Effisayil™ ON: A Study to Test Long-term Treatment With Spesolimab in People With Generalized Pustular Psoriasis Who Took Part in a Previous Study
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.
Timeline
- Start
- 2019-05-29
- Primary completion
- 2027-09-30
- Completion
- 2028-04-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Spesolimab | Monoclonal antibody | — | Intravenous |
| Subject | Spesolimab | Monoclonal antibody | — | — |