Effisayil™ ON: A Study to Test Long-term Treatment With Spesolimab in People With Generalized Pustular Psoriasis Who Took Part in a Previous Study
Condition(s) studied
Investigational drug(s) / intervention(s)
Spesolimab: Solution for infusion
Spesolimab: Solution for injection
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.
Eligibility
Primary outcome measure(s)
- Occurrence of treatment emergent adverse events (TEAEs) up to week 252 of maintenance treatment — Up to 252 Weeks
Trial sites (58)
| Facility | City | Region | Status |
|---|---|---|---|
| Oakland Hills Dermatology | Auburn Hills | Michigan | |
| Icahn School of Medicine at Mount Sinai | New York | New York | |
| Hospital Italiano de Buenos Aires | CABA | Argentina | |
| Cliniques Universitaires Saint-Luc | Brussels | Belgium | |
| Clínica Dermacross S.A. | Vitacura | Chile | |
| Sun yet-sen Memorial Hospital, Sun yet-sen Univesity | Guangzhou | China | |
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | China | |
| Shanghai Skin Disease Hospital | Shanghai | China | |
| Huashan Hospital, Fudan University | Shanghai | China | |
| Second Affiliated Hospital of Xi'an JiaoTong University | Xi'an | China | |
| HOP Saint-André | Bordeaux | France | |
| Hôpital de l'Archet | Nice | France | |
| HOP Saint-Louis | Paris | France | |
| HOP Robert Debré | Reims | France | |
| Fachklinik Bad Bentheim | Bad Bentheim | Germany | |
| Charité - Universitätsmedizin Berlin | Berlin | Germany | |
| Universitätsklinikum Bonn AöR | Bonn | Germany | |
| Universitätsklinikum Erlangen | Erlangen | Germany | |
| Universitätsklinikum Frankfurt | Frankfurt am Main | Germany | |
| Klinikum der Universität München - Campus Innenstadt | München | Germany | |
| Westfälische Wilhelms-Universität Münster | Münster | Germany | |
| Klinikum Oldenburg AöR | Oldenburg | Germany | |
| Istituto Clinico Humanitas | Rozzano (MI) | Italy | |
| Nagoya City University Hospital | Aichi, Nagoya | Japan | |
| Tokyo Medical University Ibaraki Medical Center | Ibaraki, Inashiki-gun | Japan | |
| Saitama Medical University Hospital | Saitama, Iruma-gun | Japan | |
| Tokyo Medical University Hachioji Medical Center | Tokyo, Hachioji | Japan | |
| Hospital Pulau Pinang-Pulau Pinang-21953 | George Town | Malaysia | |
| Hospital Raja Permaisuri Bainun | Ipoh | Malaysia | |
| Hospital Sultanah Aminah | Johor Bahru | Malaysia | |
| Hospital Sultan Ismail | Johor Bahru | Malaysia | |
| Queen Elizabeth Hospital | Kota Kinabalu | Malaysia | |
| Hospital Kuala Lumpur | Kuala Lumpur | Malaysia | |
| Hospital Selayang | Kuala Selangor | Malaysia | |
| Sarawak General Hospital | Kuching, Sarawak | Malaysia | |
| Hospital Pakar Sultanah Fatimah | Muar town | Malaysia | |
| Hospital Universitario Dr Jose Eleuterio Gonzalez | Monterrey | Mexico | |
| Southern Philippines Medical Center -Davao-62091 | Davao City | Philippines | |
| Iloilo Doctors Hospital | Iloilo City, Iloilo | Philippines | |
| Zenith Skin Science Center Inc. | Makati City | Philippines |
+ 18 more sites — see the full list on the official registry below.
More LEO Pharma trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03886246 on ClinicalTrials.gov ↗ ← All trials in Italy