lead Sponsor LEO Pharma
Collaborators: Boehringer Ingelheim
Conditions Generalized Pustular Psoriasis
Enrollment 131 participants
Start Date 2019-05-29
Primary Completion 2027-09-30 (estimated)
Study Completion 2028-04-27 (estimated)
Updated on ClinicalTrials.gov 2026-08-03