drugset / Trial / NCT03886246

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

NCT03886246 ↗

Phase 2 Active not recruiting 131 enrolled Boehringer Ingelheim
Non-randomizedSingle-groupOpen-labelTreatment

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

EvaluationDrugModalityDoseRoute
Subject Spesolimab Monoclonal antibody — Intravenous
Subject Spesolimab Monoclonal antibody — —