drugset / Trial / NCT05239039

An Expanded Access Program in China to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have no Other Treatment Options

NCT05239039 ↗

Phase 3 Completed 39 enrolled Boehringer Ingelheim
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This Expanded Access Program in China is open to people with a serious skin disease called Generalized Pustular Psoriasis (GPP). This program provides a medicine called spesolimab to people with a GPP flare-up who have no alternative treatment options. This means that no therapy exists and participation in a clinical study is not possible. Participants get a single infusion of spesolimab into a vein. They can get another spesolimab infusion one week after the first infusion if the doctors think it is helpful. Participants are in the program for about 4 months and visit the study site about 5 times. Participants who benefit from the treatment during that time may repeat the treatment in case they experience a new GPP flare-up. The doctors regularly check participants' health and take note of any unwanted effects.

Timeline

Start
2022-03-15
Primary completion
2023-07-17
Completion
2023-07-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Spesolimab Monoclonal antibody 900 mg Intravenous