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

Effisayil™ ON: An Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Spesolimab Treatment in Patients With Generalized Pustular Psoriasis (GPP)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Generalized Pustular Psoriasis

Interventions

Type	Name	Description
DRUG	Spesolimab	Solution for infusion
DRUG	Spesolimab	Solution for injection

Timeline

• Start date: 2019-05-29
• Primary completion: 2027-09-30
• Completion: 2028-04-27
• First posted: 2019-03-22
• Last updated: 2026-03-31

Locations

57 sites across 21 countries: United States, Argentina, Belgium, Chile, China, France, Germany, Italy, Japan, Malaysia, Mexico, Philippines, Russia, Singapore, South Korea, Spain, Taiwan, Thailand, Tunisia, Turkey (Türkiye), Vietnam

Regulatory

• FDA-regulated drug study